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COVID-19 Return to Life 2021 (Part 2)Please take the COVID-19 Ventilation Survey - Since mid-2020 when it was disclosed that COVID-19 is airborne, the guidance has been to increase ventilation inside public spaces. However, do people know what increasing ventilation means and have they taken steps to properly increase ventilation. This systems engineering analysis is constantly being updated. This web page is the most current. March 03, 2021 Initial Release. Last Modified: 01/04/2021 COVID-19 Return To Life 2021 (Part 2) (PDF) usually out of date The initial research was started in March 2020 and is documented in the following links:
A book was produced that includes the 2020 COVID-19 research published on this website and additional systems engineering content: COVID-19 A Systems Perspective. The original research eventually resulted in system architecture solutions to mitigate and eliminate the virus. It was found that the problem is massive within small enclosed spaces, problematic in large spaces, and extremely rare in outdoor spaces. It was also found that the technology exists, is relatively low cost, and is part of the system solution in elite settings. The problem is a social problem where the technology and system solutions must find their way into all facilities especially schools, airports, airplanes, bars, restaurants, etc. where large numbers of people congregate and where the facilities are not properly maintained and use the available technologies to mitigate and eliminate contagions from the air. Like in the original research, it is unclear where this research may lead. The systems perspective will continue to be the approach used to develop this research. One of the key challenges in systems engineering is to determine the key needs, key analysis, key requirements, and key system architecture approaches that will solve the problem. This is very difficult because there is the important consideration to filter out the irrelevant while not losing what may be the answer. So as this research unfolds topics will surface and they either will be abandoned, delayed, or taken to a logical conclusion. The following is offered as a definition of Systems Engineering from Systems Engineering Design: Discipline that concentrates on the design and application of the whole (system) as distinct from the parts. It involves looking at a problem in its entirety, taking into account all the facets and all the variables and relating the social to the technical aspect. -- Simon Ramo. For the specialists that are working their respective areas, in a systems effort they are represented and sit at the systems engineering table. As they present their analysis findings their work informs other specialists in completely different analysis areas. It is this cross fertilization that allows all specialists to broaden their perspectives and enables them to detect new patterns in their own body of work, especially if they are stuck. Systems engineering is the mechanism that allows specialists to quickly and effectively communicate their analysis to completely different areas and significantly shift the overall results in a positive direction. This systems engineering analysis is offered in that spirit of an effective systems engineering activity. One of the important elements that the systems perspective provides is that it includes the human condition in the system. The system solution must include the reality that people are part of the system and that they do not behave rationally. So the system must account for irrational human behavior otherwise it will fail or have very poor performance characteristics. Without the systems perspective this is always lost. The purpose of all the analysis is to enable the development of potential architecture and design solutions. Eventually the architecture(s) and design(s) must be selected. It is important to review and try to understand the research findings from 2020 as part of reviewing this research in 2021. This is a long hard read. Use the table of contents to navigate. It is constantly being updated and follows the natural flow of all systems engineering efforts; some analysis is a dead end and is abandoned, some analysis converges, some analysis diverges, and some analysis stays at a steady state level until new information surfaces, typically from a specialist on the team. More information on the systems perspective for this problem is available as part of this systems engineering analysis at: Systems Perspective.
Table of Contents
Quick SummaryThere are many COVID-19 systems research areas being addressed by this research in 2021 but probably the most important areas in 2021 are associated with our buildings especially schools. Eventually the concept of building certification surfaced to ensure that people are more safe from COVID-19 and other contagions especially in small indoor spaces. Unfortunately once again the government is hands off in this area so industry, school districts, and local governments are left on their own to figure out what really needs to be done. As always the details are massive and confusing without an entity to vet, filter, and organize the information. The City of Philadelphia has attempted to address this need with a site survey of all their schools and a restaurant program that identifies what restaurants must do to provide for a more safe space. They made the information public and it is available via the Internet. This is not the first time Philadelphia has taken a lead role in addressing public health. This research is also attempting to address this void by developing a self certification model and software tool to help people understand their facilities from a contagion perspective. The other research topics are shown in the Table of Contents. This is a quick summary of some of the other research areas: Where Did The Virus Come From?
There is massive social bifurcation and what are the implications?
There is a post vaccine world.
COVID-19 is a symptom of a much larger problem, the civilization is in big trouble.
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Research
COVID-19 FAQ Building Contagion Mitigation Certification Building Ventilation (video2)
My Systems Work
COVID-19
Systems Software
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This is a very difficult topic to address because it must consider both the mainstream and non-mainstream findings. This should have been part of the research in 2020 but there was a conscious decision to exclude this analysis because it would distract from the key system driver of understanding how the virus spreads and how it can be mitigated or eliminated. This analysis is important because it may help stimulate the Social Will to accept that all our facilities must be upgraded to mitigate and even eliminate the virus using systems that exist within elite facilities.
It does not matter where the COVID-19 virus came from, what matters is how we deal with it now that it is part of our civilization.
Regardless these are the possible virus source scenarios:
After Chinese scientists posted a draft genome of the novel coronavirus SARS-CoV-2, a team at Flinders University in Australia began running computer modeling studies of the viral sequence as part of a first step for designing a vaccine. This generated an unsuspected result - the spike proteins studding the SARS-CoV-2 virus bound more tightly to human cell receptors, a protein called ACE2, than target receptors on any other species evaluated. The COVID-19 virus was well adapted to infect only humans. This is unusual for a newly emerging pathogen. "Holy shit, that's really weird," Professor Petrovsky the team lead recalled. [1]
As Professor Petrovsky considered whether COVID-19 might have emerged in lab cultures with human cells or cells engineered to express the human ACE2 protein, a letter penned by 27 scientists appeared suddenly on February 19, 2020 in the medical journal, The Lancet. The authors insisted that SARS-CoV-2 had a natural origin, and they condemned any alternate hypotheses as conspiracy theories that create only fear, rumors, and prejudice. Petrovksy says he found the letter infuriating. Conspiracy theorists is the last thing we were, he says, and it looked to be pointing at people like us. [1]
This is a topic that requires a systems perspective. All perspectives must be considered and there is no room for stakeholders to game the situation to protect hidden self interests. The difficulty as always is to find a team that is fully driven by the systems perspective and cannot be compromised in any way including protecting careers. [2] [3]
As of March 2021 there are two mainstream scenarios for the source of COVID-19: (1) a lab leak or (2) a spill over from nature. There are additional scenarios that need to be considered if the systems perspective is to be applied: (3) genetically engineered as part of a research effort and (4) genetically engineered as part of a bioweapon. The following analysis will address these scenarios and offer some observations.
Also see section International Perspective.
References:
[1] Did the coronavirus leak from a lab? These scientists say we shouldn’t rule it out. For many scientists, challenging the idea that SARS-CoV-2 has natural origins is seen as career suicide. But a vocal few say it shouldn't be disregarded or lumped in with conspiracy theories. MIT Technology Review, March 18, 2021. webpage https://www.technologyreview.com/2021/03/18/1021030/coronavirus-leak-wuhan-lab-scientists-conspiracy, March 2021. Did the coronavirus leak from a lab? These scientists say we shouldn’t rule it out.
[2] COVID-19 A Systems Perspective, Walter Sobkiw, 2021, ISBN 9780983253044, hardback.
[3] COVID-19 Return To Life, webpage http://www.cassbeth.com/covid-19/return-to-life/index.html, March 2021. COVID-19 Return To Life.
The attempt to find the source of the virus was politicized and all allegations are irrelevant. What matters is how to mitigate and eliminate the virus since it was not contained. We have a vaccine but we know it will take years to vaccinate the world and relying on just the vaccine will take decades to eradicate COVID-19. We have technologies that are almost 100 years old that can be applied to significantly reduce long term illness and death from COVID-19 but just like with the vaccine there is no Social Will to ensure that these technologies are applied everywhere and not just limited to elite facilities and populations. [1] [2]
In the last 20 years there have been multiple pandemic and epidemic outbreaks, including SARS, chikungunya, H1N1, Middle East Respiratory Syndrome, several Ebola outbreaks, three outbreaks of norovirus, Zika, and now SARS-CoV-2. Lab release dangers are growing because of the benefits possible from genetic research and development. The risk increases with the number of labs handling bioweapons and potential pandemic pathogens. As of 2010 there were more than 1,500 labs on the planet. Many like the Wuhan lab are located in urban areas close to international airports. The largest expansion has been in China during the last four years. This is similar to an arms-race-style reaction for biodefense expansion and includes the US, Europe, and Japan. China has two new BSL-4 facilities, in Wuhan and in Harbin, and has announced plans to establish a network of hundreds of new BSL-3 and BSL-4 labs. [3]
When the atom was split in the middle of the last century many things happened including making sure the technology was not out of control. This was done by a people and a culture deeply entrenched in the systems perspective and higher ideals after dealing with the ravages of multiple World Wars and systemic economic collapse that was the Depression. This is not happening today with the new technologies in the 21st century as self interest is viewed as the best approach for all settings.
Some think that gene manipulation technology is more dangerous than the nuclear technologies in terms of potential massive irrecoverable damage. Nuclear technology is very capital intensive. All anyone can do is just steal its byproducts. So security became part of the early nuclear systems solutions. Genetic engineering technology is not capital intensive. Anyone can do it. Currently China is trying to get the genetic sequences for everyone everywhere so that they can lead the world in offering genetically engineered designer drugs tuned to each person [4]. They have formally announced plans to open hundreds of labs like in Wuhan to support the design and manufacturing of these types of drugs. It is a new industry in the 21st century.
This is happening everywhere in the world but China has set this as the number one priority for the foreseeable future. This is related to the potential source of the COVID-19. Is it natural or is it the result of a bio accident from one of these labs from someplace in the world? This excludes the possibility that it was deliberately released by some fanatics.
We may never know where COVID-19 came from but it should be sounding alarm bells everywhere about this new technology. If it is natural, we will be getting more COVID-19 like events in the future because it is in the biosphere. If it is the result of human action, that is probably a better scenario because we might be able to put it under some type of control to prevent accidents. If it the result of fanatics, it is a serious problem.
Also see section International Perspective.
Back To Where Did COVID-19 Come From
References:
[1] COVID-19 A Systems Perspective, Walter Sobkiw, 2021, ISBN 9780983253044, hardback.
[2] COVID-19 Return To Life, webpage http://www.cassbeth.com/covid-19/return-to-life/index.html, March 2021. COVID-19 Return To Life
[3] Did the coronavirus leak from a lab? These scientists say we shouldn’t rule it out. For many scientists, challenging the idea that SARS-CoV-2 has natural origins is seen as career suicide. But a vocal few say it shouldn't be disregarded or lumped in with conspiracy theories. MIT Technology Review, March 18, 2021. webpage https://www.technologyreview.com/2021/03/18/1021030/coronavirus-leak-wuhan-lab-scientists-conspiracy, March 2021. Did the coronavirus leak from a lab? These scientists say we shouldn’t rule it out.
[4] China's push to control Americans' health care future, CBS News 60 Minutes, January 31, 2021. webpage https://www.cbsnews.com/news/biodata-dna-china-collection-60-minutes-2021-01-31, March 2021. China's push to control Americans' health care future.
We know that the virus was first identified in China and it quickly found its way into Italy. On January 31, 2020 after the detection in Rome of two COVID-19 positive Chinese tourists travelling from Wuhan, the Italian Cabinet declared a 6-month national emergency. On January 13, 2020 the first recorded case of COVID-19 outside of China was confirmed in Thailand. Travelers from China would tend to fly to the West Coast of the USA and most likely arrive in San Francisco or Los Angeles. Why Italy is a key question. That is where the outbreaks should have occurred before Italy. We know that the R0 associated with air travel is very high, up to 22, and that one passenger will infect large numbers of other passengers [1] [2].
In September 2020 the following was offered about 1918 pandemic virus and COVID-19 [3]. These are key extracts from this content:
In 1918, a novel strand of influenza killed more people than the 14th century's Black Plague. But the strand of the flu didn’t just disappear. The influenza virus continuously mutated, passing through humans, pigs and other mammals. The pandemic-level virus morphed into just another seasonal flu. Descendants of the 1918 H1N1 virus make up the influenza viruses we’re fighting today.The 1918 flu is still with us, in that sense, said Ann Reid, the executive director of the National Center for Science Education who successfully sequenced the genetic makeup of the 1918 influenza virus in the 1990s. It never went away.
By 1920, the influenza virus was still a threat, but fewer people were dying from the disease. Some scientists at the time started to move on to other research. Barry wrote that William Henry Welch, a famous pathologist from Johns Hopkins who was studying the virus, found it humiliating that the outbreak was passing away without experts truly understanding the underlying cause of the disease.
What Welch didn’t predict was that the virus never truly went away. In 2009, David Morens and Jeffery Taubenberger --- two influenza experts at the National Institutes of Health --- co-authored an article with Anthony S. Fauci explaining how the descendants of the 1918 influenza virus have contributed to a pandemic era that has lasted the past hundred years. At the time the article was published, the H1N1 influenza virus in public circulation was a fourth-generation descendant of the novel virus from 1918.
All those pandemics that have happened since --- 1957, 1968, 2009 --- all those pandemics are derivatives of the 1918 flu, Taubenberger told The Post. The flu viruses that people get this year, or last year, are all still directly related to the 1918 ancestor.
Because of this, the 1918 influenza outbreak doesn’t come with a neat bookend. Society moved on, but the virus continued in some form or fashion.
We are living in a pandemic era that began around 1918, Taubenberger wrote with Fauci and Morens back in 2009 for the New England Journal of Medicine. Ever since 1918, this tenacious virus has drawn on a bag of evolutionary tricks to survive.
We continue to turn back to the 1918 outbreak as a point of comparison, said Jeremy Greene, a historian of medicine at Johns Hopkins. Some of the public health measures a hundred years ago are still put in place today. To flatten the curve, cities and towns have more or less shut down. That said, Greene cautions against drawing the parallels too closely.
There are similarities to draw between today's pandemic and the influenza outbreak a hundred years ago. Both come from winged animals --- one from birds and the other from bats. Both are respiratory viruses. Both led people to wear masks in public. Both forced cities and schools to shut down for periods of time. And, finally, in both cases, the country's leaders exacerbated problems by ignoring the early warning signs.
Despite all that, influenza viruses and coronaviruses are not the same. There's very little someone can draw from influenza to then provide treatment for the infectious disease named COVID-19, said Paul Offit, the director of the Vaccine Education Center at Children's Hospital of Philadelphia.
They’re really different viruses, Offit added.
Influenza is consistent and relatively quick when compared with the novel coronavirus. If you get exposed to the flu, you’ll start showing symptoms in one to four days after the infection. According to the Centers for Disease Control and Prevention, it tends to take five days for those infected with SARS-CoV-2 to start showing symptoms of covid-19, but the timing can fluctuate from two days to two weeks.
The novel coronavirus is not moving on the same time frame as the 1918 influenza, Greene told The Post. Everything is longer with the novel coronavirus --- the symptoms, the sickness and even the long-term complications. Doctors are concerned covid-19 can lead to lasting cardiovascular complications.
Then there are asymptomatic carriers of the disease. That one detail makes it harder to mitigate the spread of the virus by simply taking temperatures. Symptoms are not a be-all-end-all solution to tracking the disease. With that in mind, the novel coronavirus is acting more like polio, where those with mild cases don’t know they’re sick, Greene said.
It immediately raises a different set of problems for managing a disease, Greene said. One needs to relearn the way to think about who is dangerous, and that becomes, basically, everybody.
Recognizing both the similarities and differences to past pandemics can provide a meaningful mirror for the present, Greene added. The million-dollar question is: What can the 1918 influenza outbreak tell us about how our current pandemic may end?
The sad answer is not very much, Markel said. The operative word in this particular pandemic is ‘novel’ coronavirus. We’re learning as we go along, but we don’t really know that much.
The case for a Natural Source of the virus is as follows:
To accept the natural source scenario requires a confirmed contact between a naturally infected host species, such as bats that are known to be carriers of coronaviruses, and a human or humans. The details would require a confirmed time and place of the infection encounter, ahead of any other known human cases, and then show how the infection passed to other humans. Basically perfect contact tracing that would lead to patient zero.
Back To Where Did COVID-19 Come From
References:
[1] COVID-19 A Systems Perspective, Walter Sobkiw, 2021, ISBN 9780983253044, hardback.
[2] COVID-19 Return To Life, webpage http://www.cassbeth.com/covid-19/return-to-life/index.html, March 2021. COVID-19 Return To Life.
[3] The 1918 flu is still with us’: The deadliest pandemic ever is still causing problems today, The Washington Post, September 3, 2020. webpage https://www.washingtonpost.com/history/2020/09/01/1918-flu-pandemic-end, October 2020. The 1918 flu is still with us’: The deadliest pandemic ever is still causing problems today.
[4] Did the coronavirus leak from a lab? These scientists say we shouldn’t rule it out. For many scientists, challenging the idea that SARS-CoV-2 has natural origins is seen as career suicide. But a vocal few say it shouldn't be disregarded or lumped in with conspiracy theories. MIT Technology Review, March 18, 2021. webpage https://www.technologyreview.com/2021/03/18/1021030/coronavirus-leak-wuhan-lab-scientists-conspiracy, March 2021. Did the coronavirus leak from a lab? These scientists say we shouldn’t rule it out.
The decision to reconstruct the deadliest pandemic flu virus of the 20th century was made in 2005. Senior US government officials decided the reconstruction location would be at the CDC headquarters in Atlanta. Work to reconstruct the complete 1918 virus began in the summer of 2005. Using reverse genetics, plasmids for eight gene segments of the 1918 virus were inserted into human kidney cells. The plasmids then instructed the cells to reconstruct the RNA of the complete 1918 virus. For multiple weeks in July 2005 cell cultures were checked to determine if the virus appeared. By July 2005 the 1918 virus was available and laboratory studies on the reconstructed 1918 virus began in August 2005 [1].
The findings from this analysis are provided below. Placing it at the end of the this analysis may cause some readers to miss these findings.
Key Findings From This Systems Analysis
The work performed at the CDC falls into the category of big complex systems, science, and engineering. The stakes are huge and the goal of minimizing unintended consequences is paramount. Understanding the nature of the 1918 virus is critical if it is something that exists in nature because, it is not a matter of - if - but - when -, the next variant might surface. The intent is not to justify the actions taken by the USA CDC. Rather it is to suggest that if the means and methods are available to understand an aspect of nature, especially if the the nature is extremely dangerous, then should we not use all the tools available in the civilization to find that understanding. These are big issues not for the faint of heart. It is unclear if the work done by the CDC let the genie out of the bottle and provided the unofficial go ahead for humanity to venture down this path.
| Key Events | Date | Comment |
| 1918 Pandemic | 1918 February | Pandemic not contained |
| 1918 Pandemic Virus victim excavated | 1997 | Gene studies started |
| 1918 Pandemic Virus is reconstructed | 2005 August | Gene studies completed |
| SARS-CoV-1 | 2002 November | Epidemic contained |
| MERS-CoV | 2012 November | Epidemic contained |
| SARS-CoV-2 or COVID-19 | 2019 December | Pandemic not contained |
On December 17, 2019 the CDC published on their website an article associated with finding and recreating the 1918 pandemic virus. This is such a monumental moment in genetic engineering that the document on the CDC website reflecting this work is provided here in full text but without the associated pictures. This part of the systems analysis on finding the virus source is based on the CDC quest to reconstruct the 1918 Pandemic virus described below.
The Deadliest Flu: The Complete Story of the Discovery and Reconstruction of the 1918 Pandemic Virus [1]
December 17, 2019Background
The 100-year anniversary of the 1918 pandemic and the 10-year anniversary of the 2009 H1N1 pandemic are milestones that provide an opportunity to reflect on the groundbreaking work that led to the discovery, sequencing and reconstruction of the 1918 pandemic flu virus. This collaborative effort advanced understanding of the deadliest flu pandemic in modern history and has helped the global public health community prepare for contemporary pandemics, such as 2009 H1N1, as well as future pandemic threats.
The 1918 H1N1 flu pandemic, sometimes referred to as the Spanish flu, killed an estimated 50 million people worldwide, including an estimated 675,000 people in the United States. An unusual characteristic of this virus was the high death rate it caused among healthy adults 15 to 34 years of age. The pandemic lowered the average life expectancy in the United States by more than 12 years. A comparable death rate has not been observed during any of the known flu seasons or pandemics that have occurred either prior to or following the 1918 pandemic.
The virus’ unique severity puzzled researchers for decades, and prompted several questions, such as Why was the 1918 virus so deadly? , Where did the virus originate from? , and What can the public health community learn from the 1918 virus to better prepare for and defend against future pandemics? These questions drove an expert group of researchers and virus hunters to search for the lost 1918 virus, sequence its genome, recreate the virus in a highly safe and regulated laboratory setting at CDC, and ultimately study its secrets to better prepare for future pandemics. The following is a historical recounting of these efforts, complete with references and descriptions of the contributions made by all of the remarkable men and women involved.
Discovering a lost killer
For decades, the 1918 virus was lost to history, a relic of a time when the understanding of infectious pathogens and the tools to study them were still in their infancy. Following the 1918 pandemic, generations of scientists and public health experts were left with only the epidemiological evidence of the 1918 pandemic virus’ lethality and the deleterious impact it had on global populations. A small ocean-side village in Alaska called Brevig Mission would become both testament to this deadly legacy as well as crucial to the 1918 virus’ eventual discovery.
Today, fewer than 400 people live in Brevig Mission, but in the fall of 1918, around 80 adults lived there, mostly Inuit Natives. While different narratives exist as to how the 1918 virus came to reach the small village --- whether by traders from a nearby city who traveled via dog-pulled sleds or even by a local mail delivery person --- its impact on the village's population is well documented. During the five-day period from November 15-20, 1918, the 1918 pandemic claimed the lives of 72 of the villages’ 80 adult inhabitants.
Later, at the order of the local government, a mass grave site marked only by small white crosses was created on a hill beside the village --- a grim monument to a community all but erased from existence. The grave was frozen in permafrost and left untouched until 1951. That year, Johan Hultin, a 25-year-old Swedish microbiologist and Ph.D. student at the University of Iowa, set out on an expedition to Brevig Mission in the hopes of finding the 1918 virus and in the process unearth new insights and answers. Hultin believed that within that preserved burial ground he might still find traces of the 1918 virus itself, frozen in time within the tissues of the villagers whose lives it had claimed.
In 1951, Hultin successfully obtained permission from the village elders to excavate the Brevig Mission burial site. With the help of several of his university colleagues, Hultin set up a dig site over the grave. The excavation took days, as Hultin had to create campfires to thaw the earth enough to allow for digging. Two days in, Hultin came across the body of a little girl --- her body was still preserved wearing a blue dress, and her hair was adorned with red ribbons. Ultimately, Hultin successfully obtained lung tissue from four additional bodies buried at the site, but logistical and technological limitations of the time period would prove formidable.
In a conversation Hultin had decades later with CDC microbiologist Dr. Terrence Tumpey [internal reference], Hultin would explain how during the return trip from Alaska to the University of Iowa, he flew on a DC-3 propeller-driven airplane that was forced to make multiple stops along the trip to refuel. During each stop, Hultin --- ever resourceful --- would deboard the plane and attempt to re-freeze the lung samples using carbon dioxide from a fire extinguisher.
The noise generated from this activity apparently drew puzzled glances from fellow passengers and onlookers. Once back in Iowa, Hultin attempted to inject the lung tissue into chicken eggs to get the virus to grow. It did not. In the end, perhaps unsurprisingly, Hultin was unable to retrieve the 1918 virus from this initial attempt.
It wouldn’t be until 46 years later, in 1997, that Hultin would have another opportunity to pursue the 1918 virus. That year, Hultin came across an article in the journal Science authored by Jeffery Taubenberger et al. entitled, Initial Genetic Characterization of the 1918 Spanish Influenza Virus. At the time, Dr. Taubenberger was a young molecular pathologist working for the Armed Forces Institute of Pathology in Washington, D.C.
In the article, Taubenberger and his team described their initial work to sequence part of the genome of the 1918 virus. The genome is the complete list of genetic instructions that make up an organism, similar to a blueprint used for construction. Many people are familiar with the concept of DNA, which is dual-stranded and determines the fundamental genetic characteristics of nearly all living things. However, the genome of an influenza virus consists of single-stranded RNA instead. Taubenberger's team successfully extracted RNA of the 1918 virus from lung tissue obtained from a 21-year-old male U.S. service member stationed in Fort Jackson, South Carolina. The serviceman had been admitted to the camp's hospital on September 20, 1918, with a diagnosis of influenza infection and pneumonia. He died six days later on September 26, 1918, and a sample of his lung tissue was collected and preserved for later study.
From this tissue, Taubenberger's group was able to sequence nine fragments of viral RNA from four of the virus’ eight gene segments. This work did not represent a complete sequence of the entire 1918 virus’ genome, but it provided a clearer picture of the pandemic virus than ever before. Based on the 1918 virus’ sequence data Taubenberger assembled in 1997, he and his fellow researchers initially claimed that the 1918 virus was a novel influenza A (H1N1) virus that belonged to a subgroup of viruses that came from humans and pigs, as opposed to birds. However, there was still much to learn about the virus.
After reading Taubenberger's article, Hultin once again became inspired to attempt to recover the 1918 virus. Hultin wrote a letter to Taubenberger, asking if Taubenberger would be interested if he could return to Brevig Mission and obtain lung tissues from victims of the 1918 virus buried in the Alaskan permafrost. During a return phone call, Taubenberger responded, yes. A week later, Hultin departed for Brevig Mission once again with meager tools for the task. He famously borrowed his wife's garden shears to assist in the excavation.
Forty-six years had passed since Hultin's first trip to the gravesite, and he was now 72 years old. He once again sought permission to excavate the gravesite from the village council --- which he obtained --- and he also hired locals to assist in the work. Hultin paid for the trip himself at a personal cost of about $3,200. The excavation took about five days, but this time Hultin made a remarkable find.
Buried and preserved by the permafrost about 7 feet deep was the body of an Inuit woman that Hultin named Lucy. Lucy, Hultin would learn, was an obese woman who likely died in her mid-20s due to complications from the 1918 virus. Her lungs were perfectly frozen and preserved in the Alaskan permafrost. Hultin removed them, placed them in preserving fluid, and later shipped them separately to Taubenberger and his fellow researchers, including Dr. Ann Reid, at the Armed Forces Institute of Pathology. Ten days later, Hultin received a call from the scientists to confirm --- to perhaps everyone's collective astonishment --- that positive 1918 virus genetic material had indeed been obtained from Lucy's lung tissue.
Building the Blueprint
The initial impact of this discovery would first be described in a February 1999 paper in the Proceedings of the National Academy of Science (PNAS) journal entitled Origin and evolution of the 1918 Spanish influenza virus hemagglutinin gene, by Ann Reid et al. Hultin was acknowledged as a co-author. In the paper, the authors described their effort to sequence (i.e., characterize) the 1918 virus's hemagglutinin HA gene.
The HA gene of an influenza virus determines the properties of the virus's HA surface proteins. These HA surface proteins allow an influenza virus to enter and infect a healthy respiratory tract cell. HA is also targeted by antibodies produced by the immune system to fight infection. Modern flu vaccines work by targeting an influenza virus’ unique HA (a fact that virologist Dr. Peter Palese, featured later in this article, helped pioneer).
In the 1999 study, the authors succeeded in sequencing the full length HA gene sequence of the 1918 virus. To accomplish this, the authors used RNA fragments of the virus obtained from the bodies of the formerly described 21-year-old Fort Jackson service member, Lucy from Brevik Mission, and a third person, a 30-year-old male service member stationed at Camp Upton, New York. This man was admitted to the camp hospital with influenza on September 23, 1918, had a rapid clinical course of illness, and died from acute respiratory failure on September 26, 1918.
Sequencing results suggested that the ancestor of the 1918 virus infected humans sometime between 1900 and 1915. Drs. Reid and Taubenberger noted that the 1918 HA gene had a number of mammalian as opposed to avian adaptations, and was more human-like or swine-like depending on the method of analysis. Phylogenetic analysis, which is used to group influenza viruses in accordance with their evolutionary development and diversity, placed the 1918 virus’ HA within and around the root of the mammalian clade. This means that it likely was an ancestor or closely related to the earliest influenza viruses known to infect mammals. However, the authors believed the virus likely obtained its HA from avian viruses, but were unsure how long the virus may have been adapting in a mammalian host before emerging in pandemic form.
According to the authors, the existing strain to which the 1918 virus sequences were most closely related was A/sw/Iowa/30, the oldest classical swine influenza strain. The authors noted that contemporary avian influenza virus strains are very different from the 1918 pandemic virus, and unfortunately older avian strains from around the time of the 1918 pandemic were not available for study. The authors also noted that the 1918 virus’ HA1 had only four glycosylation sites, which is different from modern human HA's which have accumulated up to five additional glycosylation sites through the process of antigenic drift. Antigenic drift refers to small changes in the genes of influenza viruses that happen continually over times as the virus copies itself. Antigenic drift is one reason why there is a flu season every year and also a reason for why people can get the flu multiple times in their lifetime.
Glycosylation sites are believed to be necessary for the function of influenza viruses, and the inclusion of additional glycosylation sites is believed to be an adaptation of the virus to human hosts. Also of note, the authors did not see any genetic changes in the 1918 virus’ HA that would explain its exceptional virulence.
Unlike modern virulent avian influenza strains, such as avian influenza A (H5) and (H7) viruses, the 1918 virus’ HA did not possess a cleavage site mutation, which is a recognized genetic marker for virulence, i.e., the severity or harmfulness of a disease. The insertion of amino acids in the HA cleavage site can allow an influenza virus to grow in tissues outside of its normal host cells. In the absence of such obvious markers, Dr. Reid and her fellow researchers concluded that there were likely multiple genetic factors responsible for the 1918 virus’ severity.
A follow-up paper published in June 2000, entitled Characterization of the 1918 Spanish Influenza Virus Neuraminidase Gene, described sequencing of the 1918 virus’ neuraminidase (NA) gene. In an influenza virus, the neuraminidase gene is responsible for coding the virus’ NA surface proteins [internal image reference]. An influenza virus’ NA surface proteins allow an influenza virus to escape an infected cell and infect other cells. Therefore, it plays an important role in spreading influenza infection. The author noted that NA is also targeted by the immune system, and that antibodies against NA do not prevent infection, but they do significantly limit the ability of the virus to spread.
Of note, the authors were able to sequence the entire code of the 1918 virus’ NA from the virus sample obtained from Lucy's body. So here again, Hultin's work proved invaluable. The authors found that the NA gene of the 1918 virus shared many sequence and structural characteristics with both mammalian and avian influenza virus strains. Phylogenetic analysis suggested the NA gene of the 1918 virus was intermediately located between mammals and birds, suggesting that it likely was introduced into mammals shortly before the 1918 pandemic. Furthermore, the 1918 virus’ NA obtained from Lucy suggested that it is very similar to the ancestor of all subsequent swine and human isolates.
Overall, the phylogenetic analysis seemed to indicate that the ultimate source of the 1918 virus’ NA was avian in nature, but the authors couldn’t determine the pathway from its avian source to the virus’ final pandemic form. Regarding genetic features of the NA that could explain the 1918 virus’ severity, the researchers were once again unable to find any single feature of the 1918 NA that contributed to the virus’ virulence. For example, in some modern influenza viruses, the loss of a glycosylation site in NA at amino acid 146 (in WSN/33) contributes to virulence and also results in the virus attacking the nervous system in mice. However, this change was not found in the NA of the 1918 virus.
Following this study, a series of additional studies were published, each detailing the findings from each of the 1918 virus’ remaining genes (flu viruses have 8 genes in total). In 2001, a paper by Christopher Basler et al. published in the Proceedings of the National Academic of Science (PNAS) described the sequencing of the 1918 virus’ nonstructural (NS) gene. A 2002 study in the Journal of Virology by Ann Reid et al. described sequencing of the virus’ matrix gene. Two years later, a 2004 Journal of Virology study described the sequencing of the 1918 virus’ nucleoprotein (NP) gene. In 2005, the virus’ polymerase genes were sequenced by Taubenberger et al and described in a Nature article. This final study bookended the nearly decade long process of sequencing the entire genome of the 1918 virus.
With the entire genome of the 1918 virus now sequenced, the necessary information was in place to reconstruct a live version of the 1918 virus. However, one more intermediate step was needed to start the reverse genetics process, which was to create plasmids for each of the 1918 virus’ eight gene segments.
This task was undertaken by renowned microbiologist, Dr. Peter Palese and Dr. Adolfo Garcia-Sastre at Mount Sinai School of Medicine in New York City. A plasmid is a small circular DNA strand that can be amplified (or replicated) in the laboratory. Years earlier, Dr. Palese helped pioneer the use of plasmids in reverse genetics to produce viable influenza viruses. The techniques he developed allowed the relationships between the structure and function of viral genes to be studied, and these efforts paved the way for the techniques used to reconstruct the 1918 virus. Once Dr. Palese and his colleagues at Mount Sinai completed creation of the plasmids, they were shipped to CDC so the official process of reconstruction could begin.
The Reconstruction
The decision to reconstruct the deadliest pandemic flu virus of the 20th century was made with considerable care and attention to safety. Senior government officials decided on CDC headquarters in Atlanta as the location of the reconstruction. CDC conducted two tiers of approvals: first by CDC's Institutional Biosafety Committee and the second by CDC's Institutional Animal Care and Use Committee, before work in the laboratory began. The work would be performed using stringent biosafety and biosecurity precautions and facilities, including what's known as Biosecurity Level 3 (BSL-3) practices and facilities with enhancements.
For reference, there are four biosafety levels that correspond to the degree of risk posed by research, with 1 posing the least risk and 4 posing the greatest risk. Each biosecurity level also corresponds with specific laboratory practices and techniques, personnel training requirements, laboratory equipment, and laboratory facilities that are appropriate for the operations being performed. The stringency of these considerations --- again ranging from 1 as the lowest to 4 as the highest --- is designed to protect the personnel performing the work, the environment and the community.
Each biosecurity level includes considerations for what is known as primary and secondary barriers. Examples of primary barriers include safety cabinets, isolation chambers, gloves and gowns, whereas secondary barriers include considerations such as the construction of the facility and HEPA filtration of air in the laboratory. The specific criteria for each biosafety level are detailed in the CDC/NIH publication Biosafety in Microbiological and Biomedical Laboratories.
A BSL3 laboratory with enhancements includes a number of primary and secondary barriers and other considerations. For example, all personnel must wear a powered air purifying respirator (PAPR), double gloves, scrubs, shoe covers and a surgical gown. They also must shower before exiting the laboratory. In addition, all work with the virus or animals must be conducted within a certified Class II biosafety cabinet (BSC), and airflow within the laboratory is directionally controlled and filtered so that it cannot accidentally exit the laboratory.
For the reconstruction of the 1918 virus, additional rules were created to govern the experiments to be conducted. For example, to prevent mix-ups and cross-contamination, work on the 1918 virus could not take place alongside work on other influenza viruses.
As part of security and safety considerations, CDC's Office of the Director determined that only one person would be granted permission, laboratory access, and the tremendous responsibility of reconstructing the 1918 virus. That person was trained microbiologist Dr. Terrence Tumpey, who was approved for the project by then CDC director, Dr. Julie Gerberding. Reconstruction of the 1918 virus also was approved by the National Institute of Allergy and Infectious Disease (NIAID) within the National Institutes of Health (NIH), which partially funded the project.
Dr. Tumpey was formerly a U.S. Department of Agriculture microbiologist at the Southeast Poultry Research Laboratory in Athens, Georgia. Earlier in his career, he had applied for an American Society of Microbiology (ASM) postdoctoral fellowship with CDC microbiologist and flu expert Dr. Jacqueline Katz, who recently retired as Deputy Director of CDC's Influenza Division. This two-year fellowship in CDC's Influenza Division would mark the beginning of Dr. Tumpey's career at CDC. He officially transferred employment to CDC for the purpose of studying human health implications of influenza viruses, including the 1918 pandemic virus.
Dr. Tumpey's work to reconstruct the complete 1918 virus began in the summer of 2005. To reduce risk to colleagues and the public, he was required to work on the virus alone and only after hours when fellow colleagues had exited the laboratories for the day and gone home. A biometric fingerprint scan was required for access into the BSL-3E laboratory, and the virus storage freezers were only accessible via an iris scan of his eyes. Dr. Tumpey was required to take a prescribed prophylactic (preventative) daily dose of the influenza antiviral drug, oseltamivir, as an additional safety precaution to prevent him from becoming infected. Should he become infected, he was informed that he would be placed in quarantine and denied contact with the outside world. He understood and accepted this responsibility and its consequences.
Using reverse genetics, Dr. Tumpey took the plasmids created by Dr. Palese for each of the 1918 virus’ eight gene segments and inserted them into human kidney cells. The plasmids then instructed the cells to reconstruct the RNA of the complete 1918 virus. For multiple weeks in July 2005, colleagues and collaborators asked Dr. Tumpey if he had the 1918 virus and if it had appeared in cell-culture yet.
On the day the 1918 virus appeared in his cell-culture, Dr. Tumpey knew history had been made, and in fact, a historic virus had been brought back from extinction. He sent a playful, Neil Armstrong-inspired email later that day to colleagues and collaborators, which simply said That's one small step for man, one giant leap for mankind. Everyone then knew what had been accomplished. Dr. Tumpey had become the first man to reconstruct the complete 1918 virus. The next step was to study it and unlock its deadly secrets.
Laboratory studies on the reconstructed 1918 virus began in August 2005. A report of this work, Characterization of the Reconstructed 1918 Spanish Influenza Pandemic Virus , was published in the October 7, 2005, issue of Science. To evaluate the 1918 virus’ pathogenicity (i.e., the ability of the virus to cause disease and harm a host), animal studies involving mice were conducted. The mice were infected with the 1918 virus, and measures of morbidity (i.e., weight loss, virus replication, and 50% lethal dose titers) were collected and documented. For comparison, other mice were infected with different influenza viruses that were designed via reverse genetics to have varying combinations of genes from the 1918 virus and contemporary human seasonal influenza A(H1N1) viruses. These viruses are called recombinant viruses.
The fully reconstructed 1918 virus was striking in terms of its ability to quickly replicate, i.e., make copies of itself and spread infection in the lungs of infected mice. For example, four days after infection, the amount of 1918 virus found in the lung tissue of infected mice was 39,000 times higher than that produced by one of the comparison recombinant flu viruses.
Furthermore, the 1918 virus was highly lethal in the mice. Some mice died within three days of infection with the 1918 virus, and the mice lost up to 13% of their body weight within two days of infection with the 1918 virus. The 1918 virus was at least 100 times more lethal than one of the other recombinant viruses tested. Experiments indicated that 1918 virus’ HA gene played a large role in its severity. When the HA gene of the 1918 virus was swapped with that of a contemporary human seasonal influenza A (H1N1) flu virus known as A/Texas/36/91 or Tx/91 for short, and combined with the remaining seven genes of the 1918 virus, the resulting recombinant virus notably did not kill infected mice and did not result in significant weight loss.
Other experiments were conducted to determine if infection with the 1918 virus could spread to other vital organs of mice --- such as the brain, heart, liver and spleen. Laboratory testing did not detect virus in these organs, suggesting that the 1918 virus did not cause systemic infection in its victims.
However, one well-documented effect of the 1918 virus was rapid and severe lung damage. In 1918, victims of the pandemic virus experienced fluid-filled lungs, as well as severe pneumonia and lung tissue inflammation. Within four days post infection, mice infected with the 1918 virus experienced similar lung complications, suggesting that this was a unique aspect of the 1918 virus’ severity.
The impact of the 1918 virus on lung tissue was also studied using a human lung cell line (known as Calu-3 cells). The amount of 1918 flu virus was measured in the cells at 12, 16 and 24 hours post infection and these results were compared to those produced by recombinant viruses with a combination of genes from the 1918 virus mixed with genes from contemporary human seasonal flu viruses. Similar to the experiments involving mice, the 1918 virus quickly multiplied and spread within the human lung cells. So much so, that the 1918 virus produced as much as 50 times the amount of virus in human lung cells as one of the comparison viruses. These experiments suggested that in addition to the HA, the polymerase genes of the 1918 virus played a significant role in the virus’ infectivity and virulence in human lung tissue.
Another set of experiments was conducted to better understand the possible avian origins of the 1918 virus. The earlier sequencing efforts led by Dr. Taubenberger and Reid had suggested that the 1918 virus’ gene segments were more closely related to avian influenza A(H1N1) viruses than H1N1 viruses found in other mammals. Researchers were interested to know whether the 1918 virus would be lethal to fertilized chicken eggs, i.e., chicken eggs containing an embryo, similar to modern highly pathogenic avian influenza viruses.
To find an answer, 10-day old fertilized chicken eggs were inoculated with the 1918 virus. The 1918 virus proved lethal for the chicken egg embryos, similar to the effects caused by contemporary H1N1 bird flu viruses. Notably, comparison experiments using human seasonal influenza A(H1N1) viruses did not have this destructive effect on chicken embryos. Furthermore, the recombinant flu viruses that Dr. Tumpey created containing two, five or seven genes of the 1918 virus also did not hurt chicken embryos. Similar to the results of the studies conducted in mice and human lung cell, these fertilized chicken egg experiments indicated that the HA and polymerase genes of the 1918 virus both likely played roles in its virulence.
The work conducted by Dr. Tumpey and his CDC colleagues provided new information about the properties that contributed to the virulence of the 1918 virus. Dr. Tumpey determined that the HA and PB1 virus genes of the virus played particularly important roles in its infectiousness and severity. However, as his experiments involving recombinant flu viruses with some but not all of the 1918 virus's genes showed, it was not any single component of the 1918 virus but instead the unique combination of all of its genes together that made it so particularly dangerous.
Tumpey and colleagues wrote the constellation of all eight genes together make an exceptionally virulent virus. No other human influenza viruses tested were as exceptionally virulent. In that way, the 1918 virus was special --- a uniquely deadly product of nature, evolution and the intermingling of people and animals. It would serve as a portent of nature's ability to produce future pandemics of varying public health concern and origin.
Learning from the Past
Since 1918, the world has experienced three additional pandemics, in 1957, 1968, and most recently in 2009. These subsequent pandemics were less severe and caused considerably lower mortality rates than the 1918 pandemic. The 1957 H2N2 pandemic and the 1968 H3N2 pandemic each resulted in an estimated 1 million global deaths, while the 2009 H1N1 pandemic resulted in fewer than 0.3 million deaths in its first year. This perhaps begs the question of whether a high severity pandemic on the scale of 1918 could occur in modern times.
Many experts think so. One virus in particular has garnered international attention and concern: the avian influenza A(H7N9) virus from China. The H7N9 virus has so far caused 1,568 human infections in China with a case-fatality proportion of about 39% since 2013. However, it has not gained the capability to spread quickly and efficiently between people. If it did, experts believe it could result in a pandemic with severity comparable to the 1918 pandemic. So far, it has shown only limited ability to spread between people. Most human infections with this virus have result from exposure to birds.
When considering the potential for a modern era high severity pandemic, it is important; however, to reflect on the considerable medical, scientific and societal advancements that have occurred since 1918, while recognizing that there are a number of ways that global preparations for the next pandemic still warrant improvement.
Besides the properties of the virus itself, many additional factors contributed to the virulence of the 1918 pandemic. In 1918, the world was still engaged in World War I. Movement and mobilization of troops placed large numbers of people in close contact and living spaces were overcrowded. Health services were limited, and up to 30% of U.S. physicians were deployed to military service.
In addition, medical technology and countermeasures at the time were limited or non-existent. No diagnostic tests existed at the time that could test for influenza infection. In fact, doctors didn’t know influenza viruses existed. Many health experts at the time thought the 1918 pandemic was caused by a bacterium called Pfeiffer's bacillus, which is now known as Haemophilus influenzae.
Influenza vaccines did not exist at the time, and even antibiotics had not been developed yet. For example, penicillin was not discovered until 1928. Likewise, no flu antiviral drugs were available. Critical care measures, such as intensive care support and mechanical ventilation also were not available in 1918. Without these medical countermeasures and treatment capabilities, doctors were left with few treatment options other than supportive care.
In terms of national, state and local pandemic planning, no coordinated pandemic plans existed in 1918. Some cities managed to implement community mitigation measures, such as closing schools, banning public gatherings, and issuing isolation or quarantine orders, but the federal government had no centralized role in helping to plan or initiate these interventions during the 1918 pandemic.
Today, considerable advancements have been made in the areas of health technology, disease surveillance, medical care, medicines and drugs, vaccines and pandemic planning. Flu vaccines are now produced and updated yearly, and yearly vaccination is recommended for everyone 6 months of age and older. Antiviral drugs now exist that treat flu illness, and in the event of virus exposure, can be used for prophylaxis (prevention), as well. Importantly, many different antibiotics are now available that can be used to treat secondary bacterial infections.
Diagnostic tests for identifying influenza are now available and they are improving over time. Current rapid tests for flu, also known as RIDTs, provide results within 15 minutes and have sensitivities ranging from 50-70%. Recently, new rapid molecular assays have become available that are timely and much more accurate than RIDTs. Just as important as these advancements in diagnostic tests are the improvements that have been made in laboratory testing capacity both within the United States and globally.
The World Health Organization (WHO)'s Global Influenza Surveillance and Response System (GISRS) is a global flu surveillance network that monitors changes in seasonal flu viruses and also monitors the emergence of novel (i.e., new in humans) flu viruses, many of which originate from animal populations. Through animal and human interactions and environmental exposures, these viruses can cause human infections. CDC in Atlanta is one of WHO's six Collaborating Centers for Reference and Research on Influenza (joining others in Australia, China, Japan and the United Kingdom). The WHO collaborating centers collect influenza viruses obtained from respiratory specimens from patients around the world, and they are supported by 143 National Influenza Centers in 114 WHO member countries.
Expanding laboratory testing and flu surveillance capacity around the world has been an important focus of pandemic preparedness efforts. In 2004, CDC began an international surveillance capacity building initiative that entailed a 5-year period of financial support to improve laboratory diagnostic tests and surveillance of influenza like illness (ILI) and severe acute respiratory infection (SARI) in 39 partner countries.
In 2008, CDC established the International Reagent Resource (IRR), which provides reagents to laboratories around the world to identify seasonal influenza A and B viruses, as well as novel influenza A viruses. During the 2009 H1N1 pandemic, the IRR distributed a new CDC developed 2009 H1N1 PCR assay to domestic public health laboratories and laboratories around the world less than 2 weeks after the 2009 H1N1 virus was first identified. This considerably enhanced the ability of the global flu surveillance community to track spread of the virus.
As part of WHO's International Health Regulations (IHR), countries must notify WHO within 24 hours of any case of human infection caused by a novel influenza A virus subtype. This requirement is designed to help quickly identify emerging viruses with pandemic potential.
Since 2010, CDC has used its Influenza Risk Assessment Tool (IRAT) to evaluate and score emerging novel influenza A viruses and other viruses of potential public health concern. The score provided by the IRAT answers two questions: 1) What is the risk that a virus that is novel in humans could result in sustained human to human transmission? and: 2) What is the potential for the virus to substantially impact public health if it does gain the ability to spread efficiently from person to person? Results from the IRAT have helped public health experts target pandemic preparedness resources against the greatest disease threats and to prioritize the selection of candidate vaccine viruses and the development of pre-pandemic vaccines against emergent viruses with the greatest potential to cause a severe pandemic.
When pre-pandemic vaccines are made, they are stored in the Strategic National Stockpile, along with facemasks, antiviral drugs and other materials that can be used in case of a pandemic.
All of these resources, tools, technologies, programs and activities are excellent tools for pandemic planning, and pandemic planning itself has improved significantly since 1918. In the United States, the Department of Health and Human Services (HHS) maintains a national Pandemic Influenza Plan, and this plan was updated in 2017. The World Health Organization (WHO) has published instructions for countries to use in developing their own national pandemic plans, as well as a checklist for pandemic influenza risk and impact management.
Planners have access to other materials as well. For example, in 2014, CDC published a pandemic framework with six intervals that fall within a pandemic curve. Each interval helps with prioritizing data collection, government resources and interventions, and other important activities during the pandemic. In addition, CDC experts have devised a Pandemic Severity Assessment Framework that uses data to assign severity and transmissibility scores to pandemics. The tool is useful for planning purposes and for determining appropriate mitigations based on the severity of a pandemic. In addition, guidelines for non-pharmaceutical interventions, such as closing schools and large social gatherings, have been established and revised, for use during a pandemic.
While all of these plans, resources, products and improvements show that significant progress has been made since 1918, gaps remain, and a severe pandemic could still be devastating to populations globally. In 1918, the world population was 1.8 billion people. One hundred years later, the world population has grown to 7.6 billion people in 2018. As human populations have risen, so have swine and poultry populations as a means to feed them. This expanded number of hosts provides increased opportunities for novel influenza viruses from birds and pigs to spread, evolve and infect people. Global movement of people and goods also has increased, allowing the latest disease threat to be an international plane flight away. Due to the mobility and expansion of human populations, even once exotic pathogens, like Ebola, which previously affected only people living in remote villages of the African jungle, now have managed to find their way into urban areas, causing large outbreaks.
If a severe pandemic, such as occurred in 1918 happened today, it would still likely overwhelm health care infrastructure, both in the United States and across the world. Hospitals and doctors’ offices would struggle to meet demand from the number of patients requiring care. Such an event would require significant increases in the manufacture, distribution and supply of medications, products and life-saving medical equipment, such as mechanical ventilators. Businesses and schools would struggle to function, and even basic services like trash pickup and waste removal could be impacted.
The best defense against the flu continues to be a flu vaccine, but even today, flu vaccines face a number of challenges. One challenge is that flu vaccines are often moderately effective, even when well matched to circulating viruses. But perhaps the biggest challenge is the time required to manufacture a new vaccine against an emerging pandemic threat. Generally, it has taken about 20 weeks to select and manufacture a new vaccine.
During the 2009 H1N1 pandemic, the first doses of pandemic vaccine did not become available until 26 weeks after the decision to manufacture a monovalent vaccine. As a result, most vaccinations in the United States occurred after the peak of 2009 H1N1 illness. The HHS Pandemic Influenza Plan has a goal of reducing the timeframe to make a pandemic flu vaccine from 20 weeks to 12 weeks, but accomplishing this is challenging.
One possible solution is to create more broadly protective and longer lasting vaccines. Creation of a universal vaccine continues to elude the world's top scientists, but in the future, it could become a reality. In the meantime, health officials seek to get the most out of new and existing flu vaccine technologies, such as cell based and recombinant vaccines, which are not reliant on a supply of chicken eggs, like traditional vaccines, and have the potential to be produced faster.
One other vaccine issue is the inadequate global capacity for mass producing flu vaccines. Global pandemic flu vaccine capacity was estimated to be 6.4 billion doses in 2015, but this is not enough to cover even half of the world's population, should two doses of a pandemic vaccine be required for protection.
Other challenges at a global level include surveillance capacity, infrastructure and pandemic planning. The majority of counties that report to the WHO still do not have a national pandemic plan, and critical and clinical care capacity, especially in low income countries, continues to be inadequate to the demands of a severe pandemic. In 2005, milestones were created in the revised International Health Regulations (IHR) for countries to improve their response capacity for public health emergencies, but in 2016, only one-third of countries were in compliance.
All of these issues show that more work needs to be done, both here in the United States and internationally, to prepare for the next pandemic. On May 7, 2018, The Rollins School of Public Health at Emory University in partnership with the U.S. Centers for Disease Control and Prevention, hosted a one-day symposium on the 100-year anniversary of the 1918 influenza pandemic. The event involved experts from government and academia discussing current pandemic threats and the future of pandemic preparedness, influenza prevention and control. U.S. and global influenza experts who attended the meeting agreed that we still face great challenges to prepare for future flu pandemics, but part of the solution is recognizing these challenges and working together with the rest of the world to address them.
The COVID-19 virus is not an Influenza or as commonly called a Flu virus. It is a coronaviruses and they do not behave like Flu viruses. In the late 1990's the Internet was full of stories about the desire to access and sequence the 1918 pandemic virus. The stories ranged from nefarious forces wanting to create bioweapons to legitimate science wanting to avert a future disaster. In most instances the non-mainstream websites were concerned about unintended consequences and a massive disaster that might result from this work. Eventually this permeated the main stream and a movie called Jurasic Park was made. The movie featured the new genetic engineering technologies and the unintended consequences of bringing life back that went extinct millions of years in the past. One of the more famous series of quotes from the movie is [1]:
Dr. Ian Malcolm : Don't you see the danger, John, inherent in what you're doing here? Genetic power is the most awesome force the planet's ever seen, but you wield it like a kid that's found his dad's gun.Donald Gennaro : It's hardly appropriate to start hurling generalizations...
Dr. Ian Malcolm : If I may... Um, I'll tell you the problem with the scientific power that you're using here, it didn't require any discipline to attain it. You read what others had done and you took the next step. You didn't earn the knowledge for yourselves, so you don't take any responsibility for it. You stood on the shoulders of geniuses to accomplish something as fast as you could, and before you even knew what you had, you patented it, and packaged it, and slapped it on a plastic lunchbox, and now [bangs on the table] you're selling it, you wanna sell it. Well...
John Hammond : I don't think you're giving us our due credit. Our scientists have done things which nobody's ever done before...
Dr. Ian Malcolm : Yeah, yeah, but your scientists were so preoccupied with whether or not they could that they didn't stop to think if they should.
Back To Where Did COVID-19 Come From
References:
[1] The Deadliest Flu: The Complete Story of the Discovery and Reconstruction of the 1918 Pandemic Virus, By Douglas Jordan with contributions from Dr. Terrence Tumpey and Barbara Jester, Centers For Disease Control and Prevention CDC, December 17, 2019. webpage https://www.cdc.gov/flu/pandemic-resources/reconstruction-1918-virus.html, March 2021. The Deadliest Flu: The Complete Story of the Discovery and Reconstruction of the 1918 Pandemic Virus.
[2] Jurassic Park, Movie 1993, Writers: Michael Crichton (novel), Michael Crichton (screenplay). webpage https://www.imdb.com/title/tt0107290, March 2021. Jurassic Park.
The Huanan wet market in China where live animals are sold is thought to be the source of the COVID-19 virus. The scenarios offered are that the virus arrived naturally in the wet market or that it leaked from a bio lab in Wuhan. China as part of the official response denies that the virus originated in Huanan wet market. China also rejected the US charge from right wing political operatives that the novel coronavirus was leaked from its bio lab in Wuhan. China asserted that the pandemic was likely caused by separate outbreaks in multiple locations in the world. The Huanan wet market was closed and sealed in early 2020 [1].
Chinese Foreign Minister Wang Yi communicated that [1]:
We raced against time and were the first country to report cases to the world. More research suggests that the pandemic was likely to have been caused by separate outbreaks in multiple places in the world. When hit by an unknown coronavirus, China took immediate actions to carry out epidemiological investigation, identify the pathogen and publicise key information including the genome sequencing of the virus. All this sounded alarm bells across the world. China took the most rigorous control measures to fight the virus.
In a formal media briefing, Ms Hua launched a scathing criticism against the US [1]:
Washington should produce evidence to back its charge that the virus emerged from the Wuhan Institute of Virology (WIV). She in-turn called for a WHO probe into American military run bio labs while replying to a question on latest allegations by the US National Security Adviser Matthew Pottinger that the COVID-19 has been leaked from the WIV."There is a growing body of evidence that the (Wuhan) lab is likely the most credible source of the virus," Mr Pottinger, a staunch critic of Beijing, allegedly made the claim in a recent virtual meeting with UK officials, according to a British media report.
His allegation is nothing new as US President Donald Trump, who termed COVID-19 as "China virus", too had alleged last year that the institute may have been responsible and called for an inquiry.
"Maybe you could ask the senior US officials since they are considering origin tracing such a priority why doesn''t the US invite the WHO experts to investigate the virus in the US considering the links between the Fort Detrick lab (in Maryland) and the major flu last fall and the pandemic," Ms Hua said.
"Why doesn't the US invite journalists there," she asked.
Ms Hua said, "regarding the Wuhan lab making or leaking of the virus almost all the scientists and experts in the world including Dr Anthony Fauci, (director of the National Institute of Allergy and Infectious Diseases) openly denied this".
"Many media including American ones interviewed officials of Wuhan Institute of Virology to see the truth," she said.
"Pottinger is still hyping despicable lies and rumours. Does it reflect his own stand or that of the official stand of the US government? The US should present evidence on this. There are more reports showing evidence that pandemic broke out in multiple locations in 2020," she said.
"We hope that the WHO can lead the scientists in conducting the tracing of the organ of the virus so that we find out the truth at an early date," Ms Hua said.
Chinese Foreign Ministry spokesperson Hua Chunying's remarks came amidst reports that a ten-member team of the World Health Organisation (WHO) scientists would visit China this month to probe the origin of the coronavirus, which emerged in Wuhan in December 2019.
The case for and against an Unintended Consequence from China as the source of the virus is as follows:
To accept the lab leak scenario from China or any other country including the USA it would require confirmed evidence of possession of the virus in a lab setting, ahead of the first cases, and a likely mechanism for escape into humans. Finding the possible immediate parents of SARS-CoV-2 would help to understand the recent history of the virus but not how and where that history occurred if the work was performed in secret. Unless an offending lab is staffed with very special people, as time moves on this becomes less likely.
Back To Where Did COVID-19 Come From
References:
[1] China Denies US' Allegation That Coronavirus Originated From Wuhan Lab, WorldPress Trust of India, www.ndtv.com, January 04, 2021. webpage https://www.ndtv.com/world-news/china-denies-us-allegation-that-coronavirus-originated-from-wuhan-lab-2347646, March 2021. China Denies US' Allegation That Coronavirus Originated From Wuhan Lab.
[2] Unlikely that Covid came from Wuhan lab, WHO says, NBC News, February 9, 2021. website https://www.nbcnews.com/news/world/who-s-covid-mission-china-give-first-report-n1257105, March 2021. Unlikely that Covid came from Wuhan lab, WHO says.
[3] Did the coronavirus leak from a lab? These scientists say we shouldn’t rule it out. For many scientists, challenging the idea that SARS-CoV-2 has natural origins is seen as career suicide. But a vocal few say it shouldn't be disregarded or lumped in with conspiracy theories. MIT Technology Review, March 18, 2021. webpage https://www.technologyreview.com/2021/03/18/1021030/coronavirus-leak-wuhan-lab-scientists-conspiracy, March 2021. Did the coronavirus leak from a lab? These scientists say we shouldn’t rule it out.
[4] The Deadliest Flu: The Complete Story of the Discovery and Reconstruction of the 1918 Pandemic Virus, By Douglas Jordan with contributions from Dr. Terrence Tumpey and Barbara Jester, Centers For Disease Control and Prevention CDC, December 17, 2019. webpage https://www.cdc.gov/flu/pandemic-resources/reconstruction-1918-virus.html, March 2021. The Deadliest Flu: The Complete Story of the Discovery and Reconstruction of the 1918 Pandemic Virus.
Gain Of Function Research (GoF research or GoFR) is research that genetically or by traditional breeding techniques alters an organism in a way that may enhance the biological functions of the organism and or the gene products. The GoF research is usually performed using genetic techniques enabled by the new genetic engineering technologies that are available to many researchers. High risk GoF research introduces new hazards that can cause possible harm. The traditional barriers of entry, such as cost, into this research is relatively low so there is concern that high risk GoF research can lead to a disaster.
The term GoF is used by some to refer to research that can cause a pandemic potential pathogen to replicate more quickly or cause more harm in humans or other closely related mammals. [1] This is considered high risk GoF research. Not all GoF research is associated with pandemic potential pathogens. GoF research is performed to produce useful products that are not harmful and this is usually low risk GoF research. So, not all GoF research is the same level of dangerous risk where there can be the introduction of new hazards and resulting possible harm.
Low risk GoF research that modifies bacteria to produce human insulin or genetically altering immune cells for CAR-T cell therapy to treat cancer is considered low risk [2] because it will not introduce a new hazard and cause possible harm unless there are unintended consequences.
High risk GoF research includes altered pathogenesis, transmissibility, or host range (the types of hosts that a microorganism can infect). For example, influenza B can only infect humans and harbor seals. Introducing a mutation that allows influenza B to infect rabbits in a controlled laboratory setting is considered a high risk GoF experiment because previously the virus did not have that function. Because of the GoF research it can now cause more harm because of the new hazard to rabbits that did not previously exist. All rabbits are now at risk if there is a spill event. That type of experiment can help reveal which parts of the virus are responsible for the change in the host range to now include rabbits. This helps in the development of antiviral medicines which block this function. [1] [2]
The reasons for high risk GoF are varied. In virology, GoF research is performed to learn and better understand current and future pandemics. In vaccine development, GoF research is performed to gain a head start on a virus to develop a vaccine or therapeutic before it emerges and becomes an epidemic or pandemic.
Some forms of GoF research carry inherent biosafety and biosecurity risks, and are referred to as Dual Use Research of Concern (DURC). To mitigate these risks while allowing the benefits of this research, various governments have mandated that DURC experiments be regulated under additional oversight by institutions, committees, and government agencies (such as the NIH's recombinant DNA advisory committee). In Europe, the European Union's Dual Use Coordination Group (DUCG) exists. [1]
GoF Research Moratorium
Between 2014 and 2017, the White House Office of Science and Technology Policy and the Department of Health and Human Services instituted a GoF research moratorium and funding pause on any dual-use research into specific pandemic potential pathogens (influenza, MERS, and SARS) while the regulatory environment and review process were reconsidered and changed. Under the moratorium, any laboratory that conducted GoF research would lose funding for any project, not just the indicated pathogens. The NIH claimed that 18 studies were affected by the moratorium. [1] [2]
The moratorium was a response to laboratory incidents not related to GoF research, that occurred in 2014. The primary goal of the moratorium was to evaluate and improve laboratory safety procedures. The laboratory incidents included: [1]
Symposia and expert panels were convened by the National Science Advisory Board for Biosecurity (NSABB) and National Research Council (NRC). In May 2016, the NSABB published: Recommendations for the Evaluation and Oversight of Proposed Gain-of-Function Research [3]. On January 9 2017, the HHS published: Recommended Policy Guidance for Departmental Development of Review Mechanisms for Potential Pandemic Pathogen Care and Oversight (P3CO) [4]. This report describes how pandemic potential pathogens should be regulated, funded, stored, and researched to minimize threats to public health and safety. On December 9 2017, the NIH lifted the moratorium because GoF research was deemed important in helping to identify, understand, and develop strategies and effective countermeasures against rapidly evolving pathogens that pose a threat to public health. [1]
Mission critical systems are systems where there is the possibility of harm to people or loss of life. Mission critical systems use various fault tolerant and failsafe mechanisms to mitigate or prevent harm to people or loss of life. The greater the level of possible harm or loss of life the greater the level of system fault tolerance and failsafe mechanisms. In all cases the humans in the system are part of the analysis and fault tolerant and failsafe mechanisms are used to deal with human failure events.
From a systems perspective, the above laboratory incidents the led to the moratorium were related to human error.
Humans are the weakest link in any system and part of developing failsafe systems is to eliminate the effects of human error or conscious sabotage. There is a phrase that many use: Trust but Verify to suggest that the system is properly established. However, that is not what must be done in mission critical systems. Instead mission critical systems never trust any humans in the system and the system is structured to ensure that they are failsafe regardless of human actions. The term that is used is: Never Trust Anyone; It becomes a key requirement in the system development. It is usually not written down because it is so fundamental in the development of these types of systems. For those new to this concept the requirements are based on:
An example requirement for a mission critical system is:
The system shall be fault tolerant and failsafe in the presence of human error regardless of the cause of the human error including but not limited to fatigue, security, sensory overload, environment, mental state, physical health, incapacitation, death, or any other conditions where the human action or inaction could lead to the system causing harmful undesired operations or harmful undesired system failure to provide mission critical services.
A massive system that is based on Never Trust Anyone is the US government with its checks and balances. Remove the checks and balances and the system now must rely on trust and the founders of the US knew from experience that trust is compromised especially in times of stress. This applies to all systems and it was learned a few hundred years ago. It is fundamental to all mission critical system development today. Never trust anyone, structure the system accordingly.
GoF Experiments
In 2011, two groups were investigating how flu viruses specific to birds could cross over and create pandemics in humans [1] [2]:
Both groups manually passed H5N1 avian influenza in ferrets by taking the virus from one ferret to another, until it was capable of spreading via respiratory droplets. The normally bird-specific virus, through replication over time in the ferrets' lungs, had adopted several amino acid changes that allowed it to replicate in mammalian lungs, which are a colder than those found in birds. This small change allowed the virus to transmit via droplets in the air made when the ferrets' coughed or sneezed. [1] [2]
Advocates for the experiments claim several benefits: they answered the question of how a virus like H5N1 could possibly become airborne in humans, allowed other researchers to develop vaccines and therapeutics which specifically targeted these amino acid changes and also demonstrated that there was a linkage between transmissibility in avian viruses and lethality. While the virus had become more transmissible, it had also become significantly less deadly. Critics of the research (including members of USA Congress) responded to the publications with alarm. Others called the experiments an engineered doomsday. Questions were raised by other scientists about the relative risks and benefits of this research. [1]
In May 2013, China's National Avian Influenza Reference Laboratory (Hualan Chen), published several experiments they conducted at the BSL3+ laboratory of the Harbin Veterinary Research Institute, investigating what would happen if a 2009 H1N1 circulating in humans infected the same cell as an avian influenza H5N1. The experiments were conducted before a research pause on H5N1 experiments had been agreed upon by the greater virologist community. They used these experiments to determine that certain genes, if reassorted in a dual-infection scenario in the wild, would allow transmission of the H5N1 virus more easily in mammals (guinea pigs as a model organism for rodent species), proving that certain agricultural scenarios carry the risk of allowing H5N1 to cross over into mammals. As in the Fouchier and Kawaoka experiments above, the viruses in this study were also significantly less lethal after the modification. [1]
Critics of the 2013 Chen group study (Simon Wain-Hobson Pasteur Institute and former Royal Society President Robert May) stated that this as an unsafe experiment that was unnecessary to prove the intended conclusions, calling Chen's work appallingly irresponsible" and also raising concerns about the biosafety of the laboratory itself. Others (including the Director of the WHO Collaborating Centre on Influenza in Tokyo, Masato Tashiro) praised Chen's laboratory as "state of the art." Jeremy Farrar, director of the Oxford University Clinical Research Unit in Ho Chi Minh City, described the work as "remarkable" and said that it demonstrated the "very real threat" that "continued circulation of H5N1 strains in Asia and Egypt" poses. [1]
Gain-of-Function Research Involving Potential Pandemic Pathogens
The following is from the National Institute For Health (NIH): Gain-of-Function Research Involving Potential Pandemic Pathogens [2].
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Potential Pandemic PathogensPotential pandemic pathogens (PPPs) are bacteria, viruses, and other microorganisms that are likely highly transmissible and capable of wide, uncontrollable spread in human populations and highly virulent, making them likely to cause significant morbidity and/or mortality in humans. Examples of pathogens that have the potential to cause human pandemics, or have caused a human pandemic, include the H5N1 or H7N9 influenza viruses(link is external), also referred to as bird or avian influenzas, SARS-CoV(link is external), which caused an epidemic in several countries in 2003, and SARS-CoV-2(link is external), also known as Severe Acute Respiratory Syndrome coronavirus 2, which causes COVID-19 disease. Genetic changes or mutations in pathogens, especially viruses that have ribonucleic acid as its genetic material, regularly occur in nature. Some mutations in nature can cause pathogens to gain new functions or enhance existing characteristics such as fitness or pathogenicity (ability to cause disease). We have seen many examples of that with SARS-CoV-2 since the beginning of the pandemic.
Gain-of-Function Research
The term gain-of-function (GOF) research describes a type of research that modifies a biological agent so that it confers new or enhanced activity to that agent. Some scientists use the term broadly to refer to any such modification. However, not all research described as GOF entails the same level of risk. For example, research that involves the modification of bacteria to allow production of human insulin, or the altering of the genetic program of immune cells in CAR-T cell therapy to treat cancer generally would be considered low risk. The subset of GOF research that is anticipated to enhance the transmissibility and/or virulence of potential pandemic pathogens, which are likely to make them more dangerous to humans, has been the subject of substantial scrutiny and deliberation. Such GOF approaches can sometimes be justified in laboratories with appropriate biosafety and biosecurity controls to help us understand the fundamental nature of human-pathogen interactions, assess the pandemic potential of emerging infectious agents, and inform public health and preparedness efforts, including surveillance and the development of vaccines and medical countermeasures. This research poses biosafety and biosecurity risks, and these risks must be carefully managed. When supported with NIH funds, this subset of GOF research may only be conducted in laboratories with stringent oversight and appropriate biosafety and biosecurity controls(link is external) to help protect researchers from infection and prevent the release of microorganisms into the environment.
U.S. Government Funding Pause
In 2014, the White House Office of Science and Technology Policy (OSTP), in coordination with agencies across the U.S. Government (USG), including the Department of Health and Human Services (HHS) and the National Institutes of Health (NIH), initiated a funding pause (link is external)on GOF research that was reasonably anticipated to confer attributes to influenza, Middle East Respiratory Syndrome (MERS), or SARS viruses such that the virus would have enhanced pathogenicity and/or transmissibility in mammals via the respiratory route.
The pause allowed the USG, in partnership with the life sciences community and stakeholders, to conduct a public, deliberative process with the explicit goal of developing a new federal policy framework to guide future investments in this area of research. The deliberative process included multiple public meetings and two commissioned independent studies, including a comprehensive risk and benefit assessment of GOF research. As noted above, not all studies that may be considered GOF research pose the same level of risk. The deliberative process identified the subset of research that enhances a pathogen to make it likely highly transmissible and virulent in humans (enhanced PPP) as involving risks that warranted additional oversight.
HHS P3CO Framework
At the conclusion of the deliberative process, HHS issued its Framework for Guiding Funding Decisions about Proposed Research Involving Enhanced Potential Pandemic Pathogens (HHS P3CO Framework). This HHS P3CO Framework is responsive to and in accordance with the Recommended Policy Guidance for Departmental Development of Review Mechanisms for Potential Pandemic Pathogen Care and Oversight issued by OSTP. The Framework guides HHS funding decisions on proposed research that is reasonably anticipated to create, transfer, or use PPPs resulting from the enhancement of a pathogen's transmissibility and/or virulence in humans (enhanced PPP) and seeks to preserve the benefits of life sciences research involving enhanced PPPs while minimizing potential biosafety and biosecurity risks. Unlike the 2014 funding pause, the HHS P3CO Framework is not limited to certain pathogens. The HHS P3CO Review Group includes experts in scientific research, biosafety, biosecurity, medical countermeasures, law, ethics, public health preparedness and response, biodefense, select agent regulations, and public health policy. Research deemed acceptable under the HHS P3CO Framework must be conducted in an appropriate laboratory with stringent oversight and biosafety and biosecurity controls.
Once the HHS P3CO review and oversight process was in place, NIH announced in December 2017 that it was lifting the funding pause on NIH-supported research. Since that time, NIH has funded two projects involving enhanced PPP research subsequent to review by the HHS P3CO Review Group. Both projects involved influenza virus. The HHS P3CO Review Group determined that for both research proposals, there were no feasible, equally effective alternative methods to address the same question in a manner that poses less risk, and that the research was acceptable for HHS funding. NIH makes all funded research publicly available on NIH RePORTER. Pre-funding information about unfunded individual proposals is not made public to preserve confidentiality and protect sensitive information, preliminary data, and intellectual property.
Research Within P3CO Scope
As an example, the University of Wisconsin-Madison research experiment on influenza that was reviewed in accordance with the HHS P3CO Framework was considered acceptable for HHS funding. The research project focused on H5N1 (an avian influenza virus that represents a serious pandemic threat) and was designed to improve understanding of the features and mechanisms that would enable avian influenza viruses to transmit to mammals. The leap from birds to humans (or from birds to another species such as pigs, then to humans) has been an important way that spillover has occurred in the past with influenza A virus. In this project, mutations associated with adaptation in mammals would be introduced into H5 avian influenza viruses. The project proposed that resulting viruses would be tested for their ability to transmit between ferrets, a common animal model for studying influenza A transmission that might be relevant to humans. In the ferret experiments, additional mutations then would be introduced to see if those changes made the viruses more transmissible between ferrets. The information generated from these ferret experiments provided a basis for assessing the potential risks to humans of circulating and emerging avian influenza viruses. Identification of specific mutations enables enhanced surveillance and response efforts, because finding these mutations in future avian influenza viruses could inform a public health response by identifying the need for development and use of protective vaccines and therapeutics.
Research Outside P3CO Scope
An example of a research project that some might describe as GOF research broadly but does not meet the criteria for review under the HHS P3CO Framework involves virus manipulation that results in the ability to generate higher vaccine yield. For background, egg-based influenza vaccine viruses are not always suitable for cell-cultured vaccine production due to potential issues with growth, protein yield, and antigenic stability (a substance that evokes an immune response). To increase cell-culture influenza vaccine production, a high-growth master influenza virus adapted to cells competent for vaccine production was needed. New mutations introduced in a mouse-adapted influenza virus (A/PR/8/1934) in cell culture resulted in a virus that had increased pathogenicity in mice and increased yield in cell culture which would advance vaccine development. Because the parental or primary virus was adapted in mice, it did not meet the definition of a PPP. This research is described in this Nature paper(link is external).
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GoF Systems Perspective
Gain of Function research started with the attempt and then successful resurrection of the 1918 Pandemic Flu Virus performed by the US CDC. It was during that effort that the technologies, practices, processes, techniques, etc. were developed that would eventually lead to gene manipulation that would give massive inspiration to perform GoF research. Even though GoF research can be performed using traditional breeding techniques that are centuries old, the basic idea of quickly modifying a pathogen took roots with genetic engineering made possible with massive miniaturization technologies. The genie was let out of the bottle and it is now impossible to stop.
When the atom was split in the middle of the last century many things happened including making sure the technology was not out of control. This was done by a people and a culture deeply entrenched in the systems perspective and higher ideals after dealing with the ravages of multiple World Wars and systemic economic collapse that was the Depression. This is not happening today with the new technologies in the 21st century as self interest is viewed as the best approach for all settings.
Gene manipulation technology is more dangerous than the nuclear technologies in terms of potential massive irrecoverable damage. Nuclear technology is very capital intensive. All anyone can do is just steal its byproducts. So security became part of the early nuclear systems solutions. Genetic engineering technology is not capital intensive. Anyone can do it. This is the current state of our technology and its pattern is the same as the nuclear technology that surfaced in the last century. Collaboration and strong oversight applying massive science, engineering, and the systems perspective are the tools that we can use to control this very powerful technology that is now called Gain Of Function (GoF) Research (GoFR).
Back To Where Did COVID-19 Come From
References:
[1] Gain-of-function research, wikipedia, webpage https://en.wikipedia.org/wiki/Gain-of-function_research, September 2021.
[2] Gain-of-Function Research Involving Potential Pandemic Pathogens, National Institute For Health (NIH), July 12, 2021. webpage https://www.nih.gov/news-events/gain-function-research-involving-potential-pandemic-pathogens, September 2021. Gain-of-Function Research Involving Potential Pandemic Pathogens.
[3] A Report of the National Science Advisory Board for Biosecurity, Recommendations for the Evaluation and Oversight of Proposed Gain-of-Function Research, US Government National Science Advisory Board for Biosecurity (NSABB), May 2016. wedpage https://osp.od.nih.gov/wp-content/uploads/2016/06/NSABB_Final_Report_Recommendations_Evaluation_Oversight_Proposed_Gain_of_Function_Research.pdf, September 2021. PDF . local
[4] Recommended Policy Guidance for Departmental Development of Review Mechanisms for Potential Pandemic Pathogen Care and Oversight (P3CO), US Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, January 9, 2017. webpage https://www.phe.gov/s3/dualuse/Documents/P3CO-FinalGuidanceStatement.pdf, September 2021. PDF . local
A bioweapon suggests that some bioagent was deliberately developed and then used for some intended outcome. The bioagent might be something that is naturally harvested and packaged, naturally harvested modified and then packaged, or designed and manufactured in a lab and then packaged. The bioagent can be a bacterium, virus, protozoan, parasite, or fungus. Most immediately jump to genetic engineering of a virus to produce some type of outcome. However this suggests that we have the technology to predict the results of certain gene sequences.
The scenarios associated with a bioweapon will not provide insight into the source of a virus unless the attack is confirmed and can be sourced. When trying to determine if COVID-19 is a bioweapon that went out of control, the investigations should follow traditional paths associated with intelligence and police work. These begin with motive. What would be the motive of the attacker to release something like COVID-19. Then there is the list of possible suspects. The motive may not be visible until all the possible suspects are listed and examined. The list includes fanatics from the Middle East, USA, Eastern and Western Europe, Far East, Africa, South America, Australia, etc. In other words the entire planet. It is unlikely that China and Italy would attack their own countries.
The scenario of a genetically engineered bioweapon is taken off the table because no one has claimed responsibility for the act. It is possible that some fanatics released the virus thinking that its spread would be limited and not go beyond the intended target but that is highly unlikely. Still the scenario must be considered so that we ensure that we have extremely effective systems to detect, prevent, and mitigate such attacks. Fortunately the reality is that we are many years away from a complete understanding of viral gene functions and regulation for construction of lethal viruses. [1]
Just because the use of a bioweapon has been taken off the table it does not suggest that there was no attempt to genetically engineer such a bioweapon and that it may have accidentally escaped from a lab. Li-Meng Yan, a Chinese ophthalmologist and virologist, claimed that SARS-CoV-2 was made in a Chinese government laboratory. In April 2020, she fled to the United States and co-authored two papers. The first paper, September 14, 2020, presented theories that SARS-CoV-2 did not emerge naturally in a spillover from animals, but was produced in a laboratory [2]. The second paper, October 8, 2020, went further, claiming that SARS-CoV-2 was a bioweapon developed by laboratories under the control of the Chinese Communist Party [3]. In the papers, just below the list of authors is identification of the Rule of Law Society & Rule of Law Foundation a political organization with close ties to the extreme right in the USA. The mainstream scientific community rejected these theories using very strong and direct language.
In complex systems every analysis always has flaws. However the flaws should never be used to discredit an entire body of work. Instead the flaws must be noted, addressed, and then the analysis either abandoned because it is fatally flawed or matured. This is a process usually referred to as moving from a strawman, to an ironman, to a stoneman condition. A strawman is something that is easy to knock down with little knowledge. An ironman is difficult to knock down and requires experts to knock it down. A stoneman cannot be knocked down even if all the experts have endless amounts of time to find the flaws. It appears that the Yan analysis is somewhere between a strawman and ironman analysis. It may never reach the stoneman level of maturity but without logical, traceable, counter analysis rooted in the systems tradition, this will not happen. The scientists instead start behaving like politicians and managers driven by external forces either knowingly or unknowingly.
Unfortunately the Yan papers began with strong assertions and then provided technical content to support the assertions. The focus should have been on the technical content. In spite of this flaw, unless there is a paragraph by paragraph analysis of the technical content found in the Yan papers from those that rejected the analysis it is difficult to determine where the Yan analysis broke down and why.
In every systems analysis when systems information products are reviewed there is always a paragraph by paragraph detailed analysis. The method is very simple, a line is added after each paragraph labeled as Comment, and then a clear one word assessment is provided using words like Agree or Disagree. More words are provided when there is a disagree assessment so that a reasonable analysis can be performed moving forward. Johns Hopkins did provide such an analysis using content that is easily understood by the non specialist.
Before the review of the Yan analysis is provided the findings from this analysis are provided below. Placing it at the end of the analysis may cause some readers to miss these findings.
Key Findings From This Systems Analysis
Review of the second Yan paper [3] is not provided in this systems analysis. The papers are now part of the historical record. It probably will be decades before we know the source of the COVID-19 virus and how it spread so quickly across the planet. As suggested by this systems analysis, if it is known, the information is probably locked in military and intelligence organizations and classified with no access.
A key claim in the Yan paper is that the RaTG13 sequence is not found in nature but the Johns Hopkins review invalidated the claim by showing that the RaTG13 is found in GenBank. Assuming we can trust GenBank, this moved the analysis into the fatally flawed category. The GenBank results show that the Bat coronavirus RaTG13 complete genome was submitted by the Wuhan Institute of Virology [A]. The expectation is that the results of the Bat coronavirus RaTG13 genome submitted by the Wuhan Institute of Virology was verified. This includes duplicating the results in other independent labs using material from the Wuhan lab. It is also expected that there is a massive search to find the bats in the cave that provided the original bat material that was used for the RaTG13 genome finding. This systems analysis has not verified if this happened.
This systems analysis performed in 2020 suggested that the virus spread was a direct result of airplanes and airports. Although this is a horrible finding for the airline industry and the US Federal Aviation Administration (FAA), it is a comforting conclusion because it suggests it was not a deliberate planned attack where the virus was spread in multiple locations across the planet by maniacs.
The Yan paper [2] and comments from Johns Hopkins [4] are provided below. The comments from Johns Hopkins are marked as JH and the comments from This Analysis are marked as TA and are non italic to show that they originated from this analysis and not a referenced body of work. These are links to the TA comments:
TA1, TA2, TA3, TA4, TA5, TA6, TA7, TA8, TA9, TA10, TA11
TA1: The following are selected portions from the introduction of the JH comments.JH: Several analyses of the potential origin of SARS-CoV-2 have been published in scientific journals that provide peer review prior to publication.2,3,4,5,6,7,8,9 Peer review is central to the scientific process because scrutiny by experts allows for meaningful conclusions to be drawn about available data and reduces inappropriate extrapolation or misinterpretation. It is an imperfect process, often criticized for slowness, but peer review is a necessary part of building reliability in the scientific record. Complex scientific details are best understood and critiqued by others who are also experts in a technical field. When the audience for an article is broadened, even to a technical audience in an adjacent scientific field, data may appear smoother and less conflicting than it is in reality, leading to a blurring or skewing of its real meaning.
TA2: Eventually the scientific analysis must be reviewed by all the system stakeholders. This is a challenge when the content is highly specialized but it is possible. The approach used is to ensure that the analysis is captured in other information products that are written in such a way that anyone can understand it even everyones grandmother. In the past very sophisticated publications departments were used to help translate the content without distorting the content. This also can be performed by extremely mature professionals that have been exposed to this process multiple times in the highly specialized field. It appears that the Johns Hopkins comments are in that tradition.
JH: The report, Unusual Features of the SARS-CoV-2 Genome Suggesting Sophisticated Laboratory Modification Rather Than Natural Evolution and Delineation of Its Probable Synthetic Route,10 presents a theory about the origin of SARS-CoV-2 but offers contradictory and inaccurate information that does not support their argument. As the report has not been submitted to a scientific peer-reviewed publication, which would provide the expert scrutiny expected by the scientific community and the larger public, we aim to provide an objective analysis of details included in the report, as would be customary in a peer-review process.
TA3: It appears that the Johns Hopkins analysis of the Yan report has concluded that there is noting to salvage from the Yan analysis. It is fatally flawed.
TA4: The following is the Yan report and all the JH and TA comments. There is a conclusion at the end of this analysis of the Yan report.
Page 1
Abstract
The COVID-19 pandemic caused by the novel coronavirus SARS-CoV-2 has led to over 910,000 deaths worldwide and unprecedented decimation of the global economy. Despite its tremendous impact, the origin of SARS-CoV-2 has remained mysterious and controversial. The natural origin theory, although widely accepted, lacks substantial support. The alternative theory that the virus may have come from a research laboratory is, however, strictly censored on peer-reviewed scientific journals. Nonetheless, SARS-CoV-2 shows biological characteristics that are inconsistent with a naturally occurring, zoonotic virus. In this report, we describe the genomic, structural, medical, and literature evidence, which, when considered together, strongly contradicts the natural origin theory. The evidence shows that SARS-CoV2 should be a laboratory product created by using bat coronaviruses ZC45 and/or ZXC21 as a template and/or backbone. Building upon the evidence, we further postulate a synthetic route for SARS-CoV-2, demonstrating that the laboratory-creation of this coronavirus is convenient and can be accomplished in approximately six months. Our work emphasizes the need for an independent investigation into the relevant research laboratories. It also argues for a critical look into certain recently published data, which, albeit problematic, was used to support and claim a natural origin of SARS-CoV-2. From a public health perspective, these actions are necessary as knowledge of the origin of SARS-CoV-2 and of how the virus entered the human population are of pivotal importance in the fundamental control of the COVID-19 pandemic as well as in preventing similar, future pandemics.
TA5: They should have deleted strictly censored on peer-reviewed scientific journals and stayed with the known facts that they are presenting. It is off topic, that is the comment and reason for removal. This is a classic example of young researchers that get emotionally attached to their work. This is where an institutional publication department adds significant value to information products. Even though our systems analysis crosses this boundary, we don't care because we expect everyone to not engage in gaming a situation towards some hidden stakeholder. We come from the systems perspective and assertions with little backup information are sometimes needed to fully understand a system. This mistake from the Yan researchers can be attributed to idealistic mental models and strong emotions. The paper should have stayed on the topic of the possible source of the virus and not ventured down the censorship path. That is a very different paper, one possibly written by historians and journalists. However, the technical content in this paper should be examined. Historians and journalists should examine the other content. This is the systems perspective.
Page 2
Introduction
COVID-19 has caused a world-wide pandemic, the scale and severity of which are unprecedented. Despite the tremendous efforts taken by the global community, management and control of this pandemic remains difficult and challenging.
As a coronavirus, SARS-CoV-2 differs significantly from other respiratory and/or zoonotic viruses: it attacks multiple organs; it is capable of undergoing a long period of asymptomatic infection; it is highly transmissible and significantly lethal in high-risk populations; it is well-adapted to humans since the very start of its emergence1; it is highly efficient in binding the human ACE2 receptor (hACE2), the affinity of which is greater than that associated with the ACE2 of any other potential host2,3.
The origin of SARS-CoV-2 is still the subject of much debate. A widely cited Nature Medicine publication has claimed that SARS-CoV-2 most likely came from nature4. However, the article and its central conclusion are now being challenged by scientists from all over the world5-15. In addition, authors of this Nature Medicine article show signs of conflict of interests16,17, raising further concerns on the credibility of this publication.
The existing scientific publications supporting a natural origin theory rely heavily on a single piece of evidence - a previously discovered bat coronavirus named RaTG13, which shares a 96% nucleotide sequence identity with SARS-CoV-218. However, the existence of RaTG13 in nature and the truthfulness of its reported sequence are being widely questioned6-9,19-21. It is noteworthy that scientific journals have clearly censored any dissenting opinions that suggest a non-natural origin of SARS-CoV-28,22. Because of this censorship, articles questioning either the natural origin of SARS-CoV-2 or the actual existence of RaTG13, although of high quality scientifically, can only exist as preprints5-9,19-21 or other non-peerreviewed articles published on various online platforms10-13,23. Nonetheless, analyses of these reports have repeatedly pointed to severe problems and a probable fraud associated with the reporting of RaTG136,8,9,1921. Therefore, the theory that fabricated scientific data has been published to mislead the world's efforts in tracing the origin of SARS-CoV-2 has become substantially convincing and is interlocked with the notion that SARS-CoV-2 is of a non-natural origin.
JH: 1. On natural existence of a closely related virus. Line 17: RaTG13 is a previously discovered bat coronavirus which has about a 96% sequence identity to SARS-CoV-2,4 indicating that it is a close relative and that bats are likely involved in the evolution of SARS-CoV-2. Yan et al question the existence of RaTG13, which is found in GenBank.11 The authors cite multiple papers in their reference section that have weaknesses or flaws to make their case. In their paper, reference 7's author is not a scientist or researcher according to his ORCID profile; references 10 and 13 cannot be found online and the links provided are not active; reference 11 is an opinion piece on an anti-GMO interest group website; references 5, 6, 8, 9, and 12 appear to be authored by scientists lacking expertise in coronaviruses and/or viral evolution. Only 2 of these publications (14 and 15) were published in scientific journals with peer review, and none of the authors of these 2 articles specialize in coronaviruses or viral genetics.
TA6: This is a key claim in the Yan paper and the JH review has invalidated the claim by showing that the RaTG13 is found in GenBank. Assuming we can trust GenBank, this moved the analysis into the fatally flawed category.
TA7: The GenBank results show that the Bat coronavirus RaTG13 complete genome was submitted by the Wuhan Institute of Virology. https://www.ncbi.nlm.nih.gov/nuccore/MN996532 VRL 24-NOV-2020. https://www.ncbi.nlm.nih.gov/nuccore/MN996532.1, VRL 24-MAR-2020. https://www.ncbi.nlm.nih.gov/nuccore/MN996532.2, VRL 24-NOV-2020. [A]
TA8: The expectation is that the results of the Bat coronavirus RaTG13 complete genome submitted by the Wuhan Institute of Virology was verified. This includes duplicating the results in other independent labs using material from the Wuhan lab. It is also expected that there is a massive search to find the bats in the cave that provided the original bat material that was used for the RaTG13 genome finding. This systems analysis has not verified if this happened.
Consistent with this notion, genomic, structural, and literature evidence also suggest a non-natural origin of SARS-CoV-2. In addition, abundant literature indicates that gain-of-function research has long advanced to the stage where viral genomes can be precisely engineered and manipulated to enable the creation of novel coronaviruses possessing unique properties. In this report, we present such evidence and the associated analyses. Part 1 of the report describes the genomic and structural features of SARS-CoV2, the presence of which could be consistent with the theory that the virus is a product of laboratory modification beyond what could be afforded by simple serial viral passage. Part 2 of the report describes a highly probable pathway for the laboratory creation of SARS-CoV-2, key steps of which are supported by evidence present in the viral genome. Importantly, part 2 should be viewed as a demonstration of how SARS-CoV-2 could be conveniently created in a laboratory in a short period of time using available materials and well-documented techniques. This report is produced by a team of experienced scientists using our combined expertise in virology, molecular biology, structural biology, computational biology, vaccine development, and medicine.
JH: 2. On the capacity to predict function from genotype. Line 28: Yan et al overstate the capabilities of deducing functional changes from genetic manipulation of coronaviruses, referring to an "abundant literature indicat[ing] that gain-of-function research has long advanced to the stage where viral genomes can be precisely engineered and manipulated to enable the creation of novel coronaviruses possessing unique properties."10 Technologies like CRISPR have enabled precise, directed gene editing, and are major advances for the biological sciences. However, the report overstates current capabilities in designing phenotypes and genetic functions of viruses, which are not already elucidated, including coronaviruses, and vastly overstates the capabilities of genetic manipulation of coronaviruses in 2019, before these viruses were the focus of worldwide interrogation by the scientific community. There were 6 coronaviruses known to infect humans prior to 2020, but their prevalence and pathology in different age groups is incompletely understood, which would hamper any potential design of novel coronavirus functions. Prior to 2020, coronaviruses were not as intensely researched as other viruses that cause human disease, such as HIV, and influenza.JH: 3. Lack of current evidence countering natural origin theory. Line 27: Yan et al refer to an extensive scientific literature providing "genomic, structural, and literature evidence"10 to counter the prevailing theory in the scientific community that the origin of SARS-CoV-2 is a natural zoonosis, emerging from animals, but they do not cite any references to support their claim-a crucial basic practice for any researcher.
1. Has SARS-CoV-2 been subjected to in vitro manipulation?
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We present three lines of evidence to support our contention that laboratory manipulation is part of the history of SARS-CoV-2:
i. The genomic sequence of SARS-CoV-2 is suspiciously similar to that of a bat coronavirus discovered by military laboratories in the Third Military Medical University (Chongqing, China) and the Research Institute for Medicine of Nanjing Command (Nanjing, China).
JH: 2. Role of Chinese military lab. Lines 4-6: The United States has a number of high-containment laboratories in which viruses can be studied safely with engineering controls, including negative air pressure. Some of these labs are located at military laboratories, such as the US Army Medical Research Institute of Infectious Diseases in Frederick, Maryland. China, France, Germany, India, Russia, the United Kingdom, and many other countries similarly have laboratories operated by military researchers that are declared to the Biological Weapons Convention in confidencebuilding measures. Scientific investigation in military laboratories is not uncommon; coronavirus research performed in a Chinese military research institute is not in itself suspicious, as asserted by Yan et al.
TA9: The JH comments are out of numerical sequence when placed in the context of the Yan report. This probably reflects the priority of the comments offered in the group. This is the second most important comment in the group.
TA10: Many young researchers or those that are extremely isolated are not aware of the depth and breadth of military funded projects around the world. It is an unfortunate fact of life in high technology. This is why the concept of Dual Use is so important that was adopted in the last century but lost in this new century. This comment seems off topic but it is relevant because it is unclear what various military and intelligence organizations from around the world have concluded relative to the source of COVID-19 because the information may be classified. As the years click by history may reveal if there is additional information on the source of COVID-19.
ii. The receptor-binding motif (RBM) within the Spike protein of SARS-CoV-2, which determines the host specificity of the virus, resembles that of SARS-CoV from the 2003 epidemic in a suspicious manner. Genomic evidence suggests that the RBM has been genetically manipulated. iii. SARS-CoV-2 contains a unique furin-cleavage site in its Spike protein, which is known to greatly enhance viral infectivity and cell tropism. Yet, this cleavage site is completely absent in this particular class of coronaviruses found in nature. In addition, rare codons associated with this additional sequence suggest the strong possibility that this furin-cleavage site is not the product of natural evolution and could have been inserted into the SARS-CoV-2 genome artificially by techniques other than simple serial passage or multi-strain recombination events inside co-infected tissue cultures or animals.
JH: 3. Furin cleavage sites in coronaviruses. Lines 10-16: The authors assert that a furin cleavage site in its Spike protein is absent in coronaviruses found in nature, which is not the case.* This is fairly common in other coronaviruses16; MERS has a furin cleavage site17 within Spike. * The original version of this report included an editing error in this paragraph. It was updated on 10/14/20.
1.1 Genomic sequence analysis reveals that ZC45, or a closely related bat coronavirus, should be the backbone used for the creation of SARS-CoV-2
TA11: This paragraph numbering is typically found in USA government information products. It dates back to the the Data Item Descriptions for document preparation used extensively since the 1970's up until the PC revolution that replaced publication departments in most organizations. The paragraph name reflects a technique used to prepare thematic based information products as first introduced in Sequential Thematic Organization of Publications (STOP) in 1962. Some with extensive high technology government background have adopted this approach for preparing many information products but they do not apply a theme topic at the paragraph level unless it is a STOP proposal. Unfortunately some extreme right wing foundations have adopted this very powerful publication approach to further political agendas like government privatization. Many young systems oriented researchers get caught up in these institutions not realizing their work is being filtered to further an agenda. This looks similar to an Internet Frequently Asked Question (FAQ) but it is not, because it makes a bold standalone assertion that is then discussed in text and graphics that follow the thematic assertion. However, the review focus must remain on the technical content, even if it is flawed and comes from compromised sources, because it informs the technical research. The broader research just might miss something that is disclosed in this research.
The structure of the ~30,000 nucleotides-long SARS-CoV-2 genome is shown in Figure 1. Searching the NCBI sequence database reveals that, among all known coronaviruses, there were two related bat coronaviruses, ZC45 and ZXC21, that share the highest sequence identity with SARS-CoV-2 (each bat coronavirus is ~89% identical to SARS-CoV-2 on the nucleotide level). Similarity between the genome of SARS-CoV-2 and those of representative [B beta] coronaviruses is depicted in Figure 1. ZXC21, which is 97% identical to and shares a very similar profile with ZC45, is not shown. Note that the RaTG13 virus is excluded from this analysis given the strong evidence suggesting that its sequence may have been fabricated and the virus does not exist in nature2,6-9. (A follow-up report, which summarizes the up-to-date evidence proving the spurious nature of RaTG13, will be submitted soon)
JH: 1. On implausibility of the proposed viral genetic backbone. Lines 19-20: Scientific evidence suggests that many coronaviruses12 similar to SARS-CoV-2 have a recent common ancestor or that convergent evolution13 has occurred. Many coronaviruses infect bats and other animals, most of which have not been analyzed, so the evolutionary record has gaps until more samples are collected. Convergent evolution14 refers to the evolution of similar traits in independent organisms. Yan et al do not attempt to refute the prevailing scientific evidence on viral evolution, but assert that ZC45, a coronavirus with over 3,000 punctuated, broadly distributed nucleotide differences from SARS-CoV-2 (a significantly large number of differences), could have been used as a "backbone" or template to produce SARS-CoV-2 synthetically. ZC45 is a beta coronavirus15 isolated from a bat between 2015 and 2017 in Zhoushan city, Zhejiang province, China. ZC45 and ZXC21 were both discovered and characterized in to better understand animal reservoirs of SARS-like coronaviruses. No explanation is given for how the over 3,000 nucleotide differences SARS-CoV-2 and ZC45 could be produced; this process would be highly challenging for deliberate engineering.
Figure 1. Genomic sequence analysis reveals that bat coronavirus ZC45 is the closest match to SARS-CoV-2. Top: genomic organization of SARS-CoV-2 (2019-nCoV WIV04). Bottom: similarity plot based on the full-length
JH: 4. Dissimilarities between SARS-CoV-2 and ZC45. Figure 1.1: The report features a figure comparing sequences of various coronavirus strains. The figure's data appear accurate and demonstrate a high degree of dissimilarity between ZC45 and SARS-CoV-2, particularly in ORF1a, but the conclusion made by the authors in the text is that the strains are similar. Neither the figure nor the text clarify which genome serves as the reference.
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genome of 2019-nCoV WIV04. Full-length genomes of SARS-CoV BJ01, bat SARSr-CoV WIV1, bat SARSr-CoV HKU3-1, bat coronavirus ZC45 were used as reference sequences.
When SARS-CoV-2 and ZC45/ZXC21 are compared on the amino acid level, a high sequence identity is observed for most of the proteins. The Nucleocapsid protein is 94% identical. The Membrane protein is 98.6% identical. The S2 portion (2nd half) of the Spike protein is 95% identical. Importantly, the Orf8 protein is 94.2% identical and the E protein is 100% identical.
Orf8 is an accessory protein, the function of which is largely unknown in most coronaviruses, although recent data suggests that Orf8 of SARS-CoV-2 mediates the evasion of host adaptive immunity by downregulating MHC-I24. Normally, Orf8 is poorly conserved in coronaviruses25. Sequence blast indicates that, while the Orf8 proteins of ZC45/ZXC21 share a 94.2% identity with SARS-CoV-2 Orf8, no other coronaviruses share more than 58% identity with SARS-CoV-2 on this particular protein. The very high homology here on the normally poorly conserved Orf8 protein is highly unusual.
JH: 2. Also, lines 11-13: ZC45 and ZXC21 seem to have an 94% identity with ORF8, which is greater than with other circulating coronaviruses (59%), but this is still quite low. ORF8 has been identified20 as a protein of interest in aiding in virus assembly/packaging. Yan et al argue that SARS-CoV-2 is suspiciously similar to SARS-CoV-1, yet these 2 viruses contain less than 20% similarity in their ORF8 sequences.
Figure 2. Sequence alignment of the E proteins from different [B beta] coronaviruses demonstrates the E protein's permissiveness and tendency toward amino acid mutations. A. Mutations have been observed in different strains of SARS-CoV. GenBank accession numbers: SARS_GD01: AY278489.2, SARS_ExoN1: ACB69908.1, SARS_TW_GD1: AY451881.1, SARS_Sino1_11: AY485277.1. B. Alignment of E proteins from related bat coronaviruses indicates its tolerance of mutations at multiple positions. GenBank accession numbers: Bat_AP040581.1: APO40581.1, RsSHC014: KC881005.1, SC2018: MK211374.1, Bat_NP_828854.1: NP_828854.1, BtRs-BetaCoV/HuB2013: AIA62312.1, BM48-31/BGR/2008: YP_003858586.1. C. While the early copies of SARS-CoV-2 share 100% identity on the E protein with ZC45 and ZXC21, sequencing data of SARS-CoV2 from April 2020 indicates that mutation has occurred at multiple positions. Accession numbers of viruses: Feb_11: MN997409, ZC45: MG772933.1, ZXC21: MG772934, Apr_13: MT326139, Apr_15_A: MT263389, Apr_15_B: MT293206, Apr_17: MT350246. Alignments were done using the MultAlin webserver
(http://multalin.toulouse.inra.fr/multalin/).
JH: 1. Similarity of ORF8 between SARS-CoV-2 and ZC45. Lines 9-14. The authors' assertion that the similarity between the ORF8 gene in SARS-CoV-2 and ZC45 is unnatural (relative to sequence conservation among coronaviruses) is not supported by evidence presented. While the sequence of ORF8 varies among coronaviruses, its function is not well characterized.18 In line 10, the authors report that ORF8 may be involved in SARS-CoV-2's ability to evade the host immune response (and thus affect pathogenicity). They then suggest that ORF8 is usually dissimilar among different coronavirus strains, based on a paper by Muth et al19 that studied deletions in ORF8 during the 2003 SARS-CoV-1 epidemic. Muth et al found that a deletion of 29 nucleotides in ORF8 of SARS-CoV-1 attenuated the virus by decreasing the virus's ability to replicate. A recent paper20 identified the role of ORF8 in pathogenesis of SARS-CoV-2 as potentially playing a role in viral maturation and assembly. Importantly, this study on ORF8 was published after the emergence of SARS-CoV-2, whose mode of action is still not fully understood; this timeline does not align with Yan and colleagues' proposed timeline of events. Furthermore, the authors fail to consider the level of similarity in ORF8 between viral variants of the same strain, which could provide better context for the sequence identity between different strains. It is, therefore, inappropriate to suggest that the similarity of SARS-CoV-2 and ZC45 is unusual.
The coronavirus E protein is a structural protein, which is embedded in and lines the interior of the membrane envelope of the virion26. The E protein is tolerant of mutations as evidenced in both SARS (Figure 2A) and related bat coronaviruses (Figure 2B). This tolerance to amino acid mutations of the E
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protein is further evidenced in the current SARS-CoV-2 pandemic. After only a short two-month spread of the virus since its outbreak in humans, the E proteins in SARS-CoV-2 have already undergone mutational changes. Sequence data obtained during the month of April reveals that mutations have occurred at four different locations in different strains (Figure 2C). Consistent with this finding, sequence blast analysis indicates that, with the exception of SARS-CoV-2, no known coronaviruses share 100% amino acid sequence identity on the E protein with ZC45/ZXC21 (suspicious coronaviruses published after the start of the current pandemic are excluded18,27-31). Although 100% identity on the E protein has been observed between SARS-CoV and certain SARS-related bat coronaviruses, none of those pairs simultaneously share over 83% identity on the Orf8 protein32. Therefore, the 94.2% identity on the Orf8 protein, 100% identity on the E protein, and the overall genomic/amino acid-level resemblance between SARS-CoV-2 and ZC45/ZXC21 are highly unusual. Such evidence, when considered together, is consistent with a hypothesis that the SARS-CoV-2 genome has an origin based on the use of ZC45/ZXC21 as a backbone and/or template for genetic gain-of-function modifications.
JH: 1. Mischaracterization of sequence homology data. Lines 9-10, referring to Figure 2: The authors present a variety of homology data that are superfluous, internally inconsistent, or misinterpreted in the text. For example, the authors state that the E protein, which plays a minimal role in pathogenesis, is highly variable; however, the Figure 2 shows a fairly stable amino acid sequence. In lines 4-5, the authors state that SARS-CoV-2's E gene is highly permissible to mutations because in a 2-month period there have been 4 nonsynonymous mutations. They use this to suggest it is suspicious that early SARS-CoV-2 samples had identical identity to the purported "backbone" viruses, when SARS-CoV-2 is able to tolerate nonsynonymous mutations to the E gene and, therefore, it would be unlikely for SARS-CoV-2 to have evolved naturally to have 100% sequence identity. However, this analysis does not consider the selection bias in the samples' sequences and gaps in the existing phylogenetic trees. It is acknowledged in the field that there are gaps in the phylogenetic trees of the coronavirus family, making it difficult to determine accurately the likelihood of similarity between 2 viral variants. Additionally, Figure 2 shows only 1 sequence from an early time point in the pandemic and 4 samples from April. If other samples from February were to be included, then there might not be 100% amino acid sequence identity between SARS-CoV-2 samples and ZC45 and ZXC21. Finally, 2 strains of coronaviruses showing identical sequences in a particular gene could be an example of convergent evolution.21
Importantly, ZC45 and ZXC21 are bat coronaviruses that were discovered (between July 2015 and February 2017), isolated, and characterized by military research laboratories in the Third Military Medical University (Chongqing, China) and the Research Institute for Medicine of Nanjing Command (Nanjing, China). The data and associated work were published in 201833,34. Clearly, this backbone/template, which is essential for the creation of SARS-CoV-2, exists in these and other related research laboratories.
What strengthens our contention further is the published RaTG13 virus18, the genomic sequence of which is reportedly 96% identical to that of SARS-CoV-2. While suggesting a natural origin of SARSCoV-2, the RaTG13 virus also diverted the attention of both the scientific field and the general public away from ZC45/ZXC214,18. In fact, a Chinese BSL-3 lab (the Shanghai Public Health Clinical Centre), which published a Nature article reporting a conflicting close phylogenetic relationship between SARSCoV-2 and ZC45/ZXC21 rather than with RaTG1335, was quickly shut down for "rectification"36. It is believed that the researchers of that laboratory were being punished for having disclosed the SARS-CoV2-ZC45/ZXC21 connection. On the other hand, substantial evidence has accumulated, pointing to severe problems associated with the reported sequence of RaTG13 as well as questioning the actual existence of this bat virus in nature6,7,19-21. A very recent publication also indicated that the receptor-binding domain (RBD) of the RaTG13's Spike protein could not bind ACE2 of two different types of horseshoe bats (they closely relate to the horseshoe bat R. affinis, RaTG13's alleged natural host)2, implicating the inability of RaTG13 to infect horseshoe bats. This finding further substantiates the suspicion that the reported sequence of RaTG13 could have been fabricated as the Spike protein encoded by this sequence does not seem to carry the claimed function. The fact that a virus has been fabricated to shift the attention away from ZC45/ZXC21 speaks for an actual role of ZC45/ZXC21 in the creation of SARS-CoV-2.
JH: 2. Binding with ACE2. Lines 31-34: In a discussion about whether RaTG13 can bind various ACE2 homologs from different types of horseshoe bats, the authors neglect to point out that the ACE2 homolog of the specific species of horseshoe bat from which RaTG13 was isolated was not included in the cited binding studies. This makes conclusions about whether RaTG13 can bind ACE2 homologues incomplete.
1.2 The receptor-binding motif of SARS-CoV-2 Spike cannot be born from nature and should have been created through genetic engineering
The Spike proteins decorate the exterior of the coronavirus particles. They play an important role in infection as they mediate the interaction with host cell receptors and thereby help determine the host range and tissue tropism of the virus. The Spike protein is split into two halves (Figure 3). The front or Nterminal half is named S1, which is fully responsible for binding the host receptor. In both SARS-CoV and SARS-CoV-2 infections, the host cell receptor is hACE2. Within S1, a segment of around 70 amino acids makes direct contacts with hACE2 and is correspondingly named the receptor-binding motif (RBM) (Figure 3C). In SARS-CoV and SARS-CoV-2, the RBM fully determines the interaction with hACE2. The C-terminal half of the Spike protein is named S2. The main function of S2 includes maintaining trimer formation and,
JH: 3. Binding of Rhinolophus affinis ACE 2. Lines 34-36: Research22 has shown that the receptorbinding domain of SARS-CoV-2 binds human, pangolin, and Rhinolophus macrotis bat ACE2 receptors optimally, and that the receptor-binding domain of Rhinolophus affinis, a type of horseshoe bat, did not bind the ACE2 of orthologous (different) horseshoe bat species' ACE2. R affinis ACE2 has not been well characterized, so it could not be tested. This is interesting work in progress but does not provide substantive conclusions about the provenance of SARS-CoV-2.
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upon successive protease cleavages at the S1/S2 junction and a downstream S2' position, mediating membrane fusion to enable cellular entry of the virus.
Figure 3. Structure of the SARS Spike protein and how it binds to the hACE2 receptor. Pictures were generated based on PDB ID: 6acj37. A) Three spike proteins, each consisting of a S1 half and a S2 half, form a trimer. B) The S2 halves (shades of blue) are responsible for trimer formation, while the S1 portion (shades of red) is responsible for binding hACE2 (dark gray). C) Details of the binding between S1 and hACE2. The RBM of S1, which is important and sufficient for binding, is colored in orange. Residues within the RBM that are important for either hACE2 interaction or protein folding are shown as sticks (residue numbers follow the SARS Spike sequence).
JH: 1. Missing methods section. The report is missing a methods section, which is typically included in review articles23 and allows for critical review of the process by which the articles reviewed were chosen. Information should be included about how the alignments were created, sequence quality, and adjustments for sampling bias-all factors that affect the results and conclusions.
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Figure 4. Sequence alignment of the spike proteins from relevant coronaviruses. Viruses being compared include SARS-CoV-2 (Wuhan-Hu-1: NC_045512, 2019-nCoV_USA-AZ1: MN997409), bat coronaviruses (Bat_CoV_ZC45: MG772933, Bat_CoV_ZXC21: MG772934), and SARS coronaviruses (SARS_GZ02: AY390556, SARS: NC_004718.3). Region marked by two orange lines is the receptor-binding motif (RBM), which is important for interaction with the hACE2 receptor. Essential residues are additionally highlighted by red sticks on top. Region marked by two green lines is a furin-cleavage site that exists only in SARS-CoV-2 but not in any other lineage B [B beta] coronavirus.
JH: No comments provided. The comments on page 8 are offered.
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Similar to what is observed for other viral proteins, S2 of SARS-CoV-2 shares a high sequence identity (95%) with S2 of ZC45/ZXC21. In stark contrast, between SARS-CoV-2 and ZC45/ZXC21, the S1 protein, which dictates which host (human or bat) the virus can infect, is much less conserved with the amino acid sequence identity being only 69%.
JH: 1. On variability of Spike sequences. Lines 1-13: There are various judgments about the similarity of SARS-CoV-2 sequences to other related viruses (ZC45 and ZXC21), but no inclusion of contrasting evidence. For example, S2 is not highly variable among coronaviruses,24 but S1 is only a 69% match, making the claims that ZC45 was used as a template not credible. Convergent evolution, seen in several other viruses,25,26 including SARS-CoV-1,27 often as a virulence factor, should be considered by the authors.
Figure 4 shows the sequence alignment of the Spike proteins from six [B beta] coronaviruses. Two are viruses isolated from the current pandemic (Wuhan-Hu-1, 2019-nCoV_USA-AZ1); two are the suspected template viruses (Bat_CoV_ZC45, Bat_CoV_ZXC21); two are SARS coronaviruses (SARS_GZ02, SARS). The RBM is highlighted in between two orange lines. Clearly, despite the high sequence identity for the overall genomes, the RBM of SARS-CoV-2 differs significantly from those of ZC45 and ZXC21. Intriguingly, the RBM of SARS-CoV-2 resembles, on a great deal, the RBM of SARS Spike. Although this is not an exact "copy and paste", careful examination of the Spike-hACE2 structures37,38 reveals that all residues essential for either hACE2 binding or protein folding (orange sticks in Figure 3C and what is highlighted by red short lines in Figure 4) are "kept". Most of these essential residues are precisely preserved, including those involved in disulfide bond formation (C467, C474) and electrostatic interactions (R444, E452, R453, D454), which are pivotal for the structural integrity of the RBM (Figure 3C and 4). The few changes within the group of essential residues are almost exclusively hydrophobic "substitutions" (I428'L, L443'F, F460'Y, L472'F, Y484'Q), which should not affect either protein folding or the hACE2-interaction. At the same time, majority of the amino acid residues that are non-essential have "mutated" (Figure 4, RBM residues not labeled with short red lines). Judging from this sequence analysis alone, we were convinced early on that not only would the SARS-CoV-2 Spike protein bind hACE2 but also the binding would resemble, precisely, that between the original SARS Spike protein and hACE223. Recent structural work has confirmed our prediction39.
JH: 2. On substitution mutations within the Spike protein. Lines 16-18: Substitution mutations that are hydrophobic and classified as minor in the report, are structurally significant and not minor; many mutations are lysines to phenylalanines, which alter structure, or phenylalanine to tyrosine which alter the charge of the side group.
As elaborated below, the way that SARS-CoV-2 RBM resembles SARS-CoV RBM and the overall sequence conservation pattern between SARS-CoV-2 and ZC45/ZXC21 are highly unusual. Collectively, this suggests that portions of the SARS-CoV-2 genome have not been derived from natural quasi-species viral particle evolution.
JH: 3. Quasiviruses and evolution of RNA viruses. Lines 23-26: The authors make teleological assumptions in this passage. "As elaborated below, the way that SARS-CoV-2 RBM [receptorbinding motif] resembles SARS-CoV RBM and the overall sequence conservation pattern between SARS-CoV-2 and ZC45/ZXC21 are highly unusual. Collectively, this suggests that portions of the SARS-CoV-2 genome have not been derived from natural quasi-species viral particle evolution."10 Currently, not enough is understood about SARS quasispecies28 to argue definitively that a certain population arose from another or to eliminate the possibility of said evolution. Many of the Yan and colleagues' arguments could be explained by a mixture of convergent evolution, quasispecies, sampling bias, methodology issues, and/or a common ancestor.
If SARS-CoV-2 does indeed come from natural evolution, its RBM could have only been acquired in one of the two possible routes: 1) an ancient recombination event followed by convergent evolution or 2) a natural recombination event that occurred fairly recently.
In the first scenario, the ancestor of SARS-CoV-2, a ZC45/ZXC21-like bat coronavirus would have recombined and "swapped" its RBM with a coronavirus carrying a relatively "complete" RBM (in reference to SARS). This recombination would result in a novel ZC45/ZXC21-like coronavirus with all the gaps in its RBM "filled" (Figure 4). Subsequently, the virus would have to adapt extensively in its new host, where the ACE2 protein is highly homologous to hACE2. Random mutations across the genome would have to have occurred to eventually shape the RBM to its current form - resembling SARS-CoV RBM in a highly intelligent manner. However, this convergent evolution process would also result in the accumulation of a large amount of mutations in other parts of the genome, rendering the overall sequence identity relatively low. The high sequence identity between SARS-CoV-2 and ZC45/ZXC21 on various proteins (94-100% identity) do not support this scenario and, therefore, clearly indicates that SARS-CoV2 carrying such an RBM cannot come from a ZC45/ZXC21-like bat coronavirus through this convergent evolutionary route.
In the second scenario, the ZC45/ZXC21-like coronavirus would have to have recently recombined and swapped its RBM with another coronavirus that had successfully adapted to bind an animal ACE2 highly homologous to hACE2. The likelihood of such an event depends, in part, on the general requirements of
JH: 4. Viral recombination. Lines 30, 31, and 43: The description of viral recombination does not accurately describe how this process occurs in viruses.29,30 Viral recombination is a complex event,31 which is not a "swapping" of entire genes, as the authors suggest, but a common, important part of viral evolution.29 Reassortment can occur, but only in segmented, positivesense RNA viruses. It is likely that ancestors of SARS-CoV-2 underwent viral recombination, though this is not necessarily a complete exchange of entire gene segments.
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natural recombination: 1) that the two different viruses share significant sequence similarity; 2) that they must co-infect and be present in the same cell of the same animal; 3) that the recombinant virus would not be cleared by the host or make the host extinct; 4) that the recombinant virus eventually would have to become stable and transmissible within the host species.
In regard to this recent recombination scenario, the animal reservoir could not be bats because the ACE2 proteins in bats are not homologous enough to hACE2 and therefore the adaption would not be able to yield an RBM sequence as seen in SARS-CoV-2. This animal reservoir also could not be humans as the ZC45/ZXC21-like coronavirus would not be able to infect humans. In addition, there has been no evidence of any SARS-CoV-2 or SARS-CoV-2-like virus circulating in the human population prior to late 2019. Intriguingly, according to a recent bioinformatics study, SARS-CoV-2 was well-adapted for humans since the start of the outbreak1.
JH: 1. The potential for zoonotic emergence of coronaviruses. Line 9: There is not enough information available in the scientific literature to know whether strains related to SARS-CoV-2 may infect humans or if infections are possible but limited. Therefore, statements made by the authors about the infectivity of ZC45 are unsupported.
Only one other possibility of natural evolution remains, which is that the ZC45/ZXC21-like virus and a coronavirus containing a SARS-like RBM could have recombined in an intermediate host where the ACE2 protein is homologous to hACE2. Several laboratories have reported that some of the Sunda pangolins smuggled into China from Malaysia carried coronaviruses, the receptor-binding domain (RBD) of which is almost identical to that of SARS-CoV-227-29,31. They then went on to suggest that pangolins are the likely intermediate host for SARS-CoV-227-29,31. However, recent independent reports have found significant flaws in this data40-42. Furthermore, contrary to these reports27-29,31, no coronaviruses have been detected in Sunda pangolin samples collected for over a decade in Malaysia and Sabah between 2009 and 201943. A recent study also showed that the RBD, which is shared between SARS-CoV-2 and the reported pangolin coronaviruses, binds to hACE2 ten times stronger than to the pangolin ACE22, further dismissing pangolins as the possible intermediate host. Finally, an in silico study, while echoing the notion that pangolins are not likely an intermediate host, also indicated that none of the animal ACE2 proteins examined in their study exhibited more favorable binding potential to the SARS-CoV-2 Spike protein than hACE2 did3. This last study virtually exempted all animals from their suspected roles as an intermediate host3, which is consistent with the observation that SARS-CoV-2 was well-adapted for humans from the start of the outbreak1. This is significant because these findings collectively suggest that no intermediate host seems to exist for SARS-CoV-2, which at the very least diminishes the possibility of a recombinant event occurring in an intermediate host.
JH: 2. On intermediate hosts in viral evolution. Lines 21-23: Viruses can have complicated evolutionary origins, sometimes with intermediate hosts,32 as seen with influenza33; influenza viruses34 are also known to crossover into humans. The human ACE2 (hACE2) receptor may be optimal for SARS-CoV-2, but recent work has found that SARS-CoV-2 can actually use multiple ACE2 receptors,4 but not mice ACE2. More sampling needs to be done, but assertions about whether the hACE2 is the best receptor to bind SARS-CoV-2 cannot be supported at this time.
Even if we ignore the above evidence that no proper host exists for the recombination to take place and instead assume that such a host does exist, it is still highly unlikely that such a recombination event could occur in nature.
As we have described above, if natural recombination event is responsible for the appearance of SARSCoV-2, then the ZC45/ZXC21-like virus and a coronavirus containing a SARS-like RBM would have to recombine in the same cell by swapping the S1/RBM, which is a rare form of recombination. Furthermore, since SARS has occurred only once in human history, it would be at least equally rare for nature to produce a virus that resembles SARS in such an intelligent manner - having an RBM that differs from the SARS RBM only at a few non-essential sites (Figure 4). The possibility that this unique SARS-like coronavirus would reside in the same cell with the ZC45/ZXC21-like ancestor virus and the two viruses would recombine in the "RBM-swapping" fashion is extremely low. Importantly, this, and the other recombination event described below in section 1.3 (even more impossible to occur in nature), would both have to happen to produce a Spike as seen in SARS-CoV-2.
JH: 3. Zoonotic emergence of coronaviruses in history. Lines 36-38: Coronaviruses have caused human disease before, including SARS and MERS, and many have pointed to warning signs that coronaviruses could become a serious problem, which were not heeded prior to SARS-CoV-2. These facts are contradicted by the authors who also describe SARS-CoV-2 as "intelligent," which is teleological and counterfactual.
While the above evidence and analyses together appear to disapprove a natural origin of SARS-CoV2's RBM, abundant literature shows that gain-of-function research, where the Spike protein of a coronavirus
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was specifically engineered, has repeatedly led to the successful generation of humaninfecting coronaviruses from coronaviruses of non-human origin44-47.
JH: 1. Lack of evidence regarding gain of function research in coronaviruses. Line 2: Some gain of function research using coronaviruses has been published, but the author's statement of an "abundant" literature in this area overstates the amount known. The papers referenced do not support the author's claim that such research led to human competent viruses. One paper, Ren et al,35 inserted the Spike protein gene of all SARS-CoV-like viruses (not SARS) into a viral backbone and did not use the entire SARS virus or infect live animals.
Record also shows that research laboratories, for example, the Wuhan Institute of Virology (WIV), have successfully carried out such studies working with US researchers45 and also working alone47. In addition, the WIV has engaged in decades-long coronavirus surveillance studies and therefore owns the world's largest collection of coronaviruses. Evidently, the technical barrier is non-existent for the WIV and other related laboratories to carry out and succeed in such Spike/RBM engineering and gain-offunction research.
Figure 5. Two restriction sites are present at either end of the RBM of SARS-CoV-2, providing convenience for replacing the RBM within the spike gene. A. Nucleotide sequence of the RBM of SARS-CoV-2 (Wuhan-Hu-1). An EcoRI site is found at the 5'-end of the RBM and a BstEII site at the 3'-end. B. Although these two restriction sites do not exist in the original spike gene of ZC45, they can be conveniently introduced given that the sequence discrepancy is small (2 nucleotides) in either case. C. Amino acid sequence alignment with the RBM region highlighted (color and underscore). The RBM highlighted in orange (top) is what is defined by the EcoRI and BstEII sites in the SARS-CoV-2 (Wuhan-Hu-1) spike. The RBM highlighted in magenta (middle) is the region swapped by Dr. Fang Li and colleagues into a SARS Spike backbone39. The RBM highlighted in blue (bottom) is from the Spike protein (RBM: 424-494) of SARS-BJ01 (AY278488.2), which was swapped by the Shi lab into the Spike proteins of different bat coronaviruses replacing the corresponding segments47.
JH: 2. Lack of restriction sites in the proposed viral backbone ZC45. Figure 5: The authors describe a possible pathway for designing viruses that is out of step with current scientific methods for gene editing, casting doubt on both their analysis and their conclusions. While use of restriction sites as presented are theoretically possible in SARS-CoV-2, based on the authors' own analysis, ZC45 does not have the necessary restriction sites (of EcoRI and BstEII). Therefore, ZC45 would have to be genetically modified beyond the sequence presented for a restriction digestion to be possible. This negates the authors' argument that ZC45 is the obvious backbone of SARS-CoV-2. Restriction digests are not favored for manipulation of RNA viruses due to several obstacles: genome sizes, viral proofreading enzymes that can limit the success of restriction enzymes, and the ability to recover viruses after reverse genetic manipulation.
Strikingly, consistent with the RBM engineering theory, we have identified two unique restriction sites, EcoRI and BstEII, at either end of the RBM of the SARS-CoV-2 genome, respectively (Figure 5A). These two sites, which are popular choices of everyday molecular cloning, do not exist in the rest of this spike
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gene. This particular setting makes it extremely convenient to swap the RBM within spike, providing a quick way to test different RBMs and the corresponding Spike proteins.
Such EcoRI and BstEII sites do not exist in the spike genes of other [B beta] coronaviruses, which strongly indicates that they were unnatural and were specifically introduced into this spike gene of SARS-CoV-2 for the convenience of manipulating the critical RBM. Although ZC45 spike also does not have these two sites (Figure 5B), they can be introduced very easily as described in part 2 of this report.
It is noteworthy that introduction of the EcoRI site here would change the corresponding amino acids from -WNT- to -WNS- (Figure 5AB). As far as we know, all SARS and SARS-like bat coronaviruses exclusively carry a T (threonine) residue at this location. SARS-CoV-2 is the only exception in that this T has mutated to an S (serine), save the suspicious RaTG13 and pangolin coronaviruses published after the outbreak48.
JH: 1. On restriction sites present within the Spike protein. Lines 6-9: Restriction enzyme sites are found in all genomes and naturally occur frequently.36,37 For instance, in a commonly used adenovirus vector, the BstEII restriction enzyme site occurs 10 times. The frequency of restriction site distribution is due to the fact that they comprise stretches of 6 or 8 consecutive nucleotides, which have high-and measurable-probabilities of occurring by chance within a given genome. With contemporary gene-editing methodologies, restriction sites are rarely used. These arguments aside, Yan and colleagues falsely assert the existence of restriction enzyme sites in the SARS-CoV-2 sequence, but not in the Spike gene sequence of other beta coronaviruses, is evidence of genetic manipulation, or that the presence of restriction sites is rare. A New England BioLabs site search for restriction enzyme sites in the 5' end of the SARS-CoV-2 sequence revealed at least 7 other restriction sites in the RBM, in addition to the EcoRI site Yan et al cited as evidence of manipulation.
Once the restriction sites were successfully introduced, the RBM segment could be swapped conveniently using routine restriction enzyme digestion and ligation. Although alternative cloning techniques may leave no trace of genetic manipulation (Gibson assembly as one example), this oldfashioned approach could be chosen because it offers a great level of convenience in swapping this critical RBM.
Given that RBM fully dictates hACE2-binding and that the SARS RBM-hACE2 binding was fully characterized by high-resolution structures (Figure 3)37,38, this RBM-only swap would not be any riskier than the full Spike swap. In fact, the feasibility of this RBM-swap strategy has been proven39,47. In 2008, Dr. Zhengli Shi's group swapped a SARS RBM into the Spike proteins of several SARS-like bat coronaviruses after introducing a restriction site into a codon-optimized spike gene (Figure 5C)47. They then validated the binding of the resulted chimeric Spike proteins with hACE2. Furthermore, in a recent publication, the RBM of SARS-CoV-2 was swapped into the receptor-binding domain (RBD) of SARSCoV, resulting in a chimeric RBD fully functional in binding hACE2 (Figure 5C)39. Strikingly, in both cases, the manipulated RBM segments resemble almost exactly the RBM defined by the positions of the EcoRI and BstEII sites (Figure 5C). Although cloning details are lacking in both publications39,47, it is conceivable that the actual restriction sites may vary depending on the spike gene receiving the RBM insertion as well as the convenience in introducing unique restriction site(s) in regions of interest. It is noteworthy that the corresponding author of this recent publication39, Dr. Fang Li, has been an active collaborator of Dr. Zhengli Shi since 201049-53. Dr. Li was the first person in the world to have structurally elucidated the binding between SARS-CoV RBD and hACE238 and has been the leading expert in the structural understanding of Spike-ACE2 interactions38,39,53-56. The striking finding of EcoRI and BstEII restriction sites at either end of the SARS-CoV-2 RBM, respectively, and the fact that the same RBM region has been swapped both by Dr. Shi and by her long-term collaborator, respectively, using restriction enzyme digestion methods are unlikely a coincidence. Rather, it is the smoking gun proving that the RBM/Spike of SARS-CoV-2 is a product of genetic manipulation.
Although it may be convenient to copy the exact sequence of SARS RBM, it would be too clear a sign of artificial design and manipulation. The more deceiving approach would be to change a few nonessential residues, while preserving the ones critical for binding. This design could be well-guided by the high-resolution structures (Figure 3)37,38. This way, when the overall sequence of the RBM would appear to be more distinct from that of the SARS RBM, the hACE2-binding ability would be well-preserved. We believe that all of the crucial residues (residues labeled with red sticks in Figure 4, which are the same residues shown in sticks in Figure 3C) should have been "kept". As described earlier, while some should be direct preservation, some should have been switched to residues with similar properties, which would
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not disrupt hACE2-binding and may even strengthen the association further. Importantly, changes might have been made intentionally at non-essential sites, making it less like a "copy and paste" of the SARS RBM.
1.3 An unusual furin-cleavage site is present in the Spike protein of SARS-CoV-2 and is associated with the augmented virulence of the virus
Another unique motif in the Spike protein of SARS-CoV-2 is a polybasic furin-cleavage site located at the S1/S2 junction (Figure 4, segment in between two green lines). Such a site can be recognized and cleaved by the furin protease. Within the lineage B of [B beta] coronaviruses and with the exception of SARSCoV-2, no viruses contain a furin-cleavage site at the S1/S2 junction (Figure 6)57. In contrast, furincleavage site at this location has been observed in other groups of coronaviruses57,58. Certain selective pressure seems to be in place that prevents the lineage B of [B beta] coronaviruses from acquiring or maintaining such a site in nature.
Figure 6. Furin-cleavage site found at the S1/S2 junction of Spike is unique to SARS-CoV-2 and absent in other lineage B [B beta] coronaviruses. Figure reproduced from Hoffmann, et al57.
As previously described, during the cell entry process, the Spike protein is first cleaved at the S1/S2 junction. This step, and a subsequent cleavage downstream that exposes the fusion peptide, are both mediated by host proteases. The presence or absence of these proteases in different cell types greatly affects the cell tropism and presumably the pathogenicity of the viral infection. Unlike other proteases, furin protease is widely expressed in many types of cells and is present at multiple cellular and extracellular
JH: No comments provided.
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locations. Importantly, the introduction of a furin-cleavage site at the S1/S2 junction could significantly enhance the infectivity of a virus as well as greatly expand its cell tropism - a phenomenon well-documented in both influenza viruses and other coronaviruses59-65.
If we leave aside the fact that no furin-cleavage site is found in any lineage B [B beta] coronavirus in nature and instead assume that this site in SARS-CoV-2 is a result of natural evolution, then only one evolutionary pathway is possible, which is that the furin-cleavage site has to be derived from a homologous recombination event. Specifically, an ancestor [B beta] coronavirus containing no furin-cleavage site would have to recombine with a closely related coronavirus that does contain a furin-cleavage site.
However, two facts disfavor this possibility. First, although some coronaviruses from other groups or lineages do contain polybasic furin-cleavage sites, none of them contains the exact polybasic sequence present in SARS-CoV-2 (-PRRAR/SVA-). Second, between SARS-CoV-2 and any coronavirus containing a legitimate furin-cleavage site, the sequence identity on Spike is no more than 40%66. Such a low level of sequence identity rules out the possibility of a successful homologous recombination ever occurring between the ancestors of these viruses. Therefore, the furin-cleavage site within the SARS-CoV-2 Spike protein is unlikely to be of natural origin and instead should be a result of laboratory modification.
JH: 1. The possibility of convergent evolution in beta coronaviruses. Lines 10-12: Yan et al state that there is only 1 evolutionary pathway that could explain the appearance of SARS-CoV-2-a homologous recombination event. However, convergent evolution is another pathway for the development of the furin cleavage site, which would result in SARS-CoV-2 having the cleavage site similar to nonbeta coronaviruses. Convergent evolution is a well-established phenomenon in biology.
JH: 2. The evolution of a furin cleavage site. Lines 14-16: The authors argue that the existence of polybasic furin cleavage sites in other coronaviruses implies that convergent evolution could not have played a role in evolution of the furin cleavage site in SARS-CoV-2. The furin cleavage site refers to a specific position at the S1/S2 junction in SARS-CoV-2. This is a sequence of amino acids where the host (human) enzyme, furin,38 can cleave. This furin cleavage is essential for the proper maturation39 of the Spike glycoprotein and subsequent cell-to-cell membrane fusion in the host. They present the divergent furin cleavage site sequence in SARS-CoV-2 as evidence that homologous recombination between an ancestor beta coronavirus and a furin cleavage sitecontaining coronavirus is impossible. The argument that homologous recombination is not a likely factor in fact supports a hypothesis of convergent evolution.
Consistent with this claim, a close examination of the nucleotide sequence of the furin-cleavage site in SARS-CoV-2 spike has revealed that the two consecutive Arg residues within the inserted sequence (PRRA-) are both coded by the rare codon CGG (least used codon for Arg in SARS-CoV-2) (Figure 7)8. In fact, this CGGCGG arrangement is the only instance found in the SARS-CoV-2 genome where this rare codon is used in tandem. This observation strongly suggests that this furin-cleavage site should be a result of genetic engineering. Adding to the suspicion, a FauI restriction site is formulated by the codon choices here, suggesting the possibility that the restriction fragment length polymorphism, a technique that a WIV lab is proficient at67, could have been involved. There, the fragmentation pattern resulted from FauI digestion could be used to monitor the preservation of the furin-cleavage site in Spike as this furincleavage site is prone to deletions in vitro68,69. Specifically, RT-PCR on the spike gene of the recovered viruses from cell cultures or laboratory animals could be carried out, the product of which would be subjected to FauI digestion. Viruses retaining or losing the furin-cleavage site would then yield distinct patterns, allowing convenient tracking of the virus(es) of interest.
JH: 3. Homologous recombination. Lines 18-19: The report states that the low sequence identity between beta coronavirus and other coronaviruses that contained a furin cleavage site would be too low to allow homologous recombination to occur. If recombination had occurred, it would not have had to have occurred in the immediate area of the sequence coding the furin cleavage site; it could occur in other, more homologous regions.
Figure 7. Two consecutive Arg residues in the -PRRA- insertion at the S1/S2 junction of SARS-CoV-2 Spike are both coded by a rare codon, CGG. A FauI restriction site, 5'-(N)6GCGGG-3', is embedded in the coding sequence of the "inserted" PRRA segment, which may be used as a marker to monitor the preservation of the introduced furin-cleavage site.
In addition, although no known coronaviruses contain the exact sequence of -PRRAR/SVA- that is present in the SARS-CoV-2 Spike protein, a similar -RRAR/AR- sequence has been observed at the S1/S2 junction of the Spike protein in a rodent coronavirus, AcCoV-JC34, which was published by Dr. Zhengli Shi in 201770. It is evident that the legitimacy of -RRAR- as a functional furin-cleavage site has been known to the WIV experts since 2017.
The evidence collectively suggests that the furin-cleavage site in the SARS-CoV-2 Spike protein may not have come from nature and could be the result of genetic manipulation. The purpose of this manipulation could have been to assess any potential enhancement of the infectivity and pathogenicity of
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the laboratory-made coronavirus59-64. Indeed, recent studies have confirmed that the furin-cleavage site does confer significant pathogenic advantages to SARS-CoV-257,68.
1.4 Summary
Evidence presented in this part reveals that certain aspects of the SARS-CoV-2 genome are extremely difficult to reconcile to being a result of natural evolution. The alternative theory we suggest is that the virus may have been created by using ZC45/ZXC21 bat coronavirus(es) as the backbone and/or template. The Spike protein, especially the RBM within it, should have been artificially manipulated, upon which the virus has acquired the ability to bind hACE2 and infect humans. This is supported by the finding of a unique restriction enzyme digestion site at either end of the RBM. An unusual furin-cleavage site may have been introduced and inserted at the S1/S2 junction of the Spike protein, which contributes to the increased virulence and pathogenicity of the virus. These transformations have then staged the SARSCoV-2 virus to eventually become a highly-transmissible, onset-hidden, lethal, sequelae-unclear, and massively disruptive pathogen.
Evidently, the possibility that SARS-CoV-2 could have been created through gain-of-function manipulations at the WIV is significant and should be investigated thoroughly and independently.
2. Delineation of a synthetic route of SARS-CoV-2
In the second part of this report, we describe a synthetic route of creating SARS-CoV-2 in a laboratory setting. It is postulated based on substantial literature support as well as genetic evidence present in the SARS-CoV-2 genome. Although steps presented herein should not be viewed as exactly those taken, we believe that key processes should not be much different. Importantly, our work here should serve as a demonstration of how SARS-CoV-2 can be designed and created conveniently in research laboratories by following proven concepts and using well-established techniques.
Importantly, research labs, both in Hong Kong and in mainland China, are leading the world in coronavirus research, both in terms of resources and on the research outputs. The latter is evidenced not only by the large number of publications that they have produced over the past two decades but also by their milestone achievements in the field: they were the first to identify civets as the intermediate host for SARS-CoV and isolated the first strain of the virus71; they were the first to uncover that SARS-CoV originated from bats72,73; they revealed for the first time the antibody-dependent enhancement (ADE) of SARS-CoV infections74; they have contributed significantly in understanding MERS in all domains (zoonosis, virology, and clinical studies)75-79; they made several breakthroughs in SARS-CoV-2 research18,35,80. Last but not least, they have the world's largest collection of coronaviruses (genomic sequences and live viruses). The knowledge, expertise, and resources are all readily available within the Hong Kong and mainland research laboratories (they collaborate extensively) to carry out and accomplish the work described below.
JH: 1. On methods of a literature review. Typically, the scientific description of the steps to create a transmissible virus (as per the chart on page 15) would require biosecurity review before publication in a reputable scientific journal, as this is a dual-use concern,40 which has the potential to lower barriers toward biological weapons development. However, it should be noted that the steps described by Yan et al are not individually novel and, in our judgment, do not present a biological weapons risk, particularly as the methods chosen have been supplanted by more accurate genetic engineering tools.
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Figure 8 Diagram of a possible synthetic route of the laboratory creation of SARS-CoV-2
JH: No comment. See page 14 comment.
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2.1 Possible scheme in designing the laboratory-creation of the novel coronavirus
In this sub-section, we outline the possible overall strategy and major considerations that may have been formulated at the designing stage of the project.
To engineer and create a human-targeting coronavirus, they would have to pick a bat coronavirus as the template/backbone. This can be conveniently done because many research labs have been actively collecting bat coronaviruses over the past two decades32,33,70,72,81-85. However, this template virus ideally should not be one from Dr. Zhengli Shi's collections, considering that she is widely known to have been engaged in gain-of-function studies on coronaviruses. Therefore, ZC45 and/or ZXC21, novel bat coronaviruses discovered and owned by military laboratories33, would be suitable as the template/backbone. It is also possible that these military laboratories had discovered other closely related viruses from the same location and kept some unpublished. Therefore, the actual template could be ZC45, or ZXC21, or a close relative of them. The postulated pathway described below would be the same regardless of which one of the three was the actual template.
Once they have chosen a template virus, they would first need to engineer, through molecular cloning, the Spike protein so that it can bind hACE2. The concept and cloning techniques involved in this manipulation have been well-documented in the literature44-46,84,86. With almost no risk of failing, the template bat virus could then be converted to a coronavirus that can bind hACE2 and infect humans44-46.
JH: 1. On troubleshooting molecular cloning. Line 16: The authors' statement that there is "almost no risk of [molecular cloning] failing"10 contradicts experience with the technique, as it can be a finicky method41 requiring keen problem-solving skills.42
Second, they would use molecular cloning to introduce a furin-cleavage site at the S1/S2 junction of Spike. This manipulation, based on known knowledge60,61,65, would likely produce a strain of coronavirus that is a more infectious and pathogenic.
Third, they would produce an ORF1b gene construct. The ORF1b gene encodes the polyprotein Orf1b, which is processed post-translationally to produce individual viral proteins: RNA-dependent RNA polymerase (RdRp), helicase, guanidine-N7 methyltransferase, uridylate-specific endoribonuclease, and 2'-O-methyltransferase. All of these proteins are parts of the replication machinery of the virus. Among them, the RdRp protein is the most crucial one and is highly conserved among coronaviruses. Importantly, Dr. Zhengli Shi's laboratory uses a PCR protocol, which amplifies a particular fragment of the RdRp gene, as their primary method to detect the presence of coronaviruses in raw samples (bat fecal swap, feces, etc). As a result of this practice, the Shi group has documented the sequence information of this short segment of RdRp for all coronaviruses that they have successfully detected and/or collected.
JH: 2. Virology protocol inaccuracies. Lines 25-29: The report inaccurately describes some common laboratory techniques. For example, the report states that sequence information for short segments of coronavirus RNA-dependent RNA polymerase (RdRp) is possible due to the availability of a polymerase chain reaction (PCR) protocol used to identify coronaviruses. However, PCR is not a sequencing method, it only amplifies existent sequences. PCR is a common tool, used to determine if a specific DNA sequence is in a sample and, if so, how many copies of that sequence are in the sample. Using PCR to detect the presence of coronaviruses in a sample is a standard practice in research and clinical laboratories using standard coronavirusspecific primers, as the RdRp is highly conserved between coronaviruses. Approximately 28 current SARS-CoV-2 diagnostics43 with Emergency Use Authorization use this method and this specific gene target.
Here, the genetic manipulation is less demanding or complicated because Orf1b is conserved and likely Orf1b from any [B beta] coronavirus would be competent enough to do the work. However, we believe that they would want to introduce a particular Orf1b into the virus for one of the two possible reasons:
1. Since many phylogenetic analyses categorize coronaviruses based on the sequence similarity of the RdRp gene only18,31,35,83,87, having a different RdRp in the genome therefore could ensure that SARS-CoV-2 and ZC45/ZXC21 are separated into different groups/sub-lineages in phylogenetic studies. Choosing an RdRp gene, however, is convenient because the short RdRp segment sequence has been recorded for all coronaviruses ever collected/detected. Their final choice was the RdRp sequence from bat coronavirus RaBtCoV/4991, which was discovered in 2013. For RaBtCoV/4991, the only information ever published was the sequence of its short RdRp segment83, while neither its full genomic sequence nor virus isolation were ever reported. After amplifying the RdRp segment (or the whole ORF1b gene) of RaBatCoV/4991, they would have then used it for subsequent assembly and creation of the genome of SARS-CoV-2. Small changes in the RdRp sequence could either be introduced at the beginning (through DNA synthesis) or be generated via
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passages later on. On a separate track, when they were engaged in the fabrication of the RaTG13 sequence, they could have started with the short RdRp segment of RaBtCoV/4991 without introducing any changes to its sequence, resulting in a 100% nucleotide sequence identity between the two viruses on this short RdRp segment83. This RaTG13 virus could then be claimed to have been discovered back in 2013.
2. The RdRp protein from RaBatCoV/4991 is unique in that it is superior than RdRp from any other [B beta]coronavirus for developing antiviral drugs. RdRp has no homologs in human cells, which makes this essential viral enzyme a highly desirable target for antiviral development. As an example, Remedesivir, which is currently undergoing clinical trials, targets RdRp. When creating a novel and human-targeting virus, they would be interested in developing the antidote as well. Even though drug discovery like this may not be easily achieved, it is reasonable for them to intentionally incorporate a RdRp that is more amenable for antiviral drug development.
Fourth, they would use reverse genetics to assemble the gene fragments of spike, ORF1b, and the rest of the template ZC45 into a cDNA version of the viral genome. They would then carry out in vitro transcription to obtain the viral RNA genome. Transfection of the RNA genome into cells would allow the recovery of live and infectious viruses with the desired artificial genome.
Fifth, they would carry out characterization and optimization of the virus strain(s) to improve the fitness, infectivity, and overall adaptation using serial passage in vivo. One or several viral strains that meet certain criteria would then be obtained as the final product(s).
JH: 1. Serial passaging and virulence. Lines 19-20: Serial passaging refers to a process wherein a stock viral population is used to infect an animal, then virus from that animal is collected and used to infect another animal for a designated number of "passages." Serial passage of a virus causes the population to adapt to the animal or cell type in which it is being passaged. Passaging would lead to adaptation to another animal (if passaged in vivo) or, if in vitro, to the specific cell type used. Most human cells used in laboratory culture have significant differences compared to the commensurate cells in humans. Serial passage, then, would not necessarily make a virus more pathogenic to live humans. Additionally, passage does not necessarily increase fitness of a viral population. The report mischaracterizes the complexity of these processes and projects outcomes from passaging that are not supported by laboratory techniques.
2.2 A postulated synthetic route for the creation of SARS-CoV-2
In this sub-section, we describe in more details how each step could be carried out in a laboratory setting using available materials and routine molecular, cellular, and virologic techniques. A diagram of this process is shown in Figure 8. We estimate that the whole process could be completed in approximately 6 months.
Step 1: Engineering the RBM of the Spike for hACE2-binding (1.5 months)
The Spike protein of a bat coronavirus is either incapable of or inefficient in binding hACE2 due to the missing of important residues within its RBM. This can be exemplified by the RBM of the template virus ZC45 (Figure 4). The first and most critical step in the creation of SARS-CoV-2 is to engineer the Spike so that it acquires the ability to bind hACE2. As evidenced in the literature, such manipulations have been carried out repeatedly in research laboratories since 200844, which successfully yielded engineered coronaviruses with the ability to infect human cells44-46,88,89. Although there are many possible ways that one can engineer the Spike protein, we believe that what was actually undertaken was that they replaced the original RBM with a designed and possibly optimized RBM using SARS' RBM as a guide. As described in part 1, this theory is supported by our observation that two unique restriction sites, EcoRI and BstEII, exist at either end of the RBM in the SARS-CoV-2 genome (Figure 5A) and by the fact that such RBM-swap has been successfully carried out by Dr. Zhengli Shi and by her long-term collaborator and structure biology expert, Dr. Fang Li39,47.
Although ZC45 spike does not contain these two restriction sites (Figure 5B), they can be introduced very easily. The original spike gene would be either amplified with RT-PCR or obtained through DNA synthesis (some changes could be safely introduced to certain variable regions of the sequence) followed by PCR. The gene would then be cloned into a plasmid using restriction sites other than EcoRI and BstEII.
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Once in the plasmid, the spike gene can be modified easily. First, an EcoRI site can be introduced by converting the highlighted "gaacac" sequence (Figure 5B) to the desired "gaattc" (Figure 5A). The difference between them are two consecutive nucleotides. Using the commercially available QuikChange Site-Directed Mutagenesis kit, such a di-nucleotide mutation can be generated in no more than one week. Subsequently, the BstEII site could be similarly introduced at the other end of the RBM. Specifically, the "gaatacc" sequence (Figure 5B) would be converted to the desired "ggttacc" (Figure 5A), which would similarly require a week of time.
Once these restriction sites, which are unique within the spike gene of SARS-CoV-2, were successfully introduced, different RBM segments could be swapped in conveniently and the resulting Spike protein subsequently evaluated using established assays.
As described in part 1, the design of an RBM segment could be well-guided by the high-resolution structures (Figure 3)37,38, yielding a sequence that resembles the SARS RBM in an intelligent manner. When carrying out the structure-guided design of the RBM, they would have followed the routine and generated a few (for example a dozen) such RBMs with the hope that some specific variant(s) may be superior than others in binding hACE2. Once the design was finished, they could have each of the designed RBM genes commercially synthesized (quick and very affordable) with an EcoRI site at the 5'-end and a BstEII site at the 3'-end. These novel RBM genes could then be cloned into the spike gene, respectively. The gene synthesis and subsequent cloning, which could be done in a batch mode for the small library of designed RBMs, would take approximately one month.
These engineered Spike proteins might then be tested for hACE2-binding using the established pseudotype virus infection assays45,49,50. The engineered Spike with good to exceptional binding affinities would be selected. (Although not necessary, directed evolution could be involved here (error-prone PCR on the RBM gene), coupled with either an in vitro binding assay39,90 or a pseudotype virus infection assay45,49,50, to obtain an RBM that binds hACE2 with exceptional affinity.)
Given the abundance of literature on Spike engineering44-46,84,86 and the available high-resolution structures of the Spike-hACE2 complex37,38, the success of this step would be very much guaranteed. By the end of this step, as desired, a novel spike gene would be obtained, which encodes a novel Spike protein capable of binding hACE2 with high affinity.
JH: 1. Unrealistic timelines. Lines 25-29: The timeline offered for how an entirely novel protein can be engineered in a little studied virus, circa 2019, is not scientifically realistic.
Step 2: Engineering a furin-cleavage site at the S1/S2 junction (0.5 month)
The product from Step 1, a plasmid containing the engineered spike, would be further modified to include a furin-cleavage site (segment indicated by green lines in Figure 4) at the S1/S2 junction. This short stretch of gene sequence can be conveniently inserted using several routine cloning techniques, including QuikChange Site-Directed PCR60, overlap PCR followed by restriction enzyme digestion and ligation91, or Gibson assembly. None of these techniques would leave any trace in the sequence. Whichever cloning method was the choice, the inserted gene piece would be included in the primers, which would be designed, synthesized, and used in the cloning. This step, leading to a further modified Spike with the furin-cleavage site added at the S1/S2 junction, could be completed in no more than two weeks.
Step 3: Obtain an ORF1b gene that contains the sequence of the short RdRp segment from RaBtCoV/4991 (1 month, yet can be carried out concurrently with Steps 1 and 2)
Unlike the engineering of Spike, no complicated design is needed here, except that the RdRp gene segment from RaBtCoV/4991 would need to be included. Gibson assembly could have been used here. In this technique, several fragments, each adjacent pair sharing 20-40 bp overlap, are combined together in one simple reaction to assemble a long DNA product. Two or three fragments, each covering a significant
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section of the ORF1b gene, would be selected based on known bat coronavirus sequences. One of these fragments would be the RdRp segment of RaBtCoV/499183. Each fragment would be PCR amplified with proper overlap regions introduced in the primers. Finally, all purified fragments would be pooled in equimolar concentrations and added to the Gibson reaction mixture, which, after a short incubation, would yield the desired ORF1b gene in whole.
Step 4: Produce the designed viral genome using reverse genetics and recover live viruses (0.5 month)
Reverse genetics have been frequently used in assembling whole viral genomes, including coronavirus genomes67,92-96. The most recent example is the reconstruction of the SARS-CoV-2 genome using the transformation-assisted recombination in yeast97. Using this method, the Swiss group assembled the entire viral genome and produced live viruses in just one week97. This efficient technique, which would not leave any trace of artificial manipulation in the created viral genome, has been available since 201798,99. In addition to the engineered spike gene (from steps 1 and 2) and the ORF1b gene (from step 3), other fragments covering the rest of the genome would be obtained either through RT-PCR amplification from the template virus or through DNA synthesis by following a sequence slightly altered from that of the template virus. We believe that the latter approach was more likely as it would allow sequence changes introduced into the variable regions of less conserved proteins, the process of which could be easily guided by multiple sequence alignments. The amino acid sequences of more conserved functions, such as that of the E protein, might have been left unchanged. All DNA fragments would then be pooled together and transformed into yeast, where the cDNA version of the SARS-CoV-2 genome would be assembled via transformation-assisted recombination. Of course, an alternative method of reverse genetics, one of which the WIV has successfully used in the past67, could also be employed67,92-96,100. Although some earlier reverse genetics approaches may leave restriction sites at where different fragments would be joined, these traces would be hard to detect as the exact site of ligation can be anywhere in the ~30kb genome. Either way, a cDNA version of the viral genome would be obtained from the reverse genetics experiment. Subsequently, in vitro transcription using the cDNA as the template would yield the viral RNA genome, which upon transfection into Vero E6 cells would allow the production of live viruses bearing all of the designed properties.
JH: 1. Methods of genetic modification in viruses. Lines 11-12: The authors incorrectly state that reverse genetics systems are commonly used to assemble coronaviruses. Reverse genetics44 can be used in other virus synthesis, such as influenza. The paper the authors cite, from Thao and colleagues,41 did use reverse genetics in a yeast-based system to synthesize full length SARSCoV-2. However, previous research45 had identified that coronaviruses can be particularly difficult to engineer using reverse genetics systems, as the large size of Nidovirus genomes, replicase activity, and requirement for large transcript synthesis create obstacles. Certain methods require insertion of mutations elsewhere in the genome to manage the T7 transcription termination signals or require helper viruses to coinfect cells to aid in cloning. Recent work in dengue viruses46 and MERS47 has shown the promise of Gibson assembly in synthesizing positive-strand viruses.
JH: 2. Reverse genetics tools (and limitations). Lines 22-24: Reverse genetics and synthetic biology provide technological tools to synthesize SARS-CoV-2, as demonstrated by the methods section of the Thao paper.41 The yeast used for this synthesis of SARS-CoV-2 used a specific platform that depended on a mouse hepatitis virus. The description in Yan et al of pooling the DNA fragments together and "transforming" them into yeast will not work,48,49 as it would require a method known as transformation-associated recombination,50 calling into question the Yan analysis.
Step 5: Optimize the virus for fitness and improve its hACE2-binding affinity in vivo (2.5-3 months)
Virus recovered from step 4 needs to be further adapted undergoing the classic experiment - serial passage in laboratory animals101. This final step would validate the virus' fitness and ensure its receptororiented adaptation toward its intended host, which, according to the analyses above, should be human. Importantly, the RBM and the furin-cleavage site, which were introduced into the Spike protein separately, would now be optimized together as one functional unit. Among various available animal models (e.g. mice, hamsters, ferrets, and monkeys) for coronaviruses, hACE2 transgenic mice (hACE2-mice) should be the most proper and convenient choice here. This animal model has been established during the study of SARS-CoV and has been available in the Jackson Laboratory for many years102-104.
JH: 3. On viral passaging and adaptation. Lines 34-35: Adaptation for receptors likely improves infectability of a virus, but it does not necessarily make the virus more transmissible, pathogenic, or virulent. Even if the virus adapts for the receptor, it does not mean that the virus will be able to cause viremia or transmit to other hosts. The report falsely asserts that serial passage would "validate the virus' fitness and ensure its receptor-oriented adaptation toward its intended host"10 and also argue a contradictory theory on page 3 that the virus was not serially passaged. While viral passaging can optimize viral fitness, this is never a guarantee and has to be scientifically demonstrated.
The procedure of serial passage is straightforward. Briefly, the selected viral strain from step 4, a precursor of SARS-CoV-2, would be intranasally inoculated into a group of anaesthetized hACE2-mice. Around 2-3 days post infection, the virus in lungs would usually amplify to a peak titer. The mice would then be sacrificed and the lungs homogenized. Usually, the mouse-lung supernatant, which carries the highest viral load, would be used to extract the candidate virus for the next round of passage. After approximately 10~15 rounds of passage, the hACE2-binding affinity, the infection efficiency, and the lethality of the viral strain would be sufficiently enhanced and the viral genome stabilized101. Finally, after a series of characterization experiments (e.g. viral kinetics assay, antibodies response assay, symptom observation and pathology examination), the final product, SARS-CoV-2, would be obtained, concluding
JH: 4. SARS-CoV-2 animal models. Line 39: Finding an animal model for SARS-CoV-2 has been difficult51 and, before 2020, there was not a good animal model for SARS-CoV, so the idea of "serial passage in laboratory animals"10 would have been challenging.
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the whole creation process. From this point on, this viral pathogen could be amplified (most probably using Vero E6 cells) and produced routinely.
It is noteworthy that, based on the work done on SARS-CoV, the hACE2-mice, although suitable for SARS-CoV-2 adaptation, is not a good model to reflect the virus' transmissibility and associated clinical symptoms in humans. We believe that those scientists might not have used a proper animal model (such as the golden Syrian hamster) for testing the transmissibility of SARS-CoV-2 before the outbreak of COVID-19. If they had done this experiment with a proper animal model, the highly contagious nature of SARS-CoV-2 would be extremely evident and consequently SARS-CoV-2 would not have been described as "not causing human-to-human transmission" at the start of the outbreak.
JH: 1. Serial passaging and virulence. Lines 2-4: The authors incorrectly assert that serial passage of a virus only leads to increased virulence. The report asserts that 10 to 15 rounds of passage would improve the viral Spike protein's binding affinity and the infectivity and lethality of the virus. However, serial passaging does not always lead to genome stabilization, as some viral populations may die off.52 Of the strains that do stabilize, infection efficiency is only enhanced for the model species used for passaging, not for all species. Some of these (millions of) virions may be more lethal or infectious, just as many may be less so. Passaging cannot guarantee an outcome of viral evolution. The life cycle of a virus and infection efficiency depend on more than just receptor binding, and adaptation to 1 organ or 1 type of receptor may come at the expense of reduced ability to spread to other organs, cause viremia, shed from 1 host, or cause pathogenicity.53 Thus, improved receptor binding does not necessarily mean enhanced transmissibility or pathogenicity.54
We also speculate that the extensive laboratory-adaptation, which is oriented toward enhanced transmissibility and lethality, may have driven the virus too far. As a result, SARS-CoV-2 might have lost the capacity to attenuate on both transmissibility and lethality during its current adaptation in the human population. This hypothesis is consistent with the lack of apparent attenuation of SARS-CoV-2 so far despite its great prevalence and with the observation that a recently emerged, predominant variant only shows improved transmissibility105-108.
Serial passage is a quick and intensive process, where the adaptation of the virus is accelerated. Although intended to mimic natural evolution, serial passage is much more limited in both time and scale. As a result, less random mutations would be expected in serial passage than in natural evolution. This is particularly true for conserved viral proteins, such as the E protein. Critical in viral replication, the E protein is a determinant of virulence and engineering of it may render SARS-CoV-2 attenuated109-111 Therefore, at the initial assembly stage, these scientists might have decided to keep the amino acid sequence of the E protein unchanged from that of ZC45/ZXC21. Due to the conserved nature of the E protein and the limitations of serial passage, no amino acid mutation actually occurred, resulting in a 100% sequence identity on the E protein between SARS-CoV-2 and ZC45/ZXC21. The same could have happened to the marks of molecular cloning (restriction sites flanking the RBM). Serial passage, which should have partially naturalized the SARS-CoV-2 genome, might not have removed all signs of artificial manipulation.
JH: 2. On laboratory adaptation leading to increased virulence. Lines 16-21: Viral adaptation can include attenuation. That is one reason why viruses and bacteria are sometimes serially passaged for attenuation to be used in vaccines.55,56 It cannot be stated as Yan and colleagues do that there is a "lack of apparent attenuation"10 so far in this pandemic, because the global incidence of COVID-19 (especially asymptomatic cases) is unknown, or that viral adaptation, in vitro or in vivo, led to increase transmissibility or virulence.
JH: 3. Viral mutation rates. Line 24: The authors state that if serial passage is confined to 1 species, less random mutations occur, but this is incorrect. Mutation rates are a function of the RdRp, as well as the ExoN proofreading enzyme,57 and so repeated passage will not inherently make a virus more or less likely to mutate. However, passage does affect which mutations58 become fixed in the viral population. Coronaviruses form a quasispecies, where each variant within the population can be different from the others and have different fitnesses. Together, the population of variants infect a host, disseminate from the initial infection site, and cause pathogenesis. During a passage, the viral variants best suited for infection and pathogenesis within the model organism are selected for, but the rate of mutations occurring does not change. Because mutations can still occur, there is a possibility the virus can adapt, unless the mutations cause so many deleterious mutations that the population collapses.
3. Final remarks
Many questions remain unanswered about the origin of SARS-CoV-2. Prominent virologists have implicated in a Nature Medicine letter that laboratory escape, while not being entirely ruled out, was unlikely and that no sign of genetic manipulation is present in the SARS-CoV-2 genome4. However, here we show that genetic evidence within the spike gene of SARS-CoV-2 genome (restriction sites flanking the RBM; tandem rare codons used at the inserted furin-cleavage site) does exist and suggests that the SARS-CoV-2 genome should be a product of genetic manipulation. Furthermore, the proven concepts, well-established techniques, and knowledge and expertise are all in place for the convenient creation of this novel coronavirus in a short period of time.
Motives aside, the following facts about SARS-CoV-2 are well-supported:
1. If it was a laboratory product, the most critical element in its creation, the backbone/template virus (ZC45/ZXC21), is owned by military research laboratories.
2. The genome sequence of SARS-CoV-2 has likely undergone genetic engineering, through which the virus has gained the ability to target humans with enhanced virulence and infectivity.
Page 21 (Conclusion)
3. The characteristics and pathogenic effects of SARS-CoV-2 are unprecedented. The virus is highly transmissible, onset-hidden, multi-organ targeting, sequelae-unclear, lethal, and associated with various symptoms and complications.
4. SARS-CoV-2 caused a world-wide pandemic, taking hundreds of thousands of lives and shutting down the global economy. It has a destructive power like no other.
Judging from the evidence that we and others have gathered, we believe that finding the origin of SARS-CoV-2 should involve an independent audit of the WIV P4 laboratories and the laboratories of their close collaborators. Such an investigation should have taken place long ago and should not be delayed any further.
We also note that in the publication of the chimeric virus SHC015-MA15 in 2015, the attribution of funding of Zhengli Shi by the NIAID was initially left out. It was reinstated in the publication in 2016 in a corrigendum, perhaps after the meeting in January 2016 to reinstate NIH funding for gain-of-function research on viruses. This is an unusual scientific behavior, which needs an explanation for.
What is not thoroughly described in this report is the various evidence indicating that several coronaviruses recently published (RaTG1318, RmYN0230, and several pangolin coronaviruses27-29,31) are highly suspicious and likely fraudulent. These fabrications would serve no purpose other than to deceive the scientific community and the general public so that the true identity of SARS-CoV-2 is hidden. Although exclusion of details of such evidence does not alter the conclusion of the current report, we do believe that these details would provide additional support for our contention that SARS-CoV-2 is a laboratory-enhanced virus and a product of gain-of-function research. A follow-up report focusing on such additional evidence is now being prepared and will be submitted shortly.
JH: 1. While the impact of SARS-CoV-2 on global public health is undeniable, the pathogenic effects of SARS-CoV-2 infection at an individual or cellular level are not unprecedented. Many viruses are capable of causing high morbidity and mortality,59,60 infecting several organs, and/ or presymptomatic or asymptomatic transmission.61 Additionally, other viral infections (eg, chikungunya) also induce long-term sequelae.62 Humans have contended with many scourges and it is a certainty that COVID-19 will not be the last.
Acknowledgements
We would like to thank Daoyu Zhang for sharing with us the findings of mutations in the E proteins in different sub-groups of [B beta] coronaviruses. We also thank all the anonymous scientists and other individuals, who have contributed in uncovering various facts associated with the origin of SARS-CoV-2.
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Back To Where Did COVID-19 Come From
References:
[1] Did the coronavirus leak from a lab? These scientists say we shouldn’t rule it out. For many scientists, challenging the idea that SARS-CoV-2 has natural origins is seen as career suicide. But a vocal few say it shouldn't be disregarded or lumped in with conspiracy theories. MIT Technology Review, March 18, 2021. webpage https://www.technologyreview.com/2021/03/18/1021030/coronavirus-leak-wuhan-lab-scientists-conspiracy, March 2021. Did the coronavirus leak from a lab? These scientists say we shouldn’t rule it out.
[2] Unusual Features of the SARS-CoV-2 Genome Suggesting Sophisticated Laboratory Modification Rather Than Natural Evolution and Delineation of Its Probable Synthetic Route, Limeng Yan The University of Hong Kong, September 2020.
[3] SARS-CoV-2 Is an Unrestricted Bioweapon: A Truth Revealed through Uncovering a Large-Scale, Organized Scientific Fraud Li-Meng Yan (MD, PhD)1, Shu Kang (PhD)1, Jie Guan (PhD)1, Shanchang Hu (PhD), October 8, 2020, Rule of Law Society & Rule of Law Foundation, New York, NY, USA.
[4] In Response: Yan et al Preprint Examinations of the Origin of SARS-CoV-2, Johns Hopkins Center for Health Security, centerforhealthsecurity.org, This review has been written by Kelsey Lane Warmbrod, MS, MPH; Rachel M. West, PhD; Nancy D. Connell, PhD; and Gigi Kwik Gronvall, PhD; all from the Johns Hopkins Center for Health Security, September 21, 2020. webpage https://www.centerforhealthsecurity.org/our-work/pubs_archive/pubs-pdfs/2020/200921-in-response-yan.pdf, March 2021. In Response: Yan et al Preprint Examinations of the Origin of SARS-CoV-2
[A] GenBank Bat coronavirus RaTG13 complete genome, Wuhan Institute of Virology, National Center for Biotechnology Information, U.S. National Library of Medicine. webpages https://www.ncbi.nlm.nih.gov/nuccore/MN996532 VRL 24-NOV-2020. https://www.ncbi.nlm.nih.gov/nuccore/MN996532.1, VRL 24-MAR-2020. https://www.ncbi.nlm.nih.gov/nuccore/MN996532.2, VRL 24-NOV-2020. Accessed March 2021. GenBank Bat coronavirus RaTG13 complete genome.
The World Health Organization (WHO) formed a team to perform a global study of the origins of the SARS-CoV-2 contagion and released a Joint WHO-China study in March 2021 [1]. As part of the study they visited various locations in China including the Wuhan Institute of Virology (WIV). Before examining the WHO report on the origin of the COVID-19 virus, this analysis will begin by independently examining the Wuhan Institute of Virology and related topics.
An approach to this investigation is to use the basic journalism practice of who, what, where, when, why, and how. Interestingly the journalistic approach follows the systems perspective approach for developing a system design [A]. This is a quick first pass at the analysis and was performed before the WHO study was examined:
| Journalism | Systems Perspective | Comments |
| Who | Needs Analysis: Who are the system stakeholders. | The stakeholders are all bio labs engaged in coronavirus research around the world. It is also all the people in physical locations where the coronavirus may have jumped from an animal to a human. |
| What | System Boundary: What is the system boundary. | The system boundary initially was assumed to be China because it was first isolated in China. However the system boundary must be the entire world. |
| Where | System Location: Where was the system that is the coronavirus infection first detected. | The coronavirus infection was first isolated in China so the assumption is that it originated in China. However like with the Spanish Flu that may not be the case. |
| When | System Start: When was the system that is the coronavirus infection started. | The coronavirus infection appears to have started in late 2020. However the Spanish Flu of 1918 investigation eventually suggested that the virus was in the population before it was detected and tracked to the earliest cases in Spain. |
| Why | System Emergence: Why did the system that is the coronavirus pandemic emerge. | This one is very important because we have had multiple contagions in the past that were contained. Why did we fail to contain the coronavirus infection is a question that will asked for centuries. This analysis suggests that it was a failure of the US Government and finds the root cause to be privatization and deregulation. |
| How | System Implementation: How did the system that is the coronavirus pandemic get implemented. | The system analysis suggests that the coronavirus was spread so quickly because of airplanes and airports. The R0 infection rate is very high when traveling by air. |
The following is an independent review of the WIV and was performed before the WHO study was examined.
The Wuhan Institute of Virology (WIV), originally named as the Wuhan Microbiology Laboratory, was founded in 1956 as a research institute on virology administered by the Chinese Academy of Sciences (CAS) land is located in Jiangxia District, Wuhan, Hubei, China.
The WIV was the site of construction for the first biosafety level 4 (BSL–4) laboratory in China. It was completed in 2014 in collaboration with the French government's Centre International de Recherche en Infectiologie is an academic and research institute (CIRI) lab based in Lyon, France. Thed laboratory has 3000 square meters of BSL-4 space, two BSL-3 labs, and 20 BSL-2 labs. The BSL-4 facilities were accredited by the China National Accreditation Service for Conformity Assessment (CNAS) in January 2017, with the BSL-4 level lab put into operation in January 2018. Safety precautions taken when building the BSL–4 Wuhan were:
Some of the key findings are:
The following analysis was performed after examining the WHO report.
The WHO report on the origins of the COVID-19 virus is inconclusive [1]. Some continue to suggest without evidence that the virus came from the WIV and this is just a massive distraction. This distraction must not take away from what needs to happen, which is massive collaboration and application of our best science, engineering, and systems practices to deal with this disaster and prevent future contagion disasters.
We know that the virus is not a result of war or an act of terrorism because there have been no claims in either of those horrible scenarios. So the question of where the COVID-19 virus may have come from is irrelevant. What matters is the systems we have to protect us from future natural contagions and future lab accidents. It appears that the world has established many different labs to study the sources of horrible contagions. In the USA there was the massive effort to resurrect the 1918 Flu pandemic virus. Around the world various labs are studying the coronavirus. Military organizations are engaged in various related research efforts. This is the current state of our technology and its pattern is the same as the nuclear technology that surfaced in the last century. Collaboration and strong oversight applying massive science, engineering, and the systems perspective are the tools that we can use to control this very powerful technology.
A relevant question to ask is why the virus was not contained once it was identified. It's possible that containment was beyond our capabilities. The problem with that argument is that we know leadership in the USA lied to the public and the world about the true nature of the virus. We also know that the world depended on the USA as the natural leader in these areas to properly assess and communicate the nature of the situation. It did not happen. History, not the WHO, will eventually decide what caused the COVID-19 disaster. The choices will include:
The search for the source of the virus that is the COVID-19 disaster will continue and it eventually may be found. However, the disaster and accountability is not about the existence of the virus. The disaster and accountability is about what we did once we detected and isolated the virus. After WWII a world court was convened and war criminals were charged with crimes against humanity. There will be no world court in this case, but history will convene such a court and make its findings known to future generations. Our grandchildren will stand in judgment of us and our actions.
Also see section International Perspective.
Back To Where Did COVID-19 Come From
References:
[1] WHO-convened global study of origins of SARS-CoV-2: China Part, Joint WHO-China study: 14 January - 10 February 2021 Joint Report, World Health Organization (WHO), 30 March 2021. webpage https://www.who.int/publications/i/item/who-convened-global-study-of-origins-of-sars-cov-2-china-part, https://www.who.int/docs/default-source/coronaviruse/who-convened-global-study-of-origins-of-sars-cov-2-china-part-joint-report.pdf, April 2021. WHO-convened global study of origins of SARS-CoV-2: China Part, Joint WHO-China study: 14 January - 10 February 2021 Joint Report . PDF . local
[2] WHO-convened global study of origins of SARS-CoV-2: China Part, Joint WHO-China study: 14 January - 10 February 2021 Joint Report -ANNEXES, World Health Organization (WHO), 30 March 2021. webpage https://www.who.int/publications/i/item/who-convened-global-study-of-origins-of-sars-cov-2-china-part, https://www.who.int/docs/default-source/coronaviruse/who-convened-global-study-of-origins-of-sars-cov-2-china-part-annexes.pdf, April 2021. WHO-convened global study of origins of SARS-CoV-2: China Part, Joint WHO-China study: 14 January - 10 February 2021 Joint Report -ANNEXES. PDF . local
[3] Wuhan Institute of Virology, https://en.wikipedia.org/wiki/Wuhan_Institute_of_Virology, April 2021.
[4] Bats Are Natural Reservoirs of SARS-Like Coronaviruses, Zenodo, October 31, 2005. webpage https://zenodo.org/record/3949088#.YG3TtvkpDDc, April 2021. Bats Are Natural Reservoirs of SARS-Like Coronaviruses
[5] Bat cave solves mystery of deadly SARS virus --- and suggests new outbreak could occur, Nature, .December 01, 2017. webpage https://www.nature.com/articles/d41586-017-07766-9, April 2021. Bat cave solves mystery of deadly SARS virus --- and suggests new outbreak could occur
[6] A SARS-like cluster of circulating bat coronaviruses shows potential for human emergence, National Institutes of Health, National Center for Biotechnology Information, U.S. National Library of Medicine, November 9, 2015. webpage https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4797993, April 2021. A SARS-like cluster of circulating bat coronaviruses shows potential for human emergence
[7] Engineered bat virus stirs debate over risky research, Nature, November 12, 2015. webpage https://www.nature.com/news/engineered-bat-virus-stirs-debate-over-risky-research-1.18787, April 2021. Engineered bat virus stirs debate over risky research
[8] Discovery of a rich gene pool of bat SARS-related coronaviruses provides new insights into the origin of SARS coronavirus, National Center for Biotechnology Information, U.S. National Library of Medicine, Nov 30, 2017. webpage https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5708621, April 2021. Discovery of a rich gene pool of bat SARS-related coronaviruses provides new insights into the origin of SARS coronavirus . PDF . local
[9] Serological Evidence of Bat SARS-Related Coronavirus Infection in Humans, China, National Center for Biotechnology Information, U.S. National Library of Medicine, March 2, 2018. webpage https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6178078, April 2021. Serological Evidence of Bat SARS-Related Coronavirus Infection in Humans, China, National Center for Biotechnology Information
[10] Shi Zhengli Q&A Reply to Science Magazine, American Association for the Advancement of Science (AAAS) Science Magazine , July 23, 2020. webpage https://www.sciencemag.org/sites/default/files/Shi%20Zhengli%20Q%26A.pdf, April 2021.
[A] Systems Engineering Design Renaissance, Walter Sobkiw, ISBN: 978-0983253075, 2014. REF 2
US Intelligence on Virus Origins
Multiple US Intelligence agencies performed an analysis on the origins of COVID-19. While the US pushes for more disclosure from China, specifically the Wuhan lab, China pushes for an investigation of the US, specifically Fort Detrick. China claims that the virus slipped out of a lab at the US Army's Fort Detrick base in Maryland in 2019 and suggested the US should invite World Health Organization (WHO) experts to Fort Detrick to investigate [1]. According to the report from the US Office of the Director of National Intelligence (ODNI) only China can help solve questions about the true origins of the virus [2].
The following is from the US Unclassified Summary of Assessment on COVID-19 Origins in full. [2]
Key TakeawaysThe IC assesses that SARS-CoV-2, the virus that causes COVID-19, probably emerged and infected humans through an initial small-scale exposure that occurred no later than November 2019 with the first known cluster of COVID-19 cases arising in Wuhan, China in December 2019. In addition, the IC was able to reach broad agreement on several other key issues. We judge the virus was not developed as a biological weapon. Most agencies also assess with low confidence that SARS-CoV-2 probably was not genetically engineered; however, two agencies believe there was not sufficient evidence to make an assessment either way. Finally, the IC assesses China's officials did not have foreknowledge of the virus before the initial outbreak of COVID-19 emerged.
After examining all available intelligence reporting and other information, though, the IC remains divided on the most likely origin of COVID-19. All agencies assess that two hypotheses are plausible: natural exposure to an infected animal and a laboratory-associated incident.
- Four IC elements and the National Intelligence Council assess with low confidence that the initial SARS-CoV-2 infection was most likely caused by natural exposure to an animal infected with it or a close progenitor virus - a virus that probably would be more than 99 percent similar to SARS-CoV-2. These analysts give weight to China's officials’ lack of foreknowledge,the numerous vectors for natural exposure, and other factors.
- One IC element assesses with moderate confidence that the first human infection with SARS-CoV-2 most likely was the result of a laboratory-associated incident, probably involving experimentation, animal handling, or sampling by the Wuhan Institute of Virology. These analysts give weight to the inherently risky nature of work on coronaviruses.
- Analysts at three IC elements remain unable to coalesce around either explanation without additional information, with some analysts favoring natural origin, others a laboratory origin, and some seeing the hypotheses as equally likely.
- Variations in analytic views largely stem from differences in how agencies weigh intelligence reporting and scientific publications, and intelligence and scientific gaps.
The IC judges they will be unable to provide a more definitive explanation for the origin of COVID-19 unless new information allows them to determine the specific pathway for initial natural contact with an animal or to determine that a laboratory in Wuhan was handling SARS-CoV-2 or a close progenitor virus before COVID-19 emerged.
- The IC - and the global scientific community - lacks clinical samples or a complete understanding of epidemiological data from the earliest COVID-19 cases. If we obtain information on the earliest cases that identified a location of interest or occupational exposure, it may alter our evaluation of hypotheses.
China's cooperation most likely would be needed to reach a conclusive assessment of the origins of COVID-19. Beijing, however, continues to hinder the global investigation, resist sharing information and blame other countries, including the United States. These actions reflect, in part, China's government's own uncertainty about where an investigation could lead as well as its frustration the international community is using the issue to exert political pressure on China.
The following table summarizes the findings from the IC Elements. There are more IC elements in the Natural Source camp than in the Lab Source camp. What is relevant is that there are some IC elements considering the Lab Source as a reasonable source and that there is low confidence that the source is Natural from the remaining IC elements. Is moderate confidence equal to 4 low confidence ratings or is it 5 low confidence ratings. The question is important, but the National Intelligence Council has concluded that the results indicate a natural source.
| IC elements | Natural Source | Lab Source | Comments |
| 1 | low confidence | see note 1 | |
| 2 | low confidence | see note 1 | |
| 3 | low confidence | see note 1 | |
| 4 | low confidence | see note 1 | |
| 5 | moderate confidence | see note 2 | |
| 6 | Favor | need more info | |
| 7 | Favor | need more info | |
| 8 | equal confidence | equal confidence | need more info |
Notes:
Without additional details it is difficult to understand the conclusions from the National Intelligence Council. Further declassification of the material may be warranted given the gravity of the situation. For example, what is the additional reasoning behind the low confidence assessment other than what is provided.
In addition to the Unclassified Summary of Assessment on COVID-19 Origins, there is the 2021 Annual Threat Assessment Report [3]. The US Annual Threat Assessment includes large content associated with destabilization due to the COVID-19 disaster. This has displaced previous years threat assessments of destabilization due to Global Warming. As has been stated multiple times in this analysis, COVID-19 is a symptom and not a cause. We see the world not really behaving rationally with the COVID-19 disaster allowing primitive forces to drive decisions rather than logic, science, and engineering. If the world is unable to deal with the massive immediate disaster of COVID-19 it is unlikely it will deal with Global Warming in a logical, scientific, engineering based approach.
FORWARDIn the coming year, the United States and its allies will face a diverse array of threats that are playing out amidst the global disruption resulting from the COVID-19 pandemic and against the backdrop of great power competition, the disruptive effects of ecological degradation and a changing climate, an increasing number of empowered non-state actors, and rapidly evolving technology.
The effects of the COVID-19 pandemic will continue to strain governments and societies, fueling humanitarian and economic crises, political unrest, and geopolitical competition as countries,such as China and Russia, seek advantage through such avenues as vaccine diplomacy. No country has been completely spared, and even when a vaccine is widely distributed globally, the economic and political aftershocks will be felt for years. Countries with high debts or that depend on oil exports, tourism, or remittances face particularly challenging recoveries, while others will turn inward or be distracted by other challenges.
Ecological degradation and a changing climate will continue to fuel disease outbreaks, threaten food and water security, and exacerbate political instability and humanitarian crises. Although much of the effect of a changing climate on US security will play out indirectly in a broader political and economic context, warmer weather can generate direct, immediate impacts - for example, through more intense storms, flooding, and permafrost melting. This year we will see increasing potential for surges in migration by Central American populations, which are reeling from the economic fallout of the COVID-19 pandemic and extreme weather, including multiple hurricanes in 2020 and several years of recurring droughts and storms.
COVID-19 PANDEMIC AND DISEASES
The COVID-19 pandemic has disrupted life worldwide, with far-reaching effects that extend well beyond global health to the economic, political, and security spheres. We expect COVID-19 to remain a threat to populations worldwide until vaccines and therapeutics are widely distributed. The economic and political implications of the pandemic will ripple through the world for years.
The pandemic is raising geopolitical tensions, and great powers are jockeying for advantage and influence. States are struggling to cooperate - and in some cases are undermining cooperation - to respond to the pandemic and its economic fallout, particularly as some governments turn inward and question the merits of globalization and interdependence. Some governments, such as China and Russia, are using offers of medical supplies and vaccines to try to boost their geopolitical standing.
The economic fallout from the pandemic is likely to create or worsen instability in at least a few - and perhaps many - countries, as people grow more desperate in the face of interlocking pressures that include sustained economic downturns, job losses, and disrupted supply chains. Some hard-hit developing countries are experiencing financial and humanitarian crises, increasing the risk of surges in migration, collapsed governments, or internal conflict.
- Although global trade shows signs of bouncing back from the COVID-19-induced slump, economists caution that any recovery this year could be disrupted by ongoing or expanding pandemic effects, keeping pressure on many governments to focus on internal economic stability. In April, the international Monetary Fund estimated that the global economy would grow 6 percent this year and 4.4 percent in 2022. This year's forecast is revised up 0.5 percentage points relative to the previous forecast, reflecting expectations of vaccine-powered strengthening of activity later in the year and additional policy support in a few large economies. The global growth contraction for 2020 is estimated at 3.3 percent.
- The resurgence in COVID-19 infections early this year may have an even greater economic impact as struggling businesses in hard-hit sectors such as tourism and restaurants fold and governments face increasing budget strains.
- The effects on developing countries - especially those that rely heavily on remittances, tourism, or oil exports - may be severe and longer lasting; many developing countries already have sought debt relief.
- The economic fallout from the COVID-19 pandemic, along with conflict and weather extremes, has driven food insecurity worldwide to its highest point in more than a decade,which increases the risk of instability. The number of people experiencing high levels of acute food insecurity doubled from 135 million in 2019 to about 270 million last year, and is projected to rise to 330 million by year end.
The COVID-19 pandemic is prompting shifts in security priorities for countries around the world. As militaries face growing calls to cut budgets, gaps are emerging in UN peacekeeping operations; military training and preparedness; counter terrorism operations; and arms control monitoring, verification, and compliance. These gaps are likely to grow without a quick end to the pandemic and a rapid recovery, making managing conflict more difficult - particularly because the pandemic has not caused any diminution in the number or intensity of conflicts.
COVID-19-related disruptions to essential health services - such as vaccinations, aid delivery, and maternal and child health programs - will increase the likelihood of additional health emergencies, especially among vulnerable populations in low-income countries. As examples, the pandemic has disrupted HIV/AIDS treatments and preventative measures in Sub-Saharan Africa, as well as measles and polio vaccination campaigns in dozens of countries. World populations, including Americans, will remain vulnerable to new outbreaks of infectious diseases as risk factors persist, such as rapid and unplanned urbanization, protracted conflict and humanitarian crises, human incursions into previously unsettled land, expansion of international travel and trade, and public mistrust of government and health care workers.
Assessment of US Intelligence on Virus Origins
This analysis begins with an alternative view that COVID-19 is from a lab source. It is offered to show the ramifications of concluding that the virus originated from a lab. Then a systems analysis will be performed to try and understand the source of COVID-19 and the implications of the findings.
COVID-19 Lab Source
As described in other sections of this systems analysis, there has been large Gain of Function research efforts. The research has not been performed from a systems perspective or respected in terms of unintended consequences. There are Gain of Function research lab activities around the world. Given that a clear connection to a natural source has not been found two years into the pandemic, it is reasonable to assume at this point that the source of the virus is from a lab. This finding is based on the massive level of spread in the human population. A similar spread in the natural environment is a reasonable assumption, and with such a massive spread, there should be evidence to make a reasonable connection to patient zero. So the reasons to conclude that COVID-19 originated in a lab are:
The questions then revolve around the lab source and they are: (1) was it an accident or (2) a conscious act from a lunatic. If it was an accident, then the Wuhan Lab is likely. If it was an act from a lunatic, then all labs are suspect including Fort Detrick.
As far as fixing blame, the whole world is to blame because no one wanted to address the topic of Gain of Function research. It became the equivalent of a nuclear arms race, but in this case the disaster most likely happened. This is a very painful finding and can lead to massive destabilization. If this finding was accepted, there would be massive world wide destabilization. In the best interest of the world going forward, it is best to error on the side of a natural source. Even if there is evidence to the contrary, such as an act from a lunatic, it would be best to suppress the evidence and prevent further damage.
Systems Analysis on Virus Origins and Ramifications
In all systems analysis for a massive problem like the COVID-19 disaster all alternatives are placed on the table and considered for analysis. This is usually part of a brainstorming session to find all the alternatives no matter how bizarre and or unlikely. The following is a list of possible scenarios for the source of the COVID-19 virus and the ramifications.
COVID-19 Source Scenarios |
Destabilization |
Worst Case Outcome |
Who Benefits |
Who Is Harmed |
Comments |
| 1. Natural | Lowest |
Focus on COVID-19 mitigations | No one |
All |
This is the current conclusion from most |
| 2A. Lab Accident (Wuhan) | Low |
New lab practices, possible shutdown of some research | No one |
China |
Based on lab location and initial outbreak claims |
| 2B. Lab Accident (Wuhan) | High |
Economic sanctions & broken supply chain to US | Rival Powers |
China and US |
Pushed by US zealots with political agendas |
| 3. Lab Accident (Fort Detrick) | Low |
New lab practices, possible shutdown of some research | No one |
US |
This is suggested by China and claims of other outbreaks |
| 4. Lab Accident (Other) | Low |
New lab practices, possible shutdown of some research | No one |
Gain of Function Researchers |
All the labs collaborate, thus a possible scenario from a systems perspective |
| 5. Nation State Attack on China | Highest |
War | Attacker |
China |
Makes no sense, why would a Nation State attack China and destabilize the world |
| 6. China Attack on the World | Highest |
War | No one |
World |
Makes no sense, why would China attack its own people and destabilize their economy |
| 7. Lunatic Attack on China | High |
Massive new security restrictions | Lunatic |
China |
Virus could have come from anywhere and dropped in wet market in China |
| 8. Business Rival Attack on China | Highest |
War | Business Rival |
China |
Virus could have come from anywhere and dropped in wet market in China |
| 9. Terrorist Attack to Frame China | Highest |
War | Terrorists |
China |
No attack claims |
| 10. Lunatic Attack on the World | High |
Massive new security restrictions | No one |
All |
To reduce the population |
The above scenario analysis suggests that it is in the best interest of the world to conclude that the COVID-19 virus source is natural. Unlike in the analysis: COVID-19 Lab Source, there is data and logic that traces to the recommendation that the COVID-19 virus source should be a Natural Source, until there is overwhelming evidence to the contrary.
One of the results of trying to determine the source of the COVID-19 virus, by considering different scenarios and the ramifications, is that mitigations start to naturally flow out of the analysis. The following table shows the possible COVID-19 virus source scenarios and mitigations that should be immediately considered to prevent future events like the COVID-19 outbreak.
COVID-19 Source Scenarios |
Mitigation |
Actions Taken |
Comments |
| 1. Natural | Close all wet markets | Partial |
China closed the Wuhan wet market |
| 2. Lab Accident (Wuhan) | New lab practices, new training, shutdown of some research | Probably |
|
| 3. Lab Accident (Fort Detrick) | New lab practices, new training, shutdown of some research | Probably |
|
| 4. Lab Accident (Other) | New lab practices, new training | Probably |
|
| 5. Nation State Attack on China | Other nation state intelligence, United Nations | None |
|
| 6. China Attack on the World | Other nation state intelligence, United Nations | None |
|
| 7. Lunatic Attack on China | New screening of all lab staff | Probably |
They will seek out and recruit lab staff |
| 8. Business Rival Attack on China | New screening of all lab staff, Nation state intelligence, arrest bad business actors | Unknown |
They will seek out and compromise lab staff |
| 9. Terrorist Attack to Frame China | New screening of all lab staff, Nation state intelligence, United Nations | Unknown |
They will seek out and recruit lab staff |
| 10. Lunatic Attack on the World | New screening of all lab staff, Nation state intelligence | No one |
They will seek out and recruit lab staff |
The above scenario analysis suggests that it is prudent to perform the following:
The above analysis is probably part of the analysis performed by the US and other Military and Intelligence organizations around the world.
Beyond Military or Intelligence Analysis
The following is probably not part of any Military or Intelligence analysis.
We know from the 2021 Annual Threat Assessment Report and previous year reports that prior to the COVID-19 disaster, the major destabilizing force was Global Warming [3]. Unlike the Global Warming challenge, we do have the technology to deal with the COVID-19 disaster and the costs are very low by any standard and minuscule once compared to the Global Warming problem. For example, to vaccinate all the people on Earth, assuming 8 billion people at $10 per shot, the cost is just $160 billion dollars for a double shot. This assumes the existing infrastructure to deliver the shots is used, but even if additional infrastructure is needed to deliver the shots, it is difficult to see the costs going much beyond the costs of the actual shots. We also see that for the industrialized nations, where the economies are dependent on safe buildings, the costs associated with upgraded ventilation is also trivial once compared to the Global Warming challenge. Yet two years into the COVID-19 disaster there has been no social will to roll out the technology and solve the problem that is the COVID-19 pandemic.
Ventilation systems are not being rolled out and vaccines are in short supply from a global perspective. The world should be over flowing with vaccines at this point in time and the only issue that we should be discussing is delivery, not production. All schools and most public buildings should have effective ventilation contagion mitigation systems. Both are failed systems (global vaccination and global ventilation contagion mitigation systems) and that is why this research keeps using the words COVID-19 Disaster. It is a disaster because of the irresponsible behavior of the leaders and the people, not because of a lack of capability, technology, and industrial capacity.
The source of the COVID-19 virus is from us (natural or lab) because it spread into a world wide disaster. The solution to end the COVID-19 disaster must come from us. The issue is when will the collective us wakeup and do the right things going forward rather than fix blame and do nothing but the minimum. That is the most important COVID-19 intelligence finding and it comes from this COVID-19 research from a systems perspective analysis.
Also see section International Perspective.
Back To Where Did COVID-19 Come From
References:
[1] U.S. intelligence community says cannot solve COVID mystery without China, Reuters, August 27, 2021. webpage https://www.reuters.com/world/us-intelligence-community-still-divided-covid-19s-origin-summary-2021-08-27, August 2021. U.S. intelligence community says cannot solve COVID mystery without China, Reuters.
[2] Unclassified Summary of Assessment on COVID-19 Origins, August 27, 2021, Office of the Director of National Intelligence (ODNI). webpage https://www.dni.gov/index.php/newsroom/press-releases/item/2112-intelligence-community-statement-on-origins-of-covid-19, https://www.dni.gov/index.php/newsroom/reports-publications/reports-publications-2021/item/2236-unclassified-summary-of-assessment-on-covid-19-origins, https://www.dni.gov/files/ODNI/documents/assessments/Unclassified-Summary-of-Assessment-on-COVID-19-Origins.pdf, August 2021. PDF . local
[3] The 2021 Annual Threat Assessment Report, Office of the Director of National Intelligence (ODNI), April 09, 2021. webpage, https://www.dni.gov/files/ODNI/documents/assessments/ATA-2021-Unclassified-Report.pdf, August 2021. PDF . local
This topic is not meant to be disrespectful to all those that suffered, lost their health, and died because of the COVID-19 disaster. This topic is offered to shake people to their core so that they realize how stupid they have become. It is okay to be stupid when everything is fine and someone else is ensuring your comfortable life style. It is not okay to remain stupid in the middle of a massive disaster like COVID-19. This is a wakeup message. The clock is ticking and the virus disaster is here. It will not be going away soon and action must be taken using all our technologies and capabilities to deal with this disaster [11].
Definitions:
Stupid: This is a person that has access to education but decides not to get the the education or they are exposed to an education and they reject the content.Ignorant: This is a person that is denied an education. In the last century the massive social call was to educate everyone everywhere. Little did they know that people would decide to be stupid in the 21st century.
Author Comment: I was made aware of the difference between stupid and ignorant by a retired teacher. The comment was you can't fix stupid. It took me several months to understand this observation. Little did I know that it would define a serious social illness condition in our current society.
The following is a possible list of conspiracy theories associated with the source of the COVID-19 virus:
In the last century people needed to deal with the 1918 pandemic. They did not know what was happening and they did not have the technologies to deal with the event. They went to work and developed technologies to provide for healthy and safe environments. They realized that when they wanted to fly in an airplane they needed life support systems or the passengers would freeze to death and die from lack of oxygen as the plane flew up to 20,000 feet. This led them to develop modern forced air heating ventilation and cooling systems to provide clean air. They developed new technologies associated with electrical engineering that led to UV ceiling level lights to instantly kill dangerous viruses in public spaces. They did not pack people like sardines into airplane passenger compartments or force them to take off their shoes in a massive crowd where one sick person would make hundreds sick and possibly kill them. They did not say I want my kids back in school without first making sure the schools were safe. They did not enter public establishments known to spread sickness and death.
Unlike the previous generations which needed to develop the technologies and expertise to deal with a pandemic, we have the technologies and expertise to deal with COVID-19 but we do not have the Social Will to do what is right and required [7]. We filled our leadership positions with extremely stupid people because we have an extremely stupid population. The future is not good. We have had a year to move away from stupid and it did not happen.
There have been many news reports on TV showing a distraught mother demanding that her children go back to school. She does not express safety concerns but only demands that her children return to school. The report then ends and the news moves to another story. The reporter does not ask the mother about safety concerns, does not visit the local schools to determine what has been done to make the schools safe outside of social distancing and masking that is known to be ineffective in these settings because they are not practiced for the entire day, does not contact UV companies to get their take on making public spaces safe, does not contact HVAC companies to see what can be done, does not contact the local HVAC companies servicing the local schools and hospitals, does not even do an Internet search to see which school districts have installed ceiling level UV-C systems, what they have done with their HVAC systems and why they went down those paths. [8] [9]
The same applies to reporters visiting local businesses like restaurants. The restaurant owners demand that they must open. They show that they clean their establishments per government guidelines but they do not mention that their trade journals have articles of small businesses installing ceiling level UV-C systems, upgrading their HVAC systems, and listing companies that provide these systems. The reporters do not ask the owners about these actions taken by other business owners. The news organization does not follow up to see what businesses have done beyond the trivial and expected in even normal conditions cleaning practices. [1] [2] [3] [4]
The reporter and news organization in the above scenario are stupid people and they are very different from the irate mother. The mother may have have been denied an education while the reporter and news organization were provided an education. The mother is redeemable if given the opportunity for an education. The reporter and news organization are not redeemable because they have the education and rejected it. This is not unlike the observation made by Professor Harry G. Frankfurt in his book On Bullshit [10] where people engaged in lying may be redeemable but those engaged in bullshit are not redeemable because they don't care, they are just pushing an agenda at any cost. The stupid just use bullshit to further their own toxic agendas.
There is evidence that the society is starting to bifurcate. The rich have their own planes, are able to charter exclusive planes, and can fly anywhere in the world. They live, play, and work in state-of-the-art facilities with perfect HVAC systems, room level UV systems, and HVAC duct UV systems. The well to do are purchasing travel trailers and ensuring that their schools are being upgraded with room level UV systems, upgraded HVAC systems, and HVAC duct UV systems. They work remotely and have little need to interact with the general population. The retired who do not need to work live outside and enjoy nature. [5] [6]
The society will continue to bifurcate between those that will use technology to have healthy environments and those that will live in virus and other infection source environments as they pursue conspiracy theories.
The health specialists in our civilization offered COVID-19 guidelines, some of which were captured formally by the CDC and WHO. In the USA some of these guidelines should have immediately translated into regulations at the first sign that the guidelines were being ignored. That did not happen and history will clearly show that the blame falls directly on the Republican party in the USA because they adopted the deregulation and privatization policies in the early 1980s and never let go, even though there was clear evidence they were hurting the people at the expense of their narrow stakeholders that benefited from these policies. This social model came crashing down and was totally invalidated by the COVID-19 disaster. This policy has led to massive suffering and death. Ignoring data, facts, and reality is just like ignoring an education and it is clearly a sign that these people are extremely stupid. They even fed conspiracy theories to protect their catastrophically failed policies.
There are two approaches to fix stupid. The first is to wait for the natural system that is the society to correct itself, which may take multiple life times after much suffering and death. The second approach is to use government regulations to fix the bad or failed system in less time.
References:
[1] The Blind Horse Becomes First Restaurant In The United States To Install Far-UVC Light Technology For Real-Time Virus Mitigation And Indoor Sanitization, Globe Newswire, October 13, 2020. webpage https://www.globenewswire.com/news-release/2020/10/13/2107717/0/en/THE-BLIND-HORSE-BECOMES-FIRST-RESTAURANT- IN-THE-UNITED-STATES-TO-INSTALL-FAR-UVC-LIGHT-TECHNOLOGY-FOR-REAL-TIME- VIRUS-MITIGATION-AND-INDOOR-SANITIZATION.html, January 2021.
[2] Wisconsin Restaurant Installs COVID-Killing UV Lights, Spectrum News1, October 14, 2020. webpage https://spectrumnews1.com/wi/madison/coronavirus/2020/10/14/wisconsin-restaurant-installs-covid-killing-uv-lights-, January 2021. Wisconsin Restaurant Installs COVID-Killing UV Lights
[3] With winter approaching, some restaurants turn to UV light to make indoors safer, Products that use UV rays to purify the air are popping up in restaurants., September 02, 2020. webpage https://www.restaurantbusinessonline.com/technology/winter-approaching-some-restaurants-turn-uv-light-make-indoors-safer, January 2021. With winter approaching, some restaurants turn to UV light to make indoors safer
[4] Breathe Easier: Seattle-area restaurants invest in fancy air filtration systems, seattlerefined Sinclair Broadcast Group, October 02, 2020, webpage http://seattlerefined.com/eat-drink/breathe-easier-forward-thinking-restaurants-invest-in-air-filtration-systems, January 2021. Breathe Easier: Seattle-area restaurants invest in fancy air filtration systems
[5] Margate condo first in state to install ultraviolet light sanitizing technology, they say, Press Of Atlantic City, September 09, 2020. webpage https://pressofatlanticcity.com/margate-condo-first-in-state-to-install-ultraviolet-light-sanitizing-technology-they-say/article_5c259798-7c35-5ad8-be85-e5b7a5838aa3.html, January 2021. Margate condo first in state to install ultraviolet light sanitizing technology, they say
[6] Technology at the Forefront for Healthier High-Rise Buildings, The COVID-19 pandemic has real estate developers turning to new tech, like UV light treatments and touchless entrances, to create safer environments for residents, Mansion Global June 07, 2020. webpage https://www.mansionglobal.com/articles/technology-at-the-forefront-for-healthier-high-rise-buildings-216579, January 2021. Technology at the Forefront for Healthier High-Rise Buildings
[7] UV lights, ozone cleaners, sanitizers help shelter keep homeless safe, Catholic News Service, June 16, 2020. webpage https://angelusnews.com/news/nation/uv-lights-ozone-cleaners-sanitizers-help-shelter-keep-homeless-safe/, January 2021. UV lights, ozone cleaners, sanitizers help shelter keep homeless safe
[8] High school installs ultraviolet light system to keep students safe, WNNC, May 20, 2020. webpage https://www.wcnc.com/article/news/health/coronavirus/queens-grant-high-school-uv-light-system-coronavirus/275-c3e54672-905f-4fab-8e5f-8c58d5ca49f3, January 2021. High school installs ultraviolet light system to keep students safe
[9] Some SC schools to use ultraviolet light to fight coronavirus. A few things to know. The Herald November 10, 2020. webpage https://www.heraldonline.com/news/coronavirus/article247021112.html, January 2021. Some SC schools to use ultraviolet light to fight coronavirus. A few things to know
[10] On Bullshit Hardcover, Harry G. Frankfurt, Princeton University Press, ISBN: 978-0691122946, January 30, 2005.
[11] See section Infrastructure Bifurcation.
Leading Causes of Death
In 2020 COVID-19 was the third leading cause of death in the USA. Without the shutdown it would have been the number one cause of death. It is unclear where COVID-19 and its mutations will fall in the rank of causes of death in future years. There is data showing that some people experience reinfection. This suggests that the innate immune system was able to rid the body of the contagion without the stimulation and production of antibodies, that the virus mutated and the previous infection antibodies are not able to fully prevent the second infection, or there was a misdiagnosis.
The leading causes of death in the USA are as follows: [spreadsheet flu]
Cause of Death |
Deaths | Data Year | Comment |
Heart disease |
659,041 |
2019 [1] | Early data Jan 1 to Jun 2, 2020: 397,042 [5] |
Cancer |
599,601 |
2019 [1] | Early data 606,520 for 2020. [6] |
| COVID-19 | 548,162 |
March 2020 to April 1, 2021 [2] | |
Accidents (unintentional injuries) |
173,040 |
2019 [1] | |
Chronic lower respiratory diseases |
156,979 |
2019 [1] | |
Stroke (cerebrovascular diseases) |
150,005 |
2019 [1] | |
Alzheimer's disease |
121,499 |
2019 [1] | |
Diabetes |
87,647 |
2019 [1] | |
Nephritis, nephrotic syndrome, and nephrosis |
51,565 |
2019 [1] | |
Influenza and pneumonia |
49,783 |
2019 [1] | |
Intentional self-harm (suicide) |
47,511 |
2019 [1] |
The following table shows Flu data over the past several years [3]. It then includes the data from the COVID-19 disaster [4]. [spreadsheet flu, death rates]
Flu Season Date |
COVID19 |
2019-2020 |
2018-2019 |
2017-2018 |
2017-2018 |
2015-2016 |
2014-2015 |
2013-2014 |
2012-2013 |
2011-2012 |
2010-2011 |
Symptomatic Illnesses |
28,405,925 |
38,000,000 |
36,000,000 |
45,000,000 |
29,000,000 |
24,000,000 |
30,000,000 |
30,000,000 |
34,000,000 |
9,300,000 |
21,000,000 |
Medical Visits |
- |
18,000,000 |
17,000,000 |
21,000,000 |
14,000,000 |
11,000,000 |
14,000,000 |
13,000,000 |
16,000,000 |
4,300,000 |
10,000,000 |
Hospitalizations |
20,643,016 |
400,000 |
490,000 |
810,000 |
500,000 |
280,000 |
590,000 |
350,000 |
570,000 |
140,000 |
290,000 |
Intensive Care Unit |
4,056,815 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
On Ventilator |
1,383,024 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Loss of Life |
548,162 |
22,000 |
34,000 |
61,000 |
38,000 |
23,000 |
51,000 |
38,000 |
43,000 |
12,000 |
37,000 |
Note: From The COVID Tracking Project: Only about two-thirds of states and territories report data for Cumulative hospitalized/Ever hospitalized, and even fewer states report data for Cumulative in ICU/Ever in ICU and Cumulative on ventilator/Ever hospitalized. Therefore, adding these state and territory figures together to get a national count (as we do for other COVID-19 metrics with complete reporting such as cases and tests) drastically undercounts the true cumulative national number of COVID-19 patients who have ever been hospitalized, admitted to the the ICU, or placed on a ventilator. This incomplete reporting can lead to a misleading national picture. For example, since more states report the number of people currently in the ICU or on a ventilator than report them cumulatively, the national numbers for individuals currently in the ICU or on a ventilator sometimes exceed the cumulative values [4].
As the vaccination program continues it is expected that the death rate will subside. However, with the vaccine there is a massive desire to return to life prior to the COVID-19 disaster. The key is to vaccinate as many people as quickly as our industrial base can support. We know there are limitations in the industrial base and vaccinations will not be available for everyone including children for a number of months. There is also the issue of people who will refuse to take the vaccine. Based on this qualitative assessment it is reasonable to predict that COVID-19 still will be at a minimum the third leading cause of death in the USA in 2021.
In 2020 some strongly suggested that existing causes of death were being categorized as COVID-19. However examination of the leading causes of death specifically heart disease and cancer show that is not the case. Also the number of COVID-19 Hospitalizations and patients placed on a ventilator are extremely high. The 1918 pandemic patients were known to turn blue suggesting a lack of oxygen. The COVID-19 patients were also suffering from a lack of oxygen because of massive lung damage. A normal oxygen saturation is between 95% to 100% and below 93% suggests potential hypoxia and the start of organ damage [7]. When on a ventilator oxygen saturation is kept between 92-98% [8] [9]. When oxygen saturation drops below 85% patients are usually intubated and placed on mechanical ventilation [10].
References:
[1] Leading Causes of Death, Centers for Disease Control and Prevention, March 1, 2021. webpage https://www.cdc.gov/nchs/fastats/leading-causes-of-death.htm, April 2021. Leading Causes of Death . local
[2] CDC Cases, webpage https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/cases-in-us.html, various dates.
[3] Past Seasons Estimated Influenza Disease Burden, Centers for Disease Control and Prevention, October 01, 2020, webpage https://www.cdc.gov/flu/about/burden/past-seasons.html, April 2021. Past Seasons Estimated Influenza Disease Burden, Centers for Disease Control and Prevention.
[4] The COVID Tracking Project, The Atlantic Monthly Group March 7, 2021. webpage Source: https://covidtracking.com/data/national/hospitalization, April, 2021.
[5] More US cardiac deaths, less heart testing globally in COVID, CIDRAP - Center for Infectious Disease Research and Policy, University of Minnesota, January 11, 2021. webpage https://www.cidrap.umn.edu/news-perspective/2021/01/more-us-cardiac-deaths-less-heart-testing-globally-covid, April 2021. More US cardiac deaths, less heart testing globally in COVID.
[6] Cancer Facts & Figures 2020. American Cancer Society. webpage https://www.cancer.org/research/cancer-facts-statistics/all-cancer-facts-figures/cancer-facts-figures-2020.html, https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2020/cancer-facts-and-figures-2020.pdf, April 2021. PDF
[7] With ventilators running out, doctors say the machines are overused for Covid-19, STAT, April 8, 2020. webpage https://www.statnews.com/2020/04/08/doctors-say-ventilators-overused-for-covid-19, April 2021. With ventilators running out, doctors say the machines are overused for Covid-19.
[8] Mechanical Ventilator, London Health Sciences Centre, London Ontario Canada, October 31, 2018. webpage https://www.lhsc.on.ca/critical-care-trauma-centre/mechanical-ventilator, April 2021. Mechanical Ventilator.
[9] Oxygenation and Ventilation, National Institutes of Health, December 17, 2020. webpage https://www.covid19treatmentguidelines.nih.gov/critical-care/oxygenation-and-ventilation, April 2021. Oxygenation and Ventilation.
[10] Severe COVID-19 Symptoms: How Ventilators Can Help, UC Health, University of Cincinnati College of Medicine, June 8, 2020. webpage https://www.uchealth.com/en/media-room/covid-19/ventilators-and-covid-19, April 2021. Severe COVID-19 Symptoms: How Ventilators Can Help.
Infrastructure Bifurcation
There is evidence that the infrastructure is starting to bifurcate between facilities that will use technology to have healthy environments and facilities that will allow virus and other infection sources to be part of the facility environments [1]. This is all driven by the society and how it decides to deal with this unequal and dangerous system. There are two approaches to fix this bad system. The first is to wait for the natural system that is the society to correct itself, which may take multiple life times after much suffering and death. The second approach is to use government regulations to fix the bad or failed system in less time.
References:
[1] See section Conspiracy Theories and Social Bifurcation.
We have had a year for people to do the right thing. They have failed miserably. They only continue to pursue useless conspiracy theories like COVID-19 is not real, even in March of 2021. The only alternative is to begin with serious government regulations that will not only deal with the current COVID-19 pandemic but also future epidemics and pandemics. On April 5, 2021 the CDC released an update that the principal mode by which people are infected with COVID-19 is through exposure to respiratory droplets carrying infectious virus. It is possible for people to be infected through contact with contaminated surfaces or objects (fomites), but the risk is generally considered to be low [6]. These are some of the CDC [1] [6] WHO [2] [3] and other [4] health guidelines that should be converted into government regulations even though we have a vaccine:
The reason for the strict regulation requirement that the COVID-19 world wide pandemic must end before ignoring the regulations that must be implemented for new occupancy certificates is based on evidence that we are very closely coupled and old geographical boundaries from the previous century and other pandemics no longer applies. Unless world travel is shutdown this is a world wide problem. That will not happen.
Notice retail and work spaces were left out of the regulations. They may need to be added if the pandemic still impacts the USA.
People have ignored the guidelines. They will also ignore the regulations unless there are fines and methods of reporting offenses. The fines need to be steep to discourage the pattern of grave behavior that was set over the past year. For example, airlines are fined $100,000 per incident. Airports are fined $100,000 per day per flight. Small businesses are fined $1,000 per day of violation. Schools are charged $100,000 per day of violation. These details are for legislators finalize. This is unfortunate but this is the state of our current society driven exclusively by self interest rather than higher ideals from the previous century.
References:
[1] Ventilation in Buildings, Centers for Disease Control and Prevention, March 23, 2021. webpage https://www.cdc.gov/coronavirus/2019-ncov/community/ventilation.html, April 2021. Ventilation in Buildings
[2] WHO Publication/Guidelines Natural Ventilation for Infection Control in Health-Care Settings, World Health Organization (WHO), 2009. webpage https://www.ncbi.nlm.nih.gov/books/NBK143284/pdf/Bookshelf_NBK143284.pdf, May 2020. Natural Ventilation for Infection Control in Health-Care Settings, WHO, 2009 . local
[3] Coronavirus disease (COVID-19) advice for the public, World Health Organization (WHO) March 26, 2021. webpage https://www.who.int/emergencies/diseases/novel-coronavirus-2019/advice-for-public April 2021. Coronavirus disease (COVID-19) advice for the public
[4] The History of Ultraviolet Germicidal Irradiation for Air Disinfection, Public Health Reports/January–February 2010/Volume 125. webpage https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2789813 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2789813/pdf/phr125000015.pdf, November 2020. The History of Ultraviolet Germicidal Irradiation for Air Disinfection . PDF . local
[5] UV Lights and Lamps: Ultraviolet-C Radiation, Disinfection, and Coronavirus, UV Lights and Lamps: Ultraviolet-C Radiation, Disinfection, and Coronavirus, US Food and Drug Administration - FDA, August 19, 2020. webpage https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/uv-lights-and-lamps-ultraviolet-c-radiation-disinfection-and-coronavirus, November 2020. UV Lights and Lamps: Ultraviolet-C Radiation, Disinfection, and Coronavirus . local
[6] Science Brief: SARS-CoV-2 and Surface (Fomite) Transmission for Indoor Community Environments, Centers for Disease Control and Prevention, April 5, 2021. webpage https://www.cdc.gov/coronavirus/2019-ncov/more/science-and-research/surface-transmission.html, April 2021. Science Brief: SARS-CoV-2 and Surface (Fomite) Transmission for Indoor Community Environments . local
In theory, if the vaccines work then the global pandemic will end soon and the above regulations, while in place, would not apply. If the global pandemic does not end, regardless of reasons, then there is a reasonable path forward. The regulations stay on the books for the next pandemic because some suggest COVID-19 will continue to mutate and cause future problems.
The infrastructure upgrade associated with the proposed regulations will not only clean the environment of COVID-19 but also other viruses like the Flu, Tuberculosis, cold virus, and other contagions. It will bring the infrastructure to the same level of previous century capabilities. The following cost benefit analysis is offered to provide further insights.
The following are infrastructure upgrade cost estimates. They are based on the UV and HVAC Return To Life Analysis in 2020 (part 1) [1] [2]. [spreadsheet cost benefit]
Infrastructure Cost Details |
Costs |
Comment |
| UV Schools | $2,996,470,588 |
UV Infrastructure Cost Estimates |
| UV Commercial Office | $7,058,823,529 |
UV Infrastructure Cost Estimates |
| UV Retail | $16,764,705,882 |
UV Infrastructure Cost Estimates |
| UV Industrial property | $22,941,176,471 |
UV Infrastructure Cost Estimates |
| HVAC Upgrades | $100,000,000,000 |
Based on schools analysis |
| Total | $149,761,176,470 |
|
| Cost Benefit Analysis Costs A | $134,320,000,000 | minus commercial office space + 50% retail to capture problem areas |
| Cost Benefit Analysis Costs B | $122,849,411,765 | minus commercial office space + 50% retail + 50% industrial to capture problem areas |
| HVAC Retrofit All Schools | $107,129,337,539 |
Worst case schools analysis Proposed Legislation |
| Infrastructure Costs (billion) | $150 |
used in architecture tradeoffs in part 1 Virus Mutations & Architecture Solutions |
The annual costs due to lost productivity from just the Flu are estimated to be $17.6 billion in 2019 [3]. The following are hospitalization, loss of life, and lost productivity costs. [spreadsheet flu]
Flu Season Date |
2019-2020 |
2018-2019 |
2017-2018 |
2017-2018 |
2015-2016 |
2014-2015 |
2013-2014 |
2012-2013 |
2011-2012 |
2010-2011 |
Comment |
Symptomatic Illnesses |
38,000,000 |
36,000,000 |
45,000,000 |
29,000,000 |
24,000,000 |
30,000,000 |
30,000,000 |
34,000,000 |
9,300,000 |
21,000,000 |
[4] CDC 2017 to 2020 data may change. |
Medical Visits |
18,000,000 |
17,000,000 |
21,000,000 |
14,000,000 |
11,000,000 |
14,000,000 |
13,000,000 |
16,000,000 |
4,300,000 |
10,000,000 |
[4] CDC 2017 to 2020 data may change. |
Hospitalizations |
400,000 |
490,000 |
810,000 |
500,000 |
280,000 |
590,000 |
350,000 |
570,000 |
140,000 |
290,000 |
[4] CDC 2017 to 2020 data may change. |
Loss of Life |
22,000 |
34,000 |
61,000 |
38,000 |
23,000 |
51,000 |
38,000 |
43,000 |
12,000 |
37,000 |
[4] CDC 2017 to 2020 data may change. |
Employment to Population Ratio |
60.6% |
60.6% |
nv |
nv |
nv |
nv |
nv |
60.6% |
60.6% |
60.6% |
60.60% for 2018-2019 [3] |
Estimated Sickened Workers |
23,028,000 |
20,000,000 |
25,000,000 |
18,100,827 |
11,049,083 |
18,100,827 |
17,166,702 |
20,604,000 |
5,635,800 |
12,726,000 |
2013-2019 [3] & related |
Hospital Costs (billion) |
$6.8 |
$8.3 |
$13.8 |
$8.5 |
$4.8 |
$10 |
$5.9 |
$9.7 |
$2.4 |
$4.9 |
$17,300 male $14,900 female 2015-216 season [5]. Used $17,000 for all years. |
Loss of Life Costs (billion) |
$154 |
$238 |
$427 |
$266 |
$161 |
$357 |
$266 |
$301 |
$84 |
$259 |
$7 million per life |
Illness Costs - 10 years (billion) |
$2,588 |
|
|
|
|
|
|
|
|
|
10 years expected life of infrastructure |
Hourly Wage |
$28.00 |
$27.48 |
$26.74 |
$26.63 |
$26.63 |
$25.26 |
$24.19 |
$24.00 |
$24.00 |
$24.00 |
2013-2019 [3] & related |
Wages Lost (4 Days) |
$896.00 |
$879.36 |
$855.68 |
$852.16 |
$852.16 |
$808.32 |
$774.08 |
$768.00 |
$768.00 |
$768.00 |
2013-2019 [3] & related |
Productivity Costs (billion) |
$20.63 |
$18 |
$21.39 |
$15.4 |
$9.4 |
$14.6 |
$13.3 |
$15.82 |
$4.33 |
$9.77 |
2013-2019 [3] & related |
Productivity Costs - 10 years (billion) |
$143 |
|
|
|
|
|
|
|
|
|
10 years expected life of infrastructure |
Annual Flu Costs (billion) |
$181 |
$264 |
$462 |
$290 |
$175 |
$382 |
$285 |
$329 |
$91 |
$275 |
Health Care + Lives Lost Costs + Wages |
Total Costs - 10 years (billion) |
$2,736 |
|
|
|
|
|
|
|
|
|
Health Care + Lives Lost Costs + Wages 10 years expected life of infrastructure |
Infrastructure Costs (billion) |
$134 |
|
|
|
|
|
|
|
|
|
This is Cost A. Lower estimate is Cost B = $123 |
The above analysis is summarized as follows:
$134 billion Infrastructure Costs
$143 billion 10 year Productivity Costs
$181 billion Annual Flu Costs (hospital + loss of life + productivity)
$2,736 billion 10 year Total Costs (hospital + loss of life + productivity)
This cost benefit analysis shows the investment in reducing non COVID-19 illness will justify the upgrades because these systems will last for decades. The analysis suggests that the payback period conservatively will be less than 2 years. If the COVID-19 pandemic continues, then it allows the US to restart the civilization during the pandemic and the payback period is on the order of months. The challenge is to realize this must happen immediately because time is of the essence.
This challenge is exactly like the sanitation challenge to provide clean water and sewage management in the previous centuries. It took multiple bouts of Cholera and Dysentery before these systems were established in the 1800s. In the 1900s it was the dream of third world countries to establish clean water and sanitation systems. Providing clean air in a public building is the exact same problem. In the last century this happened naturally in the USA with the rise of forced air HVAC systems and the use of ceiling level UV-C lights. Today in the USA the HVAC systems have been tuned to minimize costs rather than health and the old ceiling level UV-C lights were thrown away because the population stopped getting contagious diseases. They became very healthy with new longer life expectancy results and the knowledge was forgotten.
No businesses will make this investment unless it is a small owner operated business that deals with the public. Once aware they will make the investment to protect their health. It is unlikely the commercial real estate and development sectors will make the investment except for exclusive projects. The only way to deal with this bad system situation is through updated building codes that trace to new regulations and or laws.
Everyone has now been educated on this subject. It is time to now make a choice. The reality is that it will happen as time moves on and in 20 years the indoor air infrastructure upgrades will just naturally emerge [6]. If it is not adopted as policy and then very effectively implemented, millions will suffer, many will die, the economy will be devastated, but life will continue. The correct answer is to always save lives.
References:
[1] COVID-19 A Systems Perspective, Walter Sobkiw, 2021, ISBN 9780983253044, hardback.
[2] COVID-19 Return To Life, webpage http://www.cassbeth.com/covid-19/return-to-life/index.html, April 2021. COVID-19 Return To Life.
[3] Flu Season to Cost Business $17B in Lost Productivity, New Jersey Business & Industry Association NJBIA, January17,2019. webpage https://njbia.org/flu-season-to-cost-business-17b-in-lost-productivity, April 2021, Flu Season to Cost Business $17B in Lost Productivity
[4] Past Seasons Estimated Influenza Disease Burden, Centers for Disease Control and Prevention, October 01, 2020, webpage https://www.cdc.gov/flu/about/burden/past-seasons.html, April 2021. Past Seasons Estimated Influenza Disease Burden, Centers for Disease Control and Prevention
[5] Inpatient Hospital Stays and Emergency Department Visits Involving Influenza, 2006-2016, Agency for Healthcare Research and Quality, October 2019. webpage https://www.hcup-us.ahrq.gov/reports/statbriefs/sb253-Influenza-Hospitalizations-ED-Visits-2006-2016.jsp, April 2021. Inpatient Hospital Stays and Emergency Department Visits Involving Influenza
[6] Technology at the Forefront for Healthier High-Rise Buildings, The COVID-19 pandemic has real estate developers turning to new tech, like UV light treatments and touchless entrances, to create safer environments for residents, Mansion Global June 07, 2020. webpage https://www.mansionglobal.com/articles/technology-at-the-forefront-for-healthier-high-rise-buildings-216579, January 2021. Technology at the Forefront for Healthier High-Rise Buildings
Healthy Buildings Certification Needs
There is evidence that some are heavily focused on the goal of providing healthy buildings in the wake of the COVID-19 disaster and the realization of other existing illnesses and possible future disasters. The problem is that there are no standards traceable to significant science and engineering performed in government labs capable of making those assessments. Industry is left to self regulate and determine what it thinks is best for an indoor building environment. The government only offers vague guidance and the guidance is usually ignored except in rare cases. Regardless, the current situation is leading to a social bifurcation where some will live, play, work, shop, and learn in healthy buildings and most will not have that opportunity [1].
The challenge is also one of the introduction of snake oil that unsuspecting facilities staff may think is a proper solution. This challenge is not unlike the challenges faced in the last century that eventually led to the establishment of the Food and Drug Administration (FDA). The FDA has a charter to protect the public from exposure to radiation including UV radiation. However, they cannot determine if an installed UV system is effective at eliminating contagions under the advertised conditions or address deceptive advertising practices.
Beyond safety, there are no non-military government standards to certify Ceiling Level UV-C, Far UV-222 Systems, HVAC systems and other possible system solutions that claim to deal with a contagion. Military standards like MIL-STD-1472 provide ventilation requirements but not from the perspective of maximizing health [2]. Updated HVAC ventilation rates and new UV standards that maximize health and prevent the spread of disease in public spaces need to be developed and then converted into local building codes. Without a lead agency or regulations snake oil will be sold into the infrastructure. As of April 2021 we already have snake oil being sold into the infrastructure and they include bad UV systems, inadequate HVAC systems, and other products. They must be removed and replaced with proper certified systems traceable to government standards established in proper government labs.
References:
[1] Technology at the Forefront for Healthier High-Rise Buildings, The COVID-19 pandemic has real estate developers turning to new tech, like UV light treatments and touchless entrances, to create safer environments for residents, Mansion Global June 07, 2020. webpage https://www.mansionglobal.com/articles/technology-at-the-forefront-for-healthier-high-rise-buildings-216579, January 2021. Technology at the Forefront for Healthier High-Rise Buildings.
[2] Human Engineering, MIL-STD-1472F, Department of Defense, 23 August 1999, MIL-STD-1472D, 14 March 1989. MIL-STD-1472F . MIL-STD-1472D . local.
Rehashing Old Knowledge
On April 23, 2021 an article stating that the risk of indoor COVID-19 infection is the same at 6 or 60 feet - MIT researchers say time spent indoors increases risk of COVID at 6 feet or 60 feet in new study challenging social distancing policies [1]. The issue is that this is not new news. The CDC disclosed the Wells-Riley equation that was developed in 1978 as part of their study on natural ventilation for infection control in health-care settings [2]. The equation is very simple and does not include distance. It only considers the number of people infected, volume of the physical space, the rate of infection, and the amount of clean air being provided.
P = D/S = 1 - exp ( - (Ipqt/Q) )
P = probability of infection for susceptibles
D = number of disease cases
S = number of susceptibles
I = number of infectors
p = breathing rate per person (m3/s)
q = quantum generation rate by an infected person (quanta/s)
t = total exposure time (s)
Q = outdoor air supply rate (m3/s)
Wells (1955) proposed a hypothetical infectious dose unit: the quantum of infection. A quantum is defined as the number of infectious airborne particles required to infect the person and may consist of one or more airborne particles. These particles are assumed to be randomly distributed throughout the air of confined spaces [4]. Riley et al. (1978) considered the intake dose of airborne pathogens in terms of the number of quanta to evaluate the probability of escaping the infection [5]. This was a modification of the Reed-Frost equation (Abbey, 1952) [6]. Together with the Poisson probability distribution describing the randomly distributed discrete infectious particles in the air the Wells-Riley equation was developed. [3]
The Wells-Riley equation roots go back into the previous century. It was always known that this is a volume versus infection rate 8th grade algebra and geometry problem.
Revisiting old science and engineering to try and change bad policy and management is pointless and a waste of time and resources. This is not about selling to poor policy makers and management. The poor policy makers and management just need to be replaced.
References:
[1] MIT researchers say time spent indoors increases risk of Covid at 6 feet or 60 feet in new study challenging social distancing policies, CNBC, April 27, 2021. webpage https://www.cnbc.com/2021/04/23/mit-researchers-say-youre-no-safer-from-covid-indoors-at-6-feet-or-60-feet-in-new-study.html, April 2021. MIT researchers say time spent indoors increases risk of Covid at 6 feet or 60 feet in new study challenging social distancing policies.
[2] WHO Publication/Guidelines Natural Ventilation for Infection Control in Health-Care Settings, World Health Organization (WHO), 2009. webpage https://www.ncbi.nlm.nih.gov/books/NBK143284/pdf/Bookshelf_NBK143284.pdf, May 2020. Natural Ventilation for Infection Control in Health-Care Settings, WHO, 2009 . local.
[3] Review and comparison between the Wells-Riley and dose-response approaches to risk assessment of infectious respiratory diseases, July 31, 2009. webpage https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7202094, April 2021. PDF.
[4] Wells, W.F. (1955) Airborne Contagion and Air Hygiene, Cambridge MA, Cambridge University Press; 117–122. [Google Scholar]
[5] Riley, E.C. , Murphy, G. and Riley, R.L. (1978) Airborne spread of measles in a suburban elementary school, Am. J. Epidemiol., 107, 421–432. [PubMed] [Google Scholar].
[6] Abbey, H. (1952) An examination of the Reed Frost theory of epidemics, Hum. Biol., 24, 201–233. [PubMed] [Google Scholar].[8] COVID-19 Return To Life, webpage http://www.cassbeth.com/covid-19/return-to-life/index.html, April 2021. COVID-19 Return To Life.
School Case History
On April 25, 2021 the Lower Merion School district reported that 8 second grade students and 2 fully vaccinated family members tested positive for the COVID-19 virus [1]. It is unclear why 2 fully vaccinated family members tested positive for the virus. The district staff evaluated the classroom HVAC system and found that a part within the ductwork above the ceiling was mostly closed allowing only about 30% of the maximum amount of fresh air into the room where the 2d grade children were infected [2]. Lower Merion began full in-person learning at the end of March 2021, after public health and education officials gave the approval. The Children's Hospital of Philadelphia recommended students return to buildings in January [4]. The Lower Merion School district maintains a dashboard [4].
Date |
Students |
Staff |
Infected |
Infected |
Infected |
Comments |
| April 30, 2021 | 8,600 |
1,550 |
265 |
150 |
415 |
Lower Merion School district dashboard [4]. School reopened after the event. The school district thinks it solved the problem. |
| April 30, 2021 | 22,727 |
512 |
Philadelphia School district dashboard [5]. |
The following is a system analysis of the Lower Merion School district infection event. Unlike the analysis performed in 2020, this analysis is based only on the single parameter of mechanical ventilation of Cubic Feet Per Minute (CFM). It can be easily converted to AUC as was shown in the 2020 system analysis. However, this analysis will stay exclusively in the CFM domain until the analysis reaches its natural point of diminishing returns and then other system factors will be considered.
The design requirement for the school HVAC system is 375 CFM and the measured rate was 120 CFM for the affected classroom.
The World Health Organization (WHO) recommends the following ventilation rates for a room size of 4×2×3 Meters, which is 13x7x10 Feet [6] [7] [8]:
From this data some analysis can be performed to surface some insights. [spreadsheet dilution]
Analysis Items |
Adult |
Adult |
|
Comment |
Human Respiration |
|
|
|
|
Total lung capacity (Liters) |
6 |
4.2 |
|
|
Total lung capacity (cu in) |
366.12 |
256.284 |
|
|
Total lung capacity (cu ft) |
0.211875 |
0.1483125 |
|
|
Respiration cu-ft/min |
12.7125 |
8.89875 |
|
If there are 10 adult males in the room the combined respiration rate is 127 CFM. This means that fresh air must be provided at a minimum of 127 CFM to replace the CO2 levels, otherwise people will get sleepy or worse. Brain function starts to be impacted once the CO2 level starts to build up in a classroom. The respiration rate for children is less and probably related to weight (e.g. adult male 175 lbs vs 2d grade male 50 lbs). Matching the respiration rate to scrub a room of CO2 will not remove an airborne contagion in a room, it must be significantly higher. There are requirements on what the rate should be to mitigate airborne contagions in patient hospital rooms. |
. |
|
|
|
|
Case History |
Value |
cu-ft |
AUC |
Comment |
Mechanical Ventilation Design Req cu-ft/min |
375 |
7,200 |
3 |
The 375 CFM value is slightly above WHO recommendation for Airborne Precautions. Room cu-ft assumption = 30ft x 30ft x 8ft |
Mechanical Ventilation Actual cu-ft/min |
120 |
7,200 |
1 |
At 120 CFM Infection happened. |
Infection cases |
8 |
|
|
|
Devices in affected building |
4200 |
|
|
One unmonitored mechanical device was set to an unacceptable condition. This is a large complex system and it is only the HVAC portion of the system. |
School district ft-2 (million) |
1.5 |
|
|
|
. |
|
|
|
|
WHO Recommendations |
l/s |
cu-ft/sec |
cu-ft/min |
Comment |
Patient Room Airborne Precautions |
160 |
5.650356 |
339.02 |
This is based on 1 patient in a room that has an airborne contagion. Room cu-ft assumption 13x7x10 ft results in AUC = 24. |
General Areas |
6 |
0.211888 |
12.71 |
|
Transit Spaces |
2.5 |
0.088287 |
5.30 |
|
1 litre = 28.3168 |
|
|
|
|
From the above analysis, this empirical data suggests that infection occurs at 120 CFM. The WHO recommendation for patient room airborne precautions is 339 CFM. This is slightly below the 375 CFM design requirement for the affected school buildings. These numbers once applied to a physical space of a 7,200 cu-ft classroom have an AUC of 3 and 1, which are significantly below what was suggested in the 2020 system analysis. The WHO recommendation for a CFM of 339 translates into an AUC of 25 for a patient room with airborne precautions. A patient room is much smaller than a classroom, thus the larger AUC performance result. This suggests that the current design of 339 CFM is insufficient even though in this case there has not yet been an infection event. When the school district corrected its unmonitored mechanical device it concluded that it solved the problem. Time will tell, they are running a live experiment because we know the previous generation engineering performance requirements when dealing with airborne precautions are not the current design performance requirements for the actual buildings that are in use today. The buildings were never designed to deal with the possibility of a deadly airborne contagion. However, the design can be upgraded.
Healthy buildings and how those buildings are Certified from a contagion mitigation perspective is the key issue. There is massive knowledge that must be converted to standards and then there is massive technology that can be used, all of which were developed in the last century. Some buildings will be fine, others will need upgraded HVAC systems, yet others may need ceiling level UV-C lights and or FAR UV-222 lights. In some cases, high touch surfaces may need to be replaced with proper materials. Social distancing and masking are not the answer for the next 20 years while we wait for the COVID-19 virus to disappear. The answer is our massive technology that our parents and grandparents developed when they had to deal will tuberculosis and other deadly contagions.
We know what needs to be done to make buildings healthy.
Toxic management must be removed. All the talking points and damage control are irrelevant. The bad policy makers must be removed or the COVID-19 disaster will just continue to destroy the civilization.
References:
[1] 8 Classmates, 2 Fully Vaccinated Family Members, Test Positive for COVID in Lower Merion, NBC 10 Philadelphia, April 25, 2021. webpage https://www.nbcphiladelphia.com/news/coronavirus/8-classmates-2-fully-vaccinated-family-members-test-positive-for-covid-in-lower-merion/2791754, May 2021. 8 Classmates, 2 Fully Vaccinated Family Members, Test Positive for COVID in Lower Merion.
[2] Lower Merion School District says a ventilation flaw could have fueled a COVID-19 outbreak in second-grade classroom, The Philadelphia Inquirer, April 26, 2021. webpage https://www.inquirer.com/education/lower-merion-school-district-penn-valley-covid-outbreak-hvac-20210426.html, May 2021. Lower Merion School District says a ventilation flaw could have fueled a COVID-19 outbreak in second-grade classroom.
[3] Parents divided after COVID-19 outbreak at Lower Merion school, WHYY PBS NPR April 27, 2021. webpage https://whyy.org/articles/parents-divided-after-covid-19-outbreak-at-lower-merion-school, May 2021. Parents divided after COVID-19 outbreak at Lower Merion school.
[4] LMSD COVID-19 Dashboard, https://www.lmsd.org/departments/health/coronavirus-response/dashboard, May 2021.
[5] School District of Philadelphia COVID-19 Dashboard, https://dashboards.philasd.org/extensions/covid-dashboard/index.html, May 2021.
[6] WHO Publication/Guidelines Natural Ventilation for Infection Control in Health-Care Settings, World Health Organization (WHO), 2009. webpage https://www.ncbi.nlm.nih.gov/books/NBK143284/pdf/Bookshelf_NBK143284.pdf, May 2020. Natural Ventilation for Infection Control in Health-Care Settings, WHO, 2009 . local
[7] COVID-19 A Systems Perspective, Walter Sobkiw, 2021, ISBN 9780983253044, hardback.
[8] COVID-19 Return To Life, webpage http://www.cassbeth.com/covid-19/return-to-life/index.html, April 2021. COVID-19 Return To Life.
There are two basic engineering requirements that are used in designing the ventilation in a room. The first is liters per second per person (l/s/person) also stated as cubic feet per second per person (cuft/s/person). The second is air update changes (AUC) or air changes per hour (ACH) in a room. The CFM designation stands for cubic feet per minute. If a rooms CFM is determined, then it can be divided by the maximum number of people in the room to determine the cuft/s/person. The CFM also can be used to determine the room AUC when the room volume is known. There are 2 potential system performance requirements to consider when designing a room to minimize airborne contagion level. The question is how should they be used and what are the numbers that will become the system requirements.
The respiration rate for an adult male is approximately 12.7 CFM (cuft/min) [1] [2]. Most rely on the standard that the ventilation be 15 CFM (cuft/min) per person. So if there are 10 people in a room, the ventilation rate should be 150 cuft/min. This will prevent CO2 from building up in the room and having people suffer from CO2 poisoning. However, it will not prevent them from catching an airborne contagion. The WHO Patient Room Airborne Precautions requirement is 339 CFM (this is for 1 patient in the room) [3]. They also provided the room volume and based on the room volume this requirement is equivalent to 24 AUC. So there is a disconnect between the 2 requirement levels for the CFM per person (15 versus 339). These are system performance requirements and there are two of them to consider. One requirement performance level (15 CFM per person) is just trying to prevent CO2 poisoning and the other (339 CFM per person) is trying to mitigate airborne contagion levels.
If the basic requirement of 15 CFM per person is applied to a typical room size for an analysis like a classroom, the AUC can drop to a level as low a 1 AUC. We know that people including children are infected with 1 AUC [4]. That means that if the virus is being expelled by an infected person it is airborne for a minimum of 1 hour. If the AUC is increased to 4 then the window of virus exposure is 15 minutes. We see that the number of people in the room is irrelevant. What is relevant is the time the virus is in the air before the air is fully exchanged. [5]
So when considering which performance requirement is relevant in mitigating airborne contagions, it is the AUC. It makes sense because there is no way CO2 poisoning will occur with AUC levels that prevent airborne contagions unless existing occupancy standards are severely exceed. Also it is easy to relate to the AUC number because it translates to virus exposure time and the lower the exposure time the less risk of infection.
AUC |
Infection Risk Window Time |
24 |
2.5 min |
10 |
6 min |
4 |
15 min |
1 |
1 hour |
0 |
full time |
When discussing room airborne contagion risk the discussion must focus only on the AUC system requirement and not be distracted with the CFM per person system requirement. The CFM per person requirement is irrelevant to the system need. All the studies related to airborne contagions are based on air changes per hour and they only offer the CFM per person when closely coupled with other related requirements like the room volume, as in the case of of the WHO guidance.
As of May 2021, most are viewing the system need from an occupancy level perspective rather than a room air change per hour perspective. That has been the guidance since it was publicly admitted that the virus is airborne. It is unclear why this confusion was allowed to start and why it continues. It is well known that when dealing with clean rooms and airborne contagions the system requirement is always in terms of air update changes in a given space.
References:
[1] COVID-19 A Systems Perspective, Walter Sobkiw, 2021, ISBN 9780983253044, hardback.
[2] COVID-19 Return To Life, webpage http://www.cassbeth.com/covid-19/return-to-life/index.html, April 2021. COVID-19 Return To Life.
[3] WHO Publication/Guidelines Natural Ventilation for Infection Control in Health-Care Settings, World Health Organization (WHO), 2009. webpage https://www.ncbi.nlm.nih.gov/books/NBK143284/pdf/Bookshelf_NBK143284.pdf, May 2020. Natural Ventilation for Infection Control in Health-Care Settings, WHO, 2009 . local
[4] 8 Classmates, 2 Fully Vaccinated Family Members, Test Positive for COVID in Lower Merion, NBC 10 Philadelphia, April 25, 2021. webpage https://www.nbcphiladelphia.com/news/coronavirus/8-classmates-2-fully-vaccinated-family-members-test-positive-for-covid-in-lower-merion/2791754, May 2021. 8 Classmates, 2 Fully Vaccinated Family Members, Test Positive for COVID in Lower Merion.
[5] MIT researchers say time spent indoors increases risk of Covid at 6 feet or 60 feet in new study challenging social distancing policies, CNBC, April 27, 2021. webpage https://www.cnbc.com/2021/04/23/mit-researchers-say-youre-no-safer-from-covid-indoors-at-6-feet-or-60-feet-in-new-study.html, April 2021. MIT researchers say time spent indoors increases risk of Covid at 6 feet or 60 feet in new study challenging social distancing policies.
Contagion Mitigation System Certification of Buildings
This systems analysis has been reduced to a model and implemented in a tool Building Contagion Mitigation Certification (BCMC) Tool.
The School District of Philadelphia prepared a COVID-19 mitigation guideline to be followed by maintenance staff. Internally it is called a guideline but it reads like a clear actionable and traceable procedure, which is exactly what is required when dealing with a serious system like mitigating the risk of infection from a deadly contagion. It is based on information from the Center for Disease Control (CDC), the Pennsylvania Department of Health (PDH), the Pennsylvania Department of Education (PDE), the Philadelphia Department of Public Health (PDPH) and the Childrens Hospital of Philadelphia (CHOP) Policy Lab [1]. This is an excellent starting point for developing a Contagion Mitigation System Certification of Buildings standard. There are multiple instructions for operating and maintaining the HVAC system. There are also multiple operating instructions for cleaning the building areas and dealing with a COVID-19 event. The following are performance requirements from the document:
The 15 CFM per person ventilation requirement in the above guideline is less than the WHO Patient Room Airborne Precautions requirement of 339 CFM per person for airborne contagion mitigation. Instead it is similar to the WHO General Areas of 12.71 CFM per person requirement. As of May 2021, that is the challenge, they like most others are viewing the system need from an occupancy perspective rather than a room air changes per hour perspective. Should the ventilation be increased to 339 CFM and what approaches are to be used to reach that level of performance are the key system issues [7]. The approaches are:
There are multiple considerations when certifying a building that mitigates airborne contagions. They include:
Certification is performed by an external entity. For complex systems where there is possible loss of life, the government performs the certification. For example, in new construction there is a certification process that includes multiple inspections as the project unfolds and then there is a final inspection with a certificate of occupancy that is issued for the building. In this case a Contagion Mitigation Certificate of Occupancy would be issued.
As part of privatization many mission critical systems like airplanes have been self certified by the manufacturer. In the industry this is called a self-licking ice cream cone and it is a terrible practice. The Boeing 737 MAX is an example of a self certification approach [2]. This should not be used as the approach to issue Contagion Mitigation Certificates of Occupancy. The certificates should be issued by the same organizations that issue new building and resold building Certificates of Occupancy.
What is needed is proper Building Contagion Mitigation standards based on sound engineering requirements, not guidance. Guidance is something that is usually ignored. It is also typically filled with vague statements associated with management damage control. Clear actionable, traceable, and testable engineering requirements are needed.
Once clear engineering requirements are identified, it is recognized that not all buildings can be mitigated from contagions at the same level. This suggests that different levels of Contagion Mitigation Certificates of Occupancy may need to be issued. They then should be publicly displayed. As time moves on and the COVID-19 contagion subsides this can be used as important data for future outbreaks of deadly contagions.
The following AUC (AUC = ACH) engineering requirements and Contagion Mitigation Levels are proposed to assess a building and issue a Contagion Mitigation Certificate. The AUC is the sum of the following:
Level |
State |
AUC |
AUC Range |
Infection Risk |
Airborne Contagion Mitigation System Building Condition |
Likely Technologies |
6 |
Green |
120 |
120+ |
30 sec |
Approaches outside ventilation conditions | Exhaust fans previously used to remove smoke filled public spaces |
5 |
Green |
50-100 |
50-120 |
1.2 min |
Similar to operating room without PPE conditions in all public affected spaces |
Large HVAC system + UV and or other |
4 |
Yellow |
24 |
24-50 |
2.5 min |
Similar to WHO patient room airborne precautions in all public affected spaces |
Small HVAC system + UV and or other |
3 |
Yellow |
10-24 |
10-24 |
6 min |
Similar to WHO patient room airborne precautions in most public spaces but not all |
Small HVAC system + UV and or other or Large HVAC system |
2 |
Orange |
4 |
4-10 |
15 min |
Marginal mitigation |
Medium HVAC system (usually heater + cooling) |
1 |
Red |
1 |
1-4 |
1 hr |
No mitigation, School data suggests infection happens [6] |
Small HVAC system (usually heater only) |
0 |
Red |
0 |
0-1 |
full time |
No ventilation | No windows, no mechanical, no UV, no other |
The following justification is offered for the Certificate State colors.
This model represents what is considered an ideal system or a perfect system. An analogy exists in electrical engineering called an Operational Amplifier or Op-Amp. It has perfect characteristics and is used to model and make system design choices. This concept is used in many systems analysis to try and understand some aspect of a system. This same concept is applied to model the risk of contagion in a physical space and determine a contagion mitigation level. Some spaces will behave better than others based on the placement of the system elements. For example, some office buildings have 4 inch x 4 foot vents placed in the ceiling at 4 foot intervals that run the length of a ceiling. They are part of the ceiling tile track that holds the ceiling tiles in place. Intuitively these systems should have very good air distribution and evacuation as they start to approach the ideal system like an Op-Amp. Outdoor settings fall into the same category. Other systems as typically found in homes or lower end public buildings will have vents in a limited number of locations in a physical space and air distribution and evacuation will be less effective. Regardless of the effectiveness of the systems, applying this model is a starting point. Data from the Philadelphia School District was used to perform a sensitivity analysis to determine the possible effects of considering various elements and it appears that because of the large "distance" or numerical range of the AUC numbers needed to achieve a particular level these characteristics will have little effect on the results. Also there are other ventilation systems like ceiling level UV-C systems that will have a more universal performance level across all facilities.
The 2020 system analysis suggested that an infected person will exhale an infection load in a very small amount of time. A cough or sneeze is orders of magnitude worse. [3] [4] The lower the infection risk window time, the lower the risk of infection, and the greater the mitigation level. A Level-6 certificate is the most effective indication of contagion mitigation.
The 2020 system analysis suggested that when trying to understand contagions, the problem is best viewed from the perspective of how long a contagion might remain in the affected space. The CFM performance metric is useful for understanding the buildup of CO2 in a space, but not for contagion mitigation. The CFM must be coupled with the associated physical space and the AUC determined.
As part of the certification, all the ventilation CFM and physical volume data needs to be gathered to determine the AUC in each space and clearly documented. This information then needs to be examined and the appropriate certification level applied to the Contagion Mitigation Certificate of Occupancy. Individual certificates need to be placed in each room and then an overall building certificate in the main lobby needs to be placed in clear public view without any special access. A building may have several Level-6 rooms but the building itself may be a Level-1 building based on a worst case finding in a portion of the building where the public may gather. The building operators can either accept the Level-1 certificate, close off the area, or upgrade that area of the building.
This is not a popular analysis finding and suggestion for a path forward. However we have been in COVID-19 disaster mode for over a year.
Welcome to the 21st century of deadly airborne contagions.
References:
[1] Cleaning and Ventilation Protocols, Addendum to 2017 General Cleaning Guidelines - COVID-19, Department of Operations - October 2020. webpage https://docs.google.com/document/d/1ujhxHbJH-_73ewQne0m40nXrVu2ejOe6P896-HJYoBE/edit, https://www.philasd.org/coronavirus/schoolstart2020/#1613754853066-88c619db-678c, May 2021. local PDF
[2] Privatization A Systems Perspective, Walter Sobkiw, 2019, ISBN 9780983253068. Privatization A Systems Perspective
[3] COVID-19 A Systems Perspective, Walter Sobkiw, 2021, ISBN 9780983253044, hardback.
[4] COVID-19 Return To Life, webpage http://www.cassbeth.com/covid-19/return-to-life/index.html, April 2021. COVID-19 Return To Life.
[5] Philadelphia School District Air Balance Reports by school. webpage https://www.philasd.org/coronavirus/schoolstart2020/#1613757068528-a10a5ddf-592d, https://drive.google.com/drive/folders/1XULamBiR3v1sB_u15rcyXOxQlq1ygsGT, May 2021. local excel cert analysis
[6] See section School Case History.
[7] Philadelphia school district to install new air purifiers despite concerns from air quality specialist, Chalkbeat Philadelphia, July 21, 2021. webpage https://philadelphia.chalkbeat.org/2021/7/21/22587784/philadelphia-district-to-install-new-air-purifiers-despite-concerns-from-air-quality-specialist, Jully 2021.Philadelphia school district to install new air purifiers despite concerns from air quality specialist.
Once the certification process starts the findings will identify possible areas for improvement. The improvements may be associated with building procedures or with building systems. The following identifies technologies with the implied products and systems that can be used to boost building certification levels.
In the 2020 system analysis, various technologies were identified to mitigate contagions [1] [2]. The analysis identified Photocatalytic Oxidation air cleaning (PCO) / Ionizers but focused on the HVAC systems, Fans, Natural Ventilation, Ceiling Level UV-C lights, and Far UV-222 lights.
In 2021 PCO / Ionizer technology is being considered by many facilities. A product called Active Pure continuously creates oxidizing molecules that has been claimed to reduce up to 99.99% of pathogens including SARS-CoV-2, Avian influenza, E.Coli, MRSA, Norovirus, Staph bacteria, Candida, Swine Flu, Hepatitis, and Legionella [3] in 3 minutes [4]. A PCO / Ionizer system bathes the entire space in molecules that destroy pathogens. It is assumed that it takes several minutes for the space to be filled with the molecules but once initiated the kill rate is assumed to be continuous as long as the device is in operation. If the kill rate is at 3 minutes then the equivalent AUC or eAUC = 20. No studies were located to add more information and provide a better understanding of these systems from an eAUC perspective. If the eAUC is 20 then this is similar to a ceiling level UV-C system which can have an eAUC = 24 according to various studies and claims from CDC related documentation. There are details such as the production rate of the molecules. For example, one product has an air processing rate of 300 CFM maximum, but if the molecules stay airborne then once initialized the coverage may be for the entire physical space for 100% of the time. As always there are engineering details associated with system sizing and resulting performance [5].
The Philadelphia school district purchased more than 9,500 PCO / Ionizer air purifiers for $4.5 million and plans to install them by the end of July 2021. Earlier in 2021 they purchased 2000+ units. The products purchased by the district use technology that neutralizes viruses by pulling oxygen and water molecules into a honeycomb matrix and releasing oxidizers back into the room. District officials at a press conference stated that the technology was originally developed for NASA and could eliminate 99% of the virus within three minutes. [5]
An alternative view is from Professor Dr. Waring, Drexel University. Purifiers only generate one tenth the amount of airflow needed to effectively neutralize airborne viral particles in the average sized classroom. The district should have rejected newer technologies that use oxidizers, and instead opted for purifiers that have high efficiency particulate air filters, or HEPA, as recommended by the Centers for Disease Control and Prevention (CDC). "The school district has squandered a huge opportunity to outfit every classroom with an appropriately sized HEPA air purifier, ... This alternative would have had large impacts on reducing any potential COVID transmission in our schools, as well as providing indoor air quality benefits lasting beyond the pandemic. [5] Dr. Waring is not alone in his guidance. Academic experts are encouraging schools to pump in more fresh air and use proven technology like HEPA filters [6].
The district did not respond to questions about how officials vetted the chosen air purifiers. Instead the response was that the school district chose to pursue purifiers that didn’t simply use HEPA filter technology but expanded beyond that to reflect technology developed by NASA. [5] This falls into the category of a management talking point and deflects from the questions being asked.
The Philadelphia School District must make public the bid process for the contract to purchase the product they selected. The bid process should have included a formal Request For Information (RFI) from the industrial base so that all vendors could present their product performance levels and perspectives on the challenge. A formal tradeoff analysis performed by the Philadelphia School District is public information and should have been disclosed. This assumes that there was an open bid process with a formal internal systems engineering tradeoff of the possible products that form the system solution. If this did not happen, it is yet another indication that the COVID-19 disaster is a symptom of a deeper social problem as discussed in other sections of this research.
The available technologies to boost certification levels are:
Technology |
Possible AUC |
Source |
Comments |
| Typical HVAC system | 4 |
Current standards [2] | Only when on |
| Special HVAC system | 60 |
Current standards [2] | Only when on |
| Fans | 100 |
Analysis [2] | Only when on |
| Open Windows | 37 |
WHO [2] | Only when open |
| Ceiling Level UV-C | 24 |
CDC [2] | Continuous airborne eAUC |
| Far UV-222 | 4+ |
Columbia University [2] | Continuous airborne and surface, eAUC is much higher but needs to be validated with more analysis |
| PCO / Ionizers |
20 |
Active Pure [3] | Continuous airborne and surface eAUC, performance is in dispute [5], dispute is an example of the need for government testing and certification and tools that allow gathering of self-certification data |
| Outside space | 3600 |
Analysis [2] | Continuous full space operation |
Note: AUC = ACH = eAUC.
Each space is unique and some technologies are more appropriate for a particular space than others. The solution needs to be a system integration solution providing the most effective system. The alternatives include the following approaches:
If multiple technologies are used there may be compatibility issues that need to be understood. There are other issues associated with some of the technologies that may limit their application in some settings.
The State of New York released a document called COVID FAQ's - August 5, 2020 and the document prohibits the use of bipolar ionization, ion generators, corona discharge, or UV technology [7]. This is from the FAQ:
12. Can we install ion generators or UV light technology in air handling units, portable units, or lighting?
SED is not permitting bipolar ionization, ion generators, corona discharge, or UV technology in schools under our jurisdiction at this time. We continue to work with NYS DOH in evaluating emerging technologies for health and safety and efficacy. We are concerned about potential negative health impacts with this technology and we are not permitting this technology until we are satisfied it is safe.
It is unclear why UV technology is on the list given its long history of use and presence in hospitals and industrial settings. This essentially locks New York into solutions based on HVAC system components. Also this document is dated August 5, 2020 but it is still available via the official New York website.
Since 2010, all portable indoor air cleaning devices sold to people or businesses in California are required to be certified by the California Air Resources Board (CARB) [11]. As of October 2020, electronic in-duct air cleaning devices are also subject to the regulation. To be certified electronic air cleaners must be tested for ozone emissions and meet an ozone emission concentration limit of 0.050 parts per million (50 ppb) [8]. A good way to think about the size of 1 ppm is to picture one drop in 15 gallons of water.
The state of California maintains a list of approved products [8]. There are a few thousand products approved by the CARB on their website. According to the CARB some devices that are advertised as air purifiers, air cleaners, or ozone generators purposely emit large amounts of ozone, the main component of smog. According to the CARB not only are such ozone generators ineffective at cleaning indoor air, but breathing ozone poses serious health risks. The CARB recommends that these ozone generators not be used and they maintain a list of these unapproved products [9]. There are only a few products not approved by the CARB on their website.
Within hours, ozone can irritate the lining of the respiratory system and cause coughing, chest tightness and shortness of breath. It can also seriously damage the cells in the lungs and airways. Long-term exposure to ozone may both cause and worsen asthma symptoms and worsen lung disease. It may also increase the risk of premature death. The effects depend on the concentration of ozone in the air, the level of physical activity, how long one is exposed to ozone, and how sensitive one is to it. Ozone can also react with other chemicals, such as terpenes (fragrance chemicals that give pine or citrus scent to some household products), to produce toxic byproducts such as formaldehyde. [10]
The types of indoor air cleaning devices regulated by the state of California are any air cleaner used in an enclosed space that can be occupied by people is covered by the regulation, except for in-duct air cleaners and those used for certain industrial applications, which are exempted in the regulation. Portable devices small enough for people to wear or carry, as well as devices designed to clean a room, building or vehicle, are regulated. Mechanical air cleaners, ionizers, electrostatic precipitators, photocatalytic oxidation air cleaners, plasma cluster devices, corona discharge ozone generators, and others are all covered by the regulation. Some of these air cleaners do not produce ozone, some generate low amounts indirectly, and some generate large amounts of ozone on purpose. [10]
References:
[1] COVID-19 A Systems Perspective, Walter Sobkiw, 2021, ISBN 9780983253044, hardback.
[2] COVID-19 Return To Life, webpage http://www.cassbeth.com/covid-19/return-to-life/index.html, April 2021. COVID-19 Return To Life.
[3] Active Pure company. website https://www.activepure.com, May 2021.
[4] ActivePure seeks emergency FDA approval for air purifier to fight Covid-19, CNBC, December 29, 2020. webpage https://www.youtube.com/watch?v=-Z_wQ29cShw, May 2021.
[5] Philadelphia school district to install new air purifiers despite concerns from air quality specialist, Chalkbeat Philadelphia, July 21, 2021. webpage https://philadelphia.chalkbeat.org/2021/7/21/22587784/philadelphia-district-to-install-new-air-purifiers-despite-concerns-from-air-quality-specialist, Jully 2021. Philadelphia school district to install new air purifiers despite concerns from air quality specialist.
[6] Schools spending millions on air purifiers often sold using overblown claims, CNN, May 11, 2021. webpage https://www.cnn.com/2021/05/03/health/air-filter-covid-scams-khn/index.html, August 2021. Schools spending millions on air purifiers often sold using overblown claims.
[7] COVID FAQ's - August 5, 2020, NYS Education Department: Office of Facilities Planning. webpage http://www.p12.nysed.gov/facplan/documents/08-05-2020COVIDFAQs.pdf, August 2021. PDF . local
[8] List of CARB-Certified Air Cleaning Devices, California Air Resources Board. webpage https://ww2.arb.ca.gov/list-carb-certified-air-cleaning-devices, August 2021. List of CARB-Certified Air Cleaning Devices.
[9] Potentially Hazardous Ozone Generators Sold as Air Purifiers, California Air Resources Board. webpage https://ww2.arb.ca.gov/our-work/programs/air-cleaners-ozone-products/potentially-hazardous-ozone-generators-sold-air, August 2021. Potentially Hazardous Ozone Generators Sold as Air Purifiers.
[10] California's Regulation to Limit Ozone Emissions from Indoor Air Cleaning Devices, California Air Resources Board, January 1, 2010. webpage https://ww2.arb.ca.gov/resources/fact-sheets/californias-regulation-limit-ozone-emissions-indoor-air-cleaning-devices. California's Regulation to Limit Ozone Emissions from Indoor Air Cleaning Devices.
[11] REGULATION FOR LIMITING OZONE EMISSIONS FROM INDOOR AIR CLEANING DEVICES. REGULATION FOR LIMITING OZONE EMISSIONS FROM INDOOR AIR CLEANING DEVICES, California Code of Regulations Title 17. Public Health Division 3. Air Resources Chapter 1. Air Resources Board Subchapter 8.7. Indoor Air Cleaning Devices Article 1. Indoor Air Cleaning Devices. webpage https://ww2.arb.ca.gov/sites/default/files/2020-03/air-cleaner-regulation.pdf. PDF . local.
PCO and Ionizers
This PCO (Photocatalytic Oxidation) and Ionizer section covers ionizers, electrostatic precipitators, photocatalytic oxidation air cleaners, plasma cluster devices, corona discharge ozone generators, and others that rely on ions or ozone to clean the air. Some devices produce ozone on purpose as a method to clean the air but they are banned in California by law because of health concerns [1] [2] [3] [4]. Other devices produce low amounts of ozone or no ozone in the ion production process. Some devices produce different types of ions suggesting different performance levels.
This analysis will examine testing that has been performed on various PCO / Ionizer products. In order to select any technology or product for a system solution, its performance must be understood. Qualitative assessments using adjectives and adverbs are never used to describe performance. Performance is always reduced to numbers. These numbers are called performance requirements or performance specifications. For the remainder of this discussion the term performance specifications or numbers will we used.
Performance specifications must always be relevant to the problem being solved by the technology and resulting product. Management and marketing may attempt to deflect from understanding the performance of a product by offering performance specifications that are irrelevant and confuse the situation. For new technologies and resulting products there is always a challenge to translate the performance specifications to a known set of performance specifications for established technologies and products. For example, contagions were studied in term of air exchanges per hour (ACH) based on open windows and mechanical air ventilation (HVAC) systems. Once ceiling level UV-C systems surfaced in the last century the performance numbers of these systems were in terms of power density and contagion (virus, bacteria, fungi) death rates. In order to compare ceiling level UV-C systems to open windows and mechanical air ventilation systems a conversion needed to occur to quantify the performance of the UV-C systems in terms of ACH. This conversion was performed and UV-C system performance is stated in terms of effective ACH or eACH.
For PCO / Ionizer systems a conversion similar to what occurred for UV-C needs to happen with PCO / Ionizer systems. The PCO / Ionizer system performance needs to be converted to an ACH. A new designation can be used such epACH for effective PCO / Ionizer ACH.
The following is an example list of possible products. There is no recommendation for or against these products. They are offered to show the possible performance specifications to consider when using these subsystems to increase ventilation.
| Product | Installation | Company | Test Lab | Test Chamber Size | Test Data |
| A. MDU/Rx | Room | www.mdurx.com (ODOROX) | www.arelabs.com | 9.1 ft x 9.1 ft x 6.8 ft | MDU RX Test Data arelabs [5] |
| A. MDU/Rx | Room | www.mdurx.com (ODOROX) | www.InnovativeBioanalysis.com | 8 ft x 8 ft x 20 ft | MDU RX Test Data IB [6] |
| A. MDU/Rx | Room | www.mdurx.com (ODOROX) | www.compbio.com | Toxicity Report [7] | |
| B. GPS FC48-AC | HVAC | www.globalplasmasolutions.com | www.InnovativeBioanalysis.com | 8 ft x 8 ft x 20 ft | GPS
Test Data 1 [8] GPS Test Data 2 [9] GPS Test Data Comments [10] |
| GPS-iMEASURE | Ion Detector | www.globalplasmasolutions.com | NA | NA | Measure ion levels |
| C. ActivePure Medical Guardian | Room | www.activepure.com [13] | University of Texas Medical Branch (UTMB) | chamber size 150 L or 5.3 cubic feet | Aerus Technology Test Data [11] |
| Air Ion Counters | Ion Counters | www.alphalabinc.com | NA | NA | Measure ion levels About Air Ions |
PCO / Ionizer Test Approaches
The test approaches for the PCO / ionizer products appear to be the same. A test chamber is injected with a virus load and the virus load is measured as a function of time. A control test chamber is used that does not have the product under test to measure the natural decline of the airborne virus load. The difference between the control load and the product under test load is determined and the performance is stated as the percent of virus eliminated at various time sample points. The test chamber sizes vary from very small room settings to tiny test chambers. The performance is then stated as some percent of the virus eliminated by a certain time.
There are 2 problems with this test approach. The first is the test chambers are too small to represent a typical public room like a classroom. The second problem is the performance number that is provided is irrelevant because it does not correlate to the accepted standard of ACH that is used to measure infection risk. For example stating that 99% of the the virus is eliminated in 1 minute is not correlated to infection risk. Further this performance specification will not allow PCO / Ionizer products to be compared to HVAC or UV based system solutions.
Modifications to the test approach can be performed and include the following:
System testing is an interesting area. Many will attempt to test for success, they basically find the best case conditions and then claim those test results. However, in a systems driven test program the testing involves real world scenarios and then tests that attempt to break the system under test. Unless a system is broken under an extreme test it can never be fully understood.
Prior to the testing, analysis should be performed to determine the ion production rate. Currently the products only report ion density in terms of cubic centimeters but the measurement distance from the devices are not reported. For example, if the performance specification of 100 ions per cc is stated, is that 1 foot or 30 feet away from the device. A time component also needs to be added so that the number of ions produced over time can be reported. Understanding the ion density in a space as the ions attract airborne contagions might allow for probability based calculations to determine the cleaning rate (ventilation rate) of the product.
Can PCO / ionizer ventilation rates in terms of an effective PCO / ionizer ACH (epACH) be determine using the currently reported PCO / ionizer performance specifications? These specifications are:
This is a challenge. The best approach would be for the industry to change their test methodology so that the ACH ventilation rates can be directly reported via real world tests.
The goal of this analysis is to examine the various product descriptions and tests to determine if there is a way to convert the data to an epAUC so that they can be compared with HVAC and UV based solutions.
Product C Test Data Analysis
The analysis of Product C test data was started first because it is similar to the product purchased by the Philadelphia School District. The analysis is based on the test data and various adjustments based on different assumptions. The adjustments were (1) reduce the virus load form the test load to what might be expected in an operational setting and assume the same contact probability and (2) increase the volume from the test chamber size to a possible room size. The Internet did have some statements that the test data may be flawed because the Ion generation rate in the test fixture may have been higher (13X ) than the product. This is not considered in the analysis and the test data is accepted.
The following is key data from the tests performed on Product C:
It is possible to calculate the number of virus particles destroyed based on the above test data. From that information it is possible to calculate the number of ions produced. The analysis then takes the path of least resistance to try and find a reasonable set of data and assumptions to surface the epAUC. This analysis is a discovery process in the hunt for a reasonable epAUC estimate. Each analysis will offer its perspective of the resulting epAUC as bounded by the assumptions in the analysis.
The following analysis uses the test data to determine the number of ions produced per minute by the device. Given the virus kill time and the number of ions needed to kill the viruses, various ion levels are then assumed to determine different epAUC ratings. This analysis is independent of room size. The next analysis will consider room size. Room size will obviously affect the epAUC.
Test Data |
Virus Load |
Injection |
99% |
Virus Load |
Killed Virus |
Ions Need |
Ions |
Ions / Min |
room |
Ions / Min |
Number of Ions / Min |
epAUC |
Product C |
50,000,000 |
15 |
3 |
10,000,000 |
9,900,000 |
1 |
9,900,000 |
3,300,000 |
9000 |
367 |
367 |
20 |
Product C |
50,000,000 |
15 |
3 |
10,000,000 |
9,900,000 |
1 |
9,900,000 |
3,300,000 |
9000 |
367 |
500 |
15 |
Product C |
50,000,000 |
15 |
3 |
10,000,000 |
9,900,000 |
1 |
9,900,000 |
3,300,000 |
9000 |
367 |
1000 |
7 |
Product C |
50,000,000 |
15 |
3 |
10,000,000 |
9,900,000 |
1 |
9,900,000 |
3,300,000 |
9000 |
367 |
2000 |
4 |
Product C |
50,000,000 |
15 |
3 |
10,000,000 |
9,900,000 |
1 |
9,900,000 |
3,300,000 |
9000 |
367 |
3000 |
2 |
Note 1: This analysis is independent of room size.
So the best case estimate from this analysis is 20 epAUC. However, a small test chamber is not a typical room size.
The above analysis shows that as the number of ions required to kill a virus increases the epAUC decrease. There is no data to determine the number of ions / min per cu-ft needed to prevent infection. This is an area that is open for future study. This is similar to what the UV analysts did when they identified the micro-watts needed to kill various contagions. Someone needs to determine the number of ions per volume of space needed to kill a virus. This can be done using probability analysis and via tests to verify the analysis.
The following analysis uses the test data to determine the epAUC based on test chamber size and room size. The room size is 30 ft x 30 ft x 10 ft which is 9,000 cu-ft. If the test chamber size is 5.3 cu-ft and the epAUC in the test chamber is 20 epAUC then expanding the space to a larger volume can be treated as a factor that when multiplied with the test result of 20 epAUC will extrapolate and provide an epAUC estimate for the room being considered in an real world setting.
Test Data |
Test Chamber |
99% Kill |
epAUC |
Room |
Test Chamber |
epAUC |
Test |
Product C |
5.3 |
3 |
20 |
9000 |
0.000588889 |
0.011777778 |
10,000,000 |
The epAUC number is very low. However, the test data is based on an extremely large virus load that is well beyond real world expectations.
The following analysis uses the test data to determine the epAUC based on changing the virus load to a more real world scenario. This becomes a factor that is used to multiply the epAUC found in the analysis based on the test chamber and room size analysis. The virus load is assumed to be 1000 and 2000 viruses per minute. The virus load is based on analysis from 2020 [12].
Test Data |
Test Chamber |
99% Kill |
epAUC |
Room |
Test Chamber |
epAUC |
Test |
Real World |
Virus Load |
Ions |
epAUC |
Product C |
5.3 |
3 |
20 |
9000 |
0.000588889 |
0.011777778 |
10,000,000 |
3000 |
3333 |
100% |
39 |
Product C |
5.3 |
3 |
20 |
9000 |
0.000588889 |
0.011777778 |
10,000,000 |
6000 |
1667 |
100% |
20 |
Product C |
5.3 |
3 |
20 |
9000 |
0.000588889 |
0.011777778 |
10,000,000 |
3000 |
3333 |
50% |
20 |
Product C |
5.3 |
3 |
20 |
9000 |
0.000588889 |
0.011777778 |
10,000,000 |
6000 |
1667 |
50% |
10 |
Product C |
5.3 |
3 |
20 |
9000 |
0.000588889 |
0.011777778 |
10,000,000 |
3000 |
3333 |
10% |
4 |
Product C |
5.3 |
3 |
20 |
9000 |
0.000588889 |
0.011777778 |
10,000,000 |
6000 |
1667 |
10% |
2 |
This analysis suggests that in a perfect case the epAUC might be as high as 39 epAUC. The problem is that it is unclear if the device can fill the room in the same way as the test chamber. The ions will contact other airborne non virus particles, some will contact surfaces, and some will never make it across the room. As the device runs it will constantly produce ions, which will clean the air of the airborne non virus particles. Once the air is relatively clean then the actual airborne virus particles will be contacted by the ions. The question then arises, what is the percent of ions that will find and kill a virus.
NASA Use PCO
In 1995 a PCO device using Active Pure technology was successfully flown and operated on Space Shuttle Columbia. The Space Shuttle had 74.3 cubic meters (2,625 cubic feet). This is approximately 1/4 the size of a classroom (9,000 cubic feet) used in this systems analysis (3.43 = 9000/2625). It is unclear what the size of the system was that was used on the Space Shuttle in 1995. If it was the same size as the products offered to schools at this time this suggest that 3-4 units would be needed to match the performance level of what was found in the Space Shuttle in 1995. The following is an extract from NASA Technology in an article: Light-Induced Oxidation Cleans Air, Surfaces, Clothes, Originally published in 2018. [13]
When ultraviolet light strikes titanium dioxide, it frees electrons that turn oxygen and moisture into highly reactive hydroxyl radicals. These charged particles then oxidize air contaminants such as volatile organic compounds, turning them into carbon dioxide and water. University researchers were trying to eliminate ethylene that accumulates around plants growing in spacecraft, but they found that their ethylene scrubber also eliminated other airborne organic compounds and neutralized bacteria, viruses, and molds.In 2009, Aerus, formerly the Electrolux vacuum cleaner company, acquired a company called EcoQuest that had a proprietary form of the technology, known as ActivePure. It didn’t just clean the air that passed through the system but sent oxidizers out into the surrounding environment, where they could not only neutralize airborne contaminants and pathogens but also settle on and clean surfaces.
It creates this blast of hydroxyl kill agents that we blow out into the atmosphere, as Urso puts it. No other technology does that.
Aerus made further enhancements, altering the mix of metals in the photocatalyst and changing the way it interacts with the ultraviolet light to make it more effective.
The oxidizers ActivePure deploys include hydroxyls, hydrogen peroxide, and superoxides, all charged particles that clean air and surfaces but pose no threat to humans or pets. They naturally distribute themselves throughout the air, so the only question is the quantity needed to clean a given space, Urso says, noting that this is why the company offers the technology in different scales and also develops custom solutions for areas of any size.
Several of Aerus Holdings’ subsidiary brands incorporate the technology into their products, including Beyond by Aerus, activTek, Vollara (formerly EcoQuest), and others. That's what's allowed us to have such a big reach and a big impact, Urso says.
Product A, B, C Test Data Analysis
see [spreadsheet]
The following table has the key test data used in the analysis. The goal of the analysis is to use the current test data to determine the possible performance of these systems in a real room size of 30 x 30 x 10 feet and a reasonable virus load.
| Test Data Analysis | Room Size cu-ft | Time min | Virus Load Control | Virus Remaining Avg | Virus Destruction % | Virus Load | epAUC | Comment | A/B cu-ft | A/B Virus Load |
| Product A: MDU/Rx | 1280 | 20 | 23,700,000 | 243,000 | 98.97% | 23,700,000 | 3 | 1 | 21.94 | |
| . | ||||||||||
| Product B: GPS FC48-AC 10K ions/cu-cm | 1280 | 15 | 4,680,000 | 3,980,000 | 14.96% | 4,680,000 | na | too many remaining viruses | ||
| Product B: GPS FC48-AC 10K ions/cu-cm | 1280 | 45 | 2,480,000 | 684,000 | 72.42% | 2,480,000 | na | too many remaining viruses | ||
| Product B: GPS FC48-AC 10K ions/cu-cm | 1280 | 60 | 1,080,000 | 98,600 | 90.87% | 1,080,000 | 1 | |||
| Product B: GPS FC48-AC 18K ions/cu-cm | 1280 | 15 | 5,120,000 | 3,560,000 | 30.47% | 5,120,000 | na | too many remaining viruses | ||
| Product B: GPS FC48-AC 18K ions/cu-cm | 1280 | 45 | 2,460,000 | 514,000 | 79.11% | 2,460,000 | na | too many remaining viruses | ||
| Product B: GPS FC48-AC 18K ions/cu-cm | 1280 | 60 | 1,120,000 | 18,600 | 98.34% | 1,120,000 | 1 | |||
| . | ||||||||||
| Product C: ActivePure Medical Guardian | 5.3 | 3 | 10,000,000 | 100,000 | 99.00% | 10,000,000 | 20 | 242 | 2.37 |
The following table shows the effects of extrapolating (mathematically increasing) the test chamber size to a room size of 30 x 30 x 10 feet. The extrapolation is linear.
| Adjust epAUC from test chamber to real world room size | Test Chamber Size cu-ft | 99% Kill Time Min | epAUC in Test Chamber | Room cu-ft | Test Chamber / Room Factor | epAUC in Room | Test Virus Load | Comment |
| Product A: MDU/Rx | 1280 | 20 | 3 | 9000 | 0.142222222 | 0.426666667 | 23,700,000 | virus load is massive compared to real world scenario, can the result change if the virus load is reduced |
| Product B: GPS FC48-AC 18K ions/cu-cm | 1280 | 60 | 1 | 9000 | 0.142222222 | 0.142222222 | 1,120,000 | virus load is massive compared to real world scenario, can the result change if the virus load is reduced |
| Product C: ActivePure Medical Guardian | 5.3 | 3 | 20 | 9000 | 0.000588889 | 0.011777778 | 10,000,000 | virus load is massive compared to real world scenario, can the result change if the virus load is reduced |
The following table shows the effects of extrapolating the room size and virus load to a more reasonable size and virus lower load. The extrapolations are linear.
| Adjust epAUC from test virus load to real world viral load | Test Chamber Size cu-ft | 99% Kill Time Min | epAUC in Test Chamber | Room cu-ft | Test Chamber / Room Factor | Room epAUC | Test Virus Load | Real World Virus Load in 3 Min | Virus Load Adjustment Factor | Ions That Find and Kill Virus % | epAUC With Virus Load Adjustment Factor | Comment |
| Product A: MDU/Rx | 1280 | 20 | 3 | 9000 | 0.142222222 | 0.426666667 | 23,700,000 | 3000 | 7900 | 100% | 3371 | this assumes the ions can uniformly fill the space and attract all the airborne virus |
| Product A: MDU/Rx | 1280 | 20 | 3 | 9000 | 0.142222222 | 0.426666667 | 23,700,000 | 6000 | 3950 | 100% | 1685 | this assumes the ions can uniformly fill the space and attract all the airborne virus |
| Product A: MDU/Rx | 1280 | 20 | 3 | 9000 | 0.142222222 | 0.426666667 | 23,700,000 | 3000 | 7900 | 50% | 1685 | |
| Product A: MDU/Rx | 1280 | 20 | 3 | 9000 | 0.142222222 | 0.426666667 | 23,700,000 | 6000 | 3950 | 50% | 843 | |
| Product A: MDU/Rx | 1280 | 20 | 3 | 9000 | 0.142222222 | 0.426666667 | 23,700,000 | 3000 | 7900 | 10% | 337 | |
| Product A: MDU/Rx | 1280 | 20 | 3 | 9000 | 0.142222222 | 0.426666667 | 23,700,000 | 6000 | 3950 | 10% | 169 | these numbers are very high |
| . | ||||||||||||
| Product B: GPS FC48-AC 18K ions/cu-cm | 1280 | 60 | 1 | 9000 | 0.142222222 | 0.142222222 | 1,120,000 | 3000 | 373 | 100% | 53 | this assumes the ions can uniformly fill the space and attract all the airborne virus |
| Product B: GPS FC48-AC 18K ions/cu-cm | 1280 | 60 | 1 | 9000 | 0.142222222 | 0.142222222 | 1,120,000 | 6000 | 187 | 100% | 27 | this assumes the ions can uniformly fill the space and attract all the airborne virus |
| Product B: GPS FC48-AC 18K ions/cu-cm | 1280 | 60 | 1 | 9000 | 0.142222222 | 0.142222222 | 1,120,000 | 3000 | 373 | 50% | 27 | |
| Product B: GPS FC48-AC 18K ions/cu-cm | 1280 | 60 | 1 | 9000 | 0.142222222 | 0.142222222 | 1,120,000 | 6000 | 187 | 50% | 13 | |
| Product B: GPS FC48-AC 18K ions/cu-cm | 1280 | 60 | 1 | 9000 | 0.142222222 | 0.142222222 | 1,120,000 | 3000 | 373 | 10% | 5 | |
| Product B: GPS FC48-AC 18K ions/cu-cm | 1280 | 60 | 1 | 9000 | 0.142222222 | 0.142222222 | 1,120,000 | 6000 | 187 | 10% | 3 | |
| Product B: GPS FC48-AC 18K ions/cu-cm | 1280 | 60 | 1 | 9000 | 0.142222222 | 0.142222222 | 1,120,000 | 3000 | 373 | 5% | 3 | |
| Product B: GPS FC48-AC 18K ions/cu-cm | 1280 | 60 | 1 | 9000 | 0.142222222 | 0.142222222 | 1,120,000 | 6000 | 187 | 5% | 1 | This suggests that the expected ion virus collision probability is 5% |
| . | ||||||||||||
| Product C: ActivePure Medical Guardian | 5.3 | 3 | 20 | 9000 | 0.000588889 | 0.011777778 | 10,000,000 | 3000 | 3333 | 100% | 39 | this assumes the ions can uniformly fill the space and attract all the airborne virus |
| Product C: ActivePure Medical Guardian | 5.3 | 3 | 20 | 9000 | 0.000588889 | 0.011777778 | 10,000,000 | 6000 | 1667 | 100% | 20 | this assumes the ions can uniformly fill the space and attract all the airborne virus |
| Product C: ActivePure Medical Guardian | 5.3 | 3 | 20 | 9000 | 0.000588889 | 0.011777778 | 10,000,000 | 3000 | 3333 | 50% | 20 | This suggest the ion virus collision probability is 50% |
| Product C: ActivePure Medical Guardian | 5.3 | 3 | 20 | 9000 | 0.000588889 | 0.011777778 | 10,000,000 | 6000 | 1667 | 50% | 10 | |
| Product C: ActivePure Medical Guardian | 5.3 | 3 | 20 | 9000 | 0.000588889 | 0.011777778 | 10,000,000 | 3000 | 3333 | 10% | 4 | |
| Product C: ActivePure Medical Guardian | 5.3 | 3 | 20 | 9000 | 0.000588889 | 0.011777778 | 10,000,000 | 6000 | 1667 | 10% | 2 |
The data and analysis using the same approach as for Product C suggests that the above analysis is missing something because product C has an epAUC that is significantly different from product A. There could be an error in the test data for product A. The data for Product A does have some anomalies where the tables do not match the values in the graphs (the exponents are different). One possibility is that the virus load in product A is incorrect. The load would have to come down by 2 orders of magnitude.
Test Data Analysis Observations
The industry has tried to test their products and provide performance specifications. The problem is no customers are willing to go to the next level and ask the questions that are relevant. The questions that are relevant are: what happens in a real room setting that includes size, existing HVAC operations, doors opening closing, people moving in and out of a room, etc. Large customers have not taken on their obligations to ensure they are providing a proper system by performing their own independent test and evaluation efforts.
It is obvious that this technology is ripe for further research. The research needs to include analysis and operational test and evaluation. However, research suggests that this is new, unknown, and difficult to understand. That is not the case. This is a resource problem where no one has decided to perform the detailed analysis and establish an effective test and evaluation program.
The testing would be very easy to perform and it is unclear why the Philadelphia School District did not setup their own test and evaluation program for all products they are considering for their schools including these devices. Had they done that, in this case the PCO / Ionizer industry could have responded. For example, the test data may have shown that in some cases all that is needed is just multiple devices in a room. Without the performance numbers that matter, once again management is controlling the decisions with talking points, but the talking points are irrelevant because the problem must be solved or people will continue to get sick and die.
At this point it is difficult to compare this technology from a contagion mitigation perspective using engineering performance specifications. There are performance numbers but they do not translate to airborne contagion mitigation assessments. This analysis was an attempt to shed light in this area but there are too many assumptions and dissimilar results. The product C epAUC numbers in this analysis don't look bad but we need to know the actual airborne contagion mitigation performance levels in terms of an epAUC that everyone will accept and help facility engineers make reasonable system design choices.
References:
[1] List of CARB-Certified Air Cleaning Devices, California Air Resources Board. webpage https://ww2.arb.ca.gov/list-carb-certified-air-cleaning-devices, August 2021. List of CARB-Certified Air Cleaning Devices.
[2] Potentially Hazardous Ozone Generators Sold as Air Purifiers, California Air Resources Board. webpage https://ww2.arb.ca.gov/our-work/programs/air-cleaners-ozone-products/potentially-hazardous-ozone-generators-sold-air, August 2021. Potentially Hazardous Ozone Generators Sold as Air Purifiers.
[3] California's Regulation to Limit Ozone Emissions from Indoor Air Cleaning Devices, California Air Resources Board, January 1, 2010. webpage https://ww2.arb.ca.gov/resources/fact-sheets/californias-regulation-limit-ozone-emissions-indoor-air-cleaning-devices. California's Regulation to Limit Ozone Emissions from Indoor Air Cleaning Devices.
[4] REGULATION FOR LIMITING OZONE EMISSIONS FROM INDOOR AIR CLEANING DEVICES. REGULATION FOR LIMITING OZONE EMISSIONS FROM INDOOR AIR CLEANING DEVICES, California Code of Regulations Title 17. Public Health Division 3. Air Resources Chapter 1. Air Resources Board Subchapter 8.7. Indoor Air Cleaning Devices Article 1. Indoor Air Cleaning Devices. webpage https://ww2.arb.ca.gov/sites/default/files/2020-03/air-cleaner-regulation.pdf. PDF . local.
[5] Determination of the ODOROX® MDU/Rx System's Efficacy against Various Bioaerosols, ARE Labs Inc, HGI Industries, Inc. www.arelabs.com, project # 10805.1, 2014. webpage https://pyure.com/wp-content/uploads/2021/03/ARE_Labs_ODOROX_Efficacy_vs_Bioaerosols.pdf, August 2021. MDU RX Test Data arelabs.
[6] MDU/Rx Bioaerosol Test, EFFICACY OF THE PYURE MDU/Rx DEVICE AGAINST AEROSOLIZED SARS-CoV-2, Innovative Bioanalysis LLC, January 01, 2021. webpage https://www.mdurx.com/wp-content/uploads/2021/01/PYURE_Final_Report_SARS_CoV_2_Testing-1.pdf, August 2021. MDU RX Test Data IB.
[7] 13-Wee GLP Toxicity Study of the Odorox Boss Hydroxyl Processor Air Cleansing Machine in Rats, Study Number: CB10-5065-R-TX, Comparative Biosciences Inc, March 1, 2011. webpage https://mdurx.com/wp-content/uploads/2021/01/Toxicology_Study_Report.pdf, August 2021. Toxicity Report.
[8] AEROSOL SARS-CoV-2USA-CA1/2020 NEUTRALIZATION BY GPS FC48-AC (FC48), EFFICACY OF THE GPS FC48-AC NPBITM IONIZATION UNIT AGAINST AIRBORN SARS-CoV-2, Innovative Bioanalysis LLC, March 18, 2021. webpage https://drive.google.com/file/d/1VQW_XEDw5MtNchsSXLlb-xIcX0Pw8Xr8/view, August 2021. GPS Test Data 1.
[9] SARS-CoV-2 In-Air and Surface Testing, April 2021. webpage https://globalplasmasolutions.com/uploads/customer-resources/GPS-SARS-CoV-2-Report-2021.pdf, August 2021. GPS Test Data 2.
[10] GPS's Unique Needlepoint Bipolar Ionization Technology Is Safe and Effective, 2021. webpage https://drive.google.com/file/d/1V5EXCx_a1iHboLETYyxtA2WHnXFVyeBz/view, August 2021. GPS Test Data Comments.
[11] Airborne Inactivation of the Novel Coronavirus SARS-CoV-2 by Aerus Technology, University of Texas Medical Branch (UTMB), 22 December 2020. webpage https://activtek.pl/wp-content/uploads/2021/05/UTMB-Airborne-SARS-CoV-2F_Final-Report.pdf, August 2021. Aerus Technology Test Data.
[12] See section Virus Load Air Exchanges Needed Model.
[13] Light-Induced Oxidation Cleans Air, Surfaces, Clothes, Originally published in 2018, NASA Technology. webpage https://spinoff.nasa.gov/Spinoff2018/cg_2.html, August 2021. Light-Induced Oxidation Cleans Air, Surfaces, Clothes.
Classroom Unit Ventilators
A classroom unit ventilator is similar to a typical in room unit ventilator, however there are unique considerations associated with a classroom setting like noise level and large population swings as students move in large groups from space to space in a school building. The unit ventilators come in different performance levels such as 750, 1000, 1250, 1500, CFM. The following table shows the ventilation performance specifications and sizes for a typical product [1].
| Description | Size A | Size B | Size C | Size D | Vendor |
| Unit Size (CFM) | 750 | 1000 | 1250 | 1500 | Trane |
| Unit Length w/o end covers (inches) | 69 | 81 | 93 | 105 | Trane |
| Unit Length w/o end covers (ft) | 5.75 | 6.75 | 7.75 | 8.75 | Trane |
| Unit Depth - Standard (inches) | 16 5/8 | 16 5/8 | 16 5/8 | 16 5/8 | Trane |
| Unit Depth - with false back (inches) | 21 1/4 | 21 1/4 | 21 1/4 | 21 1/4 | Trane |
| Unit Height - Standard (inches) | 30 | 30 | 30 | 30 | Trane |
| Shipping Weight (Lbs.) | 320 | 405 | 450 | 470 | Trane |
Based on selecting the above product Size D and assuming a classroom size of 30 ft x 30 ft x 10 ft the following system approaches and the resulting performance data are determined.
System Approach |
size |
qty |
cu-ft |
ACH |
CML |
Req Feet |
A |
1500 |
1 |
9000 |
10 |
3 |
8.75 |
B |
1500 |
2 |
9000 |
20 |
3 |
17.5 |
C |
1500 |
3 |
9000 |
30 |
4 |
26.25 |
With just 1 classroom unit ventilator the resulting ACH is 10 and the Contagion Mitigation Level (CML) level is 3. If multiple classroom unit ventilators are installed the length of the classroom the ACH is 30 and the CML is 4 which is beyond the WHO requirement of 24 ACH for airborne contagions in a room.
Many schools in the 1960's were designed using this approach. Along one wall of the classroom was a full set of windows, from the ceiling all the way down to the classroom unit ventilators, and both were the length of the wall. Most unit ventilator at the time did not offer air conditioning. Open windows were used to ventilate the classrooms during warm weather. Today the classroom unit ventilator provides air conditioning and heat as needed for effective temperature control. The internal HEPA filters capture contagions.
References:
[1] Classroom Unit Ventilator, 750 CFM to 1500 CFMVertical Classroom Unit VentilatorModel VUV, May 2006 UV-PRC003-EN, Trane Product Brochure. webpage https://www.trane.com/Commercial/Uploads/Pdf/1092/uvprc003en.pdf, August 2021. PDF . local.
Inverter 360 Cassette
The Inverter 360 Cassette is a product from Samsung. It is a ceiling mounted ventilator unit that uses a circular ventilation design that evenly spreads the ventilation across the ceiling while taking in the air from the bottom of circular structure. In terms of operational concept it is like an in room unit ventilator however because of the unique ventilation approach there are no air dead spots and the power requirements for the fan are significantly less than for other mechanical ventilation approaches.
Inverter 360 Cassette Air Conditioner / Heather Heat Pump |
The Samsung Inverter 360 Cassette AC140KN4DKH/EU specifications for the 4.5 HP unit are:
References:
[1] Inverter 360 Cassette AC140KN4DKH/EU, Samsung. webpage https://www.samsung.com/my/system-air-conditioners/ceiling-air-conditioner/ac140kn4dkh-eu, February 2022.
HEPA Air Purifiers And Sanitizers
HEPA Air Purifiers and Sanitizers use HEPA filters however, Air Sanitizers sterilize the air by also using heat or UV light. These are portable devices that are placed in a room to clean the room of particulate matter including viruses like COVID-19. They consist of a HEPA filter able to trap very small particles and a fan. The challenge for these devices is to move as much air as possible without compromising the HEPA filter. The problem is not so much with the HEPA filter but the ability of the fan in a relatively small form factor to move a large amount of air. It is a physics problem and given a certain size fan there is only so much air that can be moved. Preventing the filter from being compromised is less of a system driver because the filter size and layers can just be increased, it is not the limiting factor. The limiting factor is the fan primarily, the motor, and then the filter. Another consideration is noise from the mechanical mechanism and actual air movement. The air turbulence needs to be minimized to reduce the noise level.
As of April 22, 2021, 3.71 million US children tested positive for SARS-CoV-2, which is equivalent to about 4,931 cases per 100,000 children. Of these cases, 0.1% to 1.9% of pediatric infections resulted in hospitalization and 0.00% to 0.03% resulted in death. The following is an extract from School Ventilation: A Vital Tool to Reduce COVID-19 Spread [1]:
School administrators and decision makers should purchase HEPA air filtration units to be placed in classrooms and common occupied spaces.
School systems should use only proven technologies for improving indoor air quality: appropriate ventilation, HEPA filtration, or ultraviolet germicidal irradiation. They should not use chemical foggers or any air cleaner other than filtration and ultraviolet germicidal irradiation.
School systems should not use unproven technologies such as ozone generators, ionization, plasma, and air disinfection with chemical foggers and sprays. The effect of these cleaning methods on children has not been tested and may be detrimental to their health. The primary aim for improving air quality should be to remove contaminants and impurities from the air and not to introduce new substances into the air.
The US government should convene a federal task force dedicated to school air quality to develop guidance for long-term, sustainable, cost-effective improvements to indoor air quality in schools. This guidance should include accountability measures to assess improvements.
Author Comment: This analysis in 2020 recommended that that the Federal Government become involved and proposed legislation [2].
A HEPA filter is a particulate air filter with removal efficiencies of 99.97% or higher for a mass median particulate size of 0.30 microns (HEPA H13 can be as low as 0.1 microns). Minimum Efficiency Reporting Value (MERV) is a scaled rating of the effectiveness of air filters. The scale is designed to represent the worst case performance of a filter when dealing with particles in the range of 0.3 to 1, 1 to 3, and 3 to 10 micrometers. The MERV rating is from 1 to 16. Higher MERV ratings correspond to a greater percentage of particles in each range captured on each pass. For example, MERV 13, the most common recommendation for upgrades, captures 50% (0.3 to 1 micrometers), 85% (1 to 3 micrometers), and 90% (3 to 10 micrometers) in the 3 ranges. [1]
Coronavirus varies between 0.06 to 1.4 microns. The virus that causes COVID-19 is approximately 0.125 microns (125 nanometers) in diameter [3].
The following is an example list of possible products. There is no recommendation for or against these products. They are offered to show the possible performance specifications to consider when using these subsystems to increase ventilation.
| Product | CFM Pre Filter | CFM Post Filter | Class room cu-ft |
ACH | CADR | Watts Max | dB High | dB Med | dB Low | Weight Lbs | Size Inches | Cost Est |
Ref | Comment |
| A. Amaircare 3000 HEPA Air Purifier | - | 265 | 9000 | 1.8 | - | 84 | 57.3 | 42.9 | 32.8 | 28 | 23 H x 16 W | $719 | [A] | |
| B. Rabbit Air - Minus A2 SPA-780A - Ultra Quiet HEPA Air Purifier | - | 218 | 9000 | 1.5 | - | 61 | 51.3 | - | 25.6 | 19.4 | 20.25 H x 21.4 W x 7 D | $599 | [A] | |
| C. Austin Air Bedroom Machine HEPA & Carbon Filter Air Purifier | 400 | 250 | 9000 | 1.7
|
- | 135 | 66 | - | 50 | 45 | 23 H x 14.5 W x 14.5 D | $994 | [A] | |
| D. Airpura R600 R614 All Purpose | 560 | 412 | 9000 | 2.7 | - | 120 | 62.3 | 45.2 | 28.1 | 18+ | 23 H x 15 W | $699 | [A] | Highest CFM in industry claim |
| E. Medify MA-112 V2.0 | - | - | 9000 | - | 560 | 95 | 70 | - | - | 33.5 | 28.3 H x 15.7 W x 15.4 D | $597 | [B] | Clean Air Delivery Rate (CADR) 950 cu-m/h = 559 cu-ft/min |
| F. Blueair Classic 605 | - | - | 9000 | - | 500 | 100 | 62 | - | 32 | 31 | 13 x 20 x 26 | $874 | [B] | Certified clean air delivery rate (CADR) of 500 cubic feet per minute with a superior |
| G. Coway Airmega 400 | - | 416 | 9000 | 2.8 | - | 64 | 43.2 | - | - | 24.7 | 14.8 x 14.8 x 22.8 | $569 | [B] | Unable to verify 416 CFM stated in reference |
| H. Maxum HEPA Air Purifier | 500 | 9000 | 3.3 | - | 150 | 60 | - | 38 | - | - | $750 | [C] | ||
| I. XPOWER AP-2000 Portable HEPA Air Filtration System
|
- | 2000 | 9000 | 13.3 | - | 1037 | 98 | - | - | 85 | 32 H x 29 W 4 | $1,099 | [D] | Too loud for classroom |
Clear Air Delivery Rate (CADR) is the Cubic Feet per Minute (CFM) of air in a 1,008-cubic-foot (28.5 m3) room that has had all the particles of a given size distribution removed from the air, over and above the rate at which the particles are naturally falling out of the air. Different filters have different abilities to remove different particle distributions, so three CADR's for a given device are typically measured: smoke, pollen, and dust. Some devices are rated in terms of CADR not to be confused with Post Filter CFM. The Post Filter CFM is what is used to calculate the Air Changes per Hour (ACH) in a room. It appears that 400 CFM post HEPA filteration is what can be expected for a high end device.
For a 30 ft x 30 ft x 10 ft classroom of 9000 cu-ft the 400 CFM device will provide 2.7 ACH. If the classroom size is reduced to 25 ft x 25 ft x 8 ft the 400 CFM device will provide 4.9 ACH.
ACH = CFM * 60 / room cu-ft
The tradeoff is noise versus CFM. As the CFM increases it becomes important to increase the air vent surface area and move the motor fan assembly out of the room. An older study associated with classroom CO2 levels offers an example of the ventilation in the classroom [4].
Installation of a ventilation intervention in a classroom
A: Air sock for air supply, B: tailor made window pane, C: non-flexible duct for air exhaustion, D: ventilator |
The question then arises, is it possible to have reasonable levels of increased ventilation using HEPA Air Purifiers or Sanitizers. Yes, but the answer is not simple. Finding the products with very high performance levels is a challenge (high CFM and low dB). It also appears that multiple units will be needed in 9000 cu-ft classrooms to provide for ACH levels greater than 12, which is the CDC recommendation for hospital areas with airborne contagions. The WHO recommendation is 24 ACH.
References:
[1] School Ventilation: A Vital Tool to Reduce COVID-19 Spread, Johns Hopkins University, Johns Hopkins Center for Health Security, May 2021. webpage https://www.centerforhealthsecurity.org/our-work/pubs_archive/pubs-pdfs/2021/20210526-school-ventilation.pdf, August 2021. School Ventilation: A Vital Tool to Reduce COVID-19 Spread.
[2] COVID-19 Funding for Facility Ventilation Upgrade Recommendations and to Upgrade all Public Schools, July 3, 2020. See section Proposed Legislation.
[3] Guide to Air Cleaners in the Home, US EPA. webpage https://www.epa.gov/sites/default/files/2018-07/documents/guide_to_air_cleaners_in_the_home_2nd_edition.pdf, August 2021. Guide to Air Cleaners in the Home.
[4] A ventilation intervention study in classrooms toimprove indoor air quality: the FRESH study, Environmental Health, 2013. webpage https://pubmed.ncbi.nlm.nih.gov/24345039, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3893609/pdf/1476-069X-12-110.pdf, August 2021. PDF . local
[A] Quiet HEPA Air Purifiers: 5 Low-Noise Models, US Air Purifiers. webpage https://www.usairpurifiers.com/blog/quiet-hepa-air-purifiers-5-low-noise-models, August 2021. Quiet HEPA Air Purifiers: 5 Low-Noise Models.
[B] The 7 Best Air Purifier for Classroom Review in 2021 with Buying Guide, February 23, 2021. webpage https://reviewsofairpurifiers.com/best-air-purifier-for-classroom, August, 2021. The 7 Best Air Purifier for Classroom Review in 2021 with Buying Guide.
[C] Maxum HEPA Air Purifier, lakeair, www.lakeair.com. webpage https://www.lakeair.com/product/maxum-hepa-air-purifier, August 2021. Maxum HEPA Air Purifier.
[D] XPOWER AP-2000 Portable HEPA Air Filtration System, XPOWER, www.xpower.com. webpage https://xpower.com/shop/xpower-portable-hepa-air-filtration-system, https://www.homedepot.com/p/XPOWER-2000-CFM-Portable-3-Stage-Filtration-HEPA-Air-Purifier-System-AP-2000/314732339, August 2021. XPOWER AP-2000 Portable HEPA Air Filtration System . XPOWER AP-2000 Portable HEPA Air Filtration System
Ozone Generators
All schools, universities and colleges in Wales will be supplied with 1,800 ozone disinfecting machines to clean classrooms after a COVID-19 infection event. The room is closed and no one is allowed in the room, including animals during the disinfection process. The machines are programmed to allow an individual time to leave a room before a machine goes into operation. Once a room is disinfected the machine converts the ozone back to oxygen. The machine signals that it is safe to return into the room when the cleaning cycle is complete. The machines are only for disinfecting empty indoor spaces and not a form of air purification for occupied indoor spaces. The machines were developed at Swansea University. [1]
The purchase of the Ozone disinfecting machines by the Welsh government is controversial. There are concerns about how the ozone will react with chemicals in the room especially soft furnishings. Disinfecting air when no one is present to breath it is also a concern because it is a pointless exercise. It is suggested by some in Wales that better ventilation in schools is a safer and more effective means of mitigating COVID-19 in the classroom. It is also suggested by some in Wales that priorities should be on approaches that offer the greatest benefit in reducing the risk of infection. For example, if natural ventilation is provided for indoor settings, transmission reduces by up to 70%. [1] So there is a split between those in authority that made the decision to purchase the ozone generators and others that are considered experts in the field.
The total cost of the 1,800 machines is £3.3 million pounds and it is part of a £5.9 million pound initiative to improve air quality in classrooms and lecture halls. [1] This is £1,833 pounds per machine.
This is a surface disinfection approach used when people are not present. It does not clean the air as the infection is being released by an infected person because the room is empty while the system is On but it is Off when people are present. PCO / Ionizers were developed to minimize ozone levels and can be used when people are present, but as shown in the analysis there are no meaningful performance numbers on these systems [2]. Purchasing 1,800 machines in anticipation of infection events is not a good sign. If there are indeed that many infection events it is unlikely that the physical school sessions will continue. A possibility is that the large quantiy of machines may be used to disinfect classrooms bewteen classroom changes. However we know that would only translate to 1 Air Change per Hour (ACH), which is too low to prevent infection [5] [6].
The Welsh government is also providing CO2 sensors to schools, colleges and universities to improve ventilation, after a similar move in England [1] [7]. In England the Department for Education will spend £25 million pounds on 300,000 CO2 monitors to alert staff and students if CO2 levels rise. In England the government also started a trial of air purifiers in 30 schools in Bradford to assess their use and whether they could reduce the risk of transmission. [7]
Providing CO2 sensors to schools is yet another poor choice. We know that just maintaining the CO2 levels will not translate to the number of air changes per hour needed to mitigate the risk of infection. Maintaining the CO2 level translates to approximately 1 ACH for a typical classroom [3]. However, we know the CDC recommends 12 ACH and the WHO recommends 24 ACH [4]. We also know that infection in a classroom happens with 1 ACH [5] [6]. So maintaining the CO2 level is not appropriate. The performance of the system must be much higher.
This decision would make sense if it was made after each classroom had a ventilation performance level greater than 12 ACH.
It is unclear why management everywhere is rejecting that the virus is airborne and that the air must be properly cleaned while the people are in the room. This is a massive failure of government everywhere. They have an obligation to setup the labs, do the analysis and testing and then tell the people what must be done. Then they need to pass and enforce regulations that directly solve the problem. Currently bureaucrats in conjunction with the market are making the choices rather than informed decisions from what is really simple science and engineering.
References:
[1] Concerns over plan to use ozone to disinfect classrooms in Wales, the Guardian, August 2021. webpage https://www.theguardian.com/uk-news/2021/aug/30/concerns-over-plan-to-disinfect-classrooms-in-wales-with-ozone, August 2021. Concerns over plan to use ozone to disinfect classrooms in Wales.
[2] See section PCO and Ionizers.
[3] See section CFM Per Person Versus CFM Per Room.
[4] See section Architecture Requirements.
[5] 8 Classmates, 2 Fully Vaccinated Family Members, Test Positive for COVID in Lower Merion, NBC 10 Philadelphia, April 25, 2021. webpage https://www.nbcphiladelphia.com/news/coronavirus/8-classmates-2-fully-vaccinated-family-members-test-positive-for-covid-in-lower-merion/2791754, May 2021. 8 Classmates, 2 Fully Vaccinated Family Members, Test Positive for COVID in Lower Merion.
[6] See section School Case History.
[7] Covid: classrooms in England to get CO2 monitors to help with ventilation, the Guardian, August 2021. webpage https://www.theguardian.com/education/2021/aug/21/classrooms-england-monitor-air-quality-effort-combat-covid-better-ventilation, August 2021. Covid: classrooms in England to get CO2 monitors to help with ventilation, the Guardian.
CO2 Monitors
In England the Department for Education allocated £25 million pounds for 300,000 CO2 monitors to alert staff and students if CO2 levels rise [1] [2]. The government also started a trial of air purifiers in 30 schools in Bradford to assess their use and whether they could reduce the risk of transmission [1].
Maintaining the CO2 levels will not translate to the number of air changes per hour needed to mitigate the risk of infection. Maintaining the CO2 level translates to approximately 1 ACH for a typical classroom [3]. However, we know the CDC recommends 12 ACH and the WHO recommends 24 ACH [4]. We also know that infection in a classroom happens with 1 ACH [5] [6]. So maintaining the CO2 level is not appropriate. The performance of the system must be much higher.
This decision would make sense if it was made after each classroom had a ventilation performance level greater than 12 ACH.
It is unclear why management everywhere is rejecting that the virus is airborne and that the air must be properly cleaned while the people are in the room. This is a massive failure of government everywhere. They have an obligation to setup the labs, do the analysis and testing and then tell the people what must be done. Then they need to pass and enforce regulations that directly solve the problem. Currently bureaucrats in conjunction with the market are making the choices rather than informed decisions from what is really simple science and engineering.
[1] Covid: classrooms in England to get CO2 monitors to help with ventilation, the Guardian, August 2021. webpage https://www.theguardian.com/education/2021/aug/21/classrooms-england-monitor-air-quality-effort-combat-covid-better-ventilation, August 2021. Covid: classrooms in England to get CO2 monitors to help with ventilation, the Guardian.
[2] Concerns over plan to use ozone to disinfect classrooms in Wales, the Guardian, August 2021. webpage https://www.theguardian.com/uk-news/2021/aug/30/concerns-over-plan-to-disinfect-classrooms-in-wales-with-ozone, August 2021. Concerns over plan to use ozone to disinfect classrooms in Wales.
[3] See section CFM Per Person Versus CFM Per Room.
[4] See section Architecture Requirements.
[5] 8 Classmates, 2 Fully Vaccinated Family Members, Test Positive for COVID in Lower Merion, NBC 10 Philadelphia, April 25, 2021. webpage https://www.nbcphiladelphia.com/news/coronavirus/8-classmates-2-fully-vaccinated-family-members-test-positive-for-covid-in-lower-merion/2791754, May 2021. 8 Classmates, 2 Fully Vaccinated Family Members, Test Positive for COVID in Lower Merion.
[6] See section School Case History.
UV Systems
In 2020 this research provided a great deal of information on UV systems [1]. This following are key extracts from an article making the case for UV systems in February 2022 [2].
EXTRACT START
As the Omicron variant spreads rapidly across vaccinated and unvaccinated America, and a shocking number of Americans are still dying, many are wondering what the coming months will bring, how will they continue to protect themselves from COVID-19, and when, if ever, life will really return to something resembling the pre-pandemic normal. The good news is that this pandemic will eventually end due to effective vaccines, infection-induced herd immunity, and the further evolution of the virus. The bad news is that like seasonal influenza, COVID-variants may be with us for years to come, and this will certainly not be the last respiratory virus pandemic. We have long suffered from annual contagious respiratory infections, but exceptionally low rates of influenza and common colds during COVID-precautions have demonstrated that not all of this suffering need happen. So, we need to think clearly and scientifically about how better we can reduce the spread of viruses indoors especially when and where masks will no longer be in common use.Are there effective engineering controls that can help make indoor environments truly safer? Yes,
It’s All About the Air We Share
From the beginning of this pandemic, buildings managers, airport operators, restaurateurs, and the public have been inundated with product promotions claiming to have the latest and greatest technology to protect workers, travelers, and customers from infection with SARS-CoV-2. Products are varied, including surface sanitizers, air filtration machines, ion generators, and a host of germicidal ultraviolet (GUV) devices, ranging from hand-held wands to whole-room irradiators and walk-through portals. An imaginative architectural firm in the Netherlands even planned to flood entire city squares and outdoor sports areas with safe, germicidal 222 nanometer ultraviolet light - their “Urban Sun” project. A Sharper Image gift catalogue listed no fewer than 14 air or surface disinfection gadgets, including a tiny ion generator meant to be worn around the neck.
Not all of these devices are likely to do what they’re marketing claims. Others are almost certainly not effective at all. The challenge is to discern those from the products that could, in fact, play a significant role in our ongoing effort to limit the spread of airborne pathogens.
Marketers are quick to present in ads the results of industry-sponsored testing, typically claiming ‘99.9%” or greater reductions in particles or test bacteria or viruses. Often these reductions compare test organism concentrations in air before and after passing through a device but not what happens in a room where the device would be used, which is all that matters in the long run. The details of these company-sponsored tests are usually lacking - one common issue is the failure to mention the rate at which decontamination occurs in rooms, which is often far too slow to be of practical use. For example, a device may claim 99.9% air contamination, but only in the fine print indicate that the test was conducted over 24 hrs. That’s not useful if you’re sitting in a room with an infected person. What does matter to prevent person-to-person spread of infection is clearance in minutes. Testing is rarely controlled, unbiased, properly compared to other technologies, or conducted under real-world conditions. In fairness, it is extremely difficult and expensive to prove the efficacy of interventions to reduce infections, especially one like COVID-19 that is often asymptomatic and might go unnoticed (especially in a country, like the U.S., where testing capability has been sorely lacking), and where transmission can occur by several potential routes, or occur in any number of settings besides the site of the intervention (like on a school bus versus the classroom).
Early in the pandemic, aerosol spread of COVID-19 was considered less important than other transmission pathways. But it is now clear that vast majority of its spread is the result of inhaled aerosol, with a lesser amount attributable to direct contact with droplets.
Outdoors, dilution of any aerosols is infinite although the time it takes to dilute clouds of aerosol, depends on air movement. Think, for example, of how a cloud of cigarette smoke outdoors lingers or dissipates depending on whether there’s a breeze or not. Indoors, however, aerosols almost always linger longer than outdoors, often long enough to be inhaled by someone sharing the same space. Put another way, if you breath in an indoor setting where other people are also breathing, you will almost surely breath in some amount of air that has been recently exhaled by someone else.
Previously tuberculosis control focused on engineering and non-engineering strategies, such as prompt, effective TB treatment, but there was little commercial interest in TB-related products because the market was primarily in poor countries. COVID-19 has changed that. Suddenly there is great commercial interest in airborne infection control, for schools, hospitals, and restaurants, and a greater need to apply scientific principles and testing rigor to evaluating efficacy claims, and in making sound recommendations.
Think About Ventilation
Ventilation, natural or mechanical, is the main way that the risk of airborne infection indoors is reduced. For hospital airborne infection isolation and procedure rooms, the U.S. Centers for Disease Control and Prevention (CDC) recommends 6 to 12 room air changes per hour (ACH) with infection free outdoor air, or air that has been filtered or otherwise decontaminated. For rooms with airborne contagions the CDC recommendation is 12 ACH. One ACH occurs when a volume of air equal to that of the room enters and leaves over a period of one hour. As fresh air enters and mixes with contaminated room air, not all the contaminated air is removed by one air change. Under well mixed conditions, one air change removes approximately 63% of room air contaminants, and a second air change removes about 63% of what remains, and so on. But under real world conditions, the protection achieved by ventilation also depends on the amount of contaminant (virus in this case) being added over time, by an infected person, and on the contagiousness of the infection. The greater the infectiousness of the virus, greater the infection-free ventilation needed to keep concentrations low. For Omicron, for example, 6-12 ACH ventilation, or equivalent air disinfection, may not be enough to prevent transmission. Unfortunately, not all transmission is preventable by air disinfection, for example, transmission at very close range where there is no time to remove or inactivate viruses generated by one person before they are inhaled by someone else.
Many residential and older buildings without mechanical ventilation may have about one ACH or less due to air leakage around doors and windows but when windows are open, depending on building design, orientation, and outside weather conditions, may enjoy significantly higher ACHs. For economical heating and cooling, however, windows are normally closed, especially in larger mechanically ventilated buildings, by design, or closed by occupants in response to outside temperatures. Automated mechanical ventilation systems often bring in a minimum amount of outside air under very cold or hot outside conditions, resulting in most air being recirculated within the building, thereby recirculating air contaminants rather than removing them, [however properly maintained filters minimize the recirculated contaminates].
The relationship of room ventilation to risk of infection isn’t linear. Doubling of ventilation rate reduces the concentration of air contaminants by only about half. This means that doubling poor ventilation from 1 ACH to 2 ACH provides relatively greater improvement in protection for room occupants than, for example, the increased protection from doubling ventilation from 6-12 ACH. This is because when air contaminants are low, much more air movement is required to dilute and remove them. Moreover, increases in ventilation rates are costly, often requiring larger fans, blowers, ventilation ducts, and more electricity, as well as greater heating, cooling, and dehumidification capacity. At the same time, as noted, for the much more infectious Omicon variant, very high ventilation rates are needed to keep up with high viral concentrations and infectiousness . Therefore, because mechanical ventilation may not be sufficient to reduce the risk of infection, mechanical ventilation in public buildings should be supplemented by other methods of air disinfection. For current and future viral pathogens like SARS-CoV-19, relatively high levels of “equivalent” ventilation by supplemental air disinfection will be needed.
Image: Installation of two different types of upper-room UVC luminaires at St Augustine of Canterbury Episcopal Church, Oklahoma City, OK.
Presented with particulate air contamination, a standard engineering response is to filter the air. High-efficiency air filters can be used in building ventilation systems to assure that fewer than 99.9% of respirable-size particles are recirculated back into rooms, essentially converting recirculated air into the equivalent of infection-free outdoor air. While some filter manufacturers boast of inactivating virus with UV, bipolar ions, cold plasma, or other technologies as advantageous over simple retention, there is no practical difference for risk in rooms. Importantly, while environmentally adapted TB bacteria and fungal spores readily spread through ventilation ducts, and this is theoretically possible for SARS-CoV-2 virus, there are few if any convincing reports of COVID-19 spread from room-to-room or floor-to-floor exclusively through ventilation systems; A relevant exception being a single report of spread of waste-water contaminated air not through ventilation ducts, but through faulty plumbing stacks in a high-rise apartment building in China.
While it is often difficult to discern among several airborne infection transmission pathways, the apparent paucity of reports of transmission through ventilation ducts likely reflects the well known fragility of envelope viruses, such as SARS-CoV-2, although dilution in rooms and ventilation ducts to concentrations below infectious dose could also be playing a role. Importantly, if air recirculation in ventilation ducts is not contributing importantly to COVID-19 transmission in buildings, the value of high-efficiency filters or germicidal UV in recirculating ventilation ducts for preventing spread is speculative and limited at best. Moreover, to a person sharing air in a room with someone with infectious COVID-19, there is little comfort in knowing that the air will be decontaminated only after it leaves the room. A more effective air disinfection strategy is to rapidly decontaminate the air within the room where person-to-person transmission occurs.
In the room where it happened is a guide to the application of air-disinfection technology. The evidence-based options for enhanced in-room air decontamination include increased ventilation, portable room-air cleaners, upper-room germicidal UV, and newer whole-room Far UV. Ion generators can also be used in rooms, but the evidence for efficacy is far less than for other approaches.
Natural ventilation
Natural ventilation is by far the most common form of room decontamination worldwide that can be highly effective with proper building design and favorable outdoor conditions. However, windows are often closed in inclement weather, and wind currents are not always conducive to good air exchange within buildings. With global warming, moreover, increasing use of efficient ductless air conditioners is resulting in windows being closed, reducing natural ventilation, and greatly increasing the risk of airborne infections. Extreme air pollution is another factor limiting the use of outdoor air for air disinfection in some parts of the world. Many mechanically ventilated commercial buildings don’t have operable windows, and deep interior spaces often make natural ventilation ineffective.
Portable room-air cleaners
These comprise a wide range of devices in price and performance. They usually consist of a box with a fan or blower and air filters, with or without UV or more sophisticated technologies for trapping particles or inactivating pathogens. The major determinants of room-air cleaner efficacy are: 1) the flow rate of air processed (clean-air delivery rate) relative to room volume, 2) the flow patterns produced in the room, which determines the ability of the device to process most of the air in the room rather than reprocess the same air near the device over and over again. In many applications, room air cleaners are undersized for the room volume, producing very few equivalent ACH. But, when properly sized they can be intrusively large, and when run at an effective fan speed, many room air cleaners are noisy and produce drafts. They may be acceptable in a gym, but generate too much noise for a classroom or house of worship. Nevertheless, when they are sized to produce at least 6 equivalent ACH, room air cleaners can be an effective intervention to reduce in-room transmission of airborne infections.
Germicidal UV lamps and fixtures
Upper-room germicidal UV (GUV) fixtures are a more than 80 years old technology, well-proven, safe, and underused technology for airborne infection control. Upper room GUV works by flooding the upper room (above the heads of occupants) with sufficient germ-killing ultraviolet light to rapidly inactivate airborne pathogens. All known pathogenic microbes contain either DNA or RNA and are susceptible to GUV. Air mixing between the upper and lower room results in high rates of air disinfection in the lower, occupied room. In the 1930s upper room GUV fixtures were installed in school classrooms in two Philadelphia suburbs and were convincingly shown, compared to classrooms without fixtures, to markedly reduce the spread of measles, the most infectious of airborne respiratory viruses. It was widely used in U.S. health care settings before the discovery of antibiotics for tuberculosis, and vaccines for the childhood viral infections, measles, mumps, and rubella. Renewed interest in GUV in health care settings, homeless shelters, prisons, jails and other congregate settings followed the 1985-92 resurgence of TB in the U.S. and Europe. Since then, GUV has found its greatest application in countries endemic for TB, but it has remained an extremely useful but underdeveloped technology for any airborne infection. COVID-19 has again renewed interest in GUV, upper room as well as a newly developed shorter wavelength, called Far UV. As for visible lighting, more efficient LED sources for GUV are rapidly being developed and may be the predominant technology for upper room use in the near future.
Far UV refers to 222 nm UV that has the remarkable properties of being equally or more effective against airborne viruses and bacteria, but unable to penetrate even the thin liquid layer covering the surface of the eye, or the outermost layers of skin. While conventional upper room UV has long been safely used to disinfect air in occupied rooms, Far UV appears safer yet with little potential for even mild eye or skin irritation when used within established exposure guidelines. It does not reach the deeper layer of skin cells where solar UV can cause skin cancer. Far UV sources require effective filters to prevent exposure to unwanted longer wavelength UV that can be damaging. Applications of current Far UV fixtures might include treating air and counters between workers and clients, such as bars, salons, restaurant tables, elevators, other high contact settings. Far UV is currently being used, for example, in a Boston homeless shelter, a Boston nightclub and piano bar, and for some critical U.S. military applications.
Image: Shows the application of an upper room UV fixture in a classroom. The fixture is the black box on the upper, left side of the front wall, with blue light visible. Another fixture on the rear wall would contribute to an effective upper room air disinfection zone.
Compared to mechanical ventilation and room-air cleaners, GUV is cheaper and much more effective. Upper-room GUV decontaminates a large volume of air at once, typically the upper two feet (20%) of a room with a 9 ft ceiling, for example. Air mixing between the lower and upper room, assisted by rising warm air produced by occupants, ventilation outlets, or fans, results in high rates of air disinfection in the lower, occupied room. In a controlled study in a hospital in South Africa, we showed that GUV inactivation of airborne TB bacteria was equivalent to 24 ACH, well beyond the capacity of most mechanical ventilation systems and room-air cleaners. Independent investigators aerosolized test bacteria into an unoccupied hospital room in Russia and compared mechanical ventilation, upper room GUV, and three commercial room air cleaners. They found that upper-room GUV was about 9.4 times more cost effective than mechanical ventilation for the same amount of air disinfection. Based on the potential energy savings over ventilation, the U.S. Dept. of Energy is supporting the commercial development and deployment of LED UV technology for air and surface disinfection.
There have been several barriers to the broader acceptance and application of GUV including unfamiliarity with the technology, and especially safety concerns. GUV raises safety concerns primarily because of a public perception that it is the same as the UV in sunlight. But not all UV is the same. It is skin exposure to the more tissue-penetrating longer wavelength UV in sunlight (UV-A and UV-B radiation) that is associated with skin cancer, and eye exposure to sunlight with cataracts, whereas shorter wavelength GUV penetrates eyes and skin surfaces far less, not reaching the lens of the eye to cause cataracts, or the deep layers of skin where it could induce cancer within well-established exposure limits. As mentioned, Far UV is far less penetrating and safe for direct exposure of room occupants. Acceptance and wider deployment of safe and highly effective UV systems will require education—of professional engineers, architects, and safety personnel, as well as the general public.
But not all GUV devices on the market pass the test in terms of plausible benefit, and these detract from the credibility of the proven applications. There are numerous examples of GUV devices targeting both commercial and home applications that are not evidence-based and are unlikely to be effective in reducing COVID-19 transmission. For instance, a small GUV air disinfecting device designed to be worn around the neck cannot possibly move enough air to reduce aerosol transmission. Or, another example, small boxes with UV sources designed to decontaminate cell phones are likely no better than an occasional wipe down with alcohol. Equally irrational are GUV wands because delivering an effective germicidal dose is unpredictable when waving a wand over a surface, and they must be low power to avoid accidental direct over-exposure of eyes or skin. At an even larger scale, GUV portals have been marketed and used in building entrances or exits to “disinfect” people walking through them. This makes no sense not only because no significant decontamination of skin or clothing is possible, but respiratory virus resides in the human respiratory tract, and cannot be eliminated from the outside. Finally, the Urban Sun project for disinfecting large outdoor spaces likewise makes no sense since dilution and upward convection air currents already render the outside far safer than indoors. Under crowded indoor or indoor conditions, very close-range person to person aerosol transmission may be difficult to interrupt by air disinfection of any kind, requiring other proven interventions like vaccines, distancing, and masks.
Ionization
A variety of ionizers (bipolar, unipolar, and cold plasma) are marketed to generate positive and negative ions, deployed directly into occupied rooms or within filtration systems, to cause infectious particles to be attracted to filters or stick to each other and then settle out of the air and onto surfaces where they can no longer be inhaled. The mechanisms of action of ion generators is not fully understood and might include direct chemical inactivation of viruses and bacteria. Ion generators have been incorporated into a variety of products, with marketing claims based on industry funded performance testing, there are very few published independent studies. In an older study conducted in Lima, Peru, a crude ionization system was directly compared to upper room UV and shown to be about 50% effective in decontaminating infectious hospital air of TB organisms. UV was 73% effective. But, in that study room air ionization had a serious practical limitation: the walls of the rooms in the study were blackened with black soot that became ionized and settled out onto surfaces. Other studies have shown that ionization can produce ozone from oxygen, as well as other dangerous ions and gases. These can lead to unanticipated, potentially toxic chemical reactions with other room air contaminants. Both the safety and effectiveness of ion generators require greater study to be compared to the established interventions of ventilation, room air cleaners, and GUV.
Nearly two years into the COVID-19 pandemic, the post-pandemic world is becoming clearer. While vaccines remain the mainstay of controlling person to person aerosol transmission, the efficacy of social distancing and mask wearing has been proven scientifically, albeit not fully accepted or implemented. Since the vast majority of COVID-19 likely spreads indoors, air disinfection is an underutilized role making indoor living safer. Building ventilation, natural and mechanical, is vitally important for the health and comfort of occupants. At its best, natural ventilation can be highly effective in reducing the risk of aerosol born infection, but it is not feasible or reliable in many climates and buildings. Mechanical ventilation is designed for comfort, not infection control, and generally in most buildings cannot achieve the air change rates needed to protect against a highly infectious viral aerosol like the current COVID-19 variants.
It’s clear that for indoor spaces air disinfection is a safe and efficient way to reduce transmission. Although they are not equivalent, the three established and proven air disinfection technologies are mechanical ventilation, upper room GUV, and portable room air cleaners. Of these, upper room UV is the most cost-effective and is demonstrably safe and readily available to deploy today to reduce COVID-19 and other respiratory virus transmission. Far UV is available, even safer, and may be a more effective air disinfection technology because it works around room occupants and does not depend on room air mixing. Although limited by the ability to quietly move sufficient air in many rooms, room air cleaners also have a role for in-room air disinfection, especially in small rooms where at least 6 equivalent air changes per hour can be achieved. Implementation of effective air disinfection, while driven by the COVID-19 pandemic, should find its way into building codes and practices so that we are not as unprepared for seasonal respiratory viruses, ongoing epidemics like TB, and the next pandemic.
EXTRACT END
Most of the technical content was preserved. There was a statement associated with CO2 monitors possibly being used to detect virus levels in a room. That statement was removed because it is not relevant and could be a distraction as some may suggest there is no relationship between CO2 levels and virus concentration.
References:
[1] COVID-19 A Systems Perspective, Walter Sobkiw, 2021, ISBN 9780983253044, hardback.
[2] If We're Going to Live With COVID-19, It's Time to Clean Our Indoor Air Properly, TIME, February 1, 2022. website https://time.com/6143799/covid-19-indoor-air-cleaning
The Philadelphia School District performed a site survey of their schools and published the findings on the school district website. [1] This is an excellent system site survey and the data is captured in a spreadsheet. Each school is captured in a separate tab in the spreadsheet. There are 220 tabs suggesting that there are 220 schools that were surveyed. Each row represents a space in the school with an appropriate name that conveys the space use. The spreadsheet was converted to a single tab spreadsheet so that all the spaces in all the schools could be easily analyzed for AUC (or ACH) and Contagion Mitigation Level (CML). The CML is the number used for the Contagion Mitigation Certification Level (CMCL). [2]
The CML and CMCL are embedded in the Building Contagion Mitigation Certification (BCMC) Tool. The Philadelphia School District data was placed in the BCMC Tool for further analysis. The Philadelphia School District data was also placed in the Clean Air Buildings (CAB) database. The CAB is an open source database that was started after the BCMC release, which is a private database. The scale used in the BCMC is more stringent than the scale used in the CAB. The difference is associated with accepting that 12+ ACH provided by CDC guidelines is the starting point for facility managers to make the needed changes. It is also based on further systems analysis of ACH (or AUC).
AUC - Air Update Changes
ACH - Air Changes per Hour
AUC = ACH for all the systems analysis
The pre-contagion mitigation results are as follows. [Certification Spreadsheet]
Room Ratings
|
Overall District Rating
|
The overall District Rating is 1 Red before contagion mitigation. The post contagion mitigation results are as follow. This school district moved from Level 1 Red to Level 2 Orange. We also see that a large number of rooms moved from Level 1 Red to higher levels with a significant jump into Level 3 Yellow. The Level 3 category is approaching hospital room airborne contagion mitigation levels.
The performance of the mitigation product selected by the Philadelphia School District is in dispute [6] [7]. However, other technologies can offer the claimed perfomance level. The CMCL alerts the stakeholders so that assumptions and tests can be reviewed and fully addressed. Without this ability to visualize the products and technology choices across the entire system, the decisions will not be subjected to reasonable alternatives, tradeoffs, and selection that is always performed in a systems engineering driven activity.
Room Ratings
|
Overall District Rating
|
There was 1 room that was rated at Level 6 and 25 rooms rated at Level 5. They are as follows:
Space |
AUC |
Certification Level |
Comments |
Classrooms |
64 |
5 |
|
Classrooms |
70 |
5 |
|
Classrooms |
76 |
5 |
|
Autobody |
73 |
5 |
|
Sheet Metal |
50 |
5 |
|
Warehouse Classroom |
114 |
5 |
|
Factory Lab |
69 |
5 |
|
Offices |
327 |
6 |
Thomas Edison High School - Offices is the row label |
Janitor Close and Storage Rooms |
82 |
5 |
|
CAFE |
70 |
5 |
|
Classroom |
57 |
5 |
|
Gym |
57 |
5 |
|
Asist Prince |
117 |
5 |
|
Classroom |
72 |
5 |
|
Office |
73 |
5 |
|
Classroom |
79 |
5 |
|
1st Flr Kitchen |
68 |
5 |
|
Exercise |
105 |
5 |
|
Storage |
105 |
5 |
|
Boiler Rm. |
118 |
5 |
|
Classrooms |
60 |
5 |
|
Nurses |
59 |
5 |
|
Kitchen |
51 |
5 |
|
Kitchen |
53 |
5 |
|
MEDIA LAB B |
71 |
5 |
|
Gym- Weight Room A |
51 |
5 |
What If Analysis
The Philadelphia School District purchased 2000+ Active Pure systems. For this analysis it is assumed that the Active Pure systems have an eAUC = 20 but the performance is in dispute [6] [7]. However, other technologies can offer the claimed perfomance level. This performance level is similar to a ceiling level UV-C system. Again an eAUC of 20 for the Active Pure system is based only on broad assumptions in this analysis and the number may be significantly smaller [8]. However, for this analysis 20 eAUC is selected. In both instances the retail costs are approximately the same, and assumed to be $1500 retail price per unit. The negotiated price by Philadelphia School District for the PCO / Ionizer units are based on the district purchasing 9,500 air purifiers for $4.5 million, which is $474 per unit [6]
A What If Analysis [3] can be performed using the Philadelphia School District site survey. The site survey provided data to calculate the AUC, CML, and CMCL. The data shows that the school district purchased 2500 PCO / Ionizer like systems to help with classroom ventilation. This allowed the school district to move from a CMCL of 1 to 2 and it moved 2000+ rooms into CMCL 3. This analysis increases the number of PCO / Ionizer like systems to determine its impact on the overall school district CMCL rating. The analysis is approximate and is based on the total district cubic feet, AUC, and number of rooms. This results in a slightly different AUC number than when the individual room AUCs are calculated. This is an artifact of the site survey data where in some instances cubic feet is provided but no ventilation number is provided. Regardless the results are similar and what is desired is a What If Analysis to determine the effect of adding more mitigation technology units. The results are as follows. [Certification Spreadsheet]
For the analysis the following data was used:
eAUC / PCO |
20 | Assumption based on vendor claims |
| Total cu-ft | 92,871,681 | site survey data |
| Total HVAC CFM | 4,337,033 | site survey data |
| Total HVAC AUC | 38,489 | site survey data |
The analysis results are as follows. The cost of $1500 was used rather than $474 paid by the Philadelphia School District:
Num PCO Units |
Total eAUC |
Total AUC |
AUC |
CML |
Cost |
PCO / Room |
Comments |
0 |
0 |
38,489 |
3.0 |
1 |
|
|
|
2503 |
50,060 |
88,549 |
6.9 |
2 |
$3,754,500 |
0.19 |
From site survey. |
4503 |
90,060 |
128,549 |
10.0 |
3 |
$6,754,500 |
0.35 |
If the technology complements the HVAC system then the system quickly jumps to CML 3 |
6503 |
130,060 |
168,549 |
13.1 |
3 |
$9,754,500 |
0.51 |
This does not impact the overall rating for the school district but it continue to the number of rooms to the next CML level. |
8503 |
170,060 |
208,549 |
16.2 |
3 |
$12,754,500 |
0.66 |
|
10503 |
210,060 |
248,549 |
19.4 |
3 |
$15,754,500 |
0.82 |
|
12503 |
250,060 |
288,549 |
22.5 |
3 |
$18,754,500 |
0.97 |
|
14503 |
290,060 |
328,549 |
25.6 |
4 |
$21,754,500 |
1.13 |
It is unclear if over dosing the space with the PCO / Ionizer technology is an issue. |
16503 |
330,060 |
368,549 |
28.7 |
4 |
$24,754,500 |
1.29 |
Eventually the HVAC system becomes irrelevant |
18503 |
370,060 |
408,549 |
31.8 |
4 |
$27,754,500 |
1.44 |
Multiple units per room is probably not appropriate for most technologies. What needs to happen is the either other additional technologies are added into the system or the technology performance is increased. For example, instead of HVAC + PCO / Ionizer move to HVAC + PCO / Ionizer + UV but there may be compatibility issues that need to be understood. |
20503 |
410,060 |
448,549 |
34.9 |
4 |
$30,754,500 |
1.60 |
|
22503 |
450,060 |
488,549 |
38.0 |
4 |
$33,754,500 |
1.75 |
|
24503 |
490,060 |
528,549 |
41.2 |
4 |
$36,754,500 |
1.91 |
|
26503 |
530,060 |
568,549 |
44.3 |
4 |
$39,754,500 |
2.06 |
|
28503 |
570,060 |
608,549 |
47.4 |
4 |
$42,754,500 |
2.22 |
|
30503 |
610,060 |
648,549 |
50.5 |
5 |
$45,754,500 |
2.38 |
|
32503 |
650,060 |
688,549 |
53.6 |
5 |
$48,754,500 |
2.53 |
|
34503 |
690,060 |
728,549 |
56.7 |
5 |
$51,754,500 |
2.69 |
|
36503 |
730,060 |
768,549 |
59.8 |
5 |
$54,754,500 |
2.84 |
|
38503 |
770,060 |
808,549 |
63.0 |
5 |
$57,754,500 |
3.00 |
|
40503 |
810,060 |
848,549 |
66.1 |
5 |
$60,754,500 |
3.15 |
|
42503 |
850,060 |
888,549 |
69.2 |
5 |
$63,754,500 |
3.31 |
|
44503 |
890,060 |
928,549 |
72.3 |
5 |
$66,754,500 |
3.47 |
|
46503 |
930,060 |
968,549 |
75.4 |
5 |
$69,754,500 |
3.62 |
|
48503 |
970,060 |
1,008,549 |
78.5 |
5 |
$72,754,500 |
3.78 |
|
50503 |
1,010,060 |
1,048,549 |
81.6 |
5 |
$75,754,500 |
3.93 |
|
52503 |
1,050,060 |
1,088,549 |
84.8 |
5 |
$78,754,500 |
4.09 |
|
54503 |
1,090,060 |
1,128,549 |
87.9 |
5 |
$81,754,500 |
4.24 |
|
56503 |
1,130,060 |
1,168,549 |
91.0 |
5 |
$84,754,500 |
4.40 |
|
58503 |
1,170,060 |
1,208,549 |
94.1 |
5 |
$87,754,500 |
4.56 |
|
60503 |
1,210,060 |
1,248,549 |
97.2 |
5 |
$90,754,500 |
4.71 |
|
62503 |
1,250,060 |
1,288,549 |
100.3 |
5 |
$93,754,500 |
4.87 |
|
64503 |
1,290,060 |
1,328,549 |
103.5 |
5 |
$96,754,500 |
5.02 |
|
66503 |
1,330,060 |
1,368,549 |
106.6 |
5 |
$99,754,500 |
5.18 |
|
68503 |
1,370,060 |
1,408,549 |
109.7 |
5 |
$102,754,500 |
5.33 |
|
70503 |
1,410,060 |
1,448,549 |
112.8 |
5 |
$105,754,500 |
5.49 |
|
72503 |
1,450,060 |
1,488,549 |
115.9 |
5 |
$108,754,500 |
5.65 |
|
74503 |
1,490,060 |
1,528,549 |
119.0 |
5 |
$111,754,500 |
5.80 |
|
76503 |
1,530,060 |
1,568,549 |
122.1 |
6 |
$114,754,500 |
5.96 |
The point of the What If Analysis was to determine what it would take for the system to reach a CML of 6. |
If the technology complements the HVAC system then the system quickly jumps to CML 3. It is unclear if over dosing the space with the PCO / Ionizer technology is an issue or if PCO / Ionizer technology can handle the size of a classroom [6] [7]. The analysis suggests that eventually the HVAC system becomes irrelevant. Multiple units per room is probably not appropriate for most technologies. What needs to happen is either other additional complementary technologies are added into the system or the individual technology performance is increased. The alternatives include the following approaches:
If multiple technologies are used there may be compatibility issues that need to be understood.
Other Buildings Based On Existing Standards
The starting point for Contagion Mitigation Certification Level assessments is to examine the current standards. The standards do not reflect the actual building design and implementation but they are a starting point for what the best case expected results might be after the assessment.
There is a spreadsheet with several hundred Area Types (Rooms) identified with various AUC standard numbers that are expected to be used in the design of a physical space. [spreadsheet ACH CML]
The Certification Levels below are based on the Max AUC standard from the various sources in the spreadsheet. [spreadsheet ACH CML]
| Area |
AUC |
AUC |
Source |
Cert Level |
Area |
AUC |
AUC max |
Source |
Cert Level |
| Hospital Trauma room | 15 | - | CDC | 3 yellow |
Classroom (Art) | 16 | 20 | EPA | 3 yellow |
| Hospital room airborne precautions | 24 | - | WHO | 4 yellow |
Malls | 6 | 10 | EPA | 2 orange |
| Hospital operating room | 25 | - | 4 yellow |
Office | 8 | 30 | Greenheck | 4 yellow |
|
| Hospital rooms | 6 | 10 | EPA | 2 orange |
Engine Room | 20 | 60 | Greenheck | 5 green |
| Restaurants | 8 | 12 | EPA | 2 orange |
Kitchen | 12 | 60 | Greenheck | 5 green |
| Restaurants | 8 | 20 | NCI | 3 yellow |
Kitchen | 7 | 8 | NCI | 2 orange |
| Restaurants | 15 | 20 | wiki | 3 yellow |
Kitchen | 14 | 18 | NCI | 3 yellow |
| Bar | 15 | 30 | Greenheck | 4 yellow |
Kitchens (commercial) | 15 | 30 | EPA | 4 yellow |
| Bar | 15 | 20 | NCI | 3 yellow |
Retail | 6 | 10 | NCI, wiki, EPA | 2 orange |
| Bar | 15 | 20 | wiki | 3 yellow |
Laboratory | 12 | 30 | Greenheck | 4 yellow |
| School Classroom | 4 | 12 | EPA | 3 yellow |
Laboratory | 6 | 12 | wiki | 3 yellow |
| Auditorium | 8 | 15 | EPA | 3 yellow |
Club Houses | 20 | 30 | EPA | 4 yellow |
| Assembly Hall | 6 | 8 | EPA | 2 orange |
Theatres | 8 | 15 | EPA | 3 yellow |
There are no design standards that would result in a Level 0 or 1 Red condition as long as the lower limits of the standard were not picked for the design. Some of the design standards are Level 5 Green. Just because a design, resulting implementation, and actual test results may yield a rating above Level 0 it does not mean that the building operates at its suggested Level. The systems could be turned off or disabled. This is especially of concern in public buildings like bars and restaurants where there is no large central maintenance organization responsible for the facility. In these buildings the certification level is drastically affected because the CML is zero when the HVAC system is not running. One strategy is to apply a simple set of rules that modify the certification level with a ceiling cap based on the ability to bypass or mismanage the systems. The other strategy is to offer two separate certification levels, one for the equipment CML and one for the controls CML. The in either case the criteria might be:
Max Possible Cert Level |
System Operation | Risk of System Compromise | Comments |
6 |
Fully automated with alarms | Very Low six 9s five |
State of the art office building and schools |
4 |
Fully automated | Very Low three 9s five |
Office building, large schools, large retail stores |
3 |
Manually controlled by onsite dedicated maintenance staff | Low 1% |
Office building and large schools |
0 |
Manually controlled by building users | Very High 50% |
Bars, restaurants, clubhouses, retail stores |
An approach to capture this information in a certificate, that is physically posted in the building, is to provide the building Contagion Mitigation Level when the system is on and the Contagion Mitigation Level when the system is off (because of the high risk of system compromise). This can be accomplished with two separate certification ratings on the same physical certificate document: Contagion Mitigation Level and Contagion Mitigation Controls. The following are examples:
Certificate 1:
| Building | Contagion Mitigation Level | Contagion Mitigation Controls |
| Bar and Restaurant | Level 5 GREEN |
Level 0 RED |
Certificate 2:
| Building | Contagion Mitigation Level | Contagion Mitigation Controls |
| Large Retail Store | Level 5 GREEN |
Level 4 Yellow |
Certificate 3:
| Building | Contagion Mitigation Level | Contagion Mitigation Controls |
| State of the art School | Level 5 GREEN |
Level 6 Green |
Notice that Certificate 3 has a higher rating for the controls than the general Contagion Mitigation Level. This suggest that the school still has the possibility of adding higher levels of system performance to mitigate airborne contagions.
Observations in 2022
There is no pressure on facility managers to properly maintain, properly operate, and if needed upgrade or install building ventilation systems. It is obvious that those focused on their building ventilation performance levels are in the minority. When the public and or employee unions attempt to address these questions in work settings, clubhouses, and schools there is massive push back and data is not provided and it is being prevented from being captured by others such as employees, residents that use clubhouses, and union members. This analysis when it was performed assumed that there were reasonable people in positions of authority that were looking for very detailed and broad analysis as was performed in previous decades when similar problems surfaced. However, that approach has been rejected and only talking points are used to deflect, deny, and take no action to satisfy toxic stakeholder needs. [9]
References:
[1] Philadelphia School District Air Balance Reports by school. webpage https://www.philasd.org/coronavirus/schoolstart2020/#1613757068528-a10a5ddf-592d, https://drive.google.com/drive/folders/1XULamBiR3v1sB_u15rcyXOxQlq1ygsGT, May 2021. local excel cert analysis
[2] Philadelphia-Schools-Walkthroughs-Total-Summary_Public_final-merged.xls, May 2021. webpage http://www.cassbeth.com/covid-19/lib/Certification/Philadelphia/Certification-Analysis/Philadelphia-Schools-Walkthroughs-Total-Summary_Public_final-merged.xlsx, May 2021. local
[3] Systems Practices As Common Sense, Walter Sobkiw, ISBN: 978-0983253082, first edition 2011, ISBN: 978-0983253051, second edition 2020. REF 1
[4] COVID-19 A Systems Perspective, Walter Sobkiw, 2021, ISBN 9780983253044, hardback.
[5] COVID-19 Return To Life, webpage http://www.cassbeth.com/covid-19/return-to-life/index.html, April 2021. COVID-19 Return To Life.
[6] Philadelphia school district to install new air purifiers despite concerns from air quality specialist, Chalkbeat Philadelphia, July 21, 2021. webpage https://philadelphia.chalkbeat.org/2021/7/21/22587784/philadelphia-district-to-install-new-air-purifiers-despite-concerns-from-air-quality-specialist, Jully 2021.Philadelphia school district to install new air purifiers despite concerns from air quality specialist.
[7] Schools spending millions on air purifiers often sold using overblown claims, CNN, May 11, 2021. webpage https://www.cnn.com/2021/05/03/health/air-filter-covid-scams-khn/index.html, August 2021. Schools spending millions on air purifiers often sold using overblown claims.
[8] See section Technologies to Boost Certification Levels.
[9] HSTA: 'Ventilation is absolutely important', HAWAII TRIBUNE-HERALD, July 31, 2022. webpage https://printreplica.westhawaiitoday.com/?publink=35a28426c_134855f, 07/31/22. https://printreplica.westhawaiitoday.com/?publink=35a28426c_134855f.
What has just been described is a maturity model targeted towards contagion mitigation. Maturity models are not new and their roots trace back to the previous century. Examples include using maturity curves for employee evaluations and capability maturity model assessments of organizations engaged in software intensive systems.
In the late 1960's Hughes Aircraft was the first company to develop a large software intensive air defense system using scientific and engineering principles. It became the foundation for all future software intensive systems development at Hughes [1]. Prior to that time software was viewed as an artistic process. Embedded in this setting surfaced the concept of maturity level for developing software based on science and engineering. By the 1980s Hughes Aircraft was deeply engaged in maturity models across the organization. They were used for employee evaluations, company evaluations to assess ability to provide subsystems for Hughes system solutions, technology assessments, and other areas including software development. In the 1980s the Howard Hughes Medical Institute was forced to divest itself of Hughes Aircraft and General Motors took over Hughes Aircraft. The software maturity documentation eventually moved to Carnegie Mellon University and the Software Engineering Institute (SEI) was established with the Capability Maturity Model. The concept of a maturity model grew and SEI maintains multiple Maturity Models [2].
Today many in the high technology industries tend to associate the concept of a capability maturity model with software. However the roots of a capability maturity model concept go back many years and can be found in the way employees were and still are compensated and the way companies were evaluated when selected as part of a proposal evaluation process for a major project or program. The idea of maturity is not new and connecting maturity to some expectation was and still is a reasonable process if all the players follow the rules of civilized enlightened behavior. That last phrase is the fly in the ointment because many will find ways to reject or game a model to avoid or achieve an invalid high rating.
The early systems and software capability maturity models were more about teaching. They had content that organizations could use to try to determine what to do when engaged in a large systems and software intensive program. This was an artifact left over from Hughes Aircraft. These models are based on an ideal world; however, the ideal world does not exist. Just as in economics we know that people do not behave rationally, people do not behave rationally in organizations that do not naturally evolve into a capability maturity model mind set. The initial reaction when these models were released was don't tell me what to do. So the models moved away from teaching into more of a regulatory mode. However, again in an irrational world the organizations find ways around the models and cause havoc.
The models themselves tried to capture what was considered good from the companies and organizations that gave us our modern world. Just like the government standards and data item descriptions they are incomplete. Not because the people were lazy or driven by hidden agendas but because it was hard to capture that magic sauce that these great organizations offered to the world.
Organizational Capabilities
An organization's process capability can be examined and assessed. However that is not a complete view of the organization. This becomes very apparent when an organization is subjected to a proposal or vendor selection process. Typically the selection process includes the technical approach, company assessment, and cost. The company assessment includes items such as:
Further there are generic company capabilities that can be used to measure its capability. The following are ordered lists of company capabilities from the most capable to the least capable:
Employee Capability Maturity Curves
Capability maturity curves were used extensively in the 1970's and early 1980's to determine an employee's compensation in many premier high technology companies. Although not stated explicitly the US Government also used capability maturity to determine the compensation of a employee. This was accomplished by defining the expectations associated with each level of maturity. Then there was a factor added to the starting salary of each maturity curve as the employee gained more years of experience on a particular maturity curve. If the employee would demonstrate proficiency at the next level of maturity then the employee would be moved to the next level maturity curve, which would have a higher final salary. Each maturity curve would plateau in salary. So the expectation was that employees would jump to the next level of maturity prior to reaching the plateau on a particular salary band (maturity curve).
The following is an example of criteria that could be used to determine maturity curves in a technical organization. This concept goes back several hundred years and is based on the apprentice, journeyman, and master model. This model acknowledges that something worthy of mastering requires skilled labor rather than unskilled labor.
The US government salary scale is based on this concept where each GS level has 10 steps and movement within a GS level follows a scenario of: 1 year at steps 1-3, 2 years at steps 4-6, and 3 years at steps 7-9. Movement into a different GS scale represents movement into a different maturity level. The following words associated with each maturity level are only offered as an example and do not represent any organization.
Levels were used at Hughes Aircraft. All technical people entered at Level 7 regardless of experience, including former executives (vice presidents). They then progressed through the Hughes Aircraft maturity curves. This progression was based on observed behavior and was regardless of years of experience. The advantage of this compensation system was that young high technology staff with demonstrated maturity could command the high salaries of senior executives in other organizations .
Author Comment: This system was abandoned when leveraged buyouts surfaced in the early 1980's. There was enormous wealth built up in all of the large successful companies that could be extracted by outsiders using various financial schemes. This required relaxation of regulations and non-enforcement of laws such as racketeering and antitrust legislation. As these organizations were pillaged in much the same way a medieval village was pillaged in the middle ages, the need for these systems disappeared. Employees were just happy to have jobs and human resources was converted to a liability limiting organization to ensure that employee lawsuits would be minimized as both written and implied contracts were scrapped in a war like setting. Nobody cared about capability anymore. In this disastrous setting organizations were no longer able to deliver reasonable designs, especially software. Meanwhile there was a need for thousands of companies to start producing high quality software, not just a few, as the computer became available to everyone. Computer costs had dropped so that everyone was now able to purchase a computer. This discussion is important because it describes why multiple future capability models surfaced. It also describes the need for a contagion mitigation model in this century to deal with the COVID-19 disaster.
Stages of Growth Model
The Stages of Growth Model (SGM) is a model for the growth of computer automation in an organization. Today we refer to computer automation as information technology (IT) but the computer automation term is more accurate because it represents what was happening with the introduction of the computer. Many manual tasks performed by people were being replaced with the computer. SGM offers a structured framework for what happens when the computer is introduced into an organization. It is based on the concept that an organization evolves slowly into the new technology, in this case computer automation. There are six stages in SGM.
The challenges faced with the introduction of computer automation in the last century are the same challenges that will be faced with introducing contagion mitigation systems in this century. This description is offered to understand that the challenge is not new and there are frameworks that can be used to address this challenge. Just replace IT and software with contagion mitigation system in the following description.
Stage I - Initiation Stage
In this stage, computer automation is introduced into the organization. There are two primary reasons for this introduction. In the first case the company reaches a size where the administrative processes cannot be accomplished without computers. Also, the success of the business justifies a large investment in specialized equipment. The second case deals with computational needs where the critical size of the company is the primary reason for computer acquisition.
At this stage the personnel are unfamiliar with the technology. So they take a hands off approach to new technology. The focus is on the functional applications to reduce costs. The initial software is simple to use and cheap to implement. This offers substantial monetary savings to the company in some cost benefit analysis. The new IT department receives little attention from management and work in a carefree atmosphere.
Stage II - Contagion Stage
At Stage II, even though the benefits of computers are recognized by many in Stage I, computing still alienates many. So management explains the potential of computers to the alienated users. This eventually leads to adoption of computers in new areas and a proliferation of applications in exiting areas.
At this stage project and budgetary controls are not developed. This leads to a saturation of existing computer capacity and more sophisticated computer systems being obtained. The new system sophistication requires hiring new specialized professionals. Due to the shortage of qualified individuals, employee salaries are high. The budget for the computer organization the significantly increases and causes management concern. The price of Stage II is high, the benefits are visible, but planning and control of computer systems needs to be introduced.
Stage III - Control Stage
During Stage III centralized controls are established and a shift occurs from management of computers to management of data resources. This stage is a reaction against excessive and uncontrolled expenditures of time and money spent on computer systems. Management has recognized the need to take control of the computer operating costs. Project management and management report systems are organized. This leads to the development of programming, documentation, and operation standards. A shift occurs from management of computers to management of data resources. This shift is an outcome of analysis of how to increase management control and planning data processing operations. The shift provides flexibility in data processing that is needed for management's new controls. There is a reconstruction of data processing operation.
Stage IV - Integration Stage
During Stage IV there is adoption of new technology to integrate separate systems. This results in additional data processing cost growth similar to that of Stage II. In the last half of Stage IV, there is also dependence on computer controls, which leads to inefficiencies. These inefficiencies that are really associated with rapid growth result in another wave of problems. In the original SGM this was the last stage.
Stage V - Management Stage
In 1979 SGM was updated with this stage. Stage V has a new emphasis on managing corporate data rather than IT. The concept of Information Services (IS) surfaces and replaces data processing. It includes the development and maturity of the new concept of data administration.
Stage VI - Maturity Stage
In Stage VI, the applications mirror the organization and information flows in the company. There is emphasis on manufacturing, marketing and financial control. Manufacturing control includes forecasting, looking down the road for future needs. Marketing control deals with research. Financial control forecasts future cash requirements. When effective, this stage allows the organization to function at high levels of efficiency and effectiveness.
The SGM is very similar to the technology push pull discussions [3]. SGM can be easily adopted and used for the introduction of any new technology, process, or technique, not just computer automation. It describes a natural maturity progression from the initial neophyte stages to final sophisticated highly mature stages that exist in all settings.
Natural Human Maturity
The concept of maturity is a very general concept and is seen in nature. This is why many have surfaced it to explain unique aspects of their domains. Like many theories, these models are just extensions of what is observed in the natural world. The following is a description of the Its all Relative Model (IRM).
IRM is an explanation of human maturity and is based on the concept of measuring maturity based on years of exposure to a topic as one matures from birth to old age. It is offered as an analogue to explain and sensitized everyone to the concept of experience base. The IRM is described as follows:
Maturity Scale |
|||||
| Age | Phase | Baby | Child | Kid | Teen |
| 1 | baby | 33 | 100 | 100 | 100 |
| 2 | baby | 66 | 100 | 100 | 100 |
| 3 | Baby stage mastered | 100 | 100 | 100 | 100 |
| 4 | child | 0 | 50 | 100 | 100 |
| 5 | Child stage mastered | 0 | 100 | 100 | 100 |
| 6 | kid | 0 | 0 | 14 | 100 |
| 7 | kid | 0 | 0 | 28 | 100 |
| 8 | kid | 0 | 0 | 42 | 100 |
| 9 | kid | 0 | 0 | 56 | 100 |
| 10 | kid | 0 | 0 | 70 | 100 |
| 11 | kid | 0 | 0 | 84 | 100 |
| 12 | Kid stage mastered | 0 | 0 | 100 | 100 |
| 13 | teen | 0 | 0 | 0 | 17 |
| 14 | teen | 0 | 0 | 0 | 34 |
| 15 | teen | 0 | 0 | 0 | 51 |
| 16 | teen | 0 | 0 | 0 | 68 |
| 17 | teen | 0 | 0 | 0 | 85 |
| 18 | Teen stage mastered | 0 | 0 | 0 | 100 |
So just when you master becoming a baby you are pushed into the child frame of reference. Just when you master being a child you are pushed into the kid frame of reference. Babies know nothing about being a child. A child knows nothing about being a kid, and so on through each phase, its maturity curve and transition to the next phase. This model surfaced when attempting to properly raise my own children. It was a simple way to communicate that they are engaging in areas well outside their area of understanding. This same relationship holds true in every aspect of System Engineering and Management.
Where Did This Really Originate
The 1980s were dominated by massive hardware miniaturization. This allowed the cost of computers to significantly drop. A computer was no longer a significant capital investment. Instead it approached the cost of a typewriter in any setting. All these new computers and users gave rise to millions of new needs that required software. The few companies that were proficient in developing software could not fulfill the need. So new companies formed, many with management from other industries including the failing rust belt industries. The new software industry participants had members with failed business models and little or no knowledge of high technology or software. Meanwhile existing highly capable companies ran into trouble. A new trend of vulture capitalism surfaced where various financial schemes were used to extract wealth from many very successful high technology companies that were also software proficient. This resulted in chaos within previously stable effective companies and they were no longer able to develop effective software in a reasonable cost schedule project vehicle.
This turn of complex events significantly affected the US Government, which needed to maintain existing systems and develop new systems. The result was the Software Engineering Institute (SEI) at Carnegie Mellon University. This led to the Capability Maturity Model (CMM) and it became the foundation for the new SEI. Shortly after the introduction of the CMM, the US Government also changed their procurement strategy to include a working prototype as part of proposal submissions for software intensive projects.
Author Comment: RCA is a classic example of these events, where GE devastated the company. Only employees know how much capability, knowledge, technologies, and opportunities were lost as GE extracted wealth from RCA. Also in this same time frame Hughes was sold (as part of a political movement to eliminate non-profits) General Motors, not exactly an example of high technology or great management at that time. The thought was that Hughes would transform GM into a modern high technology company. Instead GM sold off the massive Hughes real estate assets (e.g. Fullerton Campus) and then dumped the high technology business to defense companies that refused to transition from defense to industrial and or commercial work after the fall of the Berlin Wall. This was in an atmosphere of privatized government where it became accepted to have a business derive 100% of its earnings from government funds and also make significant profits. This is contrary to RCA, where David Sarnoff publicly stated it was his patriotic duty to maintain defense divisions that did not need to make money. Instead the industrial and consumer divisions were the business and made money for RCA. Meanwhile GM eventually declared bankrupcy, probably because they sold off the last remaining real estate assets owned by Hughes Aircraft.
The Big Picture of Maturity Models
They capability maturity models were started in a stable time and used as part of normal system development. They were taken for granted and just naturally existed in organizations like Hughes Aircraft. In times of crisis the maturity models and associated assessments became critical tools as a way to try and continue to move forward. The model proposed for contagion mitigation in this century is in the same category and can be used to deal with the massive COVID-19 disaster.
The contagion mitigation model when used to assess a building provides a view of the level of maturity of the buildings ability to mitigate airborne contagions. Its value is not in the rating but in understand where the building falls in airborne contagion mitigation maturity. With that understanding various strategies can be developed to increase the level of contagion mitigation maturity until the building reaches what can be considered the highest level of contagion mitigation.
References:
[1] Hughes Aircraft's Widespread Deployment of a Continuously Improving Software Process, R.R. Willis, R.M. Rova, M.D. Scott, M.I. Johnson, J.F. Ryskowski, J.A. Moon, K.C. Shumate, T.O. Winfield, Technical Report CMU/SEI-98-TR-006, ESC-TR-98-006, May 1998.
[2] Software Engineering Institute, webpage https://www.sei.cmu.edu, May 2021.
[3] Systems Practices As Common Sense, Walter Sobkiw, ISBN: 978-0983253082, first edition 2011, ISBN: 978-0983253051, second edition 2020. REF 1
The purpose of this Product Certification Testing Strategy is to test and evaluate various products and systems for airborne contagion mitigation. The goal is to provide a common engineering metric that can be used in the design of effective airborne contagion mitigation systems. Most of the studies in the past 50 years are associated with Air Update Rates (AUC) or Air Changes Per Hour (ACH). There is a difference between the two where one represents the introduction of fresh air. For this test and evaluation platform there will be no introduction of fresh air. This will allow solutions other than HVAC systems and Fans to be evaluated like UV systems, PCO / Ionizer systems, and others systems that do not use air exchange as part of the mitigation mechanism.
When developing the testing lab the contagion needs to be taken into consideration. Biosafety levels define the levels of containment required for handling various types of biological hazards. There are four levels of containment identified by the Centers for Disease Control and Prevention (CDC).
The test approach is to use a controlled Known Test Bed (KTB) or gold standard and then a Target Test Bed (TTB) containing the product and or system under test. The approach is to use 2 separate clean rooms and feed them from a single airborne contagion source using a Y-pipe. The purpose of the Y-pipe is to ensure that each test bed receives the same amount of airborne contagion. Petri dishes are to be uniformly distributed in the same locations after the clean rooms are initiated to an ISO-3 level condition. The recommended locations are on the walls and in the spaces 3 feet apart at the 3, 6, and 8 foot levels. The size of each test bed is recommended to be a real world setting of 30 x 30 x 10 feet or 9,000 cubic feet. Each test bed is to use identical construction, materials, and configurations. The test beds are to be a minimum of ISO-3 or FED-STD-209E Class 1 rooms [1] [2].
| ISO-14644-1 | ISO-ACH | FED-STD-209E | FED-ACH | 0.1 µm | 0.2 µm | 0.3 µm | 0.5 µm | 5.0 µm |
| ISO-3 | 360-540 |
Class-1 | 35 |
7 |
3 |
1 |
||
| ISO-4 | 300-540 |
Class-10 | 350 |
75 |
30 |
10 |
||
| ISO-5 | 240-480 |
Class-100 | 750 |
300 |
100 |
|||
| ISO-6 | 150-240 |
Class-1,000 | 1,000 |
7 |
||||
| ISO-7 | 60-90 |
Class-10,000 | 10,000 |
70 |
||||
| ISO-8 | 5-48 |
Class-100,000 | 100,000 |
700 |
Note 1: Particle size greater that or equal to - Maximum Particles / cu-ft [3]
The following are the broad test steps to certify products and subsystems for contagion mitigation.
It is expected that eventually high levels of ACH for an integrated solution that uses an HVAC system will make most products or systems under test ineffective. For example high levels of ACH will prevent a ceiling level UV-C system from acting on contaminated air. That is why both test conditions must be performed: (1) the first is just the product and system under test and (2) the second is the product or system under test with an operating HVAC system in the same room.
The contagion must be as close to the contagion that is the current threat. In the case of a virus this requires live subjects like test mice. However, various bacteria in a Petri dish may be a good indicator of what to expect for a viral contagion. For a bacteria / viral calibration testing, mice in small cages can be used in place of the Petri dishes during early test and evaluation efforts.
The above proposed Product Certification Testing Strategies is a path forward that industry can handle and it will allow people to make proper engineering based choices when performing the system analysis and integration of contagion mitigation systems. In 2020 this systems analysis expected this testing to have been performed by US government labs immediately once it was known that the contagion was not contained. That date was in March 2020 when the US was shutdown. It is May 2021 and still there is no public data on any testing of this type.
In 2020 this systems analysis proposed a US Government Ventilation Test and Evaluation program using National Labs and the Industrial base from around the world. At the time the analysis stated that this would be the largest and most important test and evaluation program in history. The government would then certify the findings so that we know that the best science and engineering had been used to address this challenge. This certification would have cleared the issues associated with legal liability. Once the specifications would have been known then they could have been rolled out to the community, building checks could have been performed, and if needed certificates issued. That did not happen. So people were left on their own to determine what to do to make their buildings safe. However, people still needed common performance requirements so that the they can compare different products and make reasonable system integration decisions [3] [5]. This Product Certification Testing Strategies approach can provide the common performance requirements.
The US developed standard FED-STD-209E and it is in the public domain because it was paid for by the taxpayers. The US FED-STD-209E standard was abandoned and it moved to an ISO standard. All ISO standards are sold for a fee. The public no longer has access to this critical information that significantly impacts their lives. Also, the taxpayer was never compensated for this transition of their asset to another entity. Just like FED-STD-209E was developed using national labs, a new FED-STD-COVID-19-Mitigation standard should have been developed in 2020. However, the government walked away from its responsibilities to the people all in the broad policy approach of deregulation and privatization [6].
Once again history will not paint a nice picture of the performance of this generation [7].
References:
[1] ISO 14644-1, Classification of air cleanliness by particle concentration, ANSI Standard 2015, webpage https://www.iest.org/Standards-RPs/ISO-Standards/ISO-14644-Series, May 2021.
[2] FED-STD-209 E Airborne Particulate Cleanliness Classes in Cleanrooms and Cleanzones, US Government, September 11, 1992. PDF local E . PDF local D
[3] Clean Room Specifications & Classifications Guide, webpage https://www.advancetecllc.com/cleanroom-specifications, May 2021.
[4] COVID-19 A Systems Perspective, Walter Sobkiw, 2021, ISBN 9780983253044, hardback.
[5] COVID-19 Return To Life, webpage http://www.cassbeth.com/covid-19/return-to-life/index.html, April 2021. COVID-19 Return To Life.
[6] Privatization A Systems Perspective, Walter Sobkiw, 2019, ISBN 9780983253068. Privatization A Systems Perspective.
[7] See section Toxic Generational Choices.
The wells-Riley equation is used to predict the probability of infection in a space with a certain volume and infection load. The volume of a space is easily determined but the infection load is a challenge. Even if the infection load is approximate, Wells-Riley provides a good metric to compare spaces of different volumes. For example this research compared the probability of infection between small, large, and outside spaces. From this research it was found that the problem is massive within small enclosed spaces, problematic in large spaces, and extremely rare in outdoor spaces [1] [2].
Wells-Riley equation:
P = D/S = 1 - exp ( - (Ipqt/Q) )
P = probability of infection for susceptibles
D = number of disease cases
S = number of susceptibles
I = number of infectors
p = breathing rate per person (m3/s)
q = quantum generation rate by an infected person (quanta/s)
t = total exposure time (s)
Q = outdoor air supply rate (m3/s)Q = Space Cubic Feet * AUC
quanta = virus
Using Wells-Riley to determine the actual probability of infection has 2 major challenges. The first is determining the infection load. The second is the use of an exponential in the equation.
For the first challenge of finding the actual infection load, no one has the resources to determine the infection load except for the US government. This research disclosed estimates on the infection load under different scenarios from others attempting to measure the infection load [1] [2]. This requires massive multi billion dollar resources to bring the needed technology to perform the correct test and evaluations, so the numbers are approximate and may be incorrect. Unfortunately since the big push to privatize and deregulate the government beginning in 1980, those types of activities are not being performed, and if they are they are locked up as proprietary data in privatized companies doing the work, even though they are using taxpayer funds. So we are primarily left with pre-1980 numbers for diseases from that era and some estimates on the COVID-19 virus load from researchers doing their best with their limited resources. The following table shows virus load estimates from researchers in 2020 [1] [2].
Bio Event |
Droplets |
Virus Load |
Comment |
Single Breath |
50 - 5000 |
none |
Source [5]. This analysis uses this baseline to estimate sneeze and cough virus load. |
Infected Single Breath |
- |
20 |
A person infected with influenza releases about 3 - 20 virus RNA copies per minute of breathing. [6] COVID-19 patients exhale 1,000 to 100,000 virus particles per minute, with the highest rate seen during the early stages of COVID-19. [8] [9] |
Speaking |
- |
200 |
Increases the release of respiratory droplets about 10 times over breathing. [7] |
Sneeze |
30,000 |
6X single breath |
Source [3] [4]. |
Infected Cough or Sneeze |
200,000,000 |
40,000X single breath |
Source [3] [4]. |
In 2021 we now have evidence of when infection happens in a room with a given size and the rate of air update changes. This allows the Well-Riley equation to be tuned to match the empirical data and it makes the virus load hunt less critical. The value can be back calculated.
The second challenge of the exponent in the equation is used to approximate the effects of dilution in large spaces. There is a way to determine the effects of dilution between two spaces and that is to just calculate the volume ratio. The problem surfaces with spaces that have very high ceilings. A simple mental model suggests that dilution tends to happen around the height of the infectors and a reasonable assumption is that the maximum ceiling height to consider is 12 feet. This suggests that using the ratio of square footage is a more reasonable approach to determine the effects of dilution.
The following table shows the dilution as a function of room volume in cubic feet or room size in square feet.
cu-ft |
Ceiling ft |
Dilution (cu-ft ratio) |
. |
Ceiling ft |
L or W ft |
sq-ft |
Dilution (sq-ft ratio) |
10,000 |
12 |
1 |
|
12 |
30 |
900 |
1 |
20,000 |
12 |
2 |
12 |
41 |
1667 |
2 |
|
50,000 |
22 |
5 |
|
12 |
48 |
2273 |
3 |
100,000 |
22 |
10 |
|
12 |
67 |
4545 |
5 |
200,000 |
40 |
20 |
|
12 |
71 |
5000 |
6 |
300,000 |
4 |
30 |
|
12 |
87 |
7500 |
9 |
400,000 |
40 |
40 |
|
12 |
100 |
10000 |
12 |
The dilution analysis based on room volume and room size shows that the dilution number for a large room of 400,000 cu-ft with a ceiling height of 40 feet is 37. However if we assume the dilution tends to happen around the height of the infectors and limit that height to 12 feet the large room dilution factor drops to 11. This analysis is important once the Wells-Riley equation is revisited because it will take into account the effects of dilution based on room size. However that dilution is based on the exponent in the equation.
Given all these limitations of the well-Riley equation in real world settings, it can be tuned to match observations of infection and direct ratios of volume or square footage.
We know from empirical data that infection ours at 1 AUC in a classroom. Taking the inverse of an actual room AUC with similar size will lead to an Infection Risk metric. This is not probability of infection, it is an infection risk metric. However if the wells-Riley probability of infection is equated to the Infection Rick metric, then the wells-Riley equation can be tuned to match a simple but very effective model of infection risk.
Infection Risk = 1/AUC
Level |
State |
AUC |
Infection |
Exposure Time |
Airborne Contagion Mitigation System Building Condition |
6 |
Green |
120 |
<1 |
30 sec |
Approaches outside ventilation conditions |
5 |
Green |
50 |
2 |
1.2 min |
Similar to operating room without PPE |
4 |
Yellow |
24 |
4 |
2.5 min |
Similar to WHO patient room airborne precautions |
3 |
Yellow |
10 |
10 |
6 min |
Similar to patient room airborne precautions |
2 |
Orange |
4 |
25 |
15 min |
Marginal mitigation |
1 |
Red |
1 |
100 |
1 hr |
School data suggests infection happens [6] |
0 |
Red |
0 |
100 |
full time |
No ventilation infection happens |
The infection risk model needs to consider more that just 1/AUC because it is associated with a particular room volume. Somehow the 1/AUC reading must be augmented with another parameter to account for larger spaces. This is the Large Space Factor.
There are 3 approaches to determine the large space factor and they are to use room volume, room square footage, or return back to the Wells-Riley equation to determine the large space factor. In this case the Wells-Riley equation was used to determine the large space factor for discrete volume measurements.
Space cu-ft |
Volume Ratios |
Square Footage Ratios |
Wells Riley LS Factors |
400,000 |
40 |
12 |
7.75 |
300,000 |
30 |
9 |
5.94 |
200,000 |
20 |
6 |
4.14 |
100,000 |
10 |
5 |
2.35 |
50,000 |
5 |
3 |
1.49 |
20,000 |
2 |
2 |
1.06 |
<10,000 |
1 |
1 |
1 |
The following table shows how Wells-Riley calculation assumption of infection load was used to match the Infection Risk. It was tuned to match the Infection Risk and empirical data.
I |
p cu-ft/sec |
q/sec |
lpq sec |
lpq hr |
t sec |
hour |
lpqt |
cu-ft |
AUC |
Q hr |
POI |
Infection Risk |
Color |
1 |
0.21 |
17 |
3.57 |
12852 |
3600 |
1 |
12852 |
10,800 |
1 |
10800 |
0.695778736 |
1 |
Red |
1 |
0.21 |
17 |
3.57 |
12852 |
3600 |
1 |
12852 |
10,800 |
4 |
43200 |
0.257327417 |
0.250000 |
Orange |
1 |
0.21 |
17 |
3.57 |
12852 |
3600 |
1 |
12852 |
10,800 |
10 |
108000 |
0.112192199 |
0.100000 |
Yellow |
1 |
0.21 |
17 |
3.57 |
12852 |
3600 |
1 |
12852 |
10,800 |
24 |
259200 |
0.048374147 |
0.041667 |
Yellow |
1 |
0.21 |
17 |
3.57 |
12852 |
3600 |
1 |
12852 |
10,800 |
50 |
540000 |
0.023519014 |
0.020000 |
Green |
1 |
0.21 |
17 |
3.57 |
12852 |
3600 |
1 |
12852 |
10,800 |
120 |
1296000 |
0.009867659 |
0.008333 |
Green |
Since the Wells-Riley equation was tuned using the Infection Risk model it can be used as an alternative to determine Infection Risk. When this calculation is performed we see more movement into the upper and lower levels. This is the effects of the exponent in the equation.
References:
[1] COVID-19 A Systems Perspective, Walter Sobkiw, 2021, ISBN 9780983253044, hardback.
[2] COVID-19 Return To Life, webpage http://www.cassbeth.com/covid-19/return-to-life/index.html, April 2021. COVID-19 Return To Life.
[3] Natural Ventilation for Infection Control in Health-Care Settings, World Health Organization 2009. webpage https://www.ncbi.nlm.nih.gov/books/NBK143281, March 2020. NIH. webpage https://www.ncbi.nlm.nih.gov/books/NBK143284/pdf/Bookshelf_NBK143284.pdf, March 2020. Natural Ventilation for Infection Control in Health-Care Settings PDF . local
[4] The Gross Science of a Cough and a Sneeze, Live Science www.livescience.com, May 12, 2009. webpage https://www.livescience.com/3686-gross-science-cough-sneeze.html, May 2020. The Gross Science of a Cough and a Sneeze
[5] Factors involved in the aerosol transmission of infection and control of ventilation in healthcare premises, Journal Of Hospital Infection www.journalofhospitalinfection.com, October 01, 2006. webpage https://www.journalofhospitalinfection.com/article/S0195-6701(06)00286-6/fulltext, May 2020. Factors involved in the aerosol transmission of infection and control of ventilation in healthcare premises
[6] Influenza Virus in Human Exhaled Breath: An Observational Study, .PloS ONE www.plosone.org, July 16, 2008. webpage https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2442192 March 2020. Influenza Virus in Human Exhaled Breath: An Observational Study . PDF
[7] Aerosol emission and superemission during human speech increase with voice loudness, Nature www.nature.com, February 19, 2019. webpage https://pubmed.ncbi.nlm.nih.gov/30787335, March 2020. Aerosol emission and superemission during human speech increase with voice loudness . PDF
[8] Aerodynamic analysis of SARS-CoV-2 in two Wuhan hospitals, Nature www.nature.com, April 27, 2020. webpage https://www.nature.com/articles/s41586-020-2271-3, Marh 2020. Aerodynamic analysis of SARS-CoV-2 in two Wuhan hospitals
[9] COVID-19 patients exhale millions of viral particles per hour, News Medical www.news-medical.net, June 3, 2020. webpage https://www.news-medical.net/news/20200603/COVID-19-patients-exhale-millions-of-viral-particles-per-hour.aspx June 2020, COVID-19 patients exhale millions of viral particles per hour
CDC ACH Recommendations
The following is a July 2021 website extract from the CDC: Appendix B. Air Guidelines for Environmental Infection Control in Health-Care Facilities (2003) [1].
Analysis of this CDC data is provided at the start of the extract rather than at the end of the extract because of the possibility that it might get lost by the reader.
There are many ACH numbers provided by the CDC in Appendix B. Air Guidelines for Environmental Infection Control in Health-Care Facilities (2003). Why are there so many different ACH numbers? Do the names of the spaces affect an airborne contagions risk of infection? Keep in mind when we are considering ACH we are considering airborne elements of infection not surface elements of infection. Some contagions are not airborne. There are two important notes associated with the tables and they are:
1. The ventilation rates in this table cover ventilation for comfort, as well as for asepsis and odor control in areas of nursing facilities that directly affect resident care and are determined based on nursing facilities being predominantly No Smoking facilities. Where smoking may be allowed, ventilation rates will need adjustment. Areas where specific ventilation rates are not given in the table shall be ventilated in accordance with ASHRAE Standard 62, Ventilation for Acceptable Indoor Air Quality, and ASHRAE Handbook – HVAC Applications. OSHA standards and/or NIOSH criteria require special ventilation requirements for employee health and safety within nursing facilities.
18. The infectious disease isolation room described in these guidelines is to be used for isolating the airborne spread of infectious diseases, such as measles, varicella, or tuberculosis. The design of airborne infection isolation (AII) rooms should include the provision for normal patient care during periods not requiring isolation precautions. Supplemental recirculating devices may be used in the patient room to increase the equivalent room air exchanges; however, such recirculating devices do not provide the outside air requirements. Air may be recirculated within individual isolation rooms if HEPA filters are used. Rooms with reversible airflow provisions for the purpose of switching between protective environment and AII functions are not acceptable.
In note 1, what does smoking have to do with asepsis? Based on note 18, it appears the asepsis does not include airborne contagions. This suggests all the ACH numbers are irrelevant except for those associated with note 18 and they are: Airborne infection isolation room (17, 18) with an ACH = 12 and Isolation alcove or anteroom (17, 18) with an ACH of 10. Both of these numbers are less than other ACH numbers needed for other rooms where the maximum ACH from all the tables is ACH = 15.
The CDC physical space ACH recommendations do not come from studies in national labs [1]. Instead they come from industry via technical associations and organizations, which are always heavily influenced by industry. In this case the industrial forces are aligned with reducing costs by reducing ventilation and not ensuring maximum health or containment of airborne contagions. The numbers presented by the CDC are below numbers presented by the World Health Organization (WHO) of 160 l/s/patient (hourly average ventilation rate) for airborne precaution rooms or ACH = 24 for the room size provided (with a minimum of 80l/s/patient) (note that this only applies to new health-care facilities and major renovations) [2].
The CDC Table B.1. Air changes/hour (ACH) and time required for airborne-contaminant removal by efficiency is an interesting table and similar tables exist in other research and documents including from the WHO. From the systems perspective this table suggests that there is nothing that can be done and so what is the point of increasing ACH. This is a typical example of a phrase systems engineers often use: figures never lie but liars figure [Mark Twain]. All analysis is good even if it is wrong or paints the wrong picture. The issue is when analysis is stopped or filtered. In this case whenever this table is presented it should always be presented with other analysis perspectives. For example what is the ideal mathematical case for ACH? Can ACH be reduced to a risk level? This analysis has those perspectives and they are duplicated / summarized as follows [6]:
ACH |
Infection Risk |
Exposure Time |
Airborne Contagion Mitigation System Building Condition |
120 |
<1 |
30 sec |
Approaches outside ventilation conditions |
50 |
2 |
1.2 min |
Similar to operating room without PPE |
24 |
4 |
2.5 min |
Similar to WHO patient room airborne precautions |
10 |
10 |
6 min |
Similar to patient room airborne precautions |
4 |
25 |
15 min |
Marginal mitigation |
1 |
100 |
1 hr |
School data suggests infection happens |
0 |
100 |
full time |
No ventilation infection happens |
All of the sudden the systems perspective changes and there appears to be massive clear benefit in increasing the ACH in a facility. In 2020 this research proposed legislation to engage the national labs to perform ventilation studies in the wake of the COVID-19 disaster [3] - Proposed Legislation. The proposal was ignored.
If I owned a restaurant and as a responsible owner I wanted to ensure my space was as safe as possible from an airborne contagion infection what ACH number should I pick? Philadelphia required 15 ACH until the program was stopped in May 2021 [5].
If I sent my children to school, what ACH number should the school facilities staff follow when making any upgrades? Philadelphia publicly published their ventilation data for every school by room [5] but rather than provide an ACH guidance, a 15 CFM per occupant was provided which translates into ACH levels as low a 1. Did management confuse CFM with ACH or were they led down that path by hidden stakeholders with toxic self interests?
If I were an ethical responsible board member of a HOA community with a public building which ACH number should I pick for the facility? Should it be the CDC number of 10 or 12, should it be the Philadelphia restaurant program number of 15 ACH, should it be the WHO number of 24 ACH, or should I go for the highest number possible based on a combination of technologies? Perhaps I should just open all the windows in the facility during mild climate months as suggest by the WHO and get 45+ ACH?
We know what the elite restaurants, schools, HOA, work, play, and other facilities will do. They will pick the highest performance system by just telling their vendors we want the best, do not compromise. They will also ensure to filter out vendors selling snake oil solutions.
We know from various media sources that industry representatives have gone on record that there is nothing that can be done to make buildings safer. However, that is a lie and we know that there are physical spaces that are very safe from airborne contagions. Even clean room standards show the possibilities [4]. The issue is one of cost and who is controlling the analysis and dialog. Legislation [3] should have been passed last year in 2020, and testing [4] should have been completed by January of 2021.
*** EXTRACT START ***
| ACH § ¶ | Time (mins.) required for removal 99% efficiency |
Time (mins.) required for removal 99.9% efficiency |
|---|---|---|
| 2 | 138 | 207 |
| 4 | 69 | 104 |
| 6+ | 46 | 69 |
| 8 | 35 | 52 |
| 10+ | 28 | 41 |
| 12+ | 23 | 35 |
| 15+ | 18 | 28 |
| 20 | 14 | 21 |
| 50 | 6 | 8 |
* This table is revised from Table S3-1 in reference 4 and has been adapted from the formula for the rate of purging airborne contaminants presented in reference 1435.
+ Denotes frequently cited ACH for patient-care areas.
§ Values were derived from the formula:
t2 – t1 = – [ln (C2 / C1) / (Q / V)] X 60, with t1 = 0
where
t1 = initial timepoint in minutes
t2 = final timepoint in minutes
C1 = initial concentration of contaminant
C2 = final concentration of contaminant
C2 / C1 = 1 – (removal efficiency / 100)
Q = air flow rate in cubic feet/hour
V = room volume in cubic feet
Q / V = ACH
¶ Values apply to an empty room with no aerosol-generating source. With a person present and generating aerosol, this table would not apply. Other equations are available that include a constant generating source. However, certain diseases (e.g., infectious tuberculosis) are not likely to be aerosolized at a constant rate. The times given assume perfect mixing of the air within the space (i.e., mixing factor = 1). However, perfect mixing usually does not occur. Removal times will be longer in rooms or areas with imperfect mixing or air stagnation.213 Caution should be exercised in using this table in such situations. For booths or other local ventilation enclosures, manufacturers’ instructions should be consulted.
The following tables from the AIA Guidelines for Design and Construction of Hospitals and Health-Care Facilities, 2001 are reprinted with permission of the American Institute of Architects and the publisher (The Facilities Guidelines Institute).120
Note: This table is Table 7.2 in the AIA guidelines, 2001 edition. Superscripts used in this table refer to notes following the table.
| Area designation | Air movement relationship to adjacent area2 | Minimum air changes of outdoor air per hour3 | Minimum total air change per hour 4,5 | All air exhausted directly to outdoors6 | Recirculated by means of room units7 | Relative humidity8 (%) |
Design temperature9 (degrees F [C]) |
|---|---|---|---|---|---|---|---|
| Operating/surgical cystoscopic rooms10, 11 | Out | 3 | 15 | – | No | 30–60 | 68–73 (20–23)12 |
| Delivery room10 | Out | 3 | 15 | – | No | 30–60 | 68–73 (20–23) |
| Recovery room10 | – | 2 | 6 | – | No | 30–60 | 70–75 (21–24) |
| Critical and intensive care | – | 2 | 6 | – | No | 30–60 | 70–75 (21–24) |
| Newborn intensive care | – | 2 | 6 | – | No | 30–60 | 72–78 (22–26) |
| Treatment room13 | – | – | 6 | – | – | – | 75 (24) |
| Trauma room13 | Out | 3 | 15 | – | No | 30–60 | 70–75 (21–24) |
| Anesthesia gas storage | In | – | 8 | Yes | – | – | – |
| Endoscopy | In | 2 | 6 | – | No | 30–60 | 68–73 (20–23) |
| Bronchoscopy11 | In | 2 | 12 | Yes | No | 30–60 | 68–73 (20–23) |
| ER waiting rooms | In | 2 | 12 | Yes14, 15 | – | – | 70–75 (21–24) |
| Triage | In | 2 | 12 | Yes14 | – | – | 70–75 (21–24) |
| Radiology waiting rooms | In | 2 | 12 | Yes14, 15 | – | – | 70–75 (21–24) |
| Procedure room | Out | 3 | 15 | – | No | 30–60 | 70–75 (21–24) |
| Area designation | Air movement relationship to adjacent area2 | Minimum air changes of outdoor air per hour3 | Minimum total air change per hour 4,5 | All air exhausted directly to outdoors6 | Recirculated by means of room units7 | Relative humidity8 (%) |
Design temperature9 (degrees F [C]) |
|---|---|---|---|---|---|---|---|
| Patient room | – | 2 | 616 | – | – | – | 70–75 (21–24) |
| Toilet room | In | – | 10 | Yes | – | – | – |
| Newborn nursery suite | – | 2 | 6 | – | No | 30–60 | 72–78 (22–26) |
| Protective environment room11, 17 | Out | 2 | 12 | – | No | – | 75 (24) |
| Airborne infection isolation room17, 18 | In | 2 | 12 | Yes15 | No | – | 75 (24) |
| Isolation alcove or anteroom17, 18 | In/Out | – | 10 | Yes | No | – | – |
| Labor/delivery/recovery | – | 2 | 616 | – | – | – | 70–75 (21–24) |
| Labor/delivery/recovery/ postpartum | – | 2 | 616 | – | – | – | 70–75 (21–24) |
| Patient corridor | – | – | 2 | – | – | – | – |
| Area designation | Air movement relationship to adjacent area2 | Minimum air changes of outdoor air per hour3 | Minimum total air change per hour 4,5 | All air exhausted directly to outdoors6 | Recirculated by means of room units7 | Relative humidity8 (%) |
Design temperature9 (degrees F [C]) |
|---|---|---|---|---|---|---|---|
| X-ray (surgical/critical care and catheterization) | Out | 3 | 15 | – | No | 30-60 | 70–75 (21–24) |
| X-ray (diagnostic & treatment) | – | – | 6 | – | – | – | 75 (24) |
| Darkroom | In | – | 10 | Yes | No | – | – |
| Area designation | Air movement relationship to adjacent area2 | Minimum air changes of outdoor air per hour3 | Minimum total air change per hour 4,5 | All air exhausted directly to outdoors6 | Recirculated by means of room units7 | Relative humidity8 (%) |
Design temperature9 (degrees F [C]) |
|---|---|---|---|---|---|---|---|
| General19 | – | – | 6 | – | – | – | 75 (24) |
| Biochemistry19 | Out | – | 6 | – | No | – | 75 (24) |
| Cytology | In | – | 6 | Yes | No | – | 75 (24) |
| Glass washing | In | – | 10 | Yes | – | – | 75 (24) |
| Histology | In | – | 6 | Yes | No | – | 75 (24) |
| Microbiology19 | In | – | 6 | Yes | No | – | 75 (24) |
| Nuclear medicine | In | – | 6 | Yes | No | – | 75 (24) |
| Pathology | In | – | 6 | Yes | No | – | 75 (24) |
| Serology | Out | – | 6 | – | No | – | 75 (24) |
| Sterilizing | In | 10 | Yes | – | – | – | |
| Autopsy room11 | In | – | 12 | Yes | No | – | – |
| Nonrefrigerated body-holding room | In | – | 10 | Yes | – | – | 70 (21) |
| Pharmacy | Out | – | 4 | – | – | – | – |
| Area designation | Air movement relationship to adjacent area2 | Minimum air changes of outdoor air per hour3 | Minimum total air change per hour 4,5 | All air exhausted directly to outdoors6 | Recirculated by means of room units7 | Relative humidity8 (%) |
Design temperature9 (degrees F [C]) |
|---|---|---|---|---|---|---|---|
| Examination room | – | – | 6 | – | – | – | 75 (24) |
| Medication room | Out | – | 4 | – | – | – | – |
| Treatment room | – | – | 6 | – | – | – | 75 (24) |
| Physical therapy and hydrotherapy | In | – | 6 | – | – | – | 75 (24) |
| Soiled workroom or soiled holding | In | – | 10 | Yes | No | – | – |
| Clean workroom or clean holding | Out | – | 4 | – | – | – | – |
| Area designation | Air movement relationship to adjacent area2 | Minimum air changes of outdoor air per hour3 | Minimum total air change per hour 4,5 | All air exhausted directly to outdoors6 | Recirculated by means of room units7 | Relative humidity8 (%) |
Design temperature9 (degrees F [C]) |
|---|---|---|---|---|---|---|---|
| ETO-sterilizer room | In | – | 10 | Yes | No | 30-60 | 75 (24) |
| Sterilizer equipment room | In | – | 10 | Yes | – | – | – |
| Area designation | Air movement relationship to adjacent area2 | Minimum air changes of outdoor air per hour3 | Minimum total air change per hour 4,5 | All air exhausted directly to outdoors6 | Recirculated by means of room units7 | Relative humidity8 (%) |
Design temperature9 (degrees F [C]) |
|---|---|---|---|---|---|---|---|
| Soiled or decontamination room | In | – | 6 | Yes | No | – | 68–73 (20–23) |
| Clean workroom | Out | – | 4 | – | No | – | 75 (24) |
| Sterile storage | Out | – | 4 | – | – | 30-60 | – |
| Area designation | Air movement relationship to adjacent area2 | Minimum air changes of outdoor air per hour3 | Minimum total air change per hour 4,5 | All air exhausted directly to outdoors6 | Recirculated by means of room units7 | Relative humidity8 (%) |
Design temperature9 (degrees F [C]) |
|---|---|---|---|---|---|---|---|
| Food preparation center20 | – | – | 10 | – | No | – | – |
| Ware washing | In | – | 10 | Yes | No | – | – |
| Dietary day storage | In | – | 2 | – | – | – | – |
| Laundry, general | – | – | 10 | Yes | – | – | – |
| Soiled linen (sorting and storage) | In | – | 10 | Yes | No | – | – |
| Clean linen storage | Out | – | 2 | – | – | – | – |
| Soiled linen and trash chute room | In | – | 10 | Yes | No | – | – |
| Bedpan room | In | – | 10 | Yes | – | – | – |
| Bathroom | In | – | 10 | – | – | – | 75 (24) |
| Janitor's closet | In | – | 10 | Yes | No | – | – |
Notes:
Appendix I:
A7. Recirculating devices with HEPA filters may have potential uses in existing facilities as interim, supplemental environmental controls to meet requirements for the control of airborne infectious agents. Limitations in design must be recognized. The design of either portable or fixed systems should prevent stagnation and short circuiting of airflow. The supply and exhaust locations should direct clean air to areas where health-care workers are likely to work, across the infectious source, and then to the exhaust, so that the healthcare worker is not in position between the infectious source and the exhaust location. The design of such systems should also allow for easy access for scheduled preventative maintenance and cleaning.
A11. The verification of airflow direction can include a simple visual method such as smoke trail, ball-in-tube, or flutterstrip. These devices will require a minimum differential air pressure to indicate airflow direction.
Note: This table is Table 8.1 in the AIA guidelines, 2001 edition. Superscripts used in this table refer to notes following the table.
| Area designation | Air movement relationship to adjacent area2 | Minimum air changes of outdoor air per hour3 | Minimum total air change per hour 4 | All air exhausted directly to outdoors5 | Recirculated by means of room units6 | Relative humidity7 (%) |
Design temperature8 (degrees F [C]) |
|---|---|---|---|---|---|---|---|
| Resident room | – | 2 | 2 | – | – | –9 | 70–75 (21–24) |
| Resident unit corridor | – | – | 4 | – | – | –9 | – |
| Resident gathering areas | – | 4 | 4 | – | – | – | – |
| Toilet room | In | – | 10 | Yes | No | – | – |
| Dining rooms | – | 2 | 4 | – | – | – | 75 (24) |
| Activity rooms, if provided | – | 4 | 4 | – | – | – | – |
| Physical therapy | In | 2 | 6 | – | – | – | 75 (24) |
| Occupational therapy | In | 2 | 6 | – | – | – | 75 (24) |
| Soiled workroom or soiled holding | In | 2 | 10 | Yes | No | – | – |
| Clean workroom or clean holding | Out | 2 | 4 | – | – | (Max. 70) | 75 (24) |
| Sterilizer exhaust room | In | – | 10 | Yes | No | – | – |
| Linen and trash chute room, if provided | In | – | 10 | Yes | No | – | – |
| Laundry, general, if provided | – | 2 | 10 | Yes | No | – | – |
| Soiled linen sorting and storage | In | – | 10 | Yes | No | – | – |
| Clean linen storage | Out | – | 2 | Yes | No | – | – |
| Food preparation facilities10 | – | 2 | 10 | Yes | No | – | – |
| Dietary warewashing | In | – | 10 | Yes | No | – | – |
| Dietary storage areas | – | – | 2 | Yes | No | – | – |
| Housekeeping rooms | In | – | 10 | Yes | No | – | – |
| Bathing rooms | In | – | 10 | Yes | No | – | 75 (24) |
Notes:
*** EXTRACT END ***
References:
[1] Appendix B. Air Guidelines for Environmental Infection Control in Health-Care Facilities (2003), webpage https://www.cdc.gov/infectioncontrol/guidelines/environmental/appendix/air.html, July 2021. Appendix B. Air Guidelines for Environmental Infection Control in Health-Care Facilities (2003)
[2] WHO Publication/Guidelines Natural Ventilation for Infection Control in Health-Care Settings, World Health Organization (WHO), 2009. webpage https://www.ncbi.nlm.nih.gov/books/NBK143284/pdf/Bookshelf_NBK143284.pdf, May 2020. Natural Ventilation for Infection Control in Health-Care Settings, WHO, 2009 . local
[3] COVID-19 A Systems Perspective, Walter Sobkiw, 2021, ISBN 9780983253044, hardback. Proposed Legislation
[4] See section Product Certification Testing Strategies.
[5] See section Healthy Infrastructure.
[6] See section Contagion Mitigation System Certification of Buildings.
School Ventilation Architecture Tradeoffs
This is from a report from Johns Hopkins University the Johns Hopkins Center for Health Security School, Ventilation: A Vital Tool to Reduce COVID-19 Spread [1].
However, schools should not implement deep clean days as a matter of routine. Fomite (surface) transmission is not a major driver of the spread of SARS-CoV-2. Investments in ventilation will provide more value in risk reduction.
Poor air quality in K-12 schools is a longstanding concern, predating COVID-19.
Even when school districts invest in upgrading their HVAC systems, serious problems may still remain. A 2020 study34 showed that in schools retrofitted with new HVAC equipment, problems were found with HVAC equipment, fan control, and/or filter maintenance in 51% of classrooms studied. The problems that were detected highlight the need for better oversight on HVAC system installation and commissioning to ensure adequate classroom ventilation, as well as the need for periodic testing of ventilation systems and ongoing maintenance checks.
Qualified technicians are needed to assess HVAC system function in school facilities in a standardized manner and report the results of these assessments to appropriate stakeholders. However, according to the GAO survey of the 50 states and District of Columbia, most states do not conduct statewide assessments. School districts are usually responsible for such assessments, with funding to address identified facility needs coming from districts that likely have already strained budgets.
The US government should convene a federal task force dedicated to school air quality to develop guidance for long-term, sustainable, cost-effective improvements to indoor air quality in schools. This guidance should include accountability measures to assess improvements. [this research recommended in 2020 that legislation be passed that would enable this work]
The task force should be composed of experts in air quality, industrial hygiene, building science, HVAC systems, epidemiology, engineering, children's environmental health,and education. Together, they should develop guidance for improving, monitoring, and maintaining good indoor air quality. The task force should create standards for school systems to account for different ventilation systems, climates, and conditions around the country. It should also develop a certification for HVAC installers and commissioners and, importantly, should provide recommendations for oversight and accountability so that the nation's K-12 students and teachers have the benefit of healthy air in schools. The well-documented problems of poor indoor air quality in K-12 schools have been allowed to continue for decades. A path forward is needed to fix these problems to give students, teachers, and staff in K-12 schools the healthy air they deserve.
It is unclear why school districts are not publishing on their websites exactly what they have done to their ventilation systems. Multiple attempts to reachout to various school districts around the country are met with no response. If one does a search on the Internet of what school districts must do there are only marketing responses from vendors trying to sell their products. Only the Philadelphia School District has disclosed its site survey data of all the schools in the district and provided information on their approaches to increase classroom ventilation. Philadelphia School District Data. [6]
Architecture Requirements
Most will fixate on modern schools with modern HVAC systems and they will assume that those systems provide a sufficient level of Air Changes Per Hour (ACH) to deal with airborne contagions. However, that is not the case. They were never designed to deal with airborne contagions. They were designed for comfort levels or in the worst case to minimize the levels of CO2 in the classroom to prevent CO2 poisoning. In some instances even the CO2 levels are not properly minimized. To increase the ventilation there are various limiting factors and one of the significant limiting factors is the ducts that provide the air ventilation. If the ducts are too small, the HVAC system fans, regardless of size, will not be able to provide the needed ACH rate to deal with airborne contagions. The only alternative is to either replace the ducts or augment the existing HVAC system.
The ACH levels needed for the new reality of airborne contagions is known and they form the requirements that must be met if a classroom ventilation system is to deal with airborne contagions with a reasonable level of risk. The requirements mentioned in many sources are close to these numbers however, empirical data suggests that the classrooms are no where near those levels of performance. The following are various ACH rates from various sources for classrooms.
| Room Setting |
ACH |
ACH |
ACH |
Source |
Link (note links include commercial companies) |
| Classrooms | 10 |
15 |
10 |
Greenheck | https://www.scribd.com/document/325713225/Air-Changes-Greenheck |
| Classrooms (ART) | 16 |
20 |
16 |
Various | https://www.lakeair.com/air-changes-per-hour |
| Classrooms (ages 5 and up) | 12 |
16 |
12 |
Various | https://www.lakeair.com/air-changes-per-hour |
| Classrooms (science lab) | 16 |
20 |
16 |
Various | https://www.lakeair.com/air-changes-per-hour |
| Classrooms (shop classes) | 16 |
20 |
16 |
Various | https://www.lakeair.com/air-changes-per-hour |
| Classrooms | 6 |
20 |
6 |
Eng Tool Box | https://www.engineeringtoolbox.com/ventilation-air-flow-rate-d_115.html https://www.atlenv.com/building-ventilation-the-proper-air-changes-per-hour-ach |
| Classrooms (Real world emperical data) | 0 |
6 |
3 |
This research | See this research using the BCMC tool https://www.cassbeth.com/bcmc |
| Room with Airborne Contagion | 12 |
more |
more |
CDC | See this research https://www.cdc.gov/infectioncontrol/guidelines/environmental/appendix/air.html |
| Room with Airborne Contagion | 24 |
more |
more |
WHO | See this research https://www.ncbi.nlm.nih.gov/books/NBK143284/pdf/Bookshelf_NBK143284.pdf |
| Philadelphia Restaurant Program | 15 |
more |
more |
Philadelphia | See this research Healthy Infrastructure |
The above table shows that there are various ACH numbers provided from different sources suggesting that the classrooms are designed to those numbers. However, that is not the case. The actual design numbers maybe closer to 6 ACH. Empirical data from this research suggests that the classroom ACH can be as low as 0 with an average of 3 ACH. The CDC recommends 12 ACH and the WHO recommends 24 ACH for rooms with airborne contagion risks. The Philadelphia Health Department recommended 15 ACH for a restaurant program where 106 restaurants participated.
For airborne contagions the ventilation in terms of ACH or eACH and systems risk management are as follows:
Level |
State |
ACH |
Infection Risk |
Airborne Contagion Mitigation System Building Condition |
Likely Technologies |
6 |
Green |
120 |
30 sec |
Approaches outside ventilation conditions | Exhaust fans previously used to remove smoke filled public spaces |
5 |
Green |
50 |
1.2 min |
Similar to operating room without PPE conditions in all public affected spaces |
Large HVAC system + UV and or other |
4 |
Yellow |
24 |
2.5 min |
Similar to WHO patient room airborne precautions in all public affected spaces |
Small HVAC system + UV and or other |
3 |
Yellow |
10 |
6 min |
Similar to WHO patient room airborne precautions in most public spaces but not all |
Small HVAC system + UV and or other or Large HVAC system |
2 |
Orange |
4 |
15 min |
Marginal mitigation |
Medium HVAC system (usually heater + cooling) |
1 |
Red |
1 |
1 hr |
No mitigation, School data suggests infection happens [2] |
Small HVAC system (usually heater only) |
0 |
Red |
0 |
full time |
No ventilation | No windows, no mechanical, no UV, no other |
Architecture Advantages Disadvantages
The following shows various School Ventilation Architecture approaches and the advantages and disadvantages of each approach. The size of the classroom is 30 ft x 30 ft x 10 ft or 9,000 cubic feet.
Architecture Approach |
ACH | Advantages | Disadvantages | Comments |
| A. Building Duct Based Ventilation | see below |
see below | see below | see below |
| A1. Central Forced Air Heat System | 1 |
Exists is new schools | Based on providing heat not air conditioning, too small, not properly maintained, need additional augmentation to increase ACH, unable to modify ducts to increase ventilation because it is tightly coupled to building structure, not expandable | Unlikely solution because of massive duct upgrades |
| A2. Central HVAC System (cold climates) | 3 |
Exists is new schools | Too small, not properly maintained, need additional augmentation to increase ACH, unable to modify ducts to increase ventilation because it is tightly coupled to building structure, not expandable | Unlikely solution because of massive duct upgrades |
| A3. Central HVAC System (Hot climates) | 6 |
Exists in new schools, based on providing heat and air conditioning | Not properly maintained, need additional augmentation to increase ACH, unable to modify ducts to increase ventilation because it is tightly coupled to building structure, not expandable | Unlikely solution because of massive duct upgrades |
| A4. UV In Ducts | 1-6 |
This can be used on A1 to A3, helps HEPA filters, reduces mold and other contagions on duct surfaces | Does not clean room air, false sense of security | Of low benefit in mitigation and will not help unless ventilation is 12, 24 or more ACH |
B1. Classroom Unit Ventilators |
10 |
Proven technology, very effective, very scalable, very expandable, independent of building structure, when part of original building architecture its similar to massive window ventilation option with ACH 37+ | One unit may not be enough, complex installation, best as a replacement rather than a new system | Very workable solution but expensive |
| B2. Inverter 360 Cassette Unit Ventilators | 24+ |
Proven technology, very effective, very scalable, very expandable, independent of building structure, when part of original building architecture its similar to massive window ventilation option with ACH 37+ | One unit may not be enough, simple installation, excellent as a replacement or a new system | Very workable solution an moderate cost |
| C. External Ceiling Ducts | 24+ |
Can reach very high ACH levels beyond 24+ | Installation via windows, building external space needed, unattractive outside building, may be unattractive in building | Typically used in construction settings |
| . | ||||
D. Open Windows |
37 |
Very simple | Not possible in cold climates, may not be possible in new schools | Works in climates like Hawaii |
| E. Exhaust Fans | 24+ |
Can reach very high ACH levels beyond 24+ | Can be compromised by management where they select small residential fans rather than proper fans with carefully calculated CFM rates, room may not have external opening, room may not have ceiling opening where exhaust can be channeled | Think old house attic fans and bar and restaurant exhaust fans from the 1960s when people smoked |
| . | ||||
F. Ceiling Level UV-C |
24 |
Proven technology and effectiveness, 80+ years experience with research studies dating back to the 1940s, excellent augmentation to existing ventilation, independent of building structure, very low cost if only lights, transformers, and monitors are purchased and facilities staff build their own systems using wood or sheet metal, very scalable, very expandable | Massive disinformation current generation is not properly educated on these systems and confuse them with surface UV systems, may damage ceiling tiles unless treated | Need to overcome massive disinformnation and need to realize these systems can be built from very low cost piece parts |
G. Far UV |
3+ |
Augmentation to existing ventilation, independent of building structure, very scalable, very expandable, may be more effective UV approach in extremely high ceiling level spaces like airports, decontaminates surfaces | New technology, current generation is not properly educated on these systems, not easily sourced | Best for very high end facilities where technology can be properly managed and tracked until sizing is proven |
| . | ||||
H. Room Air Purifiers / Sanitizers |
2.7 |
Simple installation, excellent augmentation to existing ventilation, need multiple units in a 9,000 cubic foot classroom (ACH = 2.7), independent of building structure, very scalable, very expandable | Will not add much to the total ACH in a 9,000 cubic foot classroom, need multiple units in a room, eventually with more units noise will become an issue | This is better than nothing, effectiveness increases for small offices (10 x 10 x 9 = 900 cu-ft translates to ACH = 24+) |
I. PCO / Ionizers |
Unknown |
Simple installation, independent of building structure, , decontaminates surfaces, only 3.4 units per 9,000 cubic foot classroom may be needed based on Space Shuttle experience, very scalable, very expandable | Unproven technology, will not add much to the total ACH, need multiple units in a room, eventually with more units noise will become an issue, based on 1995 Space Shuttle (2,625 cubic feet) experience and assuming same performance level 3.4 units per 9,000 cubic foot classroom may be needed, people in the room will attract ions ions reducing effectiveness, may need mixing fans if no ventilation, existing ventilation will remove ions, open door and classroom changes will remove ions | This is better than nothing, effectiveness increases for small offices (10 x 10 x 9 = 900 cu-ft) |
Descriptions and Advantages Disadvantages Findings
The following are descriptions of the architectures being considered. Each architecture is also being defended with the best arguments to make the case for the architecture. In some cases that may mean that further study is needed but the expectation is that the studies will show the architecture benefits. In other cases well known architectures stand on their own merits and there is little need to make the case for the architecture approach.
Architectures A1 to A4 Building Duct Based Ventilation
These architectures are basically the same where they use a collection of internal building ducts connected to one or more heating or heating and cooling units to provide ventilation. They only differ in terms of system ventilation sizing. Architecture A1: Central Forced Air Heat System is found in schools in cool climates where air conditioning is not needed. Architecture A2: Central HVAC System (cold climates) includes air conditioning but the climate is relatively cool and a massive air conditioning subsystem is not needed. Architecture A3: Central HVAC System (Hot climates) is found in hot climates and the air conditioning subsystem is very large, however the ACH is based on comfort levels not mitigating airborne contagion levels.
On the surface it would seem that a simple solution would be to just upgrade the system fans to increase the ACH, however the size of the ducts may prohibit the flow of the air. It is unlikely that adding bigger fans and or more fans will provide the needed ACH levels. The ducts will need to be augmented or replaced but that may be impossible because of physical limitations. The only alternative in these cases is to use another architecture to augment this architecture - Building Duct Based Ventilation [5]. The augmentation architecture choices are B to I.
Architecture A4: UV In Ducts is used in Building Duct Based Ventilation systems. The UV lights installed in the ducts help to keep the ducts clean and help the HEPA filters to remove some more contagions from the environment but they do not add the needed ACH levels to reduce the risk of exposure in the room air. The room air is moving at the rate of the ventilation system and if that is below 12 ACH it is not meeting the minimum requirements of the system. If the ventilation rate is at 12, 24, or more ACH then the added value of the UV in the ducts is not to the people in the room but to the actual ducts in the system. They are kept clean of mold and other contagions that may grow on the duct surfaces. This is more of an HVAC system maintenance mechanism. If the ducts are properly maintained this is not needed. It will reduce duct maintenance costs.
Architecture B1. Classroom Unit Ventilators
These systems are found in schools built in the 1960's. They are also found in hotel rooms from the same era. These systems still exist and are part of vendor standard products today. The advantage of these systems is they are large so they can move large amounts of air and they are designed to minimize the noise level so that people can sleep in a hotel room and children are not distracted with noise in the classroom. They take up little space and can complement Building Duct Based Ventilation if used in Fan mode rather than heating and cooling mode. Given the gravity of the COVID-19 disaster these products can be easily modified to just provide the Fan and HEPA filter components.
For more information including vendors and products see section Classroom Unit Ventilators.
Architecture B2. Inverter 360 Cassette Unit Ventilators
These systems are found in new commercial construction and in buildings that have been retrofitted with new ventilation systems. The advantage of these systems is they can move very large amounts of air equally across a space and they have very low noise levels so that people can sleep in a hotel room and children are not distracted with noise in the classroom. They take up little space and do not need a Building Duct Based Ventilation. This is a game changer in terms of mechanical ventilation.
For more information including vendors and products see section Classroom Unit Ventilators.
Architecture C. External Ceiling Ducts
These systems are typically temporary solutions found at construction sites where some form of building maintenance is being performed. The advantage of this system is the massive ACH level that can be provided and the mechanical noise level is kept outside the building. The disadvantage is the network of ducts that would need to be installed in a school and the eyesore setting outside the school building. There also may be room access limitations for some percentage of the rooms. If the COVID-19 disaster should subside this system can be removed, however the advantage of providing a healthier indoor environment will be lost.
Installation of a ventilation intervention in a classroom
A: Air sock for air supply, B: tailor made window pane, C: non-flexible duct for air exhaustion, D: ventilator |
For more information including vendors and products see section HEPA Air Purifiers And Sanitizers.
Architecture D. Open Windows
This architecture is possible only in schools that were built without air conditioning. These school buildings are based on natural ventilation architecture concepts. All the rooms have large windows. Schools that were built with air conditioning systems sacrificed windows in many rooms to allow for a smaller foot print of the school building. They have interior rooms. Long open air court yards and large perimeter spaces with windows are unlikely. For the schools that have natural ventilation they should augment the windows with exhaust fans to move air on days when there is no outside air movement.
For more information see analysis performed in 2020 World Health Organization Natural Ventilation [4].
Architecture E. Exhaust Fans
This is a very simple solution, however extreme caution must be exercised to ensure that management does not compromise the solution by directing staff to buy consumer window fans. This is an engineering effort and a proper engineering firm must be hired to determine the size, number, and placement of the fans. The fans will be commercial grade found in restaurant and industrial settings. The Philadelphia School District followed this path but it is clear that management got involved and the wrong fans were purchased. Parents saw what happened and the management being political caved to the parents. Both stakeholders did not engage the professionals to find the correct solution. This is the sad story of the COVID-19 disaster. COVID-19 is not a cause it is a symptom of the massive dysfunction that has taken root in the society. Getting back to fans, they can provide ACH levels beyond 24 and are very low cost when properly designed using engineers.
For more information including vendors and products see analysis performed in 2020 HVAC and Open Ventilation Design Solutions . Direct Drive Wall Fan 48 inches. Vendor[4]
Architecture F. Ceiling Level UV-C
These systems work by creating an irradiation zone in the upper region of a room. Convection or mechanical air currents lift airborne contagions into the upper air (above 7-8 feet), they are exposed to the UV-C where they are inactivated. These systems are not to be confused with UV surface decontamination systems which can only operate when people are not in the room. Ceiling Level UV-C can operate when people are present because the UV-C is concentrated at the ceiling level and the power levels are lower.
If maintenance staff become exposed to UV-C power levels found at the ceiling level because they do not turn off the system during maintenance, depending on the exposure time, they may experience skin and eye irritation. This should never be confused with what happens to people in the room or used as an excuse to make false claims about these systems. For example, if not used properly, an electrical appliance, kitchen stove, automobile, or even home cleaning agents are more dangerous and can cause much more harm than these systems.
Schools have purchased surface level UV systems, not airborne decontamination Ceiling Level UV-C, making the purchases useless. They did not address their problem, which is the airborne contagion. Early in the COVID-19 disaster (President Trump Administration 2020), when the US Government engaged in disinformation and told everyone this was a surface contamination problem, that was a reasonable response. My mid summer of 2020 it was known that the US Government misled the people and that the contagion was airborne. This is mentioned because disinformation continues across the spectrum in the society. In the discussions of UV, the surface level UV and Ceiling Level UV-C systems are being confused and the Ceiling Level UV-C systems are being placed in the same category as the surface UV systems. Why there is massive disinformation on these systems and why some school districts lack the basic ability to make informed purchases is unclear, but it has had a serious negative impact on stopping the spread of COVID-19.
This technology is not complicated, its a light fixture. An explanation for the current (2021) confusion about Ceiling Level UV-C systems is that school districts are just following the best deals offered by sales people at a particular moment. They are treating it like a consumer impulse purchase rather than a rational industrial purchase with reasonable investigation and tradeoff considerations.
This technology is proven over 80+ years of operation. There are many studies dating back to the 1940s that show performance numbers and system sizing. We know the power levels needed for a certain kill rate for various contagions. We also know how to translate this into an eAUC performance number. We know that these systems can achieve an eACH of 24. In terms of costs, the operating power is less than mechanical ventilation to achieve the same ACH (mechanical) or eACH (UV-C) levels. The UV-C lights need to be replaced periodically (e.g. 10,000 hours). These systems can be automated with sensors to continuously monitor and report their status.
These systems are found in hospitals, commercial, and industrial settings. They can be built by facilities staff using piece parts rather than using fully integrated products and this will significantly reduce the costs if sourced from the actual manufactures. There are maintenance issues to ensure that the UV-C lights remain effective and the enclosures are not tampered where the UV-C is stopped. Monitors should be permanently installed to measure the UV-C level at the ceiling level and at the living space level to detect any tampering with the enclosures. There are many school districts, hospitals, and commercial public settings that have selected this architecture approach to deal with the COVID-19 disaster.
If the virus continues to mutate and cause serious harm the reality is that society will shift to this architecture over time because it is so effective. This is what happened in the previous century and these systems were found everywhere by the 1960's at the consumer level. As the people beat back the contagions from their time and they became very healthy, these systems outlived their usefulness and general pubic knowledge associated with these systems was lost.
For more information including vendors and products see analysis performed in 2020 Ultraviolet Germicidal Irradiation (UVGI) - Open Air [4].
Architecture G. Far UV
This is new technology and as such is somewhat unproven. However, it is being installed around the world. Its strength is its ability to clean the air and surfaces. The issue is the level of effectiveness. The numbers are still new and empirical data in the next few years similar to what happened to the Ceiling Level UV-C systems will probably validate this architecture approach. It is being used in high end facilities where there are other architectures being used to mitigate the virus such as high mechanical ventilation ACH levels and or very large spaces that dilute the virus load.
For more information including vendors and products see analysis performed in 2020 Ultraviolet Germicidal Irradiation (UVGI) - Open Air [4].
Architecture H. Room Air Purifiers / Sanitizers
These system are sized for relatively small rooms. There are commercial grade systems but they tend to be loud and large, not appropriate for a classroom setting. The issue is that they do not move a large amount of air. They may be appropriate for a small office but for a large classroom multiple units are needed. The problem is management will only approve one unit for a classroom and then offer the political answer that the problem has been addressed. The proper answer is based on engineering and the performance numbers that they use to make their decisions and those performance numbers suggest multiple units per classroom.
For more information including vendors and products see section HEPA Air Purifiers And Sanitizers.
Architecture I. PCO / Ionizers
This technology dates back to 1995 where it was used on the Space Shuttle. The issue is that scaling this technology from a small cabin in the Space Shuttle to a classroom has not been disclosed. Massive assumptions are needed from an engineering perspective to determine the number of units needed in a classroom and the reality of a different operational setting. The classroom operational setting has many children that will attract ions, reducing the ion count that inactivates the virus. There is an existing ventilation system that may remove the ions. There are classroom changes that happen every hour where once again the ions may be removed. The ideal situation would be for the industry and a school district to develop an effective test an evaluation effort to validate the application of this technology in a classroom. Stating that it works in the Space Shuttle is a management talking point and not appropriate.
For more information including vendors and products see section PCO and Ionizers.
In systems engineering analysis we use the Technology Readiness Levels (TRL) process, embraced by NASA and other government organizations (DOD, FAA, North Atlantic Treaty Organization - NATO, European Space Agency - ESA), to determine the TRL of a technology and what happens to the TRL when it moves from a proven operational setting to an unproven operational setting. When a system is moved to a new operational setting, the TRL rating is automatically dropped. A project or program is established to move the system from its low TRL in the new operational setting, to the highest TRL where it is proven in that operational setting. It can not go operational until it reaches the appropriate TRL rating. Different organizations define the TRL gates differently but they follow the same general rules for the level. They also may have more or less levels than other organizations. The following is an example of Technology Readiness Levels - TRLs [3]:
Basic Principles Observed / Reported
Technology Concept and / or Application Formulated
Analytical / Experimental Critical Function or Characteristic Proof-of-Concept
Component or Integrated Components Tested in a Laboratory Environment
Components / Subsystems Verified in a Relevant Environment
System Demonstrated / Validated in a Relevant Environment
When we move from a proven operational environment where the TRL is 6 to a new operational environment, the TRL may drop to 4, until a test and an evaluation program is established and the system is validated in the new operational setting. The fact that it is installed and there is anecdotal evidence of performance is insufficient for system validation.
Recommended School Ventilation Architectures
The recommended school ventilation architectures are based on multiple systems engineering formal decision support practices. These practices are (1) Advantages Disadvantages Analysis, (2) Architecture Ranking Analysis, and (3) MOE Based Tradeoff Analysis using Measure of Effectiveness (MOE). The Advantages Disadvantages Analysis is raw information that is used to feed the Architecture Ranking Analysis and the MOE Tradeoff Analysis. The MOE tradeoff analysis uses criteria derived from the Advantages Disadvantages Analysis. [3]
Ranking Based Tradeoff Analysis
It is assumed that each school has some form of Architecture A and that it must be augmented with the other School Ventilation Architectures. The Architecture A alternatives are as follows:
These are the other recommended School Ventilation Architectures in order of preference that must be added to Architecture A, if it cannot be upgraded to a minimum performance level of 12 ACH where 24+ ACH (or the highest performance level) is the goal:
The architectures are ordered in sequence from most preferable to least preferable. The Architecture I: PCO / Ionizers comes before Architecture G: Far UV. Both are considered unproven in the classroom setting but Architecture I: PCO / Ionizers is more accessible and it is better than doing nothing. The tradeoff also suggests that mechanical ventilation and natural ventilation is preferred over Architecture F: Ceiling Level UV-C. This is because of the massive disinformation on the Ceiling Level UV-C and the simple fact that the current generation is not properly educated on these systems. That education will take significant time to overcome the massive disinformation. This suggests that schools rather than upgrading their mechanical systems will jump directly to either Architecture H: Room Air Purifiers / Sanitizers or Architecture I: PCO / Ionizers. Empirical data suggests that is what is happening. As time moves on, if the virus does not subside, then Architecture F: Ceiling Level UV-C will be revisited and there will be a shift to these systems.
If systems engineering drives the architecture selection, Architecture F: Ceiling Level UV-C probably would be the first augmentation architecture approach. The list would be reordered as follows:
The reason Ceiling Level UV-C would take the first place spot is because the mechanical ventilation is a given. It exists, it just needs to be maintained. Few will replace their current mechanical ventilation systems and bring them to a level where they provide massive 24+ ACH levels to mitigate airborne contagions across an entire school for each room in the school. All disinformation would be stopped and performance numbers with traditional architecture tradeoff criteria would be used to understand the architectures in ubiquitous public dialog. This would show for this generation why the previous generation used Ceiling Level UV-C systems.
The begs the question, why is Architecture I: PCO / Ionizers not as good or better than Architecture F: Ceiling Level UV-C. The answer is simple. There is no data that shows performance levels in a real world operational setting like a classroom and existing performance data is not reduced to an eAUC performance number.
Many have suggested a compromise approach where Architecture H: Room Air Purifiers / Sanitizers take first place. The list would be reordered as follows:
However, we know that unless multiple units are used they are unable to provide the additional ACH needed to reach 12 ACH and they cannot reasonably reach 24+ ACH in a classroom of 9,000 cu-ft. This approach is based on the concept of this is better than nothing. It is minimalistic based on a society that lacks resources and or the social will to do what is required based on the science and engineering to fully solve the problem. This analyst suggests that this approach is caving to the whims of management and their talking points.
This begs the question, why is Architecture I: PCO / Ionizers not as good or better than Architecture H: Room Air Purifiers / Sanitizers. The answer is simple. They do not move as much air as Architecture H: Room Air Purifiers / Sanitizers. They rely on ions as the primary mode of ventilation (cleaning of the air). There is no data that shows performance levels in a real world operational setting like a classroom and existing performance data is not reduced to an eAUC performance number.
The above preference orders are based on the Tradeoff Ranking of each architecture approach suggested by the advantages and disadvantages in the following table.
Architecture Approach |
ACH |
Tradeoff Ranking |
Advantages | Disadvantages |
| A. Building Duct Based Ventilation | see below |
see below |
see below | see below |
| A1. Central Forced Air Heat System | 1 |
0 |
Exists is new schools | Based on providing heat not air conditioning, too small, not properly maintained, need additional augmentation to increase ACH, unable to modify ducts to increase ventilation because it is tightly coupled to building structure, not expandable |
| A2. Central HVAC System (cold climates) | 3 |
0 |
Exists is new schools | Too small, not properly maintained, need additional augmentation to increase ACH, unable to modify ducts to increase ventilation because it is tightly coupled to building structure, not expandable |
| A3. Central HVAC System (Hot climates) | 6 |
0 |
Exists in new schools, based on providing heat and air conditioning | Not properly maintained, need additional augmentation to increase ACH, unable to modify ducts to increase ventilation because it is tightly coupled to building structure, not expandable |
| A4. UV In Ducts | 1-6 |
0 |
This can be used on A1 to A3, helps HEPA filters, reduces mold and other contagions on duct surfaces | Does not clean room air, false sense of security Of low benefit in mitigation and will not help unless ventilation is 12, 24 or more ACH |
B1. Classroom Unit Ventilators |
10 |
2 |
Proven technology, very effective, very scalable, very expandable, independent of building structure, when part of original building architecture its similar to massive window ventilation option with ACH 37+ | One unit may not be enough, complex installation, best as a replacement rather than a new system |
| B2. Inverter 360 Cassette Unit Ventilators | 24+ |
1 |
Proven technology, very effective, very scalable, very expandable, independent of building structure, when part of original building architecture its similar to massive window ventilation option with ACH 37+ | One unit may not be enough, simple installation, excellent as a replacement or a new system |
| C. External Ceiling Ducts | 24+ |
5 |
Can reach very high ACH levels beyond 24+ | Installation via windows, building external space needed, unattractive outside building, may be unattractive in building |
| . | ||||
D. Open Windows |
37 |
3 |
Very simple | Not possible in cold climates, may not be possible in new schools |
| E. Exhaust Fans | 24+ |
4 |
Can reach very high ACH levels beyond 24+ | Can be compromised by management where they select small residential fans rather than proper fans with carefully calculated CFM rates, room may not have external opening, room may not have ceiling opening where exhaust can be channeled |
| . | ||||
F. Ceiling Level UV-C |
24 |
6 |
Proven technology and effectiveness, 80+ years experience, excellent augmentation to existing ventilation, independent of building structure, very low cost if only lights, transformers, and monitors are purchased and facilities staff build their own systems using wood or sheet metal, very scalable, very expandable | Massive disinformation, current generation is not properly educated on these systems, may damage ceiling tiles unless treated |
G. Far UV |
3+ |
9 |
Augmentation to existing ventilation, independent of building structure, very scalable, very expandable, may be more effective UV approach in extremely high ceiling level spaces like airports, decontaminates surfaces | New technology, current generation is not properly educated on these systems, not easily sourced |
| . | ||||
H. Room Air Purifiers / Sanitizers |
2.7 |
7 |
Simple installation, excellent augmentation to existing ventilation, need multiple units in a 9,000 cubic foot classroom (ACH = 2.7), independent of building structure, very scalable, very expandable | Will not add much to the total ACH in a 9,000 cubic foot classroom, need multiple units in a room, eventually with more units noise will become an issue, this is better than nothing, effectiveness increases for small offices (10 x 10 x 9 = 900 cu-ft translates to ACH = 24+) |
I. PCO / Ionizers |
Unknown |
8 |
Simple installation, independent of building structure, , decontaminates surfaces, only 3.4 units per 9,000 cubic foot classroom may be needed based on Space Shuttle experience, very scalable, very expandable | Unproven technology, will not add much to the total ACH, need multiple units in a room, eventually with more units noise will become an issue, based on 1995 Space Shuttle (2,625 cubic feet) experience and assuming same performance level 3.4 units per 9,000 cubic foot classroom may be needed, people in the room will attract ions ions reducing effectiveness, may need mixing fans if no ventilation, existing ventilation will remove ions, open door and classroom changes will remove ions, this is better than nothing, effectiveness increases for small offices (10 x 10 x 9 = 900 cu-ft translates to ACH = 24+) |
MOE Based Tradeoff Analysis
The following table is a tradeoff based on criteria and Measure of Effectiveness (MOE). The rating scale is 0-3 where 3 is best, 1 is worst, and 0 is inability to meet the basic elements of the criteria. For this tradeoff a new architecture approach is introduced, Architecture A5: Central HVAC System (Hospital / Military Grade). These systems are not found in schools but they should be added to the tradeoff to ensure that the typical in school systems are not given higher ratings based on what exists in other settings. The architecture approaches are:
| A. Building Duct Based Ventilation A1. Central Forced Air Heat System A2. Central HVAC System (cold climates) A3. Central HVAC System (Hot climates) A4. UV In Ducts A5. Central HVAC System (Hospital / Military Grade) |
B1. Classroom Unit Ventilators B2. Inverter 360 Cassette C. External Ceiling Ducts D. Open Windows E. Exhaust Fans F. Ceiling Level UV-C G. Far UV H. Room Air Purifiers / Sanitizers I. PCO / Ionizers |
Criteria |
A1 |
A2 |
A3 |
A4 |
A5 |
--- | B2 | B1 |
C |
D |
E |
F |
G |
H |
I |
Ability to reach 12 ACH |
0 |
0 |
3 |
0 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
1 |
2 |
1 |
|
Ability to go beyond 12 ACH |
0 |
0 |
2 |
0 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
1 |
1 |
1 |
|
Ability to go beyond 30 ACH |
0 |
0 |
0 |
0 |
3 |
3 |
3 |
3 |
3 |
3 |
1 |
0 |
0 |
0 |
|
Able to mitigate airborne contagion via ACH test data |
0 |
0 |
0 |
0 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
1 |
2 |
1 |
|
Decades of public room airborne contagion operation |
0 |
0 |
0 |
0 |
3 |
2 |
3 |
3 |
3 |
3 |
3 |
0 |
2 |
0 |
|
Designed to address room airborne contagions |
0 |
0 |
3 |
0 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
|
| Performance Consistency (0 = reject) | 3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
0 |
3 |
3 |
3 |
2 |
2 |
|
Total Rating |
3 |
3 |
11 |
3 |
21 |
20 | 21 |
21 |
18 |
21 |
19 |
9 |
12 |
8 |
|
| Life Cycle + Indirect Costs + Loss of Life = wash | 3 |
3 |
3 |
3 |
3 |
|
1 |
3 |
3 |
0 |
2 |
1 |
1 |
2 |
2 |
| MOE | 1 |
1 |
4 |
1 |
7 |
20 |
7 |
7 |
reject |
10 |
19 |
9 |
6 |
4 |
The cost of the various architecture approaches is driven by the operational costs associated with the power requirements for each approach. Mechanical ventilation uses the most power. The Measure of Effectiveness (MOE) or MOE = sum of tradeoff criteria / total costs [3]. MOE is a measure of goodness for each dollar spent. We see that Architecture F is 3 times better than Architecture H for each dollar spent. The interesting comparison is Architecture A3, which is the best case school setting today, is 2 to 5 times worse than Architectures B-H.
These are all existing systems and products well established in the infrastructure. Once all the external costs of establishing and maintaining the systems along with the lives saved are considered the costs become a wash. The choice is to pick the highest performance system possible. For example, some classrooms only may be mitigated with room sanitizers or PCO / ionizers because of low ceilings and insufficient space to add a classroom ventilator.
It should be noted that all the costs are being born by future generations via the Federal Government. The loss of even a single life cost is massive and basically makes the system upgrade cost differences irrelevant. The proper system approach in the wake of the COVID-19 disaster is to pick the highest performance system possible in the physical space and ignore the costs.
The system must work with the highest performance levels possible, period.
As always the details matter and it is possible that schools may be able to reach 12 ACH in all their classrooms with their existing HVAC systems. Each school must be examined and products added based on the unique situation of each room in every school. This is called systems integration and the systems integration is the biggest challenge. Systems integration is always performed using specifications that clearly state performance numbers that apply to the system challenge and that performance number is ACH.
Final Recommendations
Before any school makes a commitment to any Ventilation Architecture approach they should establish their own test and evaluation program. For example, the Philadelphia School District is a massive school district and they should bring all these architectures into a test and evaluation program to validate the architecture alternatives. Philadelphia is a massive BioTech area with access to talent, major universities, renowned healthcare institutions and laboratory space. These resources could be easily accessed and coordinated with the Philadelphia School District as the major operational real world setting to understand what must be done in schools of all types everywhere. In the absence of these recommendations and actions this systems analysis was offered. This analysis is critical because:
These simple but grave system observations are why schools must do something to significantly increase their ventilation rates. The COVID-19 disaster will take years if not decades to subside. Next year we will see the same scenarios of infections, loss of health, and death unless the school ventilation problem is properly solved.
The COVID-19 Disaster is made much worse by:
This is a massive engineering challenge and the reality is the Federal Government must get involved with performing test and evaluation of products and systems and they must develop and enforce regulations. The first regulation that must be established and enforced is the required Air Changes Per Hour (ACH) in a classroom. The CDC number is 12 ACH, the Philadelphia Health Department as part of a short restaurant program is 15 ACH, the WHO number is 24 ACH. It is obvious the government regulation should state a minimum of 12 ACH per classroom in use before a certificate of occupancy can be issued for any school. It does not matter if people can get the virus elsewhere, what matters is that they do not catch the virus in the schools. The idea that our society is allowing unsafe schools 2 years into the COVID-19 Disaster is reprehensible.
Author Comment: I really did not want to produce this systems analysis. I kept waiting for a company, government organization, or school district to perform this analysis and make it public to help others determine what they might do for their schools. Unfortunately no one has provided this analysis, so once again I have ventured down a path that would have been obvious in the past and performed by great companies, journalists, and the Federal Government before it was privatized and deregulated. Oh well. This a systems analysis. It is a starting point for those that are lost and really want to try and engage in problem solving rather than political foot work and useless management talking points.
Draft Parent Letter To Their School
After reading all this research parents are probably wondering what they can do. A suggestion is that they write a letter to their school district asking that they respond to key questions. The questions are structured such that the response cannot be compromised with damage control talking points. The questions are very specific and direct.
Dear Principal [first name],
My name is [your name] and I have a child that is attending your school. As you know COVID-19 requires ventilation to reduce the risk of infection in small indoor spaces like a classroom. I am requesting that you respond to each of the following questions so that I can assess if my child should continue to attend your school. Please answer the questions so that there is no confusion about your response.
Has the school been subjected to a site survey where every room was reviewed for ventilation and the size of the room in cubic feet and air changes per hour (ACH) was determined and clearly documented?
If the school was subjected to a site survey who performed the survey? If it was a company, please provide the company name and point of contact information. If it was district staff please provide point of contact information.
If a site survey was performed I would like a copy of the full site survey in the next 3 days. Is that a problem, if so why and what can I do to help release the information?
What is the ACH level of each room in the school? Providing the site survey report with this information clearly shown is fine.
If the ACH levels were determined to be too low, what was done to increase the ACH levels? Provide the product names. model numbers, and point of contact information. Also identify the classrooms that will receive these products. Providing the site survey report with this information clearly shown is fine.
If the ACH level for each room is less than 12 ACH per CDC guidelines for airborne contagions, what source did the district use to decide to use the lower ACH performance level?
If the above information is not posted on the district website, why is it not being disclosed?
Thank You
[your name]
The reality is that parent action is the only tool left to get the schools to properly address the COVID-19 disaster. School districts have shown that they do not want to disclose information. The Federal Government is hands off. The industrial base is only interested in selling their products even if they are sub optimal in various settings. The concept of self certification of buildings has been met with rejection. So the only alternative is for parents to become very educated on this subject by becoming experts and then holding the school district management accountable.
References:
[1] School Ventilation: A Vital Tool to Reduce COVID-19 Spread, Johns Hopkins University, Johns Hopkins Center for Health Security, May 2021. webpage https://www.centerforhealthsecurity.org/our-work/pubs_archive/pubs-pdfs/2021/20210526-school-ventilation.pdf, August 2021. School Ventilation: A Vital Tool to Reduce COVID-19 Spread.
[2] See section School Case History.
[3] Systems Practices As Common Sense, Walter Sobkiw, ISBN: 978-0983253082, first edition 2011, ISBN: 978-0983253051, second edition 2020. REF 1
[4] COVID-19 A Systems Perspective, Walter Sobkiw, 2021, ISBN 9780983253044, hardback.
[5] See section Technologies to Boost Certification Levels.
[6] Ventilation and Air Balance Reports, City of Philadelphia, March 22, 2021. webpage https://www.philasd.org/coronavirus/schoolstart2020/#ventilation, https://drive.google.com/drive/folders/1XULamBiR3v1sB_u15rcyXOxQlq1ygsGT, https://docs.google.com/spreadsheets/d/18Kn2h5zS6ivX27-msM2Pdy10HUUWaUAomAaXJJ2FK7w/edit?usp=sharing (spreadsheet) May 2021. Ventilation . Spreadsheet . local spread
School Ventilation Disaster
In one report from September 05, 2021, at least 1,000 US schools have closed in 31 states due to COVID-19 since late July 2021. Schools are struggling to find enough staff members and students are missing class due to infection or exposure. Fully vaccinated teachers against COVID-19 are testing positive for the virus after a week of in person teaching. A Texas school district temporarily closed down all of its campuses after two teachers died in the same week from COVID-19. [1]
By September 07, 2021 more than 1,400 schools across 278 districts in 35 states that began the academic year with in person sessions have closed. More than 51,000 students in Texas and 20,000 students in Mississippi tested positive for COVID-19 since the first week of school in August 2021. In Florida, more than 26,000 children tested positive the previous week and children under the age of 12 became the age group with the highest new COVID-19 case count. In Georgia, cases in children 11 to 17 years quadrupled over the previous month since schools reopened. According to the state's public health officials, Georgia is experiencing the highest number of COVID-19 outbreaks since the pandemic began and more than half are K-12 schools. [3]
There were 1,000 students, staff quarantined in Montgomery County Schools (Maryland USA) after first week back in school [2].
The Montgomery County policies currently in place are as follows [2]:
As a result of this guidance from Montgomery County county, they will quarantine [2]:
From Montgomery County, close contact is [2]:
From Montgomery County, COVID-19 symptoms include [2]:
There are no statements from the school districts identifying what ventilation exists and what has been done to upgrade inadequate ventilation in the schools. There are also no statements identifying the classrooms thought to have been the sources of the infections. It is clear that the approach is to provide minimal information.
From a systems perspective, the US school system is in catastrophic failure mode. Even though the science and engineering exists to make schools safe from the spread of COVID-19, there has been little or no action and there have been poor choices in the selection of ventilation upgrades. The blame falls on school administrators, parents, local governments and the federal government. It is more than one year since the COVID-19 shutdown. There was more than sufficient time to make the needed ventilation changes and provide the transparency that would allow for easy access of ventilation information and actions taken that could be understood by even the children attending the schools. This has not happened. There is a complete lack of information in the public mass mind on the topic of ventilation in schools and what must be done.
The media has failed to perform effective journalistic investigations and to report the facts associated with ventilation. This includes educating the public on the topic of Air Changes Per Hour (ACH), what the ACH must be to meet CDC and WHO guidelines for airborne contagions (12 ACH from CDC and 24 ACH from WHO), and what technologies are available to achieve the needed ACH rates. The media has also failed to educate the public on what the specific ventilation rates are for each classroom in each school, what the school districts have done to increase the ventilation rates, why they selected the approaches that they selected, the expected performance of these systems in terms of ACH, if these are temporary fixes or permanent upgrades, the costs, and the source of funds. There are only radom inconsistent stories that fall into the category of management talking points associated with damage control to placate the parents in some school districts. There is no evidence of a national level effort to get to the bottom of this issue and report the facts that matter to fix the failed system.
There is the possibility of emergency vaccine approval for children in October 2021, but given the poor performance of the COVID-19 vaccine distribution and acceptance, a vaccine to fix the failing system will be too little and too late for the school sessions starting in Fall 2021 and ending in Summer 2022. For those that have waited for the vaccine to solve the problem of school COVID-19 spread, they made a terrible choice and did not view the problem from a systems perspective.
References:
[1] At least 1,000 US schools have closed due to Covid since late July: report, The Hill, September 05, 2021. webpage https://thehill.com/policy/healthcare/public-global-health/570946-at-least-1000-us-schools-have-closed-due-to-covid, September 2021. At least 1,000 US schools have closed due to Covid since late July: report
[2] 1,000 students, staff quarantined in Montgomery County Schools after first week back, WUSA9 - local TV station, September 4, 2021. 1,000 students, staff quarantined in Montgomery County Schools after first week back
[3] The Looming Crisis of Kids and COVID, USA Today, September 07, 2021. webpage https://www.usnews.com/news/education-news/articles/2021-09-07/schools-approach-critical-juncture-with-kids-and-coronavirus, September 2021. The Looming Crisis of Kids and COVID
Building Contagion Mitigation Certification (BCMC) Tool
The city of Philadelphia introduced the Enhanced Ventilation Standards for Indoor Dining and Application Form for Increased Dining Capacity in February 2021. The Enhanced Ventilation Standard calls for 15 air changes per hour (ACH) for establishments wanting to increase their seating capacity from 25% to 50% [1]. The approach is brilliant and uses the incentive to increase income to offset any possible costs that may be needed to increase ventilation. The ventilation level increase will significantly mitigate contagion levels in a restaurant. The program ended in May 2021 and all other infrastructure needs elsewhere are being ignored.
The BCMC Tool is a dashboard allows building owner operators to assess Virus Mitigation Levels in their buildings and provides information to increase the Virus Mitigation Levels, if needed. The BCMC performs before and after analysis when upgrades are being considered so that choices can be made based on data. It is for organizations with limited budgets and resources like schools, restaurants, bars, community clubhouses. The tool can be used on tiny projects like a small restaurant and scales up to massive projects involving hundreds of buildings and thousands of rooms like an entire school district or real estate portfolio.
This is an engineering tool based on science and systems engineering principles but it can be used by anyone. It falls into the category of systems engineering decision support tools and uses techniques that are used on mission critical systems. Mission critical systems are systems where there is the possibility of loss of life. These systems rely on analysis where quantitative data is reduced to a level where informed systems engineering tradeoffs and risk management are performed.
The BCMC Tool was initially developed to fill the current void where the government is not identifying and enforcing new ventilation standards in the wake of the COVID-19 disaster [3] [4] [5]. It was also recognized that some organizations have large numbers of buildings to manage, like school districts, and an effective dashboard is needed to understand the ventilation in each building and the individual rooms. The tool is based on the systems analysis described in Contagion Mitigation System Certification of Buildings.
The tool comes with demo keys and is available via download or an online account. More information and the tool is available at: BCMC.
References:
[1] Enhanced Ventilation Standards for Indoor Dining and Application Form for Increased Dining Capacity, City of Philadelphia, February 14, 2021. webpage https://www.phila.gov/media/20210216105327/Enhanced-Ventilation-Standards-for-Indoor-Dining_2_16_21.pdf. PDF . local
[2] Food Establishments That Have Met Enhanced Ventilation Standards to Allow for Increased Indoor Dining Capacity, City of Philadelphia, March 09, 2021. webpage https://www.phila.gov/media/20210311122403/50CapacityRestaurants_030921.pdf. PDF . local
[3] Privatization A Systems Perspective, Walter Sobkiw, 2019, ISBN 9780983253068, hardback.
[4] COVID-19 A Systems Perspective, Walter Sobkiw, 2021, ISBN 9780983253044, hardback.
[5] See section Infrastructure Bifurcation.
CDC ACH Recommendations
Vaccine and Vaccinations
Vaccinations Impact
This systems analysis will present various data and modeling results along with system observations that transcend the data and enter into the social elements of the system. It is difficult to not offer the social system elements because the data and analysis results are so direct and sad. This analysis shows why President Biden took action on September 09, 2021.
The vaccine is enormously effective. The analysis shows that the vaccine has saved millions of lives and prevented chronic health conditions from developing in tens of millions of people. [spreadsheet]
Those who have access to the vaccine and took the vaccine are protected for now and are hoping that a new deadly variant does not surface that bypasses the current vaccination. Those in the healthcare professions who are dealing with the toxic elements of the population that refuse to be vaccinated are angry as they should be in a this horrible scenario. The rest of the world that does not have access to the vaccine but clearly wants to be vaccinated is being artificially denied access by those in power as suggested by the discussion in section: Vaccination Lotteries and Toxic People.
The following analysis shows the system vaccination performance numbers.
Date |
Total Cases |
Daily Cases |
Total Deaths |
Total Deaths |
Case fatality rates (%) |
Daily Deaths |
Vaccinated |
Lives Saved Because of Vaccine |
Chronic Health Issues % |
Chronic Health Issues Prevented Because of Vaccine |
Remaining Possible Deaths if Herd Immunity is |
% into pandemic |
Comments |
||
- |
[1] |
- |
[2] |
|
- |
- |
[3] |
- |
[4] |
- |
50% |
75% |
95% |
Cases + Vaccinated |
Dec 11, 2020 EUA Vaccine 16+ |
Feb 01, 2021 |
25,921,703 |
201,862 |
438,035 |
|
3.3 |
3124 |
5,930,000 |
193,160 |
10% |
593,000 |
4,304,520 |
5,372,928 |
9,112,355 |
9.71% |
- |
Mar 01, 2021 |
28,405,925 |
88,722 |
511,839 |
|
2.6 |
2636 |
25,470,000 |
701,772 |
10% |
2,547,000 |
2,866,450 |
3,720,210 |
6,708,370 |
16.43% |
- |
Apr 01, 2021 |
30,213,759 |
58,317 |
548,162 |
|
2.1 |
1172 |
54,610,000 |
1,317,991 |
10% |
5,461,000 |
1,674,327 |
2,367,943 |
4,795,600 |
25.86% |
- |
May 01, 2021 |
32,145,557 |
64,393 |
573,012 |
|
2.0 |
828 |
103,420,000 |
2,302,600 |
10% |
10,342,000 |
573,587 |
1,235,238 |
3,551,014 |
41.33% |
May 10, 2021 EUA Vaccine 12-15 |
Jun 01, 2021 |
33,093,238 |
30,570 |
591,539 |
Vaccine available to |
2.0 |
598 |
135,870,000 |
2,937,921 |
10% |
13,587,000 |
50% insufficient |
545,001 |
2,792,609 |
51.51% |
50% herd immunity point |
Jul 01, 2021 |
33,496,454 |
13,441 |
602,401 |
10,862 |
1.9 |
362 |
155,880,000 |
3,312,904 |
10% |
15,588,000 |
50% insufficient |
139,116 |
2,290,444 |
57.74% |
July 01, 2021 Delta is dominant |
Aug 01, 2021 |
34,926,462 |
46,129 |
610,873 |
19,334 |
1.8 |
273 |
164,450,000 |
3,471,099 |
10% |
16,445,000 |
- |
60% insufficient |
2,071,551 |
60.79% |
60% herd immunity point Aug 23, 2021 Approval Vaccine 16+ |
Sep 01, 2021 |
39,488,866 |
147,174 |
641,725 |
50,186 |
1.9 |
995 |
174,970,000 |
3,672,641 |
10% |
17,497,000 |
- |
65% insufficient |
1,861,030 |
65.38% |
Sep 22, 2021 EUA Booster 18+ |
Oct 01, 2021 |
43,289,203 |
126,678 |
694,701 |
103,162 |
2.0 |
1766 |
184,850,000 |
3,869,158 |
10% |
18,485,000 |
- |
70% insufficient |
1,660,068 |
69.55% |
Oct 21, 2021 EUA Booster 18+ Oct 29, 2021 EUA Vaccine 5-11 |
Nov 01, 2021 |
45,889,173 |
83,870 |
743,926 |
152,387 |
1.9 |
1588 |
192,450,000 |
4,012,334 |
10% |
19,245,000 |
- |
73% insufficient |
1,380,152 |
72.66% |
Nov 02, 2021 EUA Vaccine 5-11 |
Dec 01, 2022 |
48,497,243 |
86,936 |
780,131 |
188,592 |
1.8 |
1207 |
195,560,000 |
4,068,380 |
10% |
19,556,000 |
- |
74% insufficient |
1,217,213 |
74.41% |
December 20, 2021 Omnicron becomes dominant |
Jan 01, 2022 |
53,795,407 |
170,909 |
820,355 |
228,816 |
1.8 |
1298 |
204,220,000 |
4,223,194 |
10% |
20,422,000 |
- |
79% insufficient |
1,258,598 |
78.66% |
- |
Feb 01, 2022 |
74,282,892 |
660,887 |
881,887 |
290,348 |
1.8 |
1985 |
211,050,000 |
4,347,392 |
10% |
21,105,000 |
- |
87% insufficient |
586,611 |
86.99% |
Total population infected, vaccinated, died = 286,214,779 |
Mar 02, 2022 |
78,855,000 |
163,290 |
947,882 |
356,343 |
1.8 |
2357 |
214,800,000 |
4,413,468 |
10% |
21,480,000 |
- |
90% |
392,933 |
89.53% |
- |
Apr 01, 2022 |
79,904,464 |
33,854 |
977,495 |
385,956 |
1.3 |
955 |
217,640,000 |
4,450,840 |
10% |
21,764,000 |
- |
91% |
299,400 |
91% |
Each month the end date keeps sliding. The cause is because people are rejecting vaccination. This should have ended in Feb or Mar we now see it moving into summer. |
May 01, 2022 |
81,173,065 |
42,287 |
991,030 |
399,491 |
1.3 |
451 |
219,730,000 |
4,477,106 |
10% |
21,973,000 |
- |
92% |
218,589 |
92% |
- |
Jun 01, 2022 |
84,176,694 |
96,891 |
1,002,420 |
410,881 |
1.3 |
367 |
221,350,000 |
4,497,430 |
10% |
22,135,000 |
- |
93% |
113,170 |
93% |
- |
Jul 01, 2022 |
87,407,521 |
107,694 |
1,013,261 |
421,722 |
1.2 |
361 |
222,270,000 |
4,508,914 |
10% |
22,227,000 |
- |
- |
26,224 |
95% |
- |
Aug 05, 2022 |
91,805,380 |
125,653 |
1,028,062 |
436,523 |
1.2 |
423 |
223,030,000 |
4,518,196 |
10% |
22,303,000 |
- |
- |
- |
96% |
Endemic |
Sep 01, 2022 |
94,385,669 |
95,566 |
1,041,280 |
449,741 |
1.2 |
490 |
223,910,000 |
4,528,679 |
10% |
22,391,000 |
- |
- |
- |
97% |
Endemic |
Oct 01, 2022 |
96,143,199 |
58,584 |
1,053,789 |
462,250 |
1.1 |
417 |
225,284,115 |
4,544,452 |
10% |
22,528,412 |
- |
- |
- |
98% |
Endemic |
Nov 01, 2022 |
97,329,787 |
38,277 |
1,066,351 |
474,812 |
1.1 |
405 |
226,933,827 |
4,563,090 |
10% |
22,693,383 |
- |
- |
- |
99% |
Endemic |
Dec 01, 2022 |
98,481,551 |
38,392 |
1,075,779 |
484,240 |
1.1 |
314 |
228,390,445 |
4,579,389 |
10% |
22,839,045 |
- |
- |
- |
100% |
Endemic |
Jan 01, 2023 |
100,622,056 |
69,049 |
1,088,481 |
496,942 |
1.1 |
410 |
229,135,170 |
4,587,7176 |
10% |
22,913,517 |
- |
- |
- |
100% |
Endemic |
Feb 01, 2023 |
102,405,447 |
55,170 |
1,106,938 |
515,399 |
1.2 |
441 |
229,991,258 |
4,598,291 |
10% |
22,999,126 |
- |
- |
- |
- |
- |
Mar 01, 2023 |
103,451,631 |
55,223 |
1,117,624 |
526,085 |
1.1 |
465 |
230,225,193 |
4,600,457 |
10% |
23,022,519 |
- |
- |
- |
- |
- |
Apr 01, 2023 |
104,247,309 |
40,281 |
1,127,077 |
535,538 |
1.1 |
429 |
230,429,680 |
4,602,532 |
10% |
23,042,968 |
- |
- |
- |
- |
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note: CDC . CDC . CDC line 1 [1] . Johns Hopkins University & Medicine line 2 [2] . Our World In Data [3]
Total Cases (mon) = data [1]
Daily Cases = Total Cases / days in month
Total Deaths (mon) = data [2]
Total Deaths Caused By Unvaccinated = sum (Total Deaths [current month] - Total Deaths [previous month])
Case fatality rates (%) = Total Deaths * 100 / Total Cases
Daily Deaths = (Total Deaths [current month] - Total Deaths [previous month]) / days in month
Vaccinated = data [3]
Lives Saved Because of Vaccine = Vaccinated * Case fatality rates [current month] / 100 (as the infected population age decreases the death rate drops). This calculation was changed to use the following formula, Lives Saved Because of Vaccine = Lives Saved Prev Month +(Vaccinated Current Month -Vaccinated Prev Month)*(Current Month Case Fatality Percent /100), this formula applies the Monthly Case Fatality Percent to each month calculation rather than the aggregate. This was changed to address the changes in the Monthly Case Fatality Percent.
Chronic Health Issues % = data [4]
Chronic Health Issues Prevented Because of Vaccine = Vaccinated * Chronic Health Loss %
Remaining Possible Deaths if Herd Immunity is = (328,000,000 * Herd Immunity % - Lives Saved Because of Vaccine - Total Deaths} * Case fatality rates (%)
% into pandemic = (Total Cases + Vaccinated) / 328,000,000
| Date | Agency | Type | Approval | Age |
| Dec 11, 2020 | FDA | EUA | Vaccine | 16+ |
| May 10, 2021 | FDA | EUA | Vaccine | 12-15 |
| Aug 23, 2021 | FDA | Approval | Vaccine | 16+ |
| . | ||||
Sep 22, 2021 |
FDA | EUA | Booster | 18+ |
Oct 21, 2021 |
CDC | EUA | Booster | 18+ |
Oct 29, 2021 |
FDA | EUA | Vaccine | 5-11 |
Nov 02, 2021 |
CDC | EUA | Vaccine | 5-11 |
Source: Press Releases
Most view the vaccine from the perspective of building herd immunity so that life can return to normal. Others view the vaccine as a life safer and focus on the number of lives saved. As of August 2021 some view the number of deaths caused by the unvaccinated.
There is yet another system stakeholder view and that is from the perspective of those that will develop short, middle, long term, and life long negative health consequences [4] [5] [6]. This area of understanding is still very fuzzy. The reference terms are not even established as of March 2021 and there are only various vague references. The term as of March 2021 is Long Haulers and the estimates range from 10% [4] [6] to 33% [7]. Yet another study suggests cardiac involvement in 78% and myocardial inflammation in 60% independent of pre-existing conditions, severity and overall course of the acute illness, and the time from the original diagnosis [8] [9]. For this analysis the most conservative figure of 10% was selected to capture the effects of the vaccine in preventing chronic health issues.
Just because a herd immunity level is reached in the USA it does not mean the virus will be eradicated from the planet. It also does not mean that people will no longer be infected. It just suggests that the infection rate will drop significantly. How much it drops, time will tell. Because the virus will be present, unvaccinated or uninfected people still will be at risk of death. This is identified as Remaining Possible Deaths.
The Case fatality rates have decreased. This can be attributed to the elderly getting vaccinated so that only a younger segment of the population is being infected. As of September 2021, the number of infections is increasing. This can be attributed to the society opening up. The young were told to not fear COVID-19, the old either died or were vaccinated. As people went back to work and life, they found themselves inside small indoor spaces again and so the infection rate increased. Unfortunately, those who decided not to be vaccinated, because of the massive disinformation that COVID-19 would not harm the young, were harmed. Some have lost their health and some have died. Since June 01, 2021, all the deaths can be attributed to the unvaccinated. The cruel disinformation and policy of opening up before the young were vaccinated is now history.
Unfortunately the people are behaving very badly in the US. Those that are in control refuse to take a systems perspective in dealing with the COVID-19 disaster and realize that the people are the weakest link in any system. The approach of hands off government is still driving all the solutions, yet the government is continuing to pay the hospital bills for the unvaccinated. With the massive capability, technology, and industrial capacity available, the performance of the overall system solution is very poor.
On September 9, 2021 President Biden took action and announced a number of policy decisions to be implemented via Executive Orders to get the people in the US vaccinated. The expectation is that these policy decisions will have a massive positive impact on ending the COVID-19 Disaster. It is unclear if these policy decisions do enough or if more is needed especially to prevent some people from sabotaging the system and preventing the end of the COVID-19 Disaster. [10]
World wide system performance is being tracked [11].
References:
[1] CDC Cases, webpage https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/cases-in-us.html, various dates.
[2] Johns Hopkins University & Medicine Cases, webpage https://coronavirus.jhu.edu/map.html, various dates.
[3] Coronavirus (COVID-19) Vaccinations, Our World In Data, https://ourworldindata.org/covid-vaccinations, various dates
[4] Management of post-acute covid-19 in primary care, Practice Pointer, August 11, 2020. webpage https://www.bmj.com/content/370/bmj.m3026, https://www.bmj.com/content/bmj/370/bmj.m3026.full.pdf, March 2021. Management of post-acute covid-19 in primary care.
[5] As Their Numbers Grow, COVID-19 Long Haulers Stump Experts, JAMA Network, September 23, 2020. webpage https://jamanetwork.com/journals/jama/fullarticle/2771111, March, 2021. As Their Numbers Grow, COVID-19 Long Haulers Stump Experts.
[6] Long haulers: Why some people experience long-term coronavirus symptoms, UC Davis Health, February 08, 2021, webpage https://health.ucdavis.edu/coronavirus/covid-19-information/covid-19-long-haulers.html, March 2021. Long haulers: Why some people experience long-term coronavirus symptoms.
[7] Studies show long-haul COVID-19 afflicts 1 in 4 COVID-19 patients, regardless of severity, UC Davis Health, March 30, 2021. webpage https://health.ucdavis.edu/health-news/coronavirus/studies-show-long-haul-covid-19-afflicts-1-in-4-covid-19-patients-regardless-of-severity/2021/03, March 2021. Studies show long-haul COVID-19 afflicts 1 in 4 COVID-19 patients.
[8] Can COVID-19 Cause a Heart Attack?, Hackensack Meridian Health, February 15, 2021, webpage https://www.hackensackmeridianhealth.org/HealthU/2021/02/15/can-covid-19-cause-a-heart-attack/#:~:text=In%20one%20German%20study%2C,recovered%20from%20the%20virus, March 2021, Can COVID-19 Cause a Heart Attack?
[9] Outcomes of Cardiovascular Magnetic Resonance Imaging in Patients Recently Recovered From Coronavirus Disease 2019 (COVID-19), JAMA Nwetwork, July 27, 2020. webpage https://jamanetwork.com/journals/jamacardiology/fullarticle/2768916, Outcomes of Cardiovascular Magnetic Resonance Imaging in Patients Recently Recovered From Coronavirus Disease 2019 (COVID-19).
[10] President Biden's COVID-19 Action Plan, The White House, 1600 Pennsylvania Ave NW, Washington, DC 20500, September 09,2021. webpage https://www.whitehouse.gov/covidplan, September 2021. President Biden's COVID-19 Action Plan.
[11] COVID-19 pandemic by country and territory, wikipedia, September 2021. webpage https://en.wikipedia.org/wiki/COVID-19_pandemic_by_country_and_territory, September 2021.
Deaths Caused By Unvaccinated
As of May 2021 various news reports are suggesting that a segment of the USA population is refusing to take the vaccination. The unvaccinated are now the leading cause of COVID-19 infection, loss of health, and death - as of June 01, 2021 (after the vaccine became available to all in the US). This does not include the unvaccinated that have legitimate health issues or children that are still not approved to take the vaccine. Most children receive routine vaccinations for chickenpox, tetanus, diphtheria, mumps, measles, and rubella or they cannot attend most schools. The unvaccinated are not even doing what their parents did to protect their lives when they were children.
The table at the start of this section shows the detailed data and analysis results [4]. This table summarizes the results.
Date |
Total Deaths |
Total Deaths |
| Jun 01, 2021 | 591,539 |
Vaccine available to all in US |
| Jul 01, 2021 | 602,401 |
10,862 |
| Aug 01, 2021 | 610,873 |
19,334 |
| Sep 01, 2021 | 641,725 |
50,186 |
| Oct 01, 2021 | 694,701 |
103,162 |
| Nov 01, 2021 | 743,926 |
152,387 |
| Dec 01, 2021 | 780,131 |
188,592 |
| Jan 01, 2022 | 820,355 |
228,816 |
| Feb 01, 2022 | 881,887 |
290,348 |
| Mar 01, 2022 | 947,882 |
356,343 |
| Apr 01, 2022 | 977,495 |
385,956 |
| May 01, 2022 | 991,030 |
399,491 |
| Jun 01, 2022 | 1,002,420 |
410,881 |
| Jul 01, 2022 | 1,013,261 |
421,722 |
| Aug 05, 2022 | 1,028,062 |
436,523 |
| Sep 01, 2022 | 1,041,280 |
449,741 |
| Oct 01, 2022 | 1,053,789 |
462,250 |
| Nov 01, 2022 | 1,066,351 |
474,812 |
| Dec 01, 2022 | 1,075,779 |
484,240 |
| Jan 01, 2023 | 1,088,481 |
496,942 |
| Feb 01, 2023 | 1,106,938 |
515,399 |
| Mar 01, 2023 | 1,117,624 |
526,085 |
| Apr 01, 2023 | 1,127,077 |
535,538 |
As of August 2021, a booster shot [1] has been recommended. Some have suggested that the booster will ensure that the vaccinated have a large dose of antibodies so that they are not carriers of COVID-19 infecting the unvaccinated during the time between when their memory T-cells detect the contagion and they produce new antibodies should their antibodies wane. It is clear that the vaccinated rarely go to the hospital or die even when the antibodies have waned and the T-cell response is required. Currently the primary purpose of the booster is to reduce the massive hospitalizations from the unvaccinated by reducing the overall COVID-19 virus load in the social environment setting. A secondary purpose is to reduce the effects of the delta variant on those that are fully vaccinated. So the booster is being used to protect the unvaccinated who are currently causing massive suffering and death [2]. The world is outraged by this very toxic and poor choice that does not address the root cause and solve the problem [3].
In June 2021 many public and private employers, Universities, and Colleges have mandated that employees, students, faculty, and staff be vaccinated before coming into work, the office, or setting foot on campus.
References:
[1] Will You Need a COVID-19 Booster? What We Know So Far. Yale Medicine, August 18, 2021. webpage https://www.yalemedicine.org/news/covid-19-booster, August 2021. Will You Need a COVID-19 Booster? What We Know So Far. Yale Medicine
[2] See section Recent Mega Trends.
[3] WHO calls for halting COVID-19 vaccine boosters in favor of unvaccinated, Reuters, August 4, 2021. webpage https://www.reuters.com/business/healthcare-pharmaceuticals/who-calls-moratorium-covid-19-vaccine-booster-doses-until-september-end-2021-08-04, September 2021. WHO calls for halting COVID-19 vaccine boosters in favor of unvaccinated.
[4] See section Vaccinations Impact.
Lives Saved Because of Vaccine
The table at the start of this section shows the data and analysis results [1]. This table summarizes the results.
Date |
Vaccinated |
Lives Saved |
Chronic Health Issues Prevented |
Case fatality |
Comments |
Feb 01, 2021 |
5,930,000 |
193,160 |
593,000 |
3.3 |
|
Mar 01, 2021 |
25,470,000 |
701,772 |
2,547,000 |
2.6 |
|
Apr 01, 2021 |
54,610,000 |
1,317,991 |
5,461,000 |
2.1 |
|
May 01, 2021 |
103,420,000 |
2,302,600 |
10,342,000 |
2.0 |
|
Jun 01, 2021 |
135,870,000 |
2,937,921 |
13,587,000 |
2.0 |
|
Jul 01, 2021 |
155,880,000 |
3,312,904 |
15,588,000 |
1.9 |
|
Aug 01, 2021 |
164,450,000 |
3,471,099 |
16,445,000 |
1.8 |
|
Sep 01, 2021 |
174,970,000 |
3,672,641 |
17,497,000 |
1.9 |
|
Oct 01, 2021 |
184,850,000 |
3,869,158 |
18,485,000 |
2.0 |
|
Nov 01, 2021 |
192,450,000 |
4,012,334 |
19,245,000 |
1.9 |
|
Dec 01, 2021 |
195,560,000 |
4,068,380 |
19,556,000 |
1.8 |
|
Jan 01, 2022 |
204,220,000 |
4,223,194 |
20,422,000 |
1.8 |
|
Feb 01, 2022 |
211,050,000 |
4,347,392 |
21,105,000 |
1.8 |
|
Mar 01, 2022 |
214,800,000 |
4,413,468 |
21,480,000 |
1.8 |
|
Apr 01, 2022 |
217,640,000 |
4,450,840 |
21,764,000 |
1.3 |
|
May 01, 2022 |
219,730,000 |
4,477,106 |
21,973,000 |
1.3 |
|
Jun 01, 2022 |
221,350,000 |
4,497,430 |
22,135,000 |
1.3 |
|
Jul 01, 2022 |
222,270,000 |
4,508,914 |
22,227,000 |
1.2 |
|
Aug 05, 2022 |
223,030,000 |
4,518,196 |
22,303,000 |
1.2 |
Endemic |
| Sep 01, 2022 | 223,910,000 | 4,528,679 |
22,391,000 |
1.2 |
Endemic |
| Oct 01,2022 | 225,284,115 | 4,544,452 |
22,528,412 |
1.1 |
Endemic |
| Nov 01, 2022 | 226,933,827 | 4,563,090 |
22,693,383 |
1.1 |
Endemic |
| Dec 01, 2022 | 228,390,445 |
4,579,389 |
22,839,045 |
1.1 |
Endemic |
| Jan 01, 2022 | 229,135,170 |
4,587,717 |
22,913,517 |
1.1 |
Endemic |
| Feb 01, 2022 | 229,991,258 | 4,598,291 |
22,999,126 |
1.2 |
Endemic |
| Mar 01, 2022 | 230,225,193 | 4,600,457 |
23,022,519 |
1.1 |
Endemic |
| Apr 01, 2022 | 230,429,680 | 4,602,532 |
23,042,968 |
1.1 |
Endemic |
Notes:
Lives Saved Because of Vaccine = Vaccinated * Case fatality rates [current month] / 100 (as the infected population age decreases the death rate drops). Calculation was changed to use the following formula, Lives Saved Because of Vaccine = Lives Saved Prev Month +(Vaccinated Current Month -Vaccinated Prev Month)*(Current Month Case Fatality Percent /100). This formula applies the Monthly Case Fatality Percent to each month calculation rather than the aggregate. This was changed to address the changes in the Monthly Case Fatality Percent.
The vaccine is enormously effective. The analysis shows that the vaccine has saved millions of lives and prevented chronic health conditions from developing in tens of millions of people. Those who have access to the vaccine and took the vaccine are protected for now and are hoping that a new deadly variant does not surface that bypasses the current vaccination. They can live their lives with reasonable expectations of not getting hospitalized or dying from COVID-19.
Early research in 2020 suggested that the antibodies in people infected with COVID-19 dropped significantly within 2 to 3 months, causing concern that humoral immunity against the virus may decline rapidly. However, it is a normal part of the immune response that antibody levels fall after an infection has resolved. For example, in seasonal coronavirus infections, antibodies start to decline approximately one week after infection and typically only last for approximately one year. As part of the body response, T and B cells (memory) are formed after infection. These can be reactivated when another infection with the same virus occurs and they are a mechanism for long-lasting immunity [2].
The earliest vaccines against the coronavirus disease 2019 (COVID-19) were built on the messenger ribonucleic acid (mRNA) platform. These exhibited extraordinary efficacy and were given emergency use authorization in December 2020. Along with natural infection, these vaccines elicit strong humoral (neutralizing antibodies) and cellular (B and T cells) immune responses [3]. Penn Medicine researchers analyzed the T-cell responses in 47 healthy people who received two doses of the Moderna and Pfizer/BioNTech mRNA vaccines. The findings showed that the T-cell response was robust after the first vaccine dose, with no significant increase after the second dose. [4]
The vaccines result in both antibodies and T / B cell responses. The difference between the antibody response and a T / B cell response is associated with time to remove the virus. If antibodies are present, the virus removal is immediate and there may be no symptoms. With a T / B cell response, the body needs to produce antibodies and that takes time. During the time that it takes to produce the antibodies, the virus multiplies and this may result in symptoms but data as of November 2021 suggests there are very few hospitalizations and deaths. In other words the vaccines are very effective at producing both antibodies and long term T / B cell responses. [4]
T cells, also called T lymphocyte, are a type of leukocyte (white blood cell) that is part of the immune system. T cells are one of two primary types of lymphocytes and B cells are the second type (white blood cell). B cells determine the specificity of immune response to foreign substances (antigens) in the body. T cells originate in the bone marrow and mature in the thymus. In the thymus, T cells multiply and differentiate into helper, regulatory, or cytotoxic T cells or become memory T cells. They are then sent to tissues or circulate in the blood or lymphatic system. Once stimulated by the appropriate antigen, helper T cells secrete chemical messengers called cytokines, which stimulate the differentiation of B cells into plasma cells (antibody producing cells). Regulatory T cells act to control immune reactions. Cytotoxic T cells, which are activated by various cytokines, bind to and kill infected cells. [5]
References:
[1] See section Vaccinations Impact.
[2] What is the role of T cells in COVID-19 infection? Why immunity is about more than antibodies, On behalf of the Oxford COVID-19 Evidence Service Team, Centre for Evidence-Based Medicine, Nuffield Department of Primary Care Health Sciences, University of Oxford, October 19, 2020. webpage https://www.cebm.net/covid-19/what-is-the-role-of-t-cells-in-covid-19-infection-why-immunity-is-about-more-than-antibodies, December 2021. What is the role of T cells in COVID-19 infection? Why immunity is about more than antibodies . PDF . local
[3] Pfizer COVID-19 vaccine elicits durable specific memory T-cell response, News Medical Life Sciences, November 4 2021. webpage https://www.news-medical.net/news/20211104/Pfizer-COVID-19-vaccine-elicits-durable-specific-memory-T-cell-response.aspx, December 2021. Pfizer COVID-19 vaccine elicits durable specific memory T-cell response.
[4] Penn Study Details Robust T-Cell Response to mRNA COVID-19 Vaccines, Penn Medicine News, August 16, 2021. webpage https://www.pennmedicine.org/news/news-releases/2021/august/penn-study-details-robust-tcell-response-to-mrna-covid19-vaccines, December 2021. Penn Study Details Robust T-Cell Response to mRNA COVID-19 Vaccines.
[5] White blood cell, https://en.wikipedia.org/wiki/White_blood_cell, wikipedia, webpage December 2021.
COVID-19 Death Rate Ranking
The following table shows the context of the COVID-19 death rates based on the death rates associated with other diseases and the annual Flu. There is no question that the vaccine has had a massive impact. The COVID-19 virus has gone from what may have been the number one death rate for years to a much lower cause of death perhaps matching the seasonal Flu death rate. The following table shows the COVID-19 Daily deaths By Date and ranks COVID-19 leading cause of death accordingly.
Rank |
Leading Causes of Death (2019) |
Annual |
Daily |
COVID-19 |
COVID-19 |
jan |
feb | mar | apr | may | jun | jul | aug | sep | oct | nov | dec | - |
jan |
feb | mar | apr | may | jun | jul | aug | sep | oct | nov | dec |
jan |
feb 23 |
mar 23 |
apr 23 |
1 |
Heart disease [10] | 659,041 |
1,806 |
1 |
Heart |
2384 |
3124 |
2636 |
1985 |
2357 |
||||||||||||||||||||||||
2 |
Cancer [10] | 599,601 |
1,643 |
2 |
Cancer |
1766 |
1298 |
|
1298 |
|||||||||||||||||||||||||
3 |
Accidents (unintentional injuries) [10] | 173,040 |
474 |
3 |
Accidents |
1172 |
828 |
598 |
995 |
|
1598 |
1207 |
955 |
490 | 465 | |||||||||||||||||||
4 |
Chronic lower respiratory diseases [10] | 156,979 |
430 |
4 |
451 |
423 | 441 | 429 | ||||||||||||||||||||||||||
5 |
Stroke (cerebrovascular diseases) [10] | 150,005 |
411 |
417 | 405 | 410 | ||||||||||||||||||||||||||||
. |
||||||||||||||||||||||||||||||||||
6 |
Alzheimer's [10] | 121,499 |
333 |
6 |
Alzheimer's |
362 |
367 |
361 | 314 | |||||||||||||||||||||||||
7 |
Diabetes [10] | 87,647 |
240 |
7 |
Diabetes |
273 |
||||||||||||||||||||||||||||
8 |
Nephritis, nephrotic syndrome, and nephrosis [10] | 51,565 |
141 |
S |
||||||||||||||||||||||||||||||
9 |
Influenza and pneumonia [10] | 49,783 |
136 |
S |
||||||||||||||||||||||||||||||
10 |
Intentional self-harm (suicide) [10] | 47,511 |
130 |
S |
||||||||||||||||||||||||||||||
. |
||||||||||||||||||||||||||||||||||
11 |
Flu Season Average 2010-2020 [11] | 35,900 |
98 |
S |
Note: S represents what should have happened if the people were accepting the vaccine.
The problem is a large number of people decided not to be vaccinated. The result is that COVID-19 moved from being number 7 (Yellow) as leading cause of death back to number 3 (Red). This is a very sad and pathetic turn of events. On August 23, 2021, the FDA approved the first COVID-19 vaccine and employers and some governments are requiring employees to be vaccinated. If people had behaved like in the previous century then COVID-19 would have plunged into the Green zone and displaced the average Flu season by December 2021.
It is assumed by many as of September 2021, that COVID-19 is now impacting the young more than the elderly, but the Case Fatality Rates are very high. As of September 2021 the Fatality Rate is 1.9% and this is not matching expected data. Data from early in the pandemic suggested that the case fatality rates for the young were much lower. The Delta variant is one factor that may be increasing the death rates. Another factor might be reporting issues early in the pandemic, where causes of death were not being attributed to COVID-19 in the young because it was assumed that COVID-19 only caused death in the elderly. A final factor might be that there is still a large segment of the elderly that have not received a vaccine. If the death rates of the young are much higher than previously thought, then this is a very tragic turn of events. It is critical to get to the bottom of this observation.
The following data is from April 2020. [1]
| Age | 0-9 | 10-19 | 20-29 | 30-39 | 40-49 | 50-59 | 60-69 | 70-79 | 80-89 | 90+ |
|---|---|---|---|---|---|---|---|---|---|---|
| Canada as of 25 April | 0.0 | 0.1 | 0.5 | 5.2 | 16.2 | |||||
| China as of 11 February | 0.0 | 0.2 | 0.2 | 0.2 | 0.4 | 1.3 | 3.6 | 8.0 | 14.8 | |
| Denmark as of 26 April | 0.2 | 4.4 | 15.4 | 24.8 | 41.0 | |||||
| Israel as of 26 April | 0.0 | 0.0 | 0.0 | 1.0 | 0.5 | 1.5 | 8.6 | 24.8 | 34.3 | 29.3 |
| Italy as of 23 April | 0.2 | 0.0 | 0.1 | 0.4 | 0.9 | 2.6 | 10.0 | 24.9 | 30.8 | 26.1 |
| Netherlands as of 25 April | 0.0 | 0.3 | 0.1 | 0.2 | 0.5 | 1.5 | 7.6 | 23.2 | 30.0 | 29.3 |
| Portugal as of 24 April | 0.0 | 0.0 | 0.0 | 0.0 | 0.3 | 0.6 | 2.8 | 8.5 | 16.5 | |
| S. Korea as of 30 April | 0.0 | 0.0 | 0.0 | 0.2 | 0.2 | 0.8 | 2.6 | 10.4 | 24.3 | |
| Spain as of 25 April | 0.3 | 0.4 | 0.3 | 0.3 | 0.5 | 1.3 | 4.4 | 13.2 | 20.3 | 20.2 |
| Sweden as of 26 April | 0.0 | 0.0 | 0.4 | 0.4 | 1.0 | 2.3 | 6.9 | 21.2 | 30.0 | 34.0 |
| Switzerland as of 25 April | 0.9 | 0.0 | 0.0 | 0.1 | 0.0 | 0.5 | 2.7 | 10.1 | 24.0 | |
| WA state as of 25 April | 0.0 | 0.2 | 1.3 | 8.9 | 29.9 | |||||
The following US data is from March 2020. [1]
| Age | 0-19 | 20-44 | 45-54 | 55-64 | 65-74 | 75-84 | 85+ |
|---|---|---|---|---|---|---|---|
| United States as of 16 March | 0.0 | 0.1-0.2 | 0.5-0.8 | 1.4-2.6 | 2.7-4.9 | 4.3-10.5 | 10.4-27.3 |
| Note: The lower bound includes all cases. The upper bound excludes cases that were missing data. | |||||||
The following data is from 2020. It uses COVID-19 data from March and April 2020 and overlays it on US Life Expectancy data for 2017. [1] [spreadsheet Life Expect]
Note: a - Probability of dying within one year. |
|
The empirical overall death rate data from September 2021 is higher than the death rate data of the young from 2020. Either there is a segment of the elderly population that has decided not to receive the vaccine or the pandemic is much worse than originally considered. The Coronavirus Disease 2019 (COVID-19) Associated Hospitalization Surveillance Network (COVID-NET) conducts population based surveillance for laboratory confirmed COVID-19-associated hospitalizations in children (persons younger than 18 years) and adults. The data suggests that there is a segment of the elderly population that has not received the vaccine.
The following table shows the percent of hospitalizations since the start of the COVID-19 disaster [2]. [Data Spreadsheet]
Percent of Hospitalizations |
Age |
Age |
Age |
Age |
Age |
|
2020-10 |
0 |
0 |
29.4 |
20.6 |
50 |
|
2020-11 |
0 |
0 |
23.6 |
37.3 |
39.2 |
|
2020-12 |
0 |
0.3 |
26.5 |
29.9 |
43.2 |
|
2020-13 |
0.2 |
0.2 |
25.4 |
31.8 |
42.4 |
|
2020-14 |
0.4 |
0.4 |
21.1 |
33 |
45.2 |
|
2020-15 |
0.3 |
0.2 |
21.2 |
30.2 |
48.1 |
|
2020-16 |
0.3 |
0.2 |
22.6 |
29.4 |
47.4 |
|
2020-17 |
0.3 |
0.4 |
24.6 |
26.4 |
48.2 |
|
2020-18 |
0.4 |
0.7 |
25.3 |
28 |
45.6 |
|
2020-19 |
0.3 |
0.8 |
27.4 |
28.9 |
42.5 |
|
2020-20 |
0.5 |
0.6 |
28.3 |
28.7 |
41.9 |
|
2020-21 |
0.7 |
0.9 |
30.5 |
27.9 |
40.1 |
|
2020-22 |
0.7 |
1.3 |
31.9 |
26.5 |
39.6 |
|
2020-23 |
1 |
1.1 |
33 |
27.3 |
37.5 |
|
2020-24 |
1.1 |
1.1 |
35.5 |
26.5 |
35.8 |
|
2020-25 |
1.2 |
0.8 |
36.2 |
28.2 |
33.7 |
|
2020-26 |
1 |
1.5 |
39.1 |
28.2 |
30.2 |
|
2020-27 |
0.5 |
1 |
37.6 |
27 |
33.8 |
|
2020-28 |
0.8 |
1.2 |
35.3 |
28.3 |
34.4 |
|
2020-29 |
0.6 |
1.1 |
34.8 |
28.5 |
35 |
|
2020-30 |
0.9 |
0.9 |
31.8 |
29.3 |
37 |
|
2020-31 |
0.7 |
0.9 |
32.5 |
28.8 |
37.1 |
|
2020-32 |
0.6 |
1 |
33.6 |
27.4 |
37.4 |
|
2020-33 |
0.7 |
1.3 |
32.7 |
28.6 |
36.8 |
|
2020-34 |
0.7 |
1.4 |
30.4 |
28.9 |
38.6 |
|
2020-35 |
0.8 |
2 |
34.5 |
24.8 |
37.9 |
|
2020-36 |
1.5 |
1.5 |
30.7 |
26.7 |
39.6 |
Deaths 1018, August 31, 2020 to September 6, 2020 |
2020-37 |
0.6 |
1.4 |
31.3 |
27.6 |
39.2 |
|
2020-38 |
0.7 |
1.9 |
30.7 |
25.5 |
41.2 |
|
2020-39 |
1.1 |
0.9 |
29.3 |
27.4 |
41.3 |
|
2020-40 |
0.6 |
1.3 |
29.9 |
27 |
41.1 |
|
2020-41 |
0.5 |
1.2 |
26.8 |
27.2 |
44.3 |
|
2020-42 |
0.6 |
1.2 |
28.5 |
25.4 |
44.2 |
|
2020-43 |
0.4 |
1 |
24.3 |
29.8 |
44.4 |
|
2020-44 |
0.5 |
1.1 |
24.3 |
27.6 |
46.6 |
|
2020-45 |
0.6 |
1.3 |
24.6 |
27.2 |
46.2 |
|
2020-46 |
0.4 |
1.1 |
22.7 |
26.7 |
49 |
|
2020-47 |
0.5 |
0.6 |
21.1 |
26 |
51.8 |
|
2020-48 |
0.4 |
0.8 |
21.3 |
25.6 |
51.9 |
|
2020-49 |
0.7 |
0.8 |
21.3 |
25.5 |
51.8 |
|
2020-50 |
0.7 |
0.7 |
21.9 |
25.3 |
51.4 |
|
2020-51 |
0.5 |
0.7 |
20.5 |
25.8 |
52.4 |
|
2020-52 |
0.6 |
0.9 |
19.4 |
25.7 |
53.4 |
|
2020-53 |
0.5 |
0.8 |
20.3 |
25.4 |
53 |
|
2021-1 |
0.6 |
1 |
20.7 |
26.2 |
51.5 |
|
2021-2 |
0.6 |
1 |
21.5 |
26.5 |
50.5 |
|
2021-3 |
0.6 |
1 |
21.5 |
26.6 |
50.3 |
|
2021-4 |
0.6 |
1.4 |
21.9 |
26.5 |
49.6 |
|
2021-5 |
0.6 |
1.2 |
22.2 |
25.8 |
50.2 |
|
2021-6 |
0.7 |
1.5 |
25.8 |
26.6 |
45.4 |
|
2021-7 |
0.7 |
1.7 |
24.8 |
26.9 |
45.9 |
|
2021-8 |
0.5 |
1.5 |
26.4 |
28.5 |
43.1 |
|
2021-9 |
0.7 |
1.2 |
28.7 |
29.9 |
39.4 |
|
2021-10 |
1.1 |
0.9 |
28.6 |
30.9 |
38.6 |
|
2021-11 |
1 |
1.7 |
29.5 |
33.2 |
34.7 |
|
2021-12 |
0.8 |
1.4 |
28.9 |
33.5 |
35.5 |
|
2021-13 |
0.9 |
1.3 |
34.3 |
32.5 |
31 |
|
2021-14 |
0.8 |
1.1 |
35.4 |
33.1 |
29.5 |
|
2021-15 |
0.4 |
1.3 |
34.1 |
34 |
30.2 |
|
2021-16 |
1 |
1.6 |
35.3 |
31.5 |
30.6 |
|
2021-17 |
0.8 |
1.9 |
36.5 |
31.4 |
29.5 |
|
2021-18 |
0.6 |
2.3 |
35.8 |
31.6 |
29.8 |
|
2021-19 |
1.5 |
1.9 |
38.7 |
30.1 |
27.8 |
|
2021-20 |
1.3 |
1.6 |
38.1 |
27.1 |
31.8 |
|
2021-21 |
1.3 |
2.4 |
40.5 |
27.6 |
28.2 |
|
2021-22 |
1.5 |
3.5 |
36.7 |
29.3 |
29.1 |
|
2021-23 |
1.4 |
1.8 |
43 |
26 |
27.7 |
|
2021-24 |
0.8 |
2.4 |
42.4 |
25.8 |
28.7 |
|
2021-25 |
0.7 |
3.5 |
40.3 |
26.4 |
29.1 |
|
2021-26 |
1.5 |
2.6 |
41.9 |
27.8 |
26.3 |
|
2021-27 |
1.6 |
2 |
44 |
26.3 |
26.2 |
|
2021-28 |
0.9 |
2.5 |
41.1 |
25.4 |
30.2 |
|
2021-29 |
1.6 |
1.3 |
41.7 |
28.7 |
26.7 |
|
2021-30 |
0.9 |
1.3 |
39.2 |
28.6 |
30 |
|
2021-31 |
1.3 |
2.1 |
40.4 |
27.1 |
29.2 |
|
2021-32 |
1.1 |
1.8 |
37.3 |
28.5 |
31.2 |
|
2021-33 |
1.2 |
1.8 |
36.2 |
28.1 |
32.6 |
|
2021-34 |
1.5 |
2.4 |
34.4 |
27.1 |
34.6 |
995 Deaths, August 23 to August 29, 2021 |
2021-35 |
0 |
0 |
0 |
0 |
0 |
The last time the deaths approached the rate of 2021-34 (August 23 to August 29, 2021) was in 2020-36 (August 31 to September 6, 2020).
Percent of Hospitalizations |
Daily |
Age 0-4 |
Age 5-17 |
Age 18-49 |
Age 50-64 |
Age 65+ |
2020-36 |
1018 |
1.5 |
1.5 |
30.7 |
26.7 |
39.6 |
2021-34 |
995 |
1.5 |
2.4 |
34.4 |
27.1 |
34.6 |
The data suggests that there is still a large number of elderly that have not been vaccinated. As of August 25, 2021, people 65 and older are 84 percent fully vaccinated, versus 52 percent of the entire US population. Popular media reports that the US has a far higher share of seniors without full vaccine protection than many other wealthy countries, like Canada, Spain, and Britain. That discrepancy may help explain why the Delta variant has led to such a higher rate of death in the United States than in Britain where the surge in Delta infections did not lead to a big increase in hospitalizations and deaths. [3]
References:
[1] COVID-19 A Systems Perspective, Walter Sobkiw, 2021, ISBN 9780983253044, hardback.
[2] Laboratory-Confirmed COVID-19-Associated Hospitalizations, Centers for Disease Control and Prevention (CDC), August 28, 2021, webpage https://gis.cdc.gov/grasp/covidnet/COVID19_5.html, September 2021. Laboratory-Confirmed COVID-19-Associated Hospitalizations . local
[3] The 'vast majority' of U.S. COVID-19 deaths are still unvaccinated adults 65 and older, The Week, August 25, 2021. webpage https://theweek.com/delta-variant/1004119/the-vast-majority-of-us-covid-19-deaths-are-still-unvaccinated-adults-65-and, September 2021. The 'vast majority' of U.S. COVID-19 deaths are still unvaccinated adults 65 and older
COVID-19 and Flu Seasons
The Flu season by year is shown in the following table [1].
Flu Season Date |
2019-2020 |
2018-2019 |
2017-2018 |
2017-2018 |
2015-2016 |
2014-2015 |
2013-2014 |
2012-2013 |
2011-2012 |
2010-2011 |
Symptomatic Illnesses |
38,000,000 |
36,000,000 |
45,000,000 |
29,000,000 |
24,000,000 |
30,000,000 |
30,000,000 |
34,000,000 |
9,300,000 |
21,000,000 |
Medical Visits |
18,000,000 |
17,000,000 |
21,000,000 |
14,000,000 |
11,000,000 |
14,000,000 |
13,000,000 |
16,000,000 |
4,300,000 |
10,000,000 |
Hospitalizations |
400,000 |
490,000 |
810,000 |
500,000 |
280,000 |
590,000 |
350,000 |
570,000 |
140,000 |
290,000 |
Loss of Life |
22,000 |
34,000 |
61,000 |
38,000 |
23,000 |
51,000 |
38,000 |
43,000 |
12,000 |
37,000 |
As of September 2021 there are still some claiming Flu deaths that are much higher than the actual data. They then proceed to make statements that the COVID-19 is not any worse than a typical Flu season. This is obviously driven by hidden stakeholders. This outrageous lie is still believed by some in the population and it is preventing the vaccinations from being performed and causing massive death. Manipulating the mass mind in this way is nothing new and it is one of the reasons for the rise of Nazism in Germany and World War II. What is new is that this is happening in the USA in the 21st century. [2]
The Flu lie and other lies have stalled the COVID-19 Disaster recovery. The following table shows the leading causes of death and where COVID-19 was ranked by month.
Rank |
Leading Causes of Death (2019) |
Annual |
Daily |
COVID-19 |
COVID-19 |
jan |
feb | mar | apr | may | jun | jul | aug | sep | oct | nov | dec | - |
jan |
feb | mar | apr | may | jun | jul | aug | sep | oct | nov | dec | jan 23 |
feb 23 |
mar 23 |
apr 23 |
1 |
Heart disease [10] | 659,041 |
1,806 |
1 |
Heart |
2384 |
3124 |
2636 |
1985 |
2357 |
||||||||||||||||||||||||
2 |
Cancer [10] | 599,601 |
1,643 |
2 |
Cancer |
1766 |
1298 |
|
1298 |
|||||||||||||||||||||||||
3 |
Accidents (unintentional injuries) [10] | 173,040 |
474 |
3 |
Accidents |
1172 |
828 |
598 |
995 |
|
1598 |
1207 |
955 |
490 | 465 | |||||||||||||||||||
4 |
Chronic lower respiratory diseases [10] | 156,979 |
430 |
4 |
451 |
423 | 441 | 429 | ||||||||||||||||||||||||||
5 |
Stroke (cerebrovascular diseases) [10] | 150,005 |
411 |
417 | 405 | 410 | ||||||||||||||||||||||||||||
. |
||||||||||||||||||||||||||||||||||
6 |
Alzheimer's [10] | 121,499 |
333 |
6 |
Alzheimer's |
362 |
367 |
361 | 314 | |||||||||||||||||||||||||
7 |
Diabetes [10] | 87,647 |
240 |
7 |
Diabetes |
273 |
||||||||||||||||||||||||||||
8 |
Nephritis, nephrotic syndrome, and nephrosis [10] | 51,565 |
141 |
S |
||||||||||||||||||||||||||||||
9 |
Influenza and pneumonia [10] | 49,783 |
136 |
S |
||||||||||||||||||||||||||||||
10 |
Intentional self-harm (suicide) [10] | 47,511 |
130 |
S |
||||||||||||||||||||||||||||||
. |
||||||||||||||||||||||||||||||||||
11 |
Flu Season Average 2010-2020 [11] | 35,900 |
98 |
S |
Note: S represents what should have happened if the people were accepting the vaccine.
If the massive and deadly lies were not circulated into the population, then the COVID-19 deaths may have approached the level of the typical Flu season by December of 2021. It is clear that the vaccines are working and it is shown by the massive drop in the COVID-19 leading causes of deaths rank once the vaccines were finally being distributed properly on a massive scale. Instead there is a massive increase in deaths by the unvaccinated that began in September 2021. By June 2022 the unvaccinated either died or survived.
One can speculate on the motivations of these deadly lies but they all lead to the same conclusion - sabotage.
References:
[1] Past Seasons Estimated Influenza Disease Burden, Centers for Disease Control and Prevention, October 01, 2020, webpage https://www.cdc.gov/flu/about/burden/past-seasons.html, April 2021. Past Seasons Estimated Influenza Disease Burden, Centers for Disease Control and Prevention.
[2] See section Recent Mega Trends.
Vaccination Lotteries and Toxic People
The following figure shows the 1918 and COVID-19 Pandemic death trends. The figure shows the dramatic decline in deaths because of the vaccine. It is literally a step function decline. This is massive.
There is no question that the vaccine has saved millions of lives. The problem is that there is a segment of population in the USA that is refusing to be vaccinated as of June 2021. To deal with this challenge lotteries have been established [1].
The lottery versus no lottery tradeoff is very simple. A $1 million dollar vaccine lottery winner is taking away 100,000 vaccines from the people who want the vaccine but are unable to gain access to the vaccine because of financial reasons. The tradeoff of 1 life versus 100,000 lives is obvious and rather disgusting. Yet there are many articles suggesting that this is appropriate because others will enter the the lottery at the possibility of winning $1 million dollars. The $1 million dollars needs to attract 100,000+ participants. A bigger question is why would a society reward toxic people driven by extreme self interest who reject life saving measures? This is yet another indication that COVID-19 is a symptom of a much bigger problem [2].
Some might suggest that a vaccine lottery is rewarding good behavior, however that is incorrect. The root cause analysis clearly shows that refusing to get a vaccine in the first place is bad behavior, assuming there is no health condition that would warrant not taking the vaccine. As a result any lottery of this type rewards bad behavior. Rewarding bad behavior at the government level is extremely bad and toxic policy. Bad and toxic policies will eventually lead to social disaster. This is just simple root cause and effect systems analysis.
To vaccinate all the people on Earth, assuming 8 billion people at $10 per shot, the cost is just $160 billion dollars for a double shot. This assumes the existing infrastructure to deliver the shots is used, but even if additional infrastructure is needed to deliver the shots, it is difficult to see the costs going much beyond the costs of the actual shots. We also see that for the industrialized nations, where the economies are dependent on safe buildings, the costs associated with upgraded ventilation is also trivial once compared to other challenges like the war in Afghanistan or Global Warming. Yet two years into the COVID-19 disaster there has been no social will to roll out the technology and solve the problem that is the COVID-19 pandemic.
The social challenge associated with the toxic people in the United States needs to be addressed from a broader perspective. Providing financial incentives to people to get vaccinated is extremely unethical and immoral. Those financial resources should be applied to providing the vaccine to the populations that are unable to gain access to the vaccine. History will record this toxic management approach and it will be used for hundreds of years to show future generations the reason for the COVID-19 disaster was not an absence of capability, technology, and science but an absence of decency and humanity as self interest caused massive death and suffering.
References:
[1] Lotteries as public health incentives began before covid-19, Washington Post, June 20, 2021. webpage https://www.washingtonpost.com/world/2021/06/20/health-lotteries-global, July 2021. Lotteries as public health incentives began before covid-19.
[2] See section Recent Mega Trends.
President Bidens COVID-19 Action Plan
On September 9, 2021 President Biden took action and announced a number of policy decisions to be implemented via Executive Orders to get the people in the US vaccinated. The expectation is that these policy decisions will have a massive positive impact on ending the COVID-19 Disaster. It is unclear if these policy decisions do enough or if more is needed especially to prevent some people from sabotaging the system and preventing the end of the COVID-19 Disaster. [1]
The following is President Bidens COVID-19 Action Plan [2]:
*** START ***
Path out of the Pandemic
PRESIDENT BIDEN'S COVID-19 ACTION PLAN
President Biden is implementing a six-pronged, comprehensive national strategy that employs the same science-based approach that was used to successfully combat previous variants of COVID-19 earlier this year. This plan will ensure that we are using every available tool to combat COVID-19 and save even more lives in the months ahead, while also keeping schools open and safe, and protecting our economy from lockdowns and damage.
Vaccinating the Unvaccinated
Since January, the Administration has taken actions to make vaccination conveniently available to all. COVID vaccines have been available to every individual age 16 and older since April 19th and to those age 12 and older since May. The Administration took steps to make vaccines available at over 80,000 locations nationwide, worked with pharmacies to offer walk-in appointments, and put out a call to action to businesses and organizations across the nation.
The President announced vaccination requirements for the federal government in July and called on the private sector to do more to encourage vaccination as well. Since that time, employers, schools, nursing homes, restaurants, hospitals, and cities in all 50 states have announced new vaccination requirements. Since July, the share of job postings that require vaccination are up 90%. And we know these requirements work. At the beginning of August, when Tyson Foods announced its requirement only 45% of its workforce had gotten a shot. Today, it stands at 72%, meaning half of Tyson's unvaccinated workers have now gotten a shot well ahead of the company's November 1^st deadline. After United Airlines announced its vaccination requirement, more than half of its unvaccinated employees went out and got vaccinated with weeks left to go before the deadline. In Washington State, the weekly vaccination rate jumped 34% after the Governor announced requirements for state workers.
All told, these efforts and countless other Administration initiatives and policies have resulted in over 175 million fully vaccinated Americans. But there are still nearly 80 million Americans eligible to be vaccinated who have not yet gotten their first shot.
The President's plan will reduce the number of unvaccinated Americans by using regulatory powers and other actions to substantially increase the number of Americans covered by vaccination requirements these requirements will become dominant in the workplace. In addition, the plan will provide paid time off for vaccination for most workers in the country.
Requiring All Employers with 100+ Employees to Ensure their Workers are Vaccinated or Tested Weekly
The Department of Labor's Occupational Safety and Health Administration (OSHA) is developing a rule that will require all employers with 100 or more employees to ensure their workforce is fully vaccinated or require any workers who remain unvaccinated to produce a negative test result on at least a weekly basis before coming to work. OSHA will issue an Emergency Temporary Standard (ETS) to implement this requirement. This requirement will impact over 80 million workers in private sector businesses with 100+ employees.
Requiring Vaccinations for all Federal Workers and for Millions of Contractors that Do Business with the Federal Government
Building on the President's announcement in July to strengthen safety requirements for unvaccinated federal workers, the President has signed an Executive Order to take those actions a step further and require all federal executive branch workers to be vaccinated. The President also signed an Executive Order directing that this standard be extended to employees of contractors that do business with the federal government. As part of this effort, the Department of Defense, the Department of Veterans Affairs, the Indian Health Service, and the National Institute of Health will complete implementation of their previously announced vaccination requirements that cover 2.5 million people.
Requiring COVID-19 Vaccinations for Over 17 Million Health Care Workers at Medicare and Medicaid Participating Hospitals and Other Health Care Settings
The Centers for Medicare & Medicaid Services (CMS) is taking action to require COVID-19 vaccinations for workers in most health care settings that receive Medicare or Medicaid reimbursement, including but not limited to hospitals, dialysis facilities, ambulatory surgical settings, and home health agencies. This action builds on the vaccination requirement for nursing facilities recently announced by CMS, and will apply to nursing home staff as well as staff in hospitals and other CMS-regulated settings, including clinical staff, individuals providing services under arrangements, volunteers, and staff who are not involved in direct patient, resident, or client care. These requirements will apply to approximately 50,000 providers and cover a majority of health care workers across the country. Some facilities and states have begun to adopt hospital staff or health care sector vaccination mandates. This action will create a consistent standard across the country, while giving patients assurance of the vaccination status of those delivering care.
Calling on Large Entertainment Venues to Require Proof of Vaccination or Testing for Entry
The President's plan calls on entertainment venues like sports arenas, large concert halls, and other venues where large groups of people gather to require that their patrons be vaccinated or show a negative test for entry.
Requiring Employers to Provide Paid Time Off to Get Vaccinated
To continue efforts to ensure that no worker loses a dollar of pay because they get vaccinated, OSHA is developing a rule that will require employers with more than 100 employees to provide paid time off for the time it takes for workers to get vaccinated or to recover if they are under the weather post-vaccination. This requirement will be implemented through the ETS.
Further Protecting the Vaccinated
There are over 175 million fully vaccinated Americans who are largely protected from severe illness from COVID-19. While so-called breakthrough infections among this group do happen, they remain the exception: In fact, recent data indicates there is only 1 confirmed positive case per 5,000 fully vaccinated Americans per week.
But COVID-19 vaccination protection can be made even stronger. In August, the nation's top health officials Dr. Rochelle Walensky, CDC Director; Dr. Janet Woodcock, Acting FDA Commissioner; Dr. Francis Collins, NIH Director; Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases; Surgeon General Dr. Vivek Murthy; Dr. David Kessler, COVID-19 Chief Science Officer; Dr. Rachel Levine, HHS Assistant Secretary for Health; and Dr. Marcella Nunez-Smith, Chair of the COVID-19 Health Equity Task Force released an initial plan for booster shots aimed at staying ahead of the virus. The plan released by our nation's doctors allows for states, pharmacies, doctors' offices, health insurers and others to prepare for the administration of boosters. In the beginning weeks of the initial vaccination program in December 2020, the country lost precious time because we were unprepared to administer shots. By planning now, we will be able to quickly get booster shots into the arms of eligible Americans once approved.
A booster promises to give Americans their highest level of protection yet. Three-shot vaccines are common (Hepatitis B, Tetanus) and offer some of the most durable and robust protection.
Implementation of this plan depends on authorization of boosters by the Food and Drug Administration (FDA) and recommendations by the CDC's independent Advisory Committee on Immunization Practices (ACIP). As soon as authorizations are given, the Administration will be prepared to offer booster shots, starting the week of September 20th .
Providing Easy Access to Booster Shots for All Eligible Americans
The Administration is preparing for boosters to start as early as the week of September 20th , subject to authorization or approval by the FDA and a recommendation from ACIP. Getting a booster will be easy. Booster shots will be free, and widely available across 80,000 locations from pharmacies to doctors' offices to health centers.
Ensuring Americans Know Where to Get a Booster
In the initial vaccine roll-out in December, many Americans were confused about available vaccination sites and supplies. But now, when the booster shots are approved, individuals will be able to find a vaccination site at Vaccines.gov, including what vaccines are available at each site and, for many sites, what appointments are open. A toll-free number, 1-800-232-0233, will also be available in over 150 languages. Americans who have already utilized the text code 438829 or WhatsApp to get vaccine information will automatically receive a text with information on boosters, if and when recommended.
Keeping Schools Safely Open
A top priority for the Biden Administration since Day One has been to reopen schools safely and keep them open. The Administration has taken significant actions to get our kids back in the classroom, including providing $130 billion in American Rescue Plan (ARP) funds to help schools reopen, accelerate students' academic growth, address inequities exacerbated by the pandemic, allow local school districts to implement CDC-recommended COVID-19 prevention strategies, and support student and educators' social, emotional, and mental health needs. We know how to keep students safe in schools by taking the right steps to prevent transmission including getting all staff and eligible students vaccinated, implementing universal indoor masking, maintaining physical distancing, improving ventilation, and performing regular screening testing for students and school staff. The President's plan calls for additional actions to ensure all schools consistently implement these science-based prevention strategies recommended by the CDC so that they can remain open for in-person learning and maintain the health and safety of all students, staff, and families.
As we work to ensure our children are protected, we know that vaccination remains the best line of defense against COVID-19. For those adolescents aged 12 and above who are eligible for vaccination, the most important step parents can take is to get them vaccinated. To date, over half of the nation's adolescents have been vaccinated. For those too young to be vaccinated, it is especially critical that they are surrounded by vaccinated people and mask in public indoor spaces, including schools. Studies released by the CDC found that the rate of hospitalization for children was nearly four times higher in states with the lowest vaccination rates compared to states with high vaccination rates.
The FDA is undergoing a process now to evaluate a vaccine for children under the age of 12, and under the President's plan, the Administration will do whatever it takes to support those efforts, while continuing to respect and defer to the scientific decision-making of the agency.
Requiring Staff in Head Start Programs, Department of Defense Schools, and Bureau of Indian Education-Operated Schools to be Vaccinated
To help ensure the safety of students, families, and their communities, the President's plan includes requirements that teachers and staff at Head Start and Early Head Start programs, teachers and child and youth program personnel at the Department of Defense (DOD), and teachers and staff at Bureau of Indian Education-operated schools get vaccinated. The Department of Health and Human Services (HHS) will initiate rulemaking to implement this policy for Head Start and Early Head Start programs, which provide comprehensive education and child development services to ensure that children are well prepared for kindergarten. The Department of Defense operates 160 K-12 schools for students from military families across the U.S. and abroad, and the Department of the Interior operates 53 schools through the Bureau of Indian Education (BIE) across the U.S. on and off tribal lands. These schools and programs collectively serve more than 1 million children each year and employ nearly 300,000 staff. This action will help more schools and early childhood centers safely remain open and give comfort to the many parents that rely on them every day to keep their children safe.
Calling on All States to Adopt Vaccine Requirements for All School Employees
Scientific studies have shown that even one unvaccinated teacher can lead to dozens of sick school children. This is a completely avoidable outcome, and we can protect kids especially those in elementary schools and early childhood education and child care centers where children are not yet eligible for the vaccine by surrounding them with fully vaccinated adults as the first line of defense against COVID-19. In order to keep all children safely learning in school, the President's plan calls for Governors to require vaccinations for teachers and school staff. Currently, nine states, as well as the District of Columbia and Puerto Rico, have vaccination requirements for K-12 school staff, including California, Connecticut, Hawaii, Illinois, New Jersey, New Mexico, New York, Oregon, and Washington. Building on Administration policies to require vaccination among federal employees, including those serving children in DOD and BIE schools, the President is asking more states to join in requiring the vaccine for school employees to make sure we are keeping students safe.
Providing Additional Funding to School Districts for Safe School Reopening, Including Backfilling Salaries and Other Funding Withheld by States for Implementing COVID Safety Measures
The American Rescue Plan provides $130 billion to states, school districts, and tribes to support the safe reopening of schools. The President has previously announced that, if a state cuts the funding to a local school district or the pay of a local education leader who is implementing CDC-recommended prevention strategies like universal masking, the school district may use ARP funds to fill those gaps. School districts can begin spending their ARP funds right away, including to reimburse for any allowable cost dating back to when the national emergency for COVID-19 was declared. In addition, through the President's plan, the Department of Education plans to make additional funding available beyond the ARP dollars to help local school districts fill gaps when funding has been withheld by their state for implementing COVID safety measures. Local school districts will be able to apply to the Department of Education in the coming weeks to restore funding withheld by state leaders such as for school board member or superintendent salaries who have had their pay cut when a school district implemented strategies to help prevent the spread of COVID-19 in schools.
Using the Department of Education's Full Legal Authority to Protect Students' Access to In-Person Instruction
President Biden has directed the Department of Education to assess all of its available tools to take action, as appropriate and consistent with applicable law, to ensure that state and local officials are giving all students the opportunity to safely participate in full-time, in-person learning. To date, the Department has launched investigations in five states that have prohibited mask mandates at schools: Iowa, Oklahoma, South Carolina, Tennessee, and Utah. These investigations will examine whether statewide mask mandate prohibitions discriminate against students with disabilities who are at heightened risk for severe illness from COVID-19 by preventing them from safely accessing in-person education.
Getting Students and School Staff Tested Regularly
In April, HHS provided $10 billion in funding for COVID-19 screening testing for teachers, staff, and students in K-12 schools. As schools return to in-person learning, the Administration is calling on all schools to set up regular testing in their schools for students, teachers, and staff consistent with CDC guidance. CDC currently recommends that screening testing should be offered to students who have not been fully vaccinated when community transmission is at moderate, substantial, or high levels; and screening testing should be offered to all teachers and staff who have not been fully vaccinated at any level of community transmission. In combination with promoting and providing access to vaccination to all eligible members of a school community, schools will better be able to remain open for in-person learning and maintain the health and safety of all students, staff, and families. HHS and the CDC will continue to provide assistance to schools to accelerate the establishment of screening testing programs in all schools.
Providing Every Resource to the FDA to Support Timely Review of Vaccines for Individuals Under the Age of 12
President Biden's plan supports the independent scientific review of a vaccine for those individuals under the age of 12 and will provide the FDA with any needed resources to support its ongoing efforts to do this safely and as quickly as possible. The nation's public health officials will keep the public updated on the process so that parents can plan.
Increasing Testing & Requiring Masking
It will take time for the newly vaccinated to get protection from the virus. As we continue to combat COVID-19, testing is a key tool to identify infected individuals and prevent spread to others. Likewise, masking can also help slow and contain the spread of the virus and the combination of increased vaccinations and masking will have a major impact on COVID-19 transmission. President Biden's plan takes new actions to increase the amount of testing in your own home, at pharmacies, and in your doctor's office and ensures that strong mask requirements remain in place.
Mobilizing Industry to Expand Easy-to-Use Testing Production
President Biden's plan will mobilize industry due to the urgent and compelling need to accelerate the production of rapid COVID-19 tests, including at-home tests, and continue to ensure that manufacturers prioritize creating these products to prevent the spread of COVID-19 and its variants. Using authorities of the Defense Production Act and through the procurement of nearly $2 billion in rapid point-of-care and over-the-counter at-home COVID tests 280 million tests in all from multiple COVID-19 test manufacturers, the Administration will ensure a broad, sustained industrial capacity for COVID-19 test manufacturing. These tests will be available to support a range of needs, including long-term care facilities, community testing sites, critical infrastructure, shelters serving individuals experiencing homelessness, prisons and jails, and other vulnerable populations and congregate settings. Further, the action announced today will provide for tests for use by communities, adequate stockpiles, and the needed sustained production to be able to surge additional manufacturing, should we need it in the future.
Making At-Home Tests More Affordable
To improve access to rapid tests for all consumers, top retailers that sell at-home, rapid COVID-19 tests Walmart, Amazon, and Kroger will offer to sell those tests at-cost for the next three months. This means that Americans will be able to buy these tests at their local retailers or online for up to 35 percent less starting by the end of this week. The Administration has also taken action so that Medicaid must cover at-home tests for free for beneficiaries, and that states should ensure that any tools they use to manage at-home testing do not establish arbitrary barriers for people seeking care.
Sending Free Rapid, At-Home Tests to Food Banks and Community Health Centers
To ensure that every American no matter their income level can access free, convenient, at-home tests, we will send 25 million free at-home rapid tests to 1,400 community health centers and hundreds of food banks.
Expanding Free, Pharmacy Testing
As part of our strategy to ensure the most convenient access to free testing, we will expand the number of retail pharmacy sites around the country where anyone can get tested for free through the HHS free testing program to 10,000 pharmacies.
Continuing to Require Masking for Interstate Travel and Double Fines
President Biden's Executive Order, /Promoting COVID-19 Safety in Domestic and International Travel/, directed applicable agencies to take action to require mask-wearing in airports and on certain modes of public transportation, including on many airplanes, trains, maritime vessels, and intercity bus services. TSA has extended its implementing orders for air and ground travel through January 18th, 2022, and the President's plan will double fines for those who are not in compliance. The President's plan will also ensure that masking requirements remain in place on the other modes of transportation as we continue to battle COVID-19.
Continue to Require Masking on Federal Property
President Biden's Executive Order, /Protecting the Federal Workforce and Requiring Mask-Wearing, /requires masks and specific physical distancing requirements in federal buildings, on federal lands, on military bases, and other overseas locations, consistent with CDC guidance. President Biden's plan will ensure that these requirements remain in place as we continue to battle COVID-19.
Protecting Our Economic Recovery
President Biden's economic plan is working. Since Day One in office, the President has focused on jumpstarting the economy and rebuilding it from the bottom up and the middle out. America is getting back to work, and workers and small businesses are seeing the results. Since President Biden took office, there has been historic job growth more than 4 million jobs created the most in any President's first six months, with 750,000 jobs created on average per month over the last three months. Despite the challenges posed by the Delta variant, the economy created 235,000 jobs last month, and the unemployment rate fell to its lowest level since before the pandemic. The average number of new unemployment insurance claims has been cut by more than half since President Biden took office, and more than 70 percent of Americans say that now is a good time to find a quality job, up from less than 30 percent this time last year. The U.S. is the only major economy that has now exceeded its pre-pandemic growth projections, and independent forecasters believe America will this year reach the highest levels of growth in decades.
COVID-19 impacts our economy, no doubt. But, the President's plan will limit the damage and ensure that the Delta variant cannot undo this progress. The policies outlined throughout this plan will ensure that we do not return to lockdowns and shutdowns. Additionally, we will offer new support to small businesses as they continue to weather the surge caused by the Delta variant. Supporting small businesses is critical to our economic growth, since they create two-thirds of net new jobs and employ nearly half of America's private workforce. These reforms include:
New Support for Small Businesses Impacted by COVID-19
The President's plan will help more than 150,000 small businesses by strengthening the COVID Economic Injury Disaster Loan (EIDL) program, which provides long-term, low-cost loans. The improvements will allow more business to get greater and more flexible support from the $150 billion in loanable funds still available in the program. First, the Small Business Administration (SBA) will increase the maximum amount of funding a small business can borrow through this program from $500,000 to $2 million, which can be used to hire and retain employees, purchase inventory and equipment, and pay off higher-interest debt. This increase will help small businesses: an SBA analysis of current COVID EIDL borrowers who qualify for the increase shows that more than 80% have 25 employees or less. SBA will ensure that no small business has to start repaying these loans until two years after they receive the funding, so small businesses can get through the pandemic without having to worry about making payments. Next, SBA will make it easier for small businesses with multiple locations in hard-hit sectors like restaurants, hotels, and gyms to access these loans. To ensure that taxpayer dollars are used to support businesses that truly need help, SBA has implemented tightened controls and will collaborate closely with the SBA Inspector General to monitor the program. And lastly, to ensure that Main Street businesses have additional time to access remaining funds, SBA will offer a 30-day exclusive window of access where only small businesses seeking loans of $500,000 or less will receive awards after the new improved loan product launches.
Streamlining the Paycheck Protection Program (PPP) Loan Forgiveness Process
Through the PPP, the SBA has made more than 11 million loans to small businesses that can be forgiven and taken off of their books if they use the funds to keep employees on payroll. In order to receive forgiveness, borrowers have to complete an application with their PPP lender. The President's plan will make it easier for more than 3.5 million PPP borrowers with loans of $150,000 or less to get their loans wiped clean. Under the new streamlined approach, SBA sends a pre-completed application form to the borrower who can review, sign, and send back to SBA, which then works with the lender to complete the forgiveness process. Since launching this new process on August 4th , more than 820,000 small businesses have applied for forgiveness, with borrowers spending an average of 6 minutes on the application and 60% of applicants completing the process on their mobile phone. SBA expects more than 2.5 million additional small businesses to take advantage of this streamlined process in the months ahead, helping them avoid needless bureaucracy and avoid costly principal and interest payments on their loans.
Launching the Community Navigator Program to Connect Small Businesses to the Help They Need
The ARP invested $100 million to establish a new SBA Community Navigator program, which will deploy trusted community partners in underserved communities to better connect business owners to federal, state, and local resources. Community Navigators will work with small business owners every step of the way to ensure that they are able to access the help that they need. Under the President's plan, the SBA will complete the competitive review process to select Community Navigators and put them to work in underserved communities this Fall.
Improving Care for those with COVID-19
As we work to reduce cases, hospitalizations, and deaths, we will maintain our focus on treating people infected with COVID-19 and helping hard-hit health care systems in the most impacted areas. In early July, the Administration launched Surge Response Teams to help states experiencing case increases. Since then, the Administration has worked with 18 states, deploying nearly 1,000 personnel, including hundreds of EMTs, nurses and doctors on the ground providing emergency medical care; surged hundreds of ventilators, ambulances and other critical assets to support strained health care systems; stood up dozens of new, free testing sites; and assisted with local outbreak investigations.
As we continue to battle the Delta surge, the President's plan will continue to send response teams to states that request them and take additional actions to accelerate this work.
Increasing Support for COVID-Burdened Hospitals
The President's plan will provide additional support for hospitals facing capacity issues. The Department of Defense is announcing a commitment to double the number of DOD teams of clinicians deployed to support hospitals battling a surge in COVID-19 cases. These clinicians will be available for mission assignment through FEMA's response across surge states. Since the Administration launched the COVID-19 Surge Response Teams, nearly 1000 personnel have been deployed to states across the country to respond to the Delta variant, including more than 500 highly skilled health care professionals from across HHS' network of physicians, nurses, and other providers who are called up to respond to emergencies, FEMA's network of emergency medical services providers, and DOD's medical teams. These professionals have surged into COVID-19 ICUs and other acute care hospital settings to support and relieve overburdened local health care workers. In addition, the Department of Veterans Affairs have opened up over 150 hospital beds in Veterans Affairs' facilities across surge states in order to reduce the burden on local hospitals.
Getting Life-Saving Monoclonal Antibody Treatment to Those Who Need It
The United States government shipped an average of approximately 100,000 doses of monoclonal antibodies per week across July and August. The Administration will increase the average weekly pace of shipments of free monoclonal antibody treatment to states by a further 50% in September, continuing to accelerate the federal government's efforts to deliver lifesaving COVID-19 treatment. Monoclonal antibody treatments have been shown to reduce the risk of hospitalization by up to 70% for unvaccinated people at risk of developing severe disease. As hospital systems experience increased COVID-19 cases, many have identified monoclonal antibody treatment as a key tool to improve health outcomes, prevent hospitalizations and reduce the strain on overburdened hospitals.
Expanding the Pool of Health Care Professionals Providing Treatment by Deploying Federal Monoclonal Antibody Strike Teams
The COVID-19 Surge Response Teams have conducted in-person technical assistance and virtual trainings for physicians and health system officials to increase education and interest in administering these treatments. To ensure that more patients can access these lifesaving COVID-19 therapeutics, the Administration's COVID-19 surge response effort will launch monoclonal antibody strike teams to deploy clinical personnel through HHS, FEMA, and DOD to help hospitals and health systems stand up the delivery of this key treatment option. HHS will also take action to amend the Public Readiness and Emergency Preparedness (PREP) Act declaration to allow more providers, including pharmacists, to administer this treatment. These actions will ensure that more patients receive lifesaving treatments if they are infected or exposed to COVID-19.
President Biden’s plan to continue to combat COVID-19 this fall is comprehensive, science-based and relies on the power of the federal government working hand-in-hand with states, local communities, the private sector, and all Americans to put this pandemic behind us. The strategy outlined here is domestic focused. In the weeks ahead, the President will announce additional steps to build on the progress the Administration has made to combat this pandemic globally. President Biden and his Administration will continue to use every tool necessary to protect the American people from COVID-19.
The White House
1600 Pennsylvania Ave NW
Washington, DC 20500
*** END ***
The Presidents plan is specifically addressing actions by some states to cut funding if they follow Federal Government CDC recommendations. It is part of the Presidents plan under the category of: Providing Additional Funding to School Districts for Safe School Reopening, Including Backfilling Salaries and Other Funding Withheld by States for Implementing COVID Safety Measures. The President previously announced that, if a state cuts the funding to a local school district or the pay of a local education leader who is implementing CDC recommended prevention strategies like universal masking, the school district may use federal funds to fill those gaps.
It is unclear if these policy decisions do enough or if more is needed, especially to prevent some people from sabotaging the system and preventing the end of the COVID-19 Disaster.
The sabotage scenario is very real because of evidence of disinformation and resistance from many in the conservative right leadership that inflames their followers and prevents measures from being enacted to fight the COVID-19 virus. The resistance has even gone as far as passing state level legislation to sabotage the efforts to stop the COVID-19 disaster by not following Federal Government CDC recommendations. There appears to be an organized attempt to destroy this presidency at any cost in anticipation of the next election cycle. If people die in this scenario, it is unclear if the leaders responsible for this legislation e can be held accountable for violating multiple laws including Involuntary Manslaughter (Criminally Negligent) and or various violations of the US Federal Constitution.
References:
[1] Attacking anti-vaxxers, Biden mandates widespread COVID shots, tests, Reuters, September 09, 2021. webpage https://www.reuters.com/world/us/biden-deliver-six-step-plan-covid-19-pandemic-2021-09-09, September 2021. Attacking anti-vaxxers, Biden mandates widespread COVID shots, tests.
[2] President Biden's COVID-19 Action Plan, The White House, 1600 Pennsylvania Ave NW, Washington, DC 20500, September 09,2021. webpage https://www.whitehouse.gov/covidplan, September 2021. President Biden's COVID-19 Action Plan.
FDA Approval of Pfizer-BioNTech
On August 23, 2021, the FDA approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty, for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals. [1]
FDA News Release [2]
FDA Approves First COVID-19 Vaccine
Approval Signifies Key Achievement for Public Health
For Immediate Release:
August 23, 2021
Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.
The FDA's approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA's rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product, said Acting FDA Commissioner Janet Woodcock, M.D. While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today's milestone puts us one step closer to altering the course of this pandemic in the U.S.
Since Dec. 11, 2020, the Pfizer-BioNTech COVID-19 Vaccine has been available under EUA in individuals 16 years of age and older, and the authorization was expanded to include those 12 through 15 years of age on May 10, 2021. EUAs can be used by the FDA during public health emergencies to provide access to medical products that may be effective in preventing, diagnosing, or treating a disease, provided that the FDA determines that the known and potential benefits of a product, when used to prevent, diagnose, or treat the disease, outweigh the known and potential risks of the product.
FDA-approved vaccines undergo the agency's standard process for reviewing the quality, safety and effectiveness of medical products. For all vaccines, the FDA evaluates data and information included in the manufacturer's submission of a biologics license application (BLA). A BLA is a comprehensive document that is submitted to the agency providing very specific requirements. For Comirnaty, the BLA builds on the extensive data and information previously submitted that supported the EUA, such as preclinical and clinical data and information, as well as details of the manufacturing process, vaccine testing results to ensure vaccine quality, and inspections of the sites where the vaccine is made. The agency conducts its own analyses of the information in the BLA to make sure the vaccine is safe and effective and meets the FDA's standards for approval.
Comirnaty contains messenger RNA (mRNA), a kind of genetic material. The mRNA is used by the body to make a mimic of one of the proteins in the virus that causes COVID-19. The result of a person receiving this vaccine is that their immune system will ultimately react defensively to the virus that causes COVID-19. The mRNA in Comirnaty is only present in the body for a short time and is not incorporated into - nor does it alter - an individual's genetic material. Comirnaty has the same formulation as the EUA vaccine and is administered as a series of two doses, three weeks apart.
Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine. We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty's safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities, said Peter Marks, M.D., Ph.D., director of FDA's Center for Biologics Evaluation and Research. We have not lost sight that the COVID-19 public health crisis continues in the U.S. and that the public is counting on safe and effective vaccines. The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S."
FDA Evaluation of Safety and Effectiveness Data for Approval for 16 Years of Age and Older
The first EUA, issued Dec. 11, for the Pfizer-BioNTech COVID-19 Vaccine for individuals 16 years of age and older was based on safety and effectiveness data from a randomized, controlled, blinded ongoing clinical trial of thousands of individuals.
To support the FDA's approval decision today, the FDA reviewed updated data from the clinical trial which supported the EUA and included a longer duration of follow-up in a larger clinical trial population.
Specifically, in the FDA's review for approval, the agency analyzed effectiveness data from approximately 20,000 vaccine and 20,000 placebo recipients ages 16 and older who did not have evidence of the COVID-19 virus infection within a week of receiving the second dose. The safety of Comirnaty was evaluated in approximately 22,000 people who received the vaccine and 22,000 people who received a placebo 16 years of age and older.
Based on results from the clinical trial, the vaccine was 91% effective in preventing COVID-19 disease.
More than half of the clinical trial participants were followed for safety outcomes for at least four months after the second dose. Overall, approximately 12,000 recipients have been followed for at least 6 months.
The most commonly reported side effects by those clinical trial participants who received Comirnaty were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever. The vaccine is effective in preventing COVID-19 and potentially serious outcomes including hospitalization and death.
Additionally, the FDA conducted a rigorous evaluation of the post-authorization safety surveillance data pertaining to myocarditis and pericarditis following administration of the Pfizer-BioNTech COVID-19 Vaccine and has determined that the data demonstrate increased risks, particularly within the seven days following the second dose. The observed risk is higher among males under 40 years of age compared to females and older males. The observed risk is highest in males 12 through 17 years of age. Available data from short-term follow-up suggest that most individuals have had resolution of symptoms. However, some individuals required intensive care support. Information is not yet available about potential long-term health outcomes. The Comirnaty Prescribing Information includes a warning about these risks.
Ongoing Safety Monitoring
The FDA and Centers for Disease Control and Prevention have monitoring systems in place to ensure that any safety concerns continue to be identified and evaluated in a timely manner. In addition, the FDA is requiring the company to conduct postmarketing studies to further assess the risks of myocarditis and pericarditis following vaccination with Comirnaty. These studies will include an evaluation of long-term outcomes among individuals who develop myocarditis following vaccination with Comirnaty. In addition, although not FDA requirements, the company has committed to additional post-marketing safety studies, including conducting a pregnancy registry study to evaluate pregnancy and infant outcomes after receipt of Comirnaty during pregnancy.
The FDA granted this application Priority Review. The approval was granted to BioNTech Manufacturing GmbH.
Related Information
Comirnaty Prescribing Information
Cormirnaty and Pfizer-BioNTech COVID-19 Vaccine | FDA
###
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
###
References:
[1] Comirnaty and Pfizer-BioNTech COVID-19 Vaccine, FDA, August 23, 2021. webpage https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/comirnaty-and-pfizer-biontech-covid-19-vaccine, August 2021. Comirnaty and Pfizer-BioNTech COVID-19 Vaccine.
[2] FDA Approves First COVID-19 Vaccine, FDA News Release, August 23, 2021. webpage https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine, August 2021. FDA Approves First COVID-19 Vaccine.
There is data associated with the ability of the vaccines to protect people. As of April 26, 2021, more than 95 million people in the United States were fully vaccinated against COVID-19. During the same time, the CDC received reports of vaccine breakthrough infections from 46 U.S. states and territories. [3]
The following table shows the vaccine breakthrough data. [spreadsheet Vac BTI]
CDC Vaccine Breakthrough Infections Data |
April 26, 2021 |
| Fully vaccinated | 95,000,000 |
Total number of vaccine breakthrough infections reported to CDC |
9,245 |
Females |
5,827 (63%) |
People aged =60 years |
4,245 (45%) |
Asymptomatic infections |
2,525 (27%) |
Hospitalizations |
835 (9%) note 1 |
Deaths |
132 (1%) note 2 |
| Personal COVID-19 Death Chance with Vaccine | 0.0000014 |
| Personal System Health Availability with Vaccine | 0.9999986 |
Notes:
1. Of the 835 hospitalizations, 241 (29%) were reported as asymptomatic or
not related to COVID-19.
2. Of the 132 fatal cases, 20 (15%) were reported as asymptomatic or not
related to COVID-19.
The odds of death from the vaccine are very small compared to other odds of death statistics. There is a greater chance of death from a lightening strike than from the current Vaccine Breakthrough deaths. The lifetime odds of death for selected causes in the United States are as follows [4]. [spreadsheet Vac BTI]
Cause of Death |
Odds of Dying |
Heart disease |
1 in 6 |
Cancer |
1 in 7 |
All preventable causes of death |
1 in 24 |
Chronic lower respiratory disease |
1 in 27 |
Suicide |
1 in 88 |
Opioid overdose |
1 in 92 |
Fall |
1 in 106 |
Motor vehicle crash |
1 in 107 |
Gun assault |
1 in 289 |
Pedestrian incident |
1 in 543 |
Motorcyclist |
1 in 899 |
Drowning |
1 in 1,128 |
Fire or smoke |
1 in 1,547 |
Choking on food |
1 in 2,535 |
Bicyclist |
1 in 3,825 |
Sunstroke |
1 in 8,248 |
Accidental gun discharge |
1 in 8,571 |
Electrocution, radiation, extreme temperatures, and pressure |
1 in 13,394 |
Sharp objects |
1 in 29,334 |
Cataclysmic storm |
1 in 58,669 |
Hornet, wasp, and bee stings |
1 in 59,507 |
Hot surfaces and substances |
1 in 63,113 |
Dog attack |
1 in 86,781 |
Lightning |
1 in 138,849 |
Vaccine Breakthrough Deaths (see above April 26, 2021) |
1 in 719,697 |
It is reasonable to assume that the breakthrough infections were associated with small indoor spaces, but no data was provided to confirm that assumption.
In 2020 this systems analysis investigated various living scenarios and applied the Wells-Riley equation to determine the probability of infection. The probability of infection was then used to predict various system outcomes where the system boundary was the entire USA. Different system technologies where then applied to determine the level of mitigation of the COVID-19 virus. The technologies included vaccines, HVAC systems, Ceiling Level UV-C systems, and FAR UV-222 systems [1] [2].
This analysis revisits the various living scenarios and treats each living scenario as a standalone system. A new system boundary is then introduced associated with each unique individual. The system performance is then determined using the probability of infection to calculate a new set of system performance numbers. The new performance numbers are:
Infection Visits: This is how many visits to this System (scenario) before there is 100% probability of infection. A good way to view this number is in terms of weeks, months, and years.Health Availability: This is a measure of the effectiveness of the system in mitigating the chance of infection. It comes from the system reliability area where system availability and unavailability are calculated. In this case this is a measure of the system to mitigate the virus. Its meaning becomes relevant when it is compared with mission critical system availability numbers. These are systems where loss of life is possible if they fail. These mission critical systems are designed to have what is called six nines five (six 9s five) availability; this number is represented as .999 999 5. This is a very difficult number to achieve but it does exist in the infrastructure. In some cases of a disaster, an emergency system mode of operation has an availability of five 9s five which is .999 995.
COVID-19 Death Chance: Just because there is the chance of COVID-19 infection, it does not mean that it will result in death. With the vaccine(s), the chance of death is significantly lower.
[spreadsheet Probability]
System (scenario treated as standalone system) |
COVID -19 People |
Time hour |
Masks |
Probability of Infection Wells-Riley Equation |
Space cu-ft |
AUC |
Infection Visits |
Infection Visits |
Infection Visits |
System Health Availability 1-P |
System Health Availability Vaccine @90% |
System Health Availability with UV @90% |
Personal COVID-19 Death Chance with Vaccine |
Personal System Health Availability with Vaccine |
Small indoor space |
2 |
1 |
Yes |
6% |
10,800 |
1 |
16 |
160 |
1,600 |
0.9375024 |
0.9937502 |
0.9993750 |
0.0000014 |
0.9999986 |
Small indoor space |
1 |
1 |
Yes |
6% |
10,800 |
1 |
16 |
161 |
1,610 |
0.9378875 |
0.9937887 |
0.9993789 |
see row 1 |
see row 1 |
Small indoor space Small Restaurant Not sure how to eat with a mask |
1 |
1 |
Yes |
4% |
10,800 |
4 |
22 |
222 |
2,224 |
0.9550374 |
0.9955037 |
0.9995504 |
see row 1 |
see row 1 |
Small indoor space Small Restaurant Reality no mask while eating |
1 |
1 |
No |
72% |
10,800 |
4 |
1 |
14 |
139 |
0.2805977 |
0.9280598 |
0.9928060 |
see row 1 |
see row 1 |
Small indoor space |
1 |
1 |
Yes |
2% |
10,800 |
10 |
40 |
402 |
4,015 |
0.9750936 |
0.9975094 |
0.9997509 |
see row 1 |
see row 1 |
Small indoor space |
1 |
1 |
Yes |
1% |
10,800 |
40 |
134 |
1,341 |
13,407 |
0.9925413 |
0.9992541 |
0.9999254 |
see row 1 |
see row 1 |
| . | ||||||||||||||
Large indoor space |
2 |
1 |
Yes |
2% |
400,000 |
1 |
67 |
667 |
6,665 |
0.9849970 |
0.9984997 |
0.9998500 |
0.0000000 |
1.0000000 |
Large indoor space |
1 |
1 |
Yes |
1% |
400,000 |
1 |
125 |
1,248 |
12,476 |
0.9919845 |
0.9991985 |
0.9999198 |
0.0000000 |
1.0000000 |
Large indoor space |
1 |
1 |
Yes |
0% |
400,000 |
4 |
474 |
4,743 |
47,435 |
0.9978918 |
0.9997892 |
0.9999789 |
0.0000000 |
1.0000000 |
Large indoor space |
1 |
1 |
Yes |
0% |
400,000 |
10 |
1,174 |
11,738 |
117,377 |
0.9991480 |
0.9999148 |
0.9999915 |
0.0000000 |
1.0000000 |
Large indoor space |
1 |
1 |
Yes |
0% |
400,000 |
40 |
4,671 |
46,710 |
467,103 |
0.9997859 |
0.9999786 |
0.9999979 |
0.0000000 |
1.0000000 |
| . | ||||||||||||||
Small indoor space |
1 |
1 |
Yes |
6% |
10,800 |
1 |
16 |
161 |
1,610 |
0.9378875 |
0.9937887 |
0.9993789 |
see row 1 |
see row 1 |
Small indoor space |
1 |
1 |
Yes |
4% |
10,800 |
4 |
22 |
222 |
2,224 |
0.9550374 |
0.9955037 |
0.9995504 |
see row 1 |
see row 1 |
Small indoor space Best case school & work Setting |
1 |
8 |
Yes |
6% |
10,800 |
4 |
16 |
160 |
1,600 |
0.9375024 |
0.9937502 |
0.9993750 |
see row 1 |
see row 1 |
| . | ||||||||||||||
Large indoor space |
1 |
1 |
Yes |
1% |
400,000 |
1 |
125 |
1,248 |
12,476 |
0.9919845 |
0.9991985 |
0.9999198 |
0.0000000 |
1.0000000 |
Large indoor space Shopping |
1 |
1 |
Yes |
0% |
400,000 |
4 |
474 |
4,743 |
47,435 |
0.9978918 |
0.9997892 |
0.9999789 |
0.0000000 |
1.0000000 |
Large indoor space Retail Work |
1 |
8 |
Yes |
2% |
400,000 |
4 |
67 |
667 |
6,665 |
0.9849970 |
0.9984997 |
0.9998500 |
0.0000000 |
1.0000000 |
| . | ||||||||||||||
Small indoor space School Setting Small Restaurant |
1 |
1 |
Yes but 1 hour mask off |
99% |
10,800 |
1 |
1 |
10 |
101 |
0.0061992 |
0.9006199 |
0.9900620 |
see row 1 |
see row 1 |
Small indoor space School Setting |
1 |
1 |
Yes but 1 hour mask off |
72% |
10,800 |
4 |
1 |
14 |
139 |
0.2805977 |
0.9280598 |
0.9928060 |
see row 1 |
see row 1 |
Small indoor space School Setting |
1 |
1 |
Yes but 1 hour mask off |
12% |
10,800 |
40 |
8 |
84 |
838 |
0.8806603 |
0.9880660 |
0.9988066 |
see row 1 |
see row 1 |
Small indoor space |
1 |
8 |
No |
100% |
10,800 |
4 |
1 |
10 |
100 |
0.0000384 |
0.9000038 |
0.9900004 |
see row 1 |
see row 1 |
Small indoor space |
1 |
8 |
No |
64% |
10,800 |
40 |
2 |
16 |
157 |
0.3617989 |
0.9361799 |
0.9936180 |
see row 1 |
see row 1 |
| . | ||||||||||||||
Large indoor space |
1 |
1 |
No |
13% |
400,000 |
1 |
8 |
78 |
780 |
0.8717523 |
0.9871752 |
0.9987175 |
0.0000000 |
1.0000000 |
Large indoor space |
1 |
1 |
No |
3% |
400,000 |
4 |
30 |
296 |
2,965 |
0.9662695 |
0.9966269 |
0.9996627 |
0.0000000 |
1.0000000 |
Large indoor space |
1 |
1 |
No |
0.34% |
400,000 |
40 |
292 |
2,919 |
29,194 |
0.9965746 |
0.9996575 |
0.9999657 |
0.0000000 |
1.0000000 |
Large indoor space |
1 |
8 |
No |
24% |
400,000 |
4 |
4 |
42 |
417 |
0.7599520 |
0.9759952 |
0.9975995 |
0.0000000 |
1.0000000 |
Large indoor space |
1 |
8 |
No |
3% |
400,000 |
40 |
37 |
369 |
3,693 |
0.9729233 |
0.9972923 |
0.9997292 |
0.0000000 |
1.0000000 |
| . | ||||||||||||||
Outside small enclosed back yard |
1 |
4 |
No |
1% |
10,800 |
3600 |
178 |
1,775 |
NA |
0.9943678 |
0.9994368 |
NA |
0.0000000 |
1.0000000 |
Outside small enclosed back yard |
1 |
4 |
No |
0.11% |
10,800 |
18000 |
886 |
8,857 |
NA |
0.9988710 |
0.9998871 |
NA |
0.0000000 |
1.0000000 |
Outside beach park |
1 |
4 |
No |
0.02% |
400,000 |
3600 |
6,558 |
65,579 |
NA |
0.9998475 |
0.9999848 |
NA |
0.0000000 |
1.0000000 |
Outside beach park |
1 |
4 |
No |
0.00% |
400,000 |
18000 |
32,787 |
327,874 |
NA |
0.9999695 |
0.9999970 |
NA |
0.0000000 |
1.0000000 |
Outside beach park |
1 |
4 |
No |
0.00% |
4,000,000 |
3600 |
65,574 |
655,743 |
NA |
0.9999848 |
0.9999985 |
NA |
0.0000000 |
1.0000000 |
Outside beach park |
1 |
4 |
No |
0.00% |
4,000,000 |
18000 |
327,869 |
3,278,694 |
NA |
0.9999970 |
0.9999997 |
NA |
0.0000000 |
1.0000000 |
There are multiple ways to view this analysis. The first is from the perspective of each scenario being a standalone system with its own system performance. In this case we see that the system where people live outside results in the expected Health Availability approaching the design goal of mission critical systems of six 9s five availability and in some cases exceeding five 9s five availability. That is excellent. The other systems do not have that level of performance, however, examining the Infection Visits offers reasonable numbers for some living scenarios. The effect of the vaccine and the use of UV systems each multiply these numbers by 10 or for a total of 100. So what would have been a problem in 1 week suddenly becomes a problem after 2 years.
The most important perspective is to change the system boundary from the various living scenarios to the individual that is vaccinated. Within that system boundary of the individual there may be a chance of infection but as of April 2021 there is no chance of COVID-19 death and the Personal System Health availability becomes 1.0. This a perfect system performance level. Eventually some vaccinated people may die from COVID-19 but the chance will be 1 in tens or hundreds of millions. Although sad for the people impacted, the system performance is outstanding and represents a massive triumph on the part of our technologies and systems.
As with all systems the human element must be considered. The reality is not everyone will get vaccinated. There is also a time lag associated with when everyone that wants the vaccine will actually receive the vaccine. Then there is the chance of COVID-19 mutating or other contagions surfacing. All these system observations translate into the need to make the infrastructure safer from a contagion perspective. The need to upgrade, maintain, and properly use HVAC systems, add more ceiling level UV-C lights, add more FAR UV-222 lights, and replace some high touch surfaces is not gone and it must be addressed. There is still the fundamental question of why COVID-19 spread when we have been able to prevent the spread of other contagions for decades. The reality is that the answer might be in changes in our infrastructure as suggested in the 2020 system analysis [1] [2].
The system boundaries that were addressed in the 2020 system analysis and this new analysis in 2021 are as follows.
| System Boundary | System Name | Also known as | Comment |
| Planet | Planet COVID-19 Mitigation System | Return to life | |
| USA | USA Work COVID-19 Mitigation System | Return to work | System boundary was too small and thus irrelevant |
| Small Indoor Spaces | Small Indoor Spaces COVID-19 Mitigation System | Return to life | |
| Large Indoor Spaces | Large Indoor Spaces COVID-19 Mitigation System | Return to life | |
| Outdoors | Outdoors COVID-19 Mitigation System | Return to life | |
| Personal | Personal COVID-19 Mitigation System | Return to life |
References:
[1] COVID-19 A Systems Perspective, Walter Sobkiw, 2021, ISBN 9780983253044, hardback.
[2] COVID-19 Return To Life, webpage http://www.cassbeth.com/covid-19/return-to-life/index.html, April 2021. COVID-19 Return To Life.
[3] COVID-19 Breakthrough Case Investigations and Reporting, Centers For Disease Control and Prevention, April 26, 2021, April 30, 2021. webpage https://www.cdc.gov/vaccines/covid-19/health-departments/breakthrough-cases.html, May 2021. COVID-19 Breakthrough Case Investigations and Reporting.
[4] Odds of Dying, National Safety Council, 2019. webpage https://injuryfacts.nsc.org/all-injuries/preventable-death-overview/odds-of-dying, May 2021. Odds of Dying
Post Vaccine World
Many view the post vaccine world as a place where people can return to work. We know that the return to work system boundary is too small and that the actual system boundary is Return to Life. This analysis will address remote work, healthy infrastructure challenges, how we may have arrived at this point in history and how we might be able to prevent this from happening again.
Healthy Infrastructure
The Philadelphia Water Works was the first water treatment facility in the United States. It was a model for all future water works to follow in the New World. People would flock from around the planet to see this facility which combined engineering and art to solve a massive problem of safe water for the inhabitants of Philadelphia. It was born of necessity as the people decided they would not tolerate yet another yellow fever outbreak. The Museum sits on top of the original water reservoir that provided the city with water. As Philadelphia grew the reservoir and Water Works could no longer meet the needs of the city and new projects eventually replaced this once great technological and artistic achievement. It stopped operations in 1909. When I took the picture I knew nothing of the Water Works or its history. Like many things in our world it was invisible to me, until now. I only knew of its beauty in a very urban landscape setting [A].
The Philadelphia Art Museum and Water Works
Picture was taken in 1979 |
A post vaccine world implies that everyone has received a vaccine against the COVID-19 virus. However, we know that will not happen. In the USA some will refuse the vaccine [1]. In many countries the poor will not have access to the vaccine. The idea of a post vaccine world also suggests that we can return to the pre-COVID world. However, we know that is not the case. The contagion and its variants will be in the environment for decades. This is not unlike the situation that existed in the early part of the last century where there were deadly contagions that were part of normal life. It was not until multiple technologies were introduced in multiple systems that there was a decline in many deadly contagions in the USA and other parts of the world. These technologies and systems were embedded in [2] [3] [B]:
In the wake of the COVID-19 disaster the city of Philadelphia has once again taken lead actions like the Enhanced Ventilation Standards for Indoor Dining and Application Form for Increased Dining Capacity dated February 14, 2021. The Enhanced Ventilation Standard calls for 15 air changes per hour (ACH) for establishments wanting to increase their seating capacity from 25% to 50% [16] [17]. The approach is brilliant and uses the incentive to increase income to offset any possible costs that may be needed to increase ventilation. The ventilation level increase is large and will significantly mitigate contagion levels in the restaurant. It is obvious that it is traceable to existing engineering requirements associated with contagions rather than subjective minimum comfort levels. As part of the initiative they posted howto videos:
https://www.youtube.com/watch?v=HlneLDi9r54
(video on how to calculate air changes per hour)
https://www.youtube.com/watch?v=58uRfAxh6Cw
(video on how to complete the application)
These people are brilliant. The city of Philadelphia is leading the world on how to deal with the COVID-19 disaster for indoor settings. Unfortunately this program stopped in May 2021 leaving a void in this very important area of ensuring public buildings have ventilation levels that mitigate contagions rather than just provide minimum comfort levels. However, the model exists of how to determine the ACH in a restaurant along with the recommended ACH level.
The city of Philadelphia has also taken the time and effort to understand their school facilities and they have performed an extensive site survey (air balance reports) of all their school. The school district has 240+ schools and 12,000+ rooms [19]. They made this critical information public via their website. Once again Philadelphia has taken a lead in trying to deal with another aspect of the COVID-19 disaster and that is to understand the current state of the schools and share the data with the Philadelphia taxpayers and people everywhere. The product and technology choice to deal with the school ventilation challenge is in dispute [21]. However, the model exists and shows that school site surveys are needed and that they should be made public.
All the systems analysis performed to date has led to system requirements for a Post Vaccine World [2] [3] [B]. The key system requirements are:
There is a reason why airports and buildings were designed the way they were in the last century. It was not completely about form and function. There was also a reason why airplanes were never stuffed to system capacity limits in the last century. All these systems were established by people who lived through Polio, Tuberculosis, the 1918 Flu Pandemic, Cholera, Small Pox, and other terrible contagions. Not everything was written down, it just came naturally and it was also under the umbrella of doing the right thing after the massive devastation of WW I, the Depression, and WW II. It was ingrained in the culture. This was a massive mega trend. Unfortunately an unhealthy mega trend surfaced after this period and it erased the previous common sense healthy mega trend that transformed the civilization. The system has now been severely shaken.
We know that there have been changes and our buildings and airplanes have become sources of infection. There are many studies showing the problems and people know from personal experience that is the case. People would get sick but recover because the deadly contagions were eliminated by the previous generation. Now the situation has changed radically and we have a deadly contagion in our environment that has immediate detectable effects [4] [5]. There is no choice but to upgrade our infrastructure until this deadly contagion is reduced to either a level where it has no effect or it is eliminated.
Ensuring a safe infrastructure is within the boundaries of government and there are massive existing regulations that set the precedent. It is one of the reasons why we have clean water systems, buildings and bridges that do not collapse, safe HVAC systems that do not leak toxic gasses into occupied spaces, etc. Addressing safety to reduce exposure to the new deadly COVID contagion is the combined government and social challenge in the post vaccine world.
A picture is worth a thousand words. The following pictures are offered [6] [7].
Possible Infrastructure Upgrade - Airport 2020
|
The products and companies that install the Far UV-222 systems exist and are being installed and used in various airports and public buildings including Planned Real Estate Developments like condominiums [8] [9].
Possible Infrastructure Upgrade - School 2020 - Small Space
Photo: Upper-Room-Disinfection |
The products and companies that install the ceiling level UV-C systems exist and are being installed and used in various schools around the country [10] [11].
Possible Infrastructure Upgrade - Large Crowded Space
Photo: Upper-Room-Disinfection |
The products and companies that install the ceiling level UV-C systems exist and are being installed and used in large crowded spaces around the country [8] [9] [10] [11] [12] [13] [14] [15] [16] [17] [18].
St. Vincent's Hospital and Harvard School of Public Health conducted a TB/UV Shelter Study (TUSS). The study was a double-blind placebo-controlled field trial in 6 USA cities, with 14 shelters. Nearly 1200 UVGI luminaries were installed covering 200,000 sq. ft in a diverse set of buildings [7]. The studies confirmed the results from the all other studies since 1936 beginning with the first study by University of Pennsylvania in Philadelphia, PA [20]. What matters in this new study is that the technology was rediscovered and that there were 1200 UVGI luminaries easily acquired, installed, and managed. The products, systems, and companies exist. The technology is proven and it works. There is nothing special about COVID-19 that would protect it or other future contagions from these systems.
References:
[1] See section Conspiracy Theories and Social Bifurcation.
[2] COVID-19 Return To Life, sections HVAC Systems, Air Flow Rates And Natural Ventilation, Ultraviolet Germicidal Irradiation (UVGI) - Open Air, Decontamination Background and Solutions, March 2021. webpage http://www.cassbeth.com/covid-19/return-to-life/index.html, April 2021.
[3] COVID-19 Return To Life, section Design Solutions, March 2021. webpage http://www.cassbeth.com/covid-19/return-to-life/index.html, April 2021.
[4] The Sick Building Syndrome, Indian Journal of Occupational and Environmental Medicine, August 12, 2008. webpage https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2796751, August, 2020. The sick building syndrome
[5] COVID-19 Return To Life, section Airplanes and Airports, March 2021. webpage http://www.cassbeth.com/covid-19/return-to-life/index.html, April 2021.
[6] Could a New Ultraviolet Technology Fight the Spread of Coronavirus, Columbia University, June 30, 2020. webpage https://news.columbia.edu/ultraviolet-technology-virus-covid-19-UV-light, November 2020. Could a New Ultraviolet Technology Fight the Spread of Coronavirus
[7] Upper-Room-Disinfection, National Academies of Sciences, Engineering, and Medicine, September 17, 2020. webpage https://www.nationalacademies.org/event/09-16-2020/docs/D00062573057472031C5B95374B5C068AE9324D53EC4, November 2020. https://www.nationalacademies.org/event/09-16-2020/docs/DEE3D4D88EAB0A06D209581F304C3421D03E5BA597F0, May 2022. Upper-Room-Disinfection . local
[7.1] Based on Science, Does ultraviolet (UV) light kill the coronavirus? claim UV light destroys the novel coronavirus that causes COVID-19, National Academies of Sciences, Engineering, and Medicine, Published on: April 22, 2020 Last updated: March 2, 2022. webpage https://www.nationalacademies.org/based-on-science/covid-19-does-ultraviolet-light-kill-the-coronavirus, May 2022.
[7.2] The Second Gilbert W. Beebe Webinar: Safety and Efficacy of UVC to Fight Covid-19, Sep 16, 2020. webpage https://www.nationalacademies.org/event/09-16-2020/the-second-gilbert-w-beebe-webinar-safety-and-efficacy-of-uvc-to-fight-covid-19, May 2022.
[7.3] 2.1 Nardell - History of Germicidal UVC (pdf, 2 MB) - SARS-CoV-2: Dynamics of Airborne Transmission and Air Disinfection Edward Nardell, MD Professor of Medicine, Harvard Medical School. webpage https://www.nationalacademies.org/event/09-16-2020/docs/DE63EBA42A7C0AB93A2F3CCFC455B80ECA47F0B03790, May 2022 . local
[8] Margate condo first in state to install ultraviolet light sanitizing technology, they say, Press Of Atlantic City, September 09, 2020. webpage https://pressofatlanticcity.com/margate-condo-first-in-state-to-install-ultraviolet-light-sanitizing-technology-they-say/article_5c259798-7c35-5ad8-be85-e5b7a5838aa3.html, January 2021. Margate condo first in state to install ultraviolet light sanitizing technology, they say
[9] Technology at the Forefront for Healthier High-Rise Buildings, The COVID-19 pandemic has real estate developers turning to new tech, like UV light treatments and touchless entrances, to create safer environments for residents, Mansion Global June 07, 2020. webpage https://www.mansionglobal.com/articles/technology-at-the-forefront-for-healthier-high-rise-buildings-216579, January 2021. Technology at the Forefront for Healthier High-Rise Buildings
[10] High school installs ultraviolet light system to keep students safe, WNNC, May 20, 2020. webpage https://www.wcnc.com/article/news/health/coronavirus/queens-grant-high-school-uv-light-system-coronavirus/275-c3e54672-905f-4fab-8e5f-8c58d5ca49f3, January 2021. High school installs ultraviolet light system to keep students safe
[11] Some SC schools to use ultraviolet light to fight coronavirus. A few things to know. The Herald November 10, 2020. webpage https://www.heraldonline.com/news/coronavirus/article247021112.html, January 2021. Some SC schools to use ultraviolet light to fight coronavirus. A few things to know
[12] UV lights, ozone cleaners, sanitizers help shelter keep homeless safe, Catholic News Service, June 16, 2020. webpage https://angelusnews.com/news/nation/uv-lights-ozone-cleaners-sanitizers-help-shelter-keep-homeless-safe/, January 2021. UV lights, ozone cleaners, sanitizers help shelter keep homeless safe
[13] The Blind Horse Becomes First Restaurant In The United States To Install Far-UVC Light Technology For Real-Time Virus Mitigation And Indoor Sanitization, Globe Newswire, October 13, 2020. webpage https://www.globenewswire.com/news-release/2020/10/13/2107717/0/en/THE-BLIND-HORSE-BECOMES-FIRST-RESTAURANT- IN-THE-UNITED-STATES-TO-INSTALL-FAR-UVC-LIGHT-TECHNOLOGY-FOR-REAL-TIME- VIRUS-MITIGATION-AND-INDOOR-SANITIZATION.html, January 2021.
[14] Wisconsin Restaurant Installs COVID-Killing UV Lights, Spectrum News1, October 14, 2020. webpage https://spectrumnews1.com/wi/madison/coronavirus/2020/10/14/wisconsin-restaurant-installs-covid-killing-uv-lights-, January 2021. Wisconsin Restaurant Installs COVID-Killing UV Lights
[15] With winter approaching, some restaurants turn to UV light to make indoors safer, Products that use UV rays to purify the air are popping up in restaurants., September 02, 2020. webpage https://www.restaurantbusinessonline.com/technology/winter-approaching-some-restaurants-turn-uv-light-make-indoors-safer, January 2021. With winter approaching, some restaurants turn to UV light to make indoors safer
[16] Enhanced Ventilation Standards for Indoor Dining and Application Form for Increased Dining Capacity, City of Philadelphia, February 14, 2021. webpage https://www.phila.gov/media/20210216105327/Enhanced-Ventilation-Standards-for-Indoor-Dining_2_16_21.pdf. PDF . local
[17] Food Establishments That Have Met Enhanced Ventilation Standards to Allow for Increased Indoor Dining Capacity, City of Philadelphia, March 09, 2021. webpage https://www.phila.gov/media/20210311122403/50CapacityRestaurants_030921.pdf. PDF . local
[18] Breathe Easier: Seattle-area restaurants invest in fancy air filtration systems, seattlerefined Sinclair Broadcast Group, October 02, 2020, webpage http://seattlerefined.com/eat-drink/breathe-easier-forward-thinking-restaurants-invest-in-air-filtration-systems, January 2021. Breathe Easier: Seattle-area restaurants invest in fancy air filtration systems.
[19] Ventilation and Air Balance Reports, City of Philadelphia, March 22, 2021. webpage https://www.philasd.org/coronavirus/schoolstart2020/#ventilation, https://drive.google.com/drive/folders/1XULamBiR3v1sB_u15rcyXOxQlq1ygsGT, https://docs.google.com/spreadsheets/d/18Kn2h5zS6ivX27-msM2Pdy10HUUWaUAomAaXJJ2FK7w/edit?usp=sharing (spreadsheet) May 2021. Ventilation . Spreadsheet . local spreadsheet
[20] Air Disinfection in Day Schools, W.F. Wells Associate Professor in Research in Air-borne Infection, Laboratories for the Study of Air-borne Infection, the Department of Preventive Medicine and Public Health, University of Pennsylvania School of Medicine, Philadelphia, Pa. 1943. webpage https://ajph.aphapublications.org/doi/pdf/10.2105/AJPH.33.12.1436, November 2020. Air Disinfection in Day Schools . local
[21] Philadelphia school district to install new air purifiers despite concerns from air quality specialist, Chalkbeat Philadelphia, July 21, 2021. webpage https://philadelphia.chalkbeat.org/2021/7/21/22587784/philadelphia-district-to-install-new-air-purifiers-despite-concerns-from-air-quality-specialist, Jully 2021.Philadelphia school district to install new air purifiers despite concerns from air quality specialist.
[A] Sustainable development Possible with Creative Systems Engineering, Walter Sobkiw, 2008. ISBN 9780615216300.
[B] COVID-19 A Systems Perspective, Walter Sobkiw, 2021, ISBN 9780983253044, hardback.
Remote Work
Remote work, telecommuting, telework, telepresence, working from home, mobile work, remote job, work from anywhere, and flexible workplace, is a work system where employees and operator owners, do not commute or travel to a central work location, such as an office building, warehouse, or store.
Because of the pandemic, some suggest that work will change because we have learned that we can telework. However, we have been able to telework for decades because of the personal computer revolution. There were many requests in the last century to telework but it was rare when people were able to telework. A simple system stakeholder analysis shows that there are massive divergent stakeholder needs. They are as follows:
| Stakeholder | Telework Impact |
Needs |
| Management | Negative |
Reject telework because they think their role is to physically watch the workers. Telework is a threat to their jobs, their role in many cases disappears. |
| Commercial Real Estate Companies | Negative |
They need to have rents and new sales. Massive vacancies will need to repurpose the properties or cause the properties to be abandoned with massive financial loss. |
| Commercial Real Estate Investors | Negative |
With the lower demand for commercial space these investors will see the investment value drop unless these spaces are repurposed |
| Workers | Positive |
They have found that they can successfully do their work. It is very convenient with the new family life where everyone works. Quality of life significantly increases. |
| Children | Positive |
They have access to their parents when needed. Parents are home when they come home from school. Quality of life significantly increases. |
| Customers | Neutral |
Customers don't care as long as the quality is high and the costs are low. |
| All Other Companies | Positive |
Companies always want to increase profits. As long as the business does not falter the new cost savings are embraced. |
| All Other Investors | Positive |
Investors always want to increase profits. As long as the business does not falter the new cost savings are embraced. |
| Planet | Positive |
Reduced energy consumption because there are less cars on the road commuting to work. This has a huge positive impact on future sustainability. |
The stakeholder analysis shows that most of the benefits come from telework, as was suggested in the last century with the personal computer revolution. However, because there is less need for management in a telework setting, typically management acting out of self interest just rejects telework requests. There is also the commercial real estate industry and its investors that stand to significantly lose in the wake of telework. There is enormous pressure to fill office space even if it is not needed. Nothing has changed with COVID-19, these two stakeholders control the post emergency telework decision. This is during a time in our culture when everyone knows we are able to telework and that it works in many settings.
This is a very difficult situation since government regulation is not the answer even though there can be massive benefits. This is a social challenge, to deal with very powerful stakeholders that stand to lose if the system changes. In normal times government can't force a company into a telework mode. Once the COVID-19 disaster subsides the government emergency will be gone. It will require some serious systems thinking to change the status quo and shift to a future telework society.
Once the virus is declared to be under control there will be massive movement for everyone to go back into the offices and sit there even if there is no work to do. This is what the Trump administration was doing throughout the COVID-19 disaster [1] [A]. They were unable to hide the large death count because of the physical evidence in the hospitals and so the virus decided that people should continue to telework. Eventually the virus will subside, the hospitals will have few COVID patients, and so there will be massive pressure to end telework.
Some progressive organizations with effective management that can embrace change will realize that they can significantly reduce costs by maintaining their proven telework approaches developed during the pandemic. Bad organizations with their poor management unable to embrace the changes in the same and adjacent industries will go back to the old approach of maintaining large physical office spaces and become unable to compete in the marketplace. This transformation will be slow but it will happen unless there are attempts to manipulate the markets. It is also unclear if the return to the offices will lead to new worker movements that may help increase the telework system.
If telework is allowed to continue in areas where it makes sense, there will be a massive release of leisure time that is lost when sitting in offices and commuting to and from work. This leisure time may lead to new personal activities with possible positive unintended consequences:
These unintended consequences are interesting because new stakeholders that may benefit have been added to the system as follows:
The new leisure time is a form of productivity, but the gains are not made by the employers. Instead the gains are made by the society where a new more productive and perhaps more happy society emerges.
For centuries the concept of working from home was common. Most of the people lived on farms when the society was primarily agrarian. Merchants and craftsmen lived in their shops. Conceptually both work and home life were within the same circle. With the rise of the industrial revolution people needed to report to a physical location where capital intensive equipment and production lines were located, the factory. This resulted in a split between home and work life. Conceptually this is represented as 2 separate and distinct circles with little overlap - work life and home life. This condition tended to reflect the culture in the USA for most in the last century.
System A
USA Life 1945 to 2021 |
Systems B
USA Pre-Industrial Revolution |
In other parts of the world the 2 separate circles do not exist and the culture is based on the 1 circle. This is a way of life that is very different. Those that own small operator owner businesses in the USA experience this way of life. Examples include the small shop on the first floor of a building and living quarters above the business. Other examples include maintaining an office and storage in a home for a business that may provide a service like painting, plumbing, consulting, etc. In the last century, up until approximately 1980, it was not uncommon for doctors and dentists to have their business locations in their homes.
Mixing home and work life is a cultural shift with new challenges that surface in this system of work. Some of the challenges are:
The above challenges suggest a pattern that may surface in the future where those that are unable to telework may find themselves in physical work settings. This suggests that two different management approaches may emerge where one is associated with the telework setting and one is associated with the physical work location.
In the last century the time clock was introduced to ensure that people actually reported to work. The time clock was associated with production like settings rather than professional settings. It was common knowledge that many professionals worked throughout the waking day because their work is associated with thought not a physical action. An engineer conceiving the architecture of a system cannot shutdown based on a clock. That is the price that is paid by professionals. They are sitting down at a dinner table with their families but their thoughts drift into the challenges of their work as they engage in problem solving. So in theory their pay, if tied to a time clock based on hours, should be based on a 24 hour working day. Thus the concept of salary versus hourly pay. Many in the last century consciously stayed away from being promoted into professional positions because they wanted to be paid overtime for their work. Professionals based on a salary rarely made overtime. There were rare exceptions like RCA (Radio Corporation of America), which paid their engineers overtime if they were in the physical work location.
System C
Compensated work plus
Uncompensated work
Many professionals like Engineers |
System D
Compensated work
Professionals like Engineers |
The idea of tracking the time of professionals did not surface until the 1960's and did not take root until the 1970's where time cards were signed by employees coincident with the end of a pay period. As late as the 1960's some staff in highly professional and creative settings rebelled against the concept of being forced to report to the office if there was no work to be performed. Three hour lunches with colleagues was not uncommon. This is a system that allowed the USA to eventually break out of the massive poverty of the early 1900's and send people to the moon. So this system was not without merit.
Existing management and investors are actually irrelevant as stakeholders in the telework question. It is the masses of people that will decide the new businesses that they will develop and invest in as the new century unfolds. As this generation considers the possibilities of telework, they should realize that the concepts are not new. There is massive history and experience to access to enable this new system of telework to surface. A fundamental question to always ask as a society is: Do we live to work or do we work to live?
There are studies suggesting that much of the existing work is irrelevant and just a waste of time [B]. The issue is what happens when massive automation causes less work for people to perform because compensation is tied to work hours. As early as the 1960's many proposed that the work week should be reduced to 30 hours to deal with the massive automation at the time. Unfortunately the opposite happened and not only did the work hours increase but also the percentage of the population in the workforce increased as the time clock was established for everyone and connected via computers to compensation. This is an extreme failure of management. Management established a highly inefficient system that just harmed people in the last 20 years of the last century. Nothing changed in the next 20 years of the new century until the COVID-19 disaster.
The approach used in the past was to increase jobs even if they were useless and reduce compensation to increase profits. If work hours, jobs, or compensation are reduced the velocity of money is reduced. When the velocity of money drops below a certain rate there is either a recession or depression. The system challenge is how to transition to a system that either has jobs that add value as opposed to useless work and or how to increase compensation as hours are reduced because machines have taken over the tasks performed by humans. This is all under the umbrella of a telework future which may lead to the elimination of useless jobs as all work is examined for transition to telework.
The slowing of the velocity of money is tightly associated with the concentration of wealth in the hands of a few. This is not new and is well documented and understood after the 1930s depression. With massive wealth concentrated in the hands of the few and the massive loss of jobs that may happen with the new emerging telework system it is unclear what will happen with the health of the economy. Negative growth is a strong possibility unless there are system mechanisms established to prevent the negative spiral. In the past the US Government was the mechanism that was used to flood the economy with money, which would then increase the velocity of money and get the economy out of a downward spiral in anticipation of future jobs that would then naturally surface. However what happens if the jobs do not surface? How will compensation and worker time be adjusted to prepare for a new system that is extremely efficient at producing goods and services and requires little worker time?
This is a huge systems challenge.
| Individual [2] |
Wealth |
Comment |
| Jeff Bezos | $196 |
Founder Amazon dot com. See note 1. |
| Elon Musk | $175 |
Founder of PayPal. See note 1. |
| Bill Gates | $132 |
Co-founder Microsoft Corporation. See note 2. |
| Mark Zuckerberg | $110 |
Co-founder Facebook. See note 1. |
| Larry Page | $99 |
Co-founder Google. See note 1. |
| MacKenzie Scott | $60 |
Married to Jeff Bezos. See note 1. |
| Jack Ma | $49 |
Co-founder Alibaba Group. See note 1. |
Note 1: Company concept and software that makes the company is based on open source community that developed the massive Internet Infrastructure using Apache web server, UNIX, web browser, PERL applications like search engines, shopping carts, social media, secure transaction processing, etc.
Note 2: Microsoft software is based on work performed in the open source community in the 1980s associated with the UNIX workstation and the new low cost Personal Computer (PC). The concept was to recode existing capabilities found in the existing infrastructure and then make the software code proprietary with license fees on the low cost PC.
One billion dollars employs 10,000 people for a year. More importantly is that 10,000 people engaged in the economy are 10,000 sources of new creative ideas that translate into progress. Removing this creative energy eventually leads to stagnation.
References:
[1] COVID-19 Return To Life, section US Insurrection 2021, March 2021. webpage http://www.cassbeth.com/covid-19/return-to-life/index.html, April 2021.
[2] [individual name]/People also search for, webpage https://www.google.com/search, April 2021.
[A] COVID-19 A Systems Perspective, Walter Sobkiw, 2021, ISBN 9780983253044, hardback.
[B] Bullshit Jobs: A Theory, David Graeber, 2018. ISBN: 9781501143311.
Vaccine Booster
Data suggests that the vaccines remain effective in protecting against severe disease, however, some data suggests that effectiveness may be waning. Concerns have been raised that declining neutralizing antibody titers or reduced effectiveness against symptomatic disease may be a signal of significant declines in effectiveness against severe disease. Also the emergence of the highly transmissible DELTA (B.1.617.2) variant of SARS-CoV-2 has led to considerations of the potential need for booster doses for fully vaccinated individuals.
This systems analysis falls into the category of system validation. [spreadsheet]
The following was presented by Pfizer to the FDA as part of the Vaccines and Related Biological Products Advisory Committee meeting on September 17, 2021 [15].
FDA Vaccines and Related Biological Products Advisory Committee
On September 17, 2021 the FDA Vaccines and Related Biological Products Advisory Committee voted to recommend the COVID-19 vaccine booster shots for Americans 65 and older and those at high risk of severe illness. The committee also recommended vaccine booster shots for healthcare workers and others at high risk of occupational exposure to COVID-19, such as teachers. By a vote of 16 to 2, the advisory committee declined to recommend a third dose of the Pfizer (PFE.N)/BioNTech vaccine to anyone age 16 and older who received their second shot at least six months earlier. The panelists suggested the evidence supporting broad approval was inadequate, and they wanted to see more safety data, especially concerning the risk of heart inflammation in younger people after vaccination. [1]
As of September 17, 2021, there are 3 primary reasons for the FDA's Vaccines and Related Biological Products Advisory Committee rejecting the booster for the general population: [8]
The FDA is not bound by the panel's recommendation. The presentation material was made public on the Internet. [2] [3]
Vaccine Adverse Event Reporting System (VAERS)
There have been deaths associated with the COVID-19 vaccinations. [4] [5] The US CDC maintains a database and has a data mining engine to access the data [5]. Other organizations claim to use the same data as part of their data mining operations [5]. There are differences between the US CDC data mining results and data mining results from other sources.
The results from the CDC VAERS system are as follows. Report from CDC Wonder [5]
Query Date Sep 20, 2021 10:08:48 PM
Reference United States Department of Health and Human Services (DHHS), Public Health Service (PHS), Centers for Disease Control (CDC) / Food and Drug Administration (FDA), Vaccine Adverse Event Reporting System (VAERS) 1990 - 09/10/2021, CDC WONDER On-line Database. Accessed at http://wonder.cdc.gov/vaers.html on Sep 20, 2021 10:08:48 PM
Query Criteria
Event Category: Death
State / Territory: The United States/Territories/Unknown
Vaccine Products: COVID19 VACCINE (COVID19)
Group By: Age
Show Totals: True
Show Zero Values: False
Messages
Message VAERS data in CDC WONDER are updated every Friday. Hence, results
for the same query can change from week to week.
Message These results are for 6,756 total events.
Age |
Events Reported |
Percent |
< 6 months |
1 |
0.01% |
6-11 months |
0 |
0.00% |
1-2 years |
2 |
0.03% |
3-5 years |
0 |
0.00% |
6-17 years |
19 |
0.28% |
18-29 years |
97 |
1.44% |
30-39 years |
158 |
2.34% |
40-49 years |
248 |
3.67% |
50-59 years |
536 |
7.93% |
60-64 years |
499 |
7.39% |
65-79 years |
2,212 |
32.74% |
80+ years |
2,410 |
35.67% |
Unknown |
574 |
8.50% |
Total |
6,756 |
100.00% |
Note: Report from CDC Wonder [5]
When a query report is run for vaccines of all types through the years the numbers are higher for the COVID-19 vaccines. That obviously is because a huge number of COVID-19 vaccinations were administered.
Year |
Deaths Reported |
Vaccinations Administered |
2018 |
163 |
significantly lower than 2021 |
2019 |
181 |
significantly lower than 2021 |
2020 |
166 |
significantly lower than 2021 |
2021 |
6,887 |
181,380,000 + traditional vaccination rates |
Note: Report from CDC Wonder [5]
Just because a number is reported does not mean that it is a proper system performance number. Typically in any analysis absolute numbers are always questioned to determine if a key assumption is driving the absolute number and that key assumption is usually associated with the relevant sample size - did the sample size remain the same. In this case the answer is no. There were significantly lower vaccinations given in other years than in 2021.
The system performance number should be based on deaths per total vaccinations. The total number of vaccinations for September 19, 2021 is 181,380,000 full vaccinations [6]. The proper system performance number for the vaccination death rate is 6,756 / 181,380,000 = .00003725 or 1 in 26,847. The odds of death from the vaccine are very small compared to other odds of death statistics. The lifetime odds of death for selected causes in the United States are as follows [7].
Cause of Death |
Odds of Dying |
Heart disease |
1 in 6 |
Cancer |
1 in 7 |
All preventable causes of death |
1 in 24 |
Chronic lower respiratory disease |
1 in 27 |
Suicide |
1 in 88 |
Opioid overdose |
1 in 92 |
Fall |
1 in 106 |
Motor vehicle crash |
1 in 107 |
Gun assault |
1 in 289 |
| COVID-19 Deaths (Sep 20, 2021) 328 million / 672,738 | 1 in 487 |
Pedestrian incident |
1 in 543 |
Motorcyclist |
1 in 899 |
Drowning |
1 in 1,128 |
Fire or smoke |
1 in 1,547 |
Choking on food |
1 in 2,535 |
Bicyclist |
1 in 3,825 |
Sunstroke |
1 in 8,248 |
Accidental gun discharge |
1 in 8,571 |
Electrocution, radiation, extreme temperatures, and pressure |
1 in 13,394 |
| Full Vaccine Deaths (September 20, 2021) | 1 in 26,847 |
Sharp objects |
1 in 29,334 |
Cataclysmic storm |
1 in 58,669 |
Hornet, wasp, and bee stings |
1 in 59,507 |
Hot surfaces and substances |
1 in 63,113 |
Dog attack |
1 in 86,781 |
Lightning |
1 in 138,849 |
Vaccine Breakthrough Deaths (April 26, 2021) |
1 in 719,697 |
Once vaccinated, it is unclear if the Booster Vaccine Deaths is the same as for the Full Vaccine Deaths. It is reasonable to assume that if one survived the full vaccination, then there should be no deaths from the vaccination booster. The big system question is when will the Vaccine Breakthrough Deaths begin to rise. Some suggest, in particular Pfizer, that December 2021 will be a system performance point of inflection (change) in the wrong direction and that the system also will be stressed with traditional Flu outbreaks. There is a desire by some to roll out the booster prior to this time, December 2021, so that there is no sudden increase in Vaccine Breakthrough Deaths if immunity significantly drops.
There are other report runs from CDC Wonder - The Vaccine Adverse Event Reporting System (VAERS). See local CDC Wonder reports The data mining parameters included:
Unfortunately there are those who are using the number of vaccination deaths to suggest that there is a problem with the vaccines. However, this is just another horrible disinformation effort to confuse the people who don't know how to ask the next level of the question. The question is simple, how many COVID-19 vaccinations were administered in 2021 compared to other vaccinations in other years. Seems trivial, but there is a massive social challenge, because the Internet is full of this misleading and toxic information, and unfortunately people are lacking in basic science and math skills to understand the situation. This is important because basic science and math education in the current generation appears to have failed for many, and it is a root cause of the COVID-19 disaster vaccination system failure as of September 2021.
CDC Statement on ACIP Booster Recommendations
Press Release
For Immediate Release: Friday, September 24, 2021
Contact: Media Relations
(404) 639-3286
CDC Statement on ACIP Booster Recommendations [9]
Today, CDC Director Rochelle P. Walensky, M.D., M.P.H., endorsed the CDC Advisory Committee on Immunization Practices (ACIP) recommendation for a booster shot of the Pfizer-BioNTech COVID-19 vaccine in certain populations and also recommended a booster dose for those in high risk occupational and institutional settings. The Food and Drug Administration’s (FDA) authorization and CDC’s guidance for use are important steps forward as we work to stay ahead of the virus and keep Americans safe.
This updated interim guidance from CDC allows for millions of Americans who are at highest risk for COVID-19 to receive a Pfizer-BioNTech COVID-19 booster shot to help increase their protection.
CDC recommends:
Many of the people who are now eligible to receive a booster shot received their initial vaccine early in the vaccination program and will benefit from additional protection. With the Delta variant’s dominance as the circulating strain and cases of COVID-19 increasing significantly across the United States, a booster shot will help strengthen protection against severe disease in those populations who are at high-risk for exposure to COVID-19 or the complications from severe disease.
CDC will continue to monitor the safety and effectiveness of COVID-19 vaccines to ensure appropriate recommendations to keep all Americans safe. We will also evaluate with similar urgency available data in the coming weeks to swiftly make additional recommendations for other populations or people who got the Moderna or Johnson & Johnson vaccines.
The following is attributable to Dr. Walensky:
As CDC Director, it is my job to recognize where our actions can have the greatest impact. At CDC, we are tasked with analyzing complex, often imperfect data to make concrete recommendations that optimize health. In a pandemic, even with uncertainty, we must take actions that we anticipate will do the greatest good.
I believe we can best serve the nation’s public health needs by providing booster doses for the elderly, those in long-term care facilities, people with underlying medical conditions, and for adults at high risk of disease from occupational and institutional exposures to COVID-19. This aligns with the FDA’s booster authorization and makes these groups eligible for a booster shot. Today, ACIP only reviewed data for the Pfizer-BioNTech vaccine. We will address, with the same sense of urgency, recommendations for the Moderna and J&J vaccines as soon as those data are available.
While today’s action was an initial step related to booster shots, it will not distract from our most important focus of primary vaccination in the United States and around the world. I want to thank ACIP for their thoughtful discussion and scientific deliberation on the current data which informed my recommendation.
###
The CDC departed from the ACIP recommendations and decided to include more people in the first round of booster shots. The group added to the age 65+ group are those 18+ with underlying medical conditions and those 18+ in high risk of infection occupational or institutional settings, including teachers and healthcare providers.
Pfizer Vaccine Rollout Schedule
On August 23, 2021, the FDA approved the Pfizer-BioNTech COVID-19 Vaccine, that will be marketed as Comirnaty, for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for people 12 through 15, for the administration of a third dose in certain immunocompromised people, and for a single booster dose in people [10]:
The following table summarizes the rollout schedule for the Pfizer vaccine [11].
| Age | Final Protocol Submission | Study Completion | Final Report Submission | Emergency Use Authorization | FDA Approval | Comments |
| 16+ | December 11, 2020 | August 23, 2021 |
2 doses 3 weeks apart
|
|||
| 12+ | May 10, 2021 | 2 doses 3 weeks apart | ||||
| 12+ | August 12, 2021 | 3rd dose for individuals 12+ years and who have undergone solid organ transplantation, or diagnosed with conditions considered to have an equivalent level of immunocompromise | ||||
| 65+ | August 23, 2021 | Booster | ||||
| 18+ | August 23, 2021 | Booster, 18 through 64 at high risk of severe COVID-19; and 18 through 64 whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19 | ||||
| 12 to 15 | October 7, 2020 | May 31, 2023 | October 31, 2023 | Deferred pediatric Study C4591001 to evaluate the safety and effectiveness of COMIRNATY in children 12 years through 15 years of age | ||
| 6 mon to 12 | February 8, 2021 | November 30, 2023 | May 31, 2024 | Deferred pediatric Study C4591007 to evaluate the safety and effectiveness of COMIRNATY in infants and children 6 months to <12 years of age | ||
| infants to 6 mon | January 31, 2022 | July 31, 2024 | October 31, 2024 | Deferred pediatric Study C4591023 to evaluate the safety and effectiveness of COMIRNATY in infants <6 months of age |
All the studies and timelines are as follows [11]:
| Study | Final Protocol Submission | Study Completion | Final Report Submission | Key Study Issue |
| 1. Deferred pediatric Study C4591001 to evaluate the safety and effectiveness of COMIRNATY in children 12 years through 15 years of age. | October 7, 2020 | May 31, 2023 | October 31, 2023 | children 12-15 |
| 2. Deferred pediatric Study C4591007 to evaluate the safety and effectiveness of COMIRNATY in infants and children 6 months to <12 years of age. | February 8, 2021 | November 30, 2023 | May 31, 2024 | children 6 mon to 12 |
| 3. Deferred pediatric Study C4591023 to evaluate the safety and effectiveness of COMIRNATY in infants <6 months of age. | January 31, 2022 | July 31, 2024 | October 31, 2024 | infants <6 mon |
| 4. Study C4591009, entitled A Non-Interventional Post-Approval Safety
Study of the Pfizer-BioNTech COVID-19 mRNA Vaccine in the United States,
to evaluate the occurrence of myocarditis and pericarditis following
administration of COMIRNATY.
Other Dates:
|
August 31, 2021 | June 30, 2025 | October 31, 2025 | Heart Inflamtaion |
| 5. Study C4591021, entitled Post Conditional Approval Active Surveillance
Study Among Individuals in Europe Receiving the Pfizer-BioNTech Coronavirus
Disease 2019 (COVID-19) Vaccine, to evaluate the occurrence of myocarditis
and pericarditis following administration of COMIRNATY.
Other Dates:
|
March 31, 2024 | September 30, 2024 | Heart Inflamtaion in Europe | |
| 6. Study C4591021 substudy to describe the natural history of myocarditis and pericarditis following administration of COMIRNATY. | January 31, 2022 | March 31, 2024 | September 30, 2024 | Heart Inflamation |
| 7. Study C4591036, a prospective cohort study with at least 5 years of follow-up for potential long-term sequelae of myocarditis after vaccination (in collaboration with Pediatric Heart Network). | November 30, 2021 | December 31, 2026 | May 31, 2027 | Heart Inflamation including children |
| 8. Study C4591007 substudy to prospectively assess the incidence of subclinical myocarditis following administration of the second dose of COMIRNATY in a subset of participants 5 through 15 years of age. | September 30, 2021 | November 30, 2023 | May 31, 2024 | Heart Inflamation in children 5-15 |
| 9. Study C4591031 substudy to prospectively assess the incidence of subclinical myocarditis following administration of a third dose of COMIRNATY in a subset of participants 16 to 30 years of age. | November 30, 2021 | June 30, 2022 | December 31, 2022 | Heart Inflamation in young people 16-30 |
| 10. Study C4591022, entitled Pfizer-BioNTech COVID-19 Vaccine Exposure during Pregnancy: A Non-Interventional Post-Approval Safety Study of Pregnancy and Infant Outcomes in the Organization of Teratology Information Specialists (OTIS)/MotherToBaby Pregnancy Registry. | July 1, 2021 | June 30, 2025 | December 31, 2025 | Pregnancy and abnormalities of physiological development |
| 11. Study C4591007 substudy to evaluate the immunogenicity and safety of lower dose levels of COMIRNATY in individuals 12 through <30 years of age. | September 30, 2021 | November 30, 2023 | May 31, 2024 | lower dose in age 12-30 |
| 12. Study C4591012, entitled Post-emergency Use Authorization Active Safety Surveillance Study Among Individuals in the Veteran’s Affairs Health System Receiving Pfizer-BioNTech Coronavirus Disease 2019 (COVID-19) Vaccine. | January 29, 2021 | June 30, 2023 | December 31, 2023 | Veterans (this does not make sense, why the special self-interest treatment) |
| 13.Study C4591014, entitled Pfizer-BioNTech COVID-19 BNT162b2 Vaccine Effectiveness Study - Kaiser Permanente Southern California. | March 22, 2021 | December 31, 2022 | June 30, 2023 | California effectiveness |
There are multiple studies associated with possible impacts to the Heart.
Pfizer Safety Data Booster Review Timeframe
There are 2 data sources available to understand the Pfizer safety results. The information was presented by the Vaccines and Related Biological Products Advisory Committee to the FDA at a meeting September 17, 2021. They are:
Safety Data Pfizer Controlled Study Group
The following is an extract from the Vaccines and Related Biological Products Advisory Committee Meeting September 17, 2021, FDA Briefing Document, Application for licensure of a booster dose for COMIRNATY (COVID-19 Vaccine, mRNA) [12].
*** EXTRACT START ***
On August 23, 2021, FDA approved COMIRNATY (COVID-19 Vaccine, mRNA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older. The vaccine is based on the SARS-CoV-2-spike glycoprotein antigen encoded by modified mRNA and formulated in lipid particles (LNPs). The approved regimen is a 2-dose primary vaccination series administered 3 weeks apart. During clinical development, the vaccine, containing 30 µg mRNA, was called BNT162b2.
On August 25, 2021, Pfizer submitted a supplement to their Biologics License Application (BLA) for COMIRNATY seeking approval for administration of a booster dose approximately 6 months after primary series. To support the need for a booster dose, the submission referenced several observational studies that suggest waning of protection in the setting of the current Delta variant surge among individuals who previously received a 2-dose series.
This BLA supplement includes safety and immunogenicity data assessed against the reference strain (wild-type) from approximately 300 immunocompetent adults 18 through 55 years of age enrolled in an ongoing Phase 2/3 study (C4591001) who completed the primary vaccination series consisting of two doses of BNT162b2 administered intramuscularly (IM) and who received a BNT162b2 booster dose approximately 6 months after completion of the 2- dose primary series. Efficacy was not evaluated for Phase 3 BNT162b2 booster group participants. Supportive data from the Phase 1 portion of this study in participants 18 through 55 years of age (N=11) and 65 through 85 years of age (N=12) who had received a 30 µg BNT162b2 prototype vaccine approximately 7 to 9 months after their second dose were also included and consisted of safety data and immunogenicity data evaluating neutralizing antibody titers elicited by the booster dose against the reference strain (wild-type) of SARS-CoV-2 and variants of concern (VOCs).
The effectiveness of the booster dose is based on immunobridging analyses from the Phase 3 group of participants 18 through 55 years of age comparing 50% neutralizing antibody titers against the reference strain at 1 month after the booster dose to those observed at 1 month post-primary series among participants without evidence of prior SARS-CoV-2 infection. Immunobridging analyses included hypothesis testing for:
Additionally, the geometric mean-fold rise (GMFR) from before the booster dose to 1 month after the booster dose was analyzed descriptively. Pfizer proposes to infer effectiveness of the booster dose against the Delta variant from exploratory descriptive analyses of 50% neutralizing antibody titers against this variant evaluated among subjects from the Phase 1 portion of the study.
Solicited and unsolicited safety data from booster recipients (12 Phase 1 participants 65 through 85 years of age and 306 Phase 2 participants 18 through 55 years of age) were reviewed and compared to labeled safety data from the reactogenicity subset (N=~2700) of recipients of the 2-dose primary series. Safety following the booster dose was assessed for a median of 2.6 months among both Phase 1 and Phase 2/3 study participants. Reported frequencies and severities of local and systemic solicited adverse reactions following the booster dose were not substantially different from those following Dose 2 of the primary series. Reported frequencies and severities of solicited adverse reactions following the booster dose were lower among the 12 Phase 1 participants 65 through 85 years of age compared with the 306 Phase 3 participants 18 through 55 years of age, similar to age group-related differences in reactogenicity associated with the primary series. Lymphadenopathy (16/306; 5.2%) was the most common unsolicited adverse event (AE); all events of lymphadenopathy occurred within 3 days of vaccination. No other adverse events of clinical interest (i.e., myocarditis, pericarditis, Bell’s Palsy, appendicitis)were reported following the booster dose. The incidence post-booster dose was substantially higher than the rate reported among adults after any of the 2 doses of the primary series (83/21,926; 0.4%). However, most (n=15) were mild to moderate in severity and lasted between 2 to 8 days. Two cases of mild lymphadenopathy were reported as ongoing and resolving at the time of last assessment. No deaths were reported following the booster dose, and one nonfatal serious adverse event (acute myocardial infarction 2 months after the booster dose, assessed as unrelated to study vaccination) was reported.
*** EXTRACT END ***
The following table shows the Frequency of Solicited Local Reactions by Severity, Within 7 Days After Dose 2 Compared to After Booster Dose of BNT162b2 30 µg Among Participants in Phase 1/2/3 Study C4591001 [12] [13]. [spreadsheet]
Solicited Local Reactions |
Dose 1 |
Dose 2 |
Booster |
Booster |
| Injection Site Pain | ||||
| Any | 2426 (83.7) | 2101 (78.3) | 240 (83.0) | 8 (66.7) |
| Mild d | 1464 (50.5) | 1274 (47.5) | 174 (60.2) | 8 (66.7) |
| Moderate | 923 (31.8) | 788 (29.4) | 65 (22.5) | 0 (0.0) |
| Severe | 39 (1.3) | 39 (1.5) | 1 (0.3) | 0 (0.0) |
| Swelling | ||||
| Any (>2.0 cm) | 184 (6.3) | 183 (6.8) | 23 (8.0) | 0 (0.0) |
| Mild e | 124 (4.3) | 110 (4.1) | 13 (4.5) | 0 (0.0) |
| Moderate | 54 (1.9) | 66 (2.5) | 9 (3.1) | 0 (0.0) |
| Severe | 6 (0.2) | 7 (0.3) | 1 (0.3) | 0 (0.0) |
| Redness | ||||
| Any (>2.0 cm) | 156 (5.4) | 151 (5.6) | 17 (5.9) | 0 (0.0) |
| Mild e | 113 (3.9) | 90 (3.4) | 10 (3.5) | 0 (0.0) |
| Moderate | 36 (1.2) | 50 (1.9) | 7 (2.4) | 0 (0.0) |
| Severe 7 (0.2) | 11 (0.4) | 0 (0.0) | 0 (0.0) |
Notes:
The following table shows the Frequency of Solicited Systemic Reactions, by Severity, Within 7 Days After Dose 2 Compared to After Booster Dose of BNT162b2 30 µg Among Participants in Phase 1/2/3 Study [12] [13]. [spreadsheet]
Solicited Systemic Reactions |
Dose 1 |
Dose 2 |
Booster |
Booster |
| Fatigue | ||||
| Any | 1431 (49.4) | 1649 (61.5) | 185 (63.8) | 5 (41.7) |
| Mild a | 760 (26.2) | 558 (20.8) | 69 (23.8) | 2 (16.7) |
| Moderate | 630 (21.7) | 949 (35.4) | 103 (35.5) | 3 (25.0) |
| Severe | 41 (1.4) | 142 (5.3) | 13 (4.5) | 0 (0.0) |
| Headache | ||||
| Any | 1262 (43.5) | 1448 (54.0) | 140 (48.4) | 5 (41.7) |
| Mild a | 785 (27.1) | 699 (26.1) | 83 (28.7) | 4 (33.3) |
| Moderate | 444 (15.3) | 469 (17.5) | 54(18.7) | 1 (8.3) |
| Severe | 33 (1.1) | 91 (3.4) | 3 (1.0) | 0 (0.0) |
| New/worsened muscle pain Any | ||||
| 664 (22.9) | 1055 (39.3) | 113 (39.1) | 4 (33.3) | |
| Milda | 353 (12.2) | 441 (16.4) | 52 (18.0) | 2 (16.7) |
| Moderate | 296 (10.2) | 552 (20.6) | 57 (19.7) | 2 (16.7) |
| Severe | 15 (0.5) | 62 (2.3) | 4 (1.4) | 0 (0.0) |
| Chills | ||||
| Any | 479 (16.5) | 1015 (37.8) | 84 (29.1) | 2 (16.7) |
| Milda | 338 (11.7) | 477 (17.8) | 37 (12.8) | 0 (0.0) |
| Moderate | 126 (4.3) | 469 (17.5) | 44 (15.2) | 2 (16.7) |
| Severe | 15 (0.5) | 69 (2.6) | 3 (1.0) | 0 (0.0) |
| New/worsened joint pain | ||||
| Any | 342 (11.8) | 638 (23.8) | 73 (25.3) | 2 (16.7) |
| Mild a | 200 (6.9) | 291 (10.9) | 36 (12.5) | 0 (0.0) |
| Moderate | 137 (4.7) | 320 (11.9) | 36 (12.5) | 2 (16.7) |
| Severe | 5 (0.2) | 27 (1.0) | 1 (0.3) | 0 (0.0) |
| Diarrhea | ||||
| Any | 309 (10.7) | 269 (10.0) | 25 (8.7) | 0 (0.0) |
| Mild b | 251 (8.7) | 219 (8.2) | 21 (7.3) | |
| Moderate | 55 (1.9) | 44 (1.6) | 4 (1.4) | |
| Severe | 3 (0.1) | 6 (0.2) | 0 | |
| Vomiting | 34 (1.2) | 58 (2.2) | 5 (1.7) | 0 (0.0) |
| Mild c | 29 (1.0) | 42 (1.6) | 5 (1.7) | |
| Moderate | 5 (0.2) | 12 (0.4) | 0 (0.0) | |
| Severe | 0 (0.0) | 4 (0.1) | 0 (0.0) | |
| Fever | ||||
| >=38.0 C | 119 (4.1) | 440 (16.4) | 25 (8.7) | 0 (0.0) |
| >=38.0 to 38.4 C | 86 (3.0) | 254 (9.5) | 12 (4.2) | |
| >38.4 to 38.9 C | 25 (0.9) | 146 (5.4) | 12 (4.2) | |
| >38.9 to 40.0 C | 8 (0.3) | 39 (1.5) | 1 (0.3) | |
| >40.0 C | 0 (0.0) | 1 (0.0) | 0 (0.0) | |
| Antipyretic or pain medication used | 805 (27.8) | 1213 (45.2) | 135 (46.7) | 4(33.3) |
Notes:
Based on the studies to be performed by Pfizer in the next few years there is concern associated with Pericarditis and Myocarditis. See section Pfizer Vaccine Rollout Schedule.
Pericarditis is inflammation of the pericardium, a sac-like structure with two thin layers of tissue that surround the heart to hold it in place. A small amount of fluid keeps the layers separate so there's less friction between them as the heart beats. Pericarditis can be caused by a viral infection or heart attack. In many cases, the cause is unknown. The most common symptom is sharp, stabbing chest pain that may travel to the left shoulder and neck. Pericarditis usually begins suddenly but does not last long. Most cases are mild and usually improve without treatment. Treatment for more severe cases may include medications and, rarely, surgery.
Myocarditis is usually caused by a viral infection. A severe case can weaken the heart, which can lead to heart failure, abnormal heartbeat, and sudden death. Symptoms include chest pain, abnormal heartbeat, and shortness of breath. Treatment may include medication to regulate the heartbeat and improve heart function. In rare but severe cases, a device may be needed to help the heart function.
Safety Data Real World Evidence (RWE) Israel
There is data from a very large population and it is associated with Israel. Based on evidence for waning in Israel, and the trajectory towards exceeding national hospitalization capacity given the rapid rise in severe cases, Israel decided to begin a 3d vaccination campaign on July 30, 2021, starting with the elderly [14].
Gender |
Age group |
Vaccinated |
Myocarditis cases |
Vaccinated |
Myocarditis cases |
Vaccinated |
Myocarditis cases |
Female |
12-15 |
186,655 |
0 |
134,637 |
1 |
163 |
0 |
Female |
16-19 |
242,497 |
0 |
215,725 |
2 |
55,107 |
0 |
Female |
20-24 |
260,693 |
1 |
239,427 |
6 |
79,174 |
0 |
Female |
25-29 |
244,705 |
0 |
226,471 |
1 |
74,222 |
0 |
Female |
30+ |
2,116,016 |
3 |
2,013,329 |
8 |
1,273,773 |
0 |
Male |
12-15 |
174,597 |
1 |
126,723 |
9 |
142 |
0 |
Male |
16-19 |
248,673 |
3 |
217,006 |
33 |
57,195 |
0 |
Male |
20-24 |
272,641 |
6 |
248,747 |
26 |
85,961 |
0 |
Male |
25-29 |
255,426 |
3 |
236,913 |
20 |
77,325 |
0 |
Male |
30+ |
1,973,238 |
10 |
1,882,588 |
32 |
1,211,543 |
1 |
Notes: 1. In many other vaccines Myocarditis appears in less than 30 days.
The report on Septmber 13, 2021 of the data from Isreal concluded that the Booster dose in Israel was effective and so far had a safety profile similar to the other doses.
A reasonable systems mental model suggests that those susceptible to vaccine negative effects would have surfaced with the early vaccination doses. It is unclear if those that developed Myocarditis in the early shots would develop Myocarditis with future shots. It is also unclear if those that had Myocarditis decided to take a second and third vaccine shot. This systems analysis of the data presented suggests that the Myocarditis case results match the systems mental model which is the first step in accepting systems data and model results. Are the results reasonable and expected is a key systems analysis check.
The following table summarizes the negative effects of the Booster in Isreal [14].
Data Item |
Isreal |
Vaccinated |
2,800,000 |
| Booster | 2,004,064 |
Non serious reports |
1,328 |
Serious reports |
19 |
Deaths see 1 |
5 |
Notes: 1. All were 65+ and had serious pre-existing conditions.
It is unclear why 800,000 (30%) of the people did not receive the Booster shot. It may be associated with the time requirement of 5 months before a booster can be provided.
Pfilzer Vaccine Waning Analysis
Just like in the safety analysis, there are 2 data sources available to understand the Pfizer vaccine waning results. The information was presented by the Vaccines and Related Biological Products Advisory Committee to the FDA at a meeting September 17, 2021. They are:
Waning Analysis Retrospective Cohort Study Kaiser Permanente Southern California
In the Kaiser Permanente Southern California (KPSC) Retrospective Cohort study, electronic health records from KPSC between Dec 14, 2020 and Aug 8, 2021 were analyzed to assess vaccine effectiveness against infections and related hospitalization. The KPSC Retrospective Cohort study had approximately 3.4 million members >=12 years of age with >=1 year prior membership. The study period was from Dec 14, 2020 to Aug 8, 2021. The whole genome sequencing was on all samples from Mar 4, 2021 to Jul 21, 2021. [16]
The following is a figure if SARS-CoV-2 Infection over time [16].
Note: CI is Confidence Interval (CI)
The infections over time data suggests that protection against infection is waning over time. Vaccine effectiveness against infections declined from 88% (95% CI: 86-89) during the first month after full vaccination to 47% (43-51) after >= 5 months.
The following is a figure of COVID-19 Related Hospitalizations over time [16].
The SARS-CoV-2 Hospitalizations over time data suggests that protection against hospitalizations is NOT waning over time.
This data can be interpreted in two ways. The first is that infection rate increases is just a precursor of what is to follow, which is hospitalizations. The second is that there is more testing being performed as time moves forward.
The following figure shows the vaccine waning over time based on infections data. Adjusted VE Against SARS-CoV-2 Infections, KPSC Members >=12 Years of Age. There is no statistically significant difference in rate of decline between Delta and other sequenced variants (p=0.30). [16]
Among sequenced infections, estimates against both Delta and other (non-Delta) sequenced variants were high at <1 month after full vaccination (against Delta: 93% [85-97] vs other variants: 97% [95-99], p=.289). At >4 months after full vaccination, against Delta infections declined to 53% (39-65) and against other variants to 67% (45-80), p=.254. [16]
The following table shows the vaccine effectiveness based on KPSC infections data extracted from the above figure. [16]
Variants |
VE |
VE Range |
VE |
VE Range |
Other |
97% |
95-99% |
67% |
45-80% |
Delta |
93% |
85-97% |
53% |
39-65% |
Note: no statistically significant difference in rate of decline between Delta and other sequenced variants (p=0.30)
The difference in rate of decline between Delta and other variants was not statistically significant (p=.303). Vaccine effectiveness against hospitalization for Delta for all ages was high overall (93% [85-97]). The variant specific analysis suggests that reductions in effectiveness over time are due to waning effectiveness rather than Delta escaping vaccine protection because that effectiveness against Delta infections was >90% at month 1. Reductions in effectiveness in infections by time since being fully vaccinated were observed irrespective of variant, and effectiveness against Delta hospitalizations remained high over the entire study period. [16]
The retrospective KPSC study suggests that vaccine effectiveness reductions are primarily due to waning vaccine induced immunity rather than due to Delta escaping vaccine protection.
Waning Analysis Real World Evidence (RWE) Israel
Waning immunity was observed across multiple age groups. The following figure shows the rate of confirmed SARS-CoV-2 infections by vaccination period and age group Per 1000 persons, during July 11, 2021 and July 31, 2021 in Israel.
Waning immunity was also observed for severe disease in the age 60+ group. The following figure shows the Severe COVID-19 cases Per 1000 persons, during July 11, 2021 and July 31, 2021.
Waning immunity against severe disease may occur also in younger age groups. The following figure shows the Rates of severe COVID-19 by vaccination period and age group per 1000 persons, July 11 to August 15, 2021.
Waning Analysis Overall Pfizer Results
An analysis of efficacy up to six months after Dose 2 shows that initial vaccine efficacy slightly wanes over time in the pre-Delta period [16]:
The following was offered to the FDA as a result of Pfizer waning studies [16]:
Real-World evidence (RWE) from Israel and United States suggest that Vaccine Effectiveness (VE) against COVID-19 infection wanes approximately 6 to 8 months following the second dose when the delta variant is predominant. The Israel Ministry of Health (MOH) and Pfizer have a data sharing agreement. A retrospective Kaiser Permanente Southern California (KPSC) study suggests that VE reductions are primarily due to waning vaccine induced immunity rather than due to Delta escaping vaccine protection. Waning vaccine effectiveness is further supported by the recent FDA requested post-hoc analysis of breakthrough cases in the C4591001 pivotal Phase 3 clinical study. While waning VE against hospitalization was not observed in the US, data from Israel suggests that reduced effectiveness against severe disease may eventually follow reductions in VE against SARS-CoV-2 infections. [14]
Pfizer Booster Effectiveness
There are 4 data sources available to understand the Pfizer effectiveness results. The information was presented by the Vaccines and Related Biological Products Advisory Committee to the FDA at a meeting on September 17, 2021. They are:
Retrospective Cohort Study Kaiser Permanente Southern California (KPSC)
UNDER CONSTRUCTION
Pfizer Booster Effectiveness Israel
In Israel, a 3rd Booster Dose Restored High Levels of Effectiveness for Both Infections and Severe COVID-19. Fold reduction in risk of developing SARS-CoV-2 outcomes after three doses of BNT162b2 (vs. 2 doses only) among adults 60 years of age who were fully vaccinated before March 1, 2021[16]. The following table summarizes the findings.
BNT162b2 Doses |
Confirmed Infection |
Severe COVID-19 |
2 doses only a |
reference |
reference |
3 doses b |
11.4-fold (10.0, 12.9) |
15.5-fold (10.5, 22.8) |
Notes:
The fold reductions translate to roughly 95% effectiveness after a booster against infections and severe disease in the Delta era.
The report on Septmber 13, 2021 of the data from Isreal concluded that the Booster dose in Israel showed:
Longitudinal Health and Wellbeing COVID-19 UK National Core Study
This analysis is from a broader prspective. The following was provided at the start of the presentation: "This study aims to understand the health, social and economic impacts of the COVID-19 pandemic by uniting established population cohorts and national anonymised electronic health records to inform policy". The presentation addressed Methodological issues in estimating vaccine efficacy during the rollout. The topics were [17]:
The key elements from the presentation were [17]:
The following table shows the Estimated Effectiveness of Vaccines in Observational Studies [17].
Study Location (reference) |
Vaccine |
Vaccine vs |
Lower Limit |
Upper Limit |
| USA, Southern California KPSC (1) | BNT162b2 or mRNA-1273 | 93 | 84 | 96 |
| USA, Minnesota (2) | BNT162b2 | 75 | 24 | 94 |
| mRNA-1273 | 81 | 33 | 96 | |
| USA, New York (3) | BNT162b2; mRNA-1273; Ad26.COV2.S | 94.4 | 92.7 | 95.7 |
| USA 13 jurisdictions (5) | BNT162b2; mRNA-1273; Ad26.COV2.S | 90.4 | 87.7 | 92.5 |
| USA, 7 locations VISION network (7) | BNT162b2 | 87 | 85 | 90 |
| mRNA-1273 | 91 | 83 | 93 | |
| USA, 9 States VISION network (8) | BNT162b2 | 80 | 73 | 85 |
| mRNA-1273 | 95 | 92 | 97 | |
| USA, 5 VA Medical Centers (9) | mRNA-1273 | 89 | 80 | 94 |
| USA (14) | mRNA-1273 | 96 | 91 | 98 |
| Israel, (4) | BNT162b2 | 88 | 94 | 91 |
| Qatar (10) | BNT162b2 | 89.7 | 61 | 98.1 |
| Qatar (11) | mRNA-1273 | 100 | 41.2 | 100 |
| Singapore (12) | BNT162b2 or mRNA-1273 | 93 | 66 | 98 |
| UK (13) | BNT162b2 | 96 | 86 | 99 |
Effectiveness Overall Pfizer Results
The following benefit risk summary was offered [16]:
References:
[1] FDA advisers recommend COVID boosters for 65 and older, reject broad approval, Reuters, September 17, 2021. webpage, https://www.reuters.com/world/us/us-covid-19-booster-debate-moves-fda-vaccine-advisory-committee-2021-09-17, September 2021. FDA advisers recommend COVID boosters for 65 and older, reject broad approval.
[2] Vaccines and Related Biological Products Advisory Committee, US Food and Drug Administration - FDA, September 17, 2021. webpage https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-september-17-2021-meeting-announcement, September 2021. Vaccines and Related Biological Products Advisory Committee. local
[3] Vaccines and Related Biological Products Advisory Committee - 9/17/2021, YouTube.com. webpage, https://www.youtube.com/watch?v=WFph7-6t34M, September 2021. Vaccines and Related Biological Products Advisory Committee - 9/17/2021.
[4] National Vaccine Information Center, MEDALERTS, webpage https://www.medalerts.org/vaersdb/index.php, September 2021. National Vaccine Information Center - comment: this is not the US government database search.
[5] CDC Wonder, The Vaccine Adverse Event Reporting System (VAERS), US CDC. webpage https://wonder.cdc.gov/vaers.html. September 2021. CDC Wonder - comment: this is the official US Government database search.
[6] Coronavirus (COVID-19) Vaccinations, Our World In Data, https://ourworldindata.org/covid-vaccinations, September 20, 2021.
[7] Odds of Dying, National Safety Council, 2019. webpage https://injuryfacts.nsc.org/all-injuries/preventable-death-overview/odds-of-dying, May 2021. Odds of Dying.
[8] 3 reasons why the FDA rejected Pfizer's booster shot for general population, Yahoo.com News, September 20, 2021. webpage https://finance.yahoo.com/news/3-reasons-why-fda-rejected-booster-shots-195236606.html, September 2021. 3 reasons why the FDA rejected Pfizer's booster shot for general population.
[9] CDC Statement on ACIP Booster Recommendations, Press Release, Centers For Disease Control and Prevention - CDC, September 24, 2021. webpage https://www.cdc.gov/media/releases/2021/p0924-booster-recommendations-.html, September 2021. CDC Statement on ACIP Booster Recommendations.
[10] Comirnaty and Pfizer-BioNTech COVID-19 Vaccine, US Food and Drug Administration - FDA, August 23, 2021. webpage https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/comirnaty-and-pfizer-biontech-covid-19-vaccine, September 2021. Comirnaty and Pfizer-BioNTech COVID-19 Vaccine
[11] Pfizer Approval Letter, US Food and Drug Administration - FDA, August 23, 2021. webpage https://www.fda.gov/media/151710/download, September 2021. Pfizer Approval Letter . local
[12] Vaccines and Related Biological Products Advisory Committee Meeting September 17, 2021, FDA Briefing Document, Application for licensure of a booster dose for COMIRNATY (COVID-19 Vaccine, mRNA), webpage https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-september-17-2021-meeting-announcement, https://www.fda.gov/media/152176/download, September 2021. All Documents . PDF . local
[13] FDA Review of Effectiveness and Safety of COMIRNATY (COVID-19 Vaccine, mRNA) Booster Dose Biologics License Application Supplement, Vaccines and Related Biological Products Advisory Committee September 17, 2021 Meeting Presentation- Booster Dose FDA Review of Effectiveness and Safety, webpage https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-september-17-2021-meeting-announcement, https://www.fda.gov/media/152239/download, September 2021. All Documents . PDF . local
[14] Booster protection against confirmed infections and severe disease - data from Israel, Vaccines and Related Biological Products Advisory Committee September 17, 2021 Meeting Presentation- Booster Protection against confirmed infections and severe disease- data from Israel, September 17, 2021. webpage https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-september-17-2021-meeting-announcement, https://www.fda.gov/media/152205/download, September 2021. All Documents . PDF . local
[15] Comirnaty(COVID-19 Vaccine, mRNA)Supplemental Biologics License Applicationfor a booster dose in individuals 16 years of age and older, Vaccines and Related Biological Products Advisory Committee September 17, 2021 Meeting Presentation-Supplemental BLA for a booster dose in individuals 16 years of age and older, September 17, 2021. webpage https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-september-17-2021-meeting-announcement, https://www.fda.gov/media/152205/download, September 2021. All Documents . PDF . local
[16] BNT162b2 [COMIRNATY (COVID-19 Vaccine, mRNA)] Booster (Third) Dose Vaccines and Related Biological Products Advisory Committee, Vaccines and Related Biological Products Advisory Committee September 17, 2021 Meeting Presentation- Booster Dose Pfizer, September 17, 2021. webpage https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-september-17-2021-meeting-announcement, https://www.fda.gov/media/152240/download, September 2021. All Documents . PDF . local
[17] Vaccines and Related Biological Products Advisory Committee September 17, 2021 Meeting Presentation - Real-world effectiveness of COVID-19 Vaccines, Vaccines and Related Biological Products Advisory Committee September 17, 2021 Meeting Presentation, Real-world effectiveness of COVID-19 vaccines, University of Bristol, UK, webpage https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-september-17-2021-meeting-announcement, https://www.fda.gov/media/152241/download, September 2021. All Documents . PDF . local
Recent Mega Trends
How we arrived at this point in history and how we might prevent this from happening again is a huge systems analysis challenge. This will be studied for hundreds of years. This analysis is offered from the perspective of examining recent mega trends in the USA.
The mega trend that existed after World War II and the mega trend that surfaced approximately in 1980 can be associated with different philosophies. The predominant philosophies practiced in the culture suggests a cultural mega trend. The following summarizes various philosophies and suggests that certain philosophies were predominant in the culture between 1945 and 1980. After 1980 there was a shift and a new cultural mega trend surfaced. For this analysis they are named as System A and System B. The allocations and limited comments are subjective but not without merit. In the areas where there is massive divergence in philosophies it is probably reasonable.
Philosophy |
Description |
System A |
System B |
System C |
Logical Positivism |
Also called Logical Empiricism is a philosophy that scientific knowledge is the only kind of factual knowledge and that all traditional metaphysical doctrines are to be rejected as meaningless. The best way to philosophize is through science. Science is truth. An individual with this philosophical core is a Logical Positivist. | X |
rejected |
X |
Greek Cynicism |
A philosophy where the purpose of life was to live in virtue in agreement with nature. As reasoning creatures, people can gain happiness by rigorous training and by living in a way which is natural for themselves, rejecting all conventional desires for wealth, power, and fame. Instead, they are to lead a simple life free from all possessions. | partial within reason |
rejected |
partial within reason |
Cynicism |
This was originally Greek Cynicism but it changed by the 19th century. The emphasis on the negative aspects of Cynic philosophy led to the modern understanding of Cynicism to mean disbelief in the sincerity or goodness of human motives and actions. It has also moved into a philosophy where the rules of society should be ignored. | frowned upon |
X |
negative |
Humanism |
A philosophy placing importance on human rather than divine or supernatural matters. It stresses the potential value and goodness of human beings, emphasizes common human needs, and seeks solely rational ways of solving human problems. In modern times it is aligned with secularism and may refer to a nontheistic life stance centered on human agency and looking to science rather than revelation from a supernatural source to understand the world. Renaissance Humanism is a philosophy where meaning is found in the human form through art. | X |
rejected |
X |
Altruism |
A philosophy that we should live by only bringing happiness to others. It is the principle and moral practice of concern for the happiness of other human beings or other animals,resulting in a high quality of life both material and spiritual. In an extreme case, altruism may become a synonym of selflessness, which is the opposite of selfishness. | X |
rejected |
X |
Transcendentalism |
A philosophy that our deepest connection is with nature. Philosophical and social movement which developed in New England around 1836 in reaction to rationalism. Divinity pervades all nature and humanity. There is inherent goodness in people and nature. Society and its institutions corrupt the purity of the individual. People are at their best when truly self-reliant and independent. There is divine experience inherent in the every day, rather than believing in a distant heaven. Physical and spiritual phenomena are part of dynamic processes rather than discrete entities. | partial |
partial |
harmless |
Traditionalism |
All moral and religious truth comes from divine revelation passed on by tradition and human reason is incapable of attaining it. Belief in the existence of a perennial wisdom or perennial philosophy, primordial and universal truths which form the source for, and are shared by, all the major world religions. There are primordial and universal religious truths which are at the foundations of all major world religions. A philosophy that the best way of life is a return to the past. | within reason |
X |
harmless |
Egoism |
A philosophy that we should live by only bringing happiness to ourselves. Treats self-interest as the foundation of morality. Ethical egoism does not require moral agents to harm the interests and well-being of others when making moral deliberation. What is in an agent's self-interest may be incidentally detrimental, beneficial, or neutral in its effect on others. However, when practiced by individuals this is usually extreme self interest at the cost of all other interests. Winner take all is the tendency even if it is possible to have win win situations. | rejected |
X |
reject extremely toxic |
Nihilism |
A philosophy where there is no point to anything because it all ends in nothingness because we are all going to die. It is the rejection of all religious and moral principles in the belief that life is meaningless. It is negation towards life or towards fundamental concepts such as knowledge, existence, and the meaning of life. Human values are baseless, that life is meaningless, that knowledge is impossible, or that some set of entities do not exist. Modern Nihilism comes from the Nietzschean crisis of nihilism with two central concepts: the destruction of higher values and the opposition to the affirmation of life. Earlier forms of nihilism were more selective in negating specific social, moral, political and aesthetic thought. In popular use it refers to forms of existential nihilism where life is without intrinsic value, meaning, or purpose. Other prominent positions within nihilism include the rejection of all normal and ethical views, the rejection of all social and political institutions, the stance that no knowledge can or does exist, and a number of metaphysical positions, which assert that non-abstract objects do not exist, that composite objects do not exist, or even that life itself does not exist. | rejected |
partially embraced |
reject extremely toxic |
| Utilitarianism | A philosophy that balances Altruism with Egoism. Actions that maximize happiness and well-being for all affected individuals. Actions that tend to produce benefit, advantage, pleasure, good, or happiness and to prevent mischief, pain, evil, or unhappiness to the party whose interest is considered. Treat one's self with no higher regard than one has for others. One is not obligated to sacrifice one's own interests to help others' interests, so long as one's own interests are substantially equivalent to the others' interests and well-being, but the choice to do so is permitted. | X |
rejected |
X |
Vannevar Bush was a key scientific adviser in the USA and he and others in the Franklin D. Roosevelt administration were working on stopping what they thought was the start of a new dark age. President Roosevelt asked his advisors what was happening and the response was that we were entering a new dark age. President Roosevelts' response was to ask how long it would last in terms of 2, 3, or 5 years. The response was, no you don't understand, we are entering a dark age that might last 500, 700, 900 years. As the war was ending and the outcome was clear, president Roosevelt asked Vannevar Bush to identify what should happen after the war. The brain trust produced a document called Science The Endless Frontier [1]. This is the start of System A. This document established the policies of the USA after WW II up until approximately 1980 when the USA started to reject the New Deal.
On January 20, 1961, John F. Kennedy, the youngest US president ever elected, gave an inaugural address and stated: Ask not what your country can do for you - ask what you can do for your country. This challenged every American to contribute in some way to the public good. It inspired children and adults to see the importance of civic action and public service This is System [A] that started in 1945.
The USA transitioned from System A to System B. The transition started in the 1980. There are many references that document the transition from newspapers, magazines, movies, and other media. In an interview on the BBC documentary, The Trap What Happened to Our Dream of Freedom, conservative economist James M. Buchanan criticized the concept of public interest, asking what it is and suggested that it consists purely of self-interest of the governing bureaucrats. Buchanan also proposed that organizations should employ managers who are motivated only by money. He described those who are motivated by other factors, such as job satisfaction or a sense of public duty as zealots [2]. The implication being that they are to be removed from power and authority in all institutions.
We know that System A was not bad compared to System B. There was war and hunger in System A but Nuclear War was avoided and in general the entire civilization was uplifted and enjoyed health and prosperity. We know that System B was starting to cause massive economic problems and that there was a general decline in the quality of life in the civilization. We now know that System B catastrophically failed with the spread of the COVID-19 virus that has now become the COVID-19 disaster. The key reasons why System B failed are:
The big question is what should System C be in terms of philosophical approaches. The suggested approach is to reject the elements that led to the collapse of the civilization. They are marked as - reject extremely toxic. In addition, there are certain philosophies that were rejected in System B that need to be reestablished in System C. They are marked with an X in System C.
It is not easy designing a system that is a civilization. This is probably the most important systems analysis that this generation must perform and they have to get it right and do it quickly. The price is enormous and can be as high as the civilization entering into a dark age that can last for hundreds of years. This challenge is not unlike the challenge faced by President Roosevelt and the people in the last century.
References:
[1] Science The Endless Frontier, US Government Office of Scientific Research and Development, United States Government Printing Office, Washington: 1945. webpage https://www.nsf.gov/od/lpa/nsf50/vbush1945.htm, November 2020. Science The Endless Frontier . local
[2] The Trap What Happened to Our Dream of Freedom, BBC Documentary, Adam Curtis, March 2007.
Toxic Civilization Actions
Toxic Legislation
In 2021 legislation has been submitted at the state level to remove COVID-19 legal liability in planned real estate developments. Management companies in these communities have contacted residents urging them to support this legislation otherwise facilities will continue to be closed and legal liability will be on the volunteers suggesting that the management companies have no liability concerns.
Before this analysis is offered it is clear that COVID-19 is not a legal problem. It is not a social problem. It is not a political problem. COVID-19 is a deadly contagion that has shut down our civilization and the only way to deal with it is by using our best technologies. COVID-19 is a technology problem and legislation should be coming from the perspective of using all our technologies to mitigate and remove the COVID-19 and other future deadly contagions.
This is an example of a typical message sent by home owners associations management companies [1] [2]:
Please support New Legislation
We have important news about legislation introduced by Assemblymen. You all are quite aware of the liability issues that contributed to preventing the vast majority of all community association pools, gyms, and other amenities in New Jersey from opening last year. As a means of helping avoid that difficult situation again this year, this new legislation will render it easier for executive boards to make the important decision whether to open community association pools and other amenities.
Assemblymen from Atlantic County introduced A4979. A senator from Mercer and Middlesex Counties, introduced the identical bill in the Senate, S3584, which is modeled after language which your CAI Legislative Action Committee (LAC-NJ) recommended.
Bills A4979 and S3584 provide that any illness, injury or death from or related to an exposure to or transmission of COVID19 on the premises of a planned real estate development shall not give rise to any cause of action. This immunity would not apply to acts or omissions constituting a crime, actual fraud, actual malice, gross negligence, recklessness, or willful misconduct.
We need your help to encourage your local legislators to support A4979 and S3584. Please send an email to your local legislators in support of the bill which benefits every member of a community association.
Contact info: Senator, Assemblyman
Sample Language:
I am writing to request your support of S3584 and A4979 which would protect common interest community associations and their volunteer board members from causes of action for damages arising from a COVID-19 exposure or transmission on the premises of their planned real estate development. This immunity would not apply to acts or omissions constituting a crime, actual fraud, actual malice, gross negligence, recklessness, or willful misconduct.
Please consider and support this legislation for the following reasons:
1. This legislation is vital because our associations are non-profit and our volunteer board members may be sued personally for COVID-19 claims.
2. It will give volunteer board members an important tool to provide comfort when considering how and when to safely re-open their amenities.
3. Last year the vast majority of community associations across our state did not open their recreational amenities due largely for fear of uninsured COVID-19 claims resulting in residents of community associations being denied access to their recreational amenities.
4. It is unique from other pending immunity bills because it is narrowly focused to protect planned real estate developments and their volunteer board members and will allow for the safe reopening of their amenities.
5. It is industry specific and serves all common interest communities.
Thank you for your anticipated support for this important legislation that would benefit the nearly 1.5 million people who live and work in common interest communities in New Jersey.
This is the A4979 legislation text [3].
ASSEMBLY, No. 4979
STATE OF NEW JERSEY
219th LEGISLATURE
INTRODUCED NOVEMBER 12, 2020Sponsored by:
Assemblyman VINCENT MAZZEO
District 2 (Atlantic)
Assemblyman JOHN ARMATO
District 2 (Atlantic)SYNOPSIS
Establishes immunity relating to COVID-19 spread in planned real estate developments.
CURRENT VERSION OF TEXT
As introduced.
An Act establishing immunity relating to COVID-19 spread in planned real estate developments and supplementing Title 2A of the New Jersey Statutes.
Be It Enacted by the Senate and General Assembly of the State of New Jersey:
1. a. Any illness, injury, death, or other damages arising from, or related to, an exposure to, or transmission of, COVID-19 on the premises of a planned real estate development shall not give rise to any cause of action.
b. The immunity provided pursuant to subsection a. of this section shall not apply to acts or omissions constituting a crime, actual fraud, actual malice, gross negligence, recklessness, or willful misconduct.
c. As used in this section:
COVID-19 means the coronavirus disease 2019, as announced by the World Health Organization on February 11, 2020, and first identified in Wuhan, China.
Planned real estate development means the same as that term is defined in section 3 of P.L.1977, c.419 (C.45:22A-23).
2. This act shall take effect immediately.
STATEMENT
This bill would prohibit any causes of action for damages arising from a COVID-19 exposure or transmission on the premises of a planned real estate development. This immunity would not apply to acts or omissions constituting a crime, actual fraud, actual malice, gross negligence, recklessness, or willful misconduct.
This the the S3584 text [4].
SENATE, No. 3584
STATE OF NEW JERSEY
219th LEGISLATURE
INTRODUCED MARCH 25, 2021Sponsored by:
Senator LINDA R. GREENSTEIN
District 14 (Mercer and Middlesex)SYNOPSIS
Establishes immunity relating to COVID-19 spread in planned real estate developments.
CURRENT VERSION OF TEXT
As introduced.
An Act establishing immunity relating to COVID-19 spread in planned real estate developments and supplementing Title 2A of the New Jersey Statutes.
Be It Enacted by the Senate and General Assembly of the State of New Jersey:
1. a. Any illness, injury, death, or other damages arising from, or related to, an exposure to, or transmission of, COVID-19 on the premises of a planned real estate development shall not give rise to any cause of action.
b. The immunity provided pursuant to subsection a. of this section shall not apply to acts or omissions constituting a crime, actual fraud, actual malice, gross negligence, recklessness, or willful misconduct.
c. As used in this section:
COVID-19 means the coronavirus disease 2019, as announced by the World Health Organization on February 11, 2020, and first identified in Wuhan, China.
Planned real estate development means the same as that term is defined in section 3 of P.L.1977, c.419 (C.45:22A-23).
2. This act shall take effect immediately.
STATEMENT
This bill would prohibit any causes of action for damages arising from a COVID-19 exposure or transmission on the premises of a planned real estate development. This immunity would not apply to acts or omissions constituting a crime, actual fraud, actual malice, gross negligence, recklessness, or willful misconduct.
In response to the proposed legislation in A4979 / S 3584, the following was provided to the sponsors of the bills.
Subject: COVID Legislation Planned Real Estate Developments
We have recently been made aware of proposed legislation A4979 / S3584 to remove legal liability from COVID-19 spread in planned real estate developments. We urge you to drop this toxic deadly legislation immediately.
There is a massive split that is occurring between elite communities and other communities. The elite communities have invested in upgraded HVAC systems, ceiling level UV-C systems, and Far UV-222 systems in their planned real estate developments and schools. Because of money, they have access to proper engineering firms and their desire to provide the safest conditions that industry can provide are not squashed by external influences. The non elite communities are either not aware of what is possible or when they are made aware are quickly challenged by the lack of funds. They then reject the topic because there is no government regulations for them to upgrade their systems to match the elite communities.
Instead of this legislation, which will make people sick and cause death, we need legislation that will prevent people from getting sick and dying. The legislation needs to be in the form of new regulations now that we have a deadly virus in our environment. Future legislation can be developed for funds in the form of grants and tax incentives so that the COVID-19 infrastructure can be upgraded by all other communities.
SYNOPSIS
Establishes regulations to maximize the safety of planned real estate development facilities from the grave harm caused by COVID-19.
CURRENT VERSION OF TEXT
Not introduced yet.
This is proposed legislation instead of A4979 and S3584, which will cause illness and death
An Act establishing regulations to use proper building HVAC, ceiling level UV-C, and Far UV-222 systems to minimized the spread COVID-19 in planned real estate developments and supplementing Title 2A of the New Jersey Statutes.
Be It Enacted by the Senate and General Assembly of the State of New Jersey:
1. No planned real estate development public club houses can open until the COVID-19 world pandemic is over unless they install ceiling level UV-C lights or Far UV-222 lights in all public areas and HVAC systems are upgraded to support a minimum of 6 AUC or more in all areas.
2. All installed ceiling level UV-C and Far UV-222 systems must be inspected and approved according to approved standards by local authorities before a COVID-19 certificate of occupancy can be issued.
3. All HVAC systems must be inspected and approved according to approved standards by local authorities before a COVID-19 certificate of occupancy can be issued.
4. Definitions:
"AUC" air update changes per hour.
"ceiling level" also called upper-room or upper-air.
"ceiling level UV-C" is a form of Ultraviolet germicidal irradiation (UVGI) to kill or inactivate microorganisms. Developed in 1936. Products are available in the commercial market.
"COVID-19" means the coronavirus disease 2019, as announced by the World Health Organization on February 11, 2020, and first identified in Wuhan, China.
"Far UV-222" is a form of Ultraviolet germicidal irradiation (UVGI) to kill or inactivate microorganisms. Developed by University of Columbia. Products are available in the commercial market.
"HVAC" means Heating Ventilation and Cooling.
"Planned real estate development" means the same as that term is defined in section 3 of P.L.1977, c.419 (C.45:22A-23).
"UV" means Ultraviolet.
5. This act shall take effect immediately.
STATEMENT
This bill will save lives and improve the quality of life for millions of people. This bill will reduce the number of COVID-19 infections, COVID-19 long terms health losses, and COVID-19 deaths. There are 1.5 million people who live and work in common interest communities in New Jersey that are at risk of grave harm.
Please do not act on the grave legislation that is A4979 and S3584. Instead consider the above legislation that will save lives and improve the quality of life of thousands of people.
*** End ***
COVID-19 is not a legal problem. It is a Technology and Access Problem. Legislation should never remove the rights of citizens who are harmed. All legislation should encourage health and life not sickness and death.
This is an example of the Social Bifurcation that is happening around the COVID-19 disaster [5]. With the A4979 and S3584 legislation the elite settings have the most healthy facilities and everyone else will be unable to take legal action when they get sick and die in their unhealthy facilities. History will record this as yet another toxic action taken during the COVID-19 disaster.
References:
[1] NJ LAC (Legal Action Committe) Needs Your Help, April 2, 2021, Community Associations Institute Keystone Chapter. webpage https://www.cai-padelval.org/nj-lac-needs-your-help, April 2021.
[2] NJ-LAC ALERT: WE NEED YOUR HELP! To Get Immunity Legislation for Planned Real Estate Developments Passed into Law in New Jersey, Community Associations Institute New Jersey Legislative Action Committee. webpage https://cainj.org/cai-nj-legislative, April 2021.
[3] A4979, STATE OF NEW JERSEY, 219th LEGISLATURE, INTRODUCED NOVEMBER 12, 2020. webpage https://www.njleg.state.nj.us/bills/BillView.asp?BillNumber=A4979, https://www.njleg.state.nj.us/2020/Bills/A5000/4979_I1.HTM, April 2021.
[4] S3584, STATE OF NEW JERSEY, 219th LEGISLATURE, INTRODUCED MARCH 25, 2021. https://www.njleg.state.nj.us/bills/BillView.asp?BillNumber=A4979, https://www.njleg.state.nj.us/2020/Bills/A5000/4979_I1.HTM, April 2021.
[5] See section Conspiracy Theories and Social Bifurcation.
Toxic Management
In 2020 this research addressed the topic of massive management failure and the practices extremely bad and dangerous management engage in organizations, like a criminal enterprise or a nation state that has lost its soul [1] [2]. This topic is different and examines what some may consider legitimate management practices but are actually toxic. These practices will be noted in history as one of the primary reasons for the COVID-19 disaster.
Toxic Management:
Proper Management:
A classic example of toxic management attempting to control the message is the introduction of the word falsehood during the Trump Administration to deflect from the correct words of lie and inaccurate. Never has this author heard the use of the word falsehood to replace the words lie or inaccurate over the last 6 decades. In 2021 the word is still being used in place of the words lie and inaccurate. It is an imprecise word and because of its rare use it does not evoke the same reaction of outrage and anger that the words lie or inaccurate invoke. That is why it was selected and that is why this is an indication of extremely toxic management. The emotions of outrage and anger are important because they result in the system need to make immediate massive corrective actions to solve the problem. It is a critical feedback loop and if it is disabled it prevents the system from self correcting.
References:
[1] COVID-19 Return To Life, section Management Failure, March 2021. webpage http://www.cassbeth.com/covid-19/return-to-life/index.html, April 2021.
[2] COVID-19 A Systems Perspective, Walter Sobkiw, 2021, ISBN 9780983253044, hardback.
Toxic Generational Choices
Previously there were many outbreaks of disease, some of which became local epidemics, but since the end of World War II there were always intervention and containment results. So why did COVID-19 turn into a pandemic that shut down the civilization? A possible explanation is a tipping point may have been reached where the number of bad participants in the society has exceeded a threshold. We always had toxic government and management but there were always people to push back and hold the toxic elements in authority accountable. In some cases people lost their jobs, careers, wealth, health, families, and life. Usually there would be a lost job and in some instances a lost career. When toxic government was being challenged the stakes elevated to a loss of life level.
The possible causes might be:
A key new element in the social system is the rise of social media. This is different than the rise of the Internet. The Internet was available during other times of disease outbreaks and yet there was containment. However, the previous generation that developed the Internet was still active and alive in the civilization and they were following the values that surfaced after World War II. Those values were embodied in: Ask not what your country can do for you - ask what you can do for your country, which easily translates to Ask not what someone can do for you - ask what you can do for someone. In other words a people that look outward, instead of a people that only look inward with massive self interest.
It is interesting to see how the Republican party is targeting its fellow party members and attempting to remove them from power. This is exactly the same scenario and tactics that were used once corporate downsizing was started in the 1980's. People were targeted and systematically removed for no apparent reason. In hindsight this was part of a strategy to remove powerful people in the corporate setting at all levels who were driven by the philosophies embedded in the simple phrase of Ask not what your country can do for you – ask what you can do for your country. They were replaced by people who follow orders based on self interest. By the year 2000 the transformation in corporate culture was complete. This transformation probably happened across the entire society.
Meanwhile damage control is being performed and history is being modified. On May 7, 2021 an opinion piece appeared trying to explain why it took so long to accept the facts about COVID-19 [1]. The problem is the facts were known by the US Government and others including newspaper reporters but they did not disclose it to the people [2]. They lied, pure and simple. The end results were the massive spread of COVID-19 and massive death. In taped interviews with journalist Bob Woodward on Feb. 7, 2020, President Trump said that the virus was more dangerous than the flu, even as he told the country otherwise [2]. It is clear that it was known from the beginning that the virus is spread through the air. President Trump stated the following in the audio interview.
It is obvious that the US Government and media knew that the virus was airborne but they did not inform the public or take action to mitigate the virus spread from the airborne element. This information was made public on September 09, 2020.
The following is an excerpt from a May 7, 2021 opinion piece in the New York Times [1]. Comments to this excerpt from This Analysis are marked as TA and numbered.
A few sentences have shaken a century of science.
A week ago, more than a year after the World Health Organization declared that we face a pandemic, a page on its website titled Coronavirus Disease (Covid-19): How Is It Transmitted? got a seemingly small update.
The agency's response to that question had been that current evidence suggests that the main way the virus spreads is by respiratory droplets - which are expelled from the mouth and quickly fall to the ground - among people who are in close contact with each other.
The revised response still emphasizes transmission in close contact but now says it may be via aerosols - smaller respiratory particles that can float - as well as droplets. It also adds a reason the virus can also be transmitted in poorly ventilated and/or crowded indoor settings, saying this is because aerosols remain suspended in the air or travel farther than 1 meter.
The change didn’t get a lot of attention. There was no news conference, no big announcement.
Then, on Friday, the Centers for Disease Control and Prevention also updated its guidance on Covid-19, clearly saying that inhalation of these smaller particles is a key way the virus is transmitted, even at close range, and put it on top of its list of how the disease spreads.
There was no news conference by the C.D.C. either.
TA1: The public has officially known since mid 2020 that COVID-19 is airborne and spread primarily via aerosols not droplets. The websites are only just now being updated in May 2021.
But these latest shifts challenge key infection control assumptions that go back a century, putting a lot of what went wrong last year in context. They may also signal one of the most important advancements in public health during this pandemic.
TA2: This is inaccurate. It is not an advancement in public health. It has been known for decades.
If the importance of aerosol transmission had been accepted early, we would have been told from the beginning that it was much safer outdoors, where these small particles disperse more easily, as long as you avoid close, prolonged contact with others. We would have tried to make sure indoor spaces were well ventilated, with air filtered as necessary. Instead of blanket rules on gatherings, we would have targeted conditions that can produce superspreading events: people in poorly ventilated indoor spaces, especially if engaged over time in activities that increase aerosol production, like shouting and singing. We would have started using masks more quickly, and we would have paid more attention to their fit, too. And we would have been less obsessed with cleaning surfaces.
TA3: This is clear evidence that the above claim of an advancement is not accurate.
Dig deeper into the moment.
Our mitigations would have been much more effective, sparing us a great deal of suffering and anxiety.
Since the pandemic is far from over, with countries like India facing devastating surges, we need to understand both why this took so long to come about and what it will mean.
Initially, SARS-CoV-2 was seen as a disease spread by respiratory droplets, except in rare cases of aerosol transmission during medical procedures like intubation. Countertops, boxes and other possible fomites - contaminated surfaces - were seen as a threat because if we touched them after droplets fell on them, it was believed the virus could make its way to our hands, then our noses, eyes or mouths.
TA4: The only ones that saw this as a disease spread by respriatory droplets are the general public because they were denied access to the information and they were lied to by the President of the United States and US Government offcials. [2]
The implications of this were illustrated when I visited New York City in late April - my first trip there in more than a year.
A giant digital billboard greeted me at Times Square, with the message Protecting yourself and others from Covid-19. Guidance from the World Health Organization.
First, Hygiene flashed, urging me to wash my hands, practice respiratory hygiene, avoid touching my face and wear a mask when necessary. Next, Social distancing told me to avoid close contact with people (illustrated by people separated by one meter), avoid shaking hands and stay home if unwell. Then Medical help advised me to follow local medical protocols.
I was stunned that the final instruction was Stay informed.
That billboard neglected the clearest epidemiological pattern of this pandemic: The vast majority of transmission has been indoors, sometimes beyond a range of three or even six feet. The superspreading events that play a major role in driving the pandemic occur overwhelmingly, if not exclusively, indoors.
The billboard had not a word about ventilation, nothing about opening windows or moving activities outdoors, where transmission has been rare and usually only during prolonged and close contact. (Ireland recently reported 0.1 percent of Covid-19 cases were traced to outdoor transmission.)
The omission is not surprising. Throughout the pandemic, the W.H.O. was slow to accept the key role that infectious particles small enough to float could be playing.
TA5: The WHO is irrelevant. What matters is how the President of the United States behaved because he disclosed that he knew the COVID-19 virus was airborne and deadly in February 2020. This suggests that the United States Government with its massive resources knew long before February 2020. This includes the CDC, DOD, and other government agencies all of which are staffed with people [2]. For those who are not aware, it is illegal to stamp illegal activities as classified. Hiding information about a deadly disease that could kill millions of US citizens falls into the category of a possible criminal act that should be handled by the courts.
Mary-Louise McLaws, an epidemiologist at the University of New South Wales in Sydney, Australia, and a member of the W.H.O. committees that craft infection prevention and control guidance, wanted all this examined but knew the stakes made it harder to overcome the resistance. She told The Times last year, If we started revisiting airflow, we would have to be prepared to change a lot of what we do. She said it was a very good idea, but she added, It will cause an enormous shudder through the infection control society.
This assumption that these larger droplets that can travel only a few feet are the main way the disease spreads is one of the key reasons the W.H.O. and the C.D.C. didn’t recommend masks at first. Why bother if one can simply stay out of their range? After the C.D.C. recommended masks in April 2020, the W.H.O. shifted last June, but it first suggested ordinary people generally wear masks if physical distancing could not be maintained, and still said health care workers performing screenings in the community did not need to wear masks if they could stay that single meter away from patients. The W.H.O. last updated its mask guidance in December but continued to insist that mask use indoors was not necessary if people could remain separated by that mere meter - this time conceding that if ventilation might not be adequate, masks should be worn indoors, regardless of distancing.
TA6: This is just more evidence that it was known that COVID-19 is airborne and that a massive disinformation campaign had been initiated.
In contrast, if the aerosols had been considered a major form of transmission, in addition to distancing and masks, advice would have centered on ventilation and airflow, as well as time spent indoors. Small particles can accumulate in enclosed spaces, since they can remain suspended in the air and travel along air currents. This means that indoors, three or even six feet, while helpful, is not completely protective, especially over time.
TA7: This analysis performed in 2020 disclosed these findings. These are all well known findings. All this analysis did was provide the numbers in one place that no one could deny.
To see this misunderstanding in action, look at what's still happening throughout the world. In India, where hospitals have run out of supplemental oxygen and people are dying in the streets, money is being spent on fleets of drones to spray anti-coronavirus disinfectant in outdoor spaces. Parks, beaches and outdoor areas keep getting closed around the world. This year and last, organizers canceled outdoor events for the National Cherry Blossom Festival in Washington, D.C. Cambodian customs officials advised spraying disinfectant outside vehicles imported from India. The examples are many.
TA8: This is not a misunderstanding. This is a direct result of a disinformation campaign that has led to millions of people getting sick and dying. That damage control word must never be forgotten by future generations when they try to determine what happened and how they were hurt by the current policy makers and people in positions of authority.
Meanwhile, many countries allowed their indoor workplaces to open but with inadequate aerosol protections. There was no attention to ventilation, installing air filters as necessary or even opening windows when possible, more to having people just distancing three or six feet, sometimes not requiring masks beyond that distance, or spending money on hard plastic barriers, which may be useless at best. (Just this week, President Biden visited a school where students were sitting behind plastic shields.)
This occurred throughout the world in the past year. The United States has been a bit better, but the C.D.C. did not really accept aerosol transmission until October, though still relegating it to a secondary role until its change on Friday, which put the risk infection from inhaling these tiny particles first on its list of means of transmission.
TA9: Future generations will perform the equivalent of running courts in their history books where various players will be charged with crimes against humanity. There is no escape from this legacy.
The scientific wrangling, resistance and controversy that prevented a change in guidance stem from a century of mistaken assumptions whose roots go back to the origins of germ theory of disease in the 19th century.
TA10: More disinformation. A great deal was learned in the previous century. It was the engineers who studied particle flows that pushed the understanding to new levels and that is why we have force air heating cooling and ventilation (HVAC) systems. It is also why we had Ceiling Level UV-C lights in many public buildings in the last century. To claim that our knowledge was stuck at the level of when germ theory surfaced is just wrong.
Until germ theory became established in the 19th century, many people believed that deadly diseases like cholera were caused by miasma - stinking fumes from organic or rotting material. It wasn’t easy to persuade people that creatures so small that they could not be seen in a seemingly innocent glass of water could be claiming so many lives.
This was a high-stakes fight: Getting the transmission mechanisms of a disease wrong can lead to mitigations that not only are ineffective but also make things worse. During the 19th century, fearing miasma, Londoners worked hard to direct their stinky sewers into the nearby Thames River, essentially spreading cholera even more.
But clear evidence doesn’t easily overturn tradition or overcome entrenched feelings and egos. John Snow, often credited as the first scientific epidemiologist, showed that a contaminated well was responsible for a 1854 London cholera epidemic by removing the suspected pump's handle and documenting how the cases plummeted afterward. Many other scientists and officials wouldn’t believe him for 12 years, when the link to a water source showed up again and became harder to deny. (He died years earlier.)
Similarly, when the Hungarian physician Ignaz Semmelweis realized the importance of washing hands to protect patients, he lost his job and was widely condemned by disbelieving colleagues. He wasn’t always the most tactful communicator, and his colleagues resented his brash implication that they were harming their patients (even though they were). These doctors continued to kill their patients through cross-contamination for decades, despite clear evidence showing how death rates had plummeted in the few wards where midwives and Dr. Semmelweis had succeeded in introducing routine hand hygiene. He ultimately died of an infected wound.
Disentangling causation is difficult, too, because of confusing correlations and conflations. Terrible smells frequently overlap with unsanitary conditions that can contribute to ill health, and in mid-19th-century London, death rates from cholera were higher in parts of the city with poor living conditions.
Along the way to modern public health shaped largely by the fight over germs, a theory of transmission promoted by the influential public health figure Charles Chapin took hold.
Dr. Chapin asserted in the early 1900s that respiratory diseases were most likely spread at close range by people touching bodily fluids or ejecting respiratory droplets, and did not allow for the possibility that such close-range infection could occur by inhaling small floating particles others emitted. He was also concerned that belief in airborne transmission, which he associated with miasma theories, would make people feel helpless and drop their guard against contact transmission. This was a mistake that would haunt infection control for the next century and more.
In modern medical parlance, respiratory transmission routes are divided between the larger droplets, associated with diseases that spread at close distance, and the smaller aerosols (sometimes also called droplet nuclei), associated with diseases like measles that we know can spread at long distance and are usually highly contagious. Indeed, studies showing that respiratory diseases spread more easily in proximity to infected people seemingly confirmed the role of droplets.
It was in this context in early 2020 that the W.H.O. and the C.D.C. asserted that SARS-CoV-2 was transmitted primarily via these heavier, short-range droplets, and provided guidance accordingly.
TA11: More disinformation. A great deal was learned in the previous century. It was the engineers who studied particle flows that pushed the understanding to new levels and that is why we have forced air heating cooling and ventilation (HVAC) systems. It is also why we had Ceiling Level UV-C lights in many public buildings in the last century. By the end of the last century our machines and test equipment were able to track tiny particles and their behavior under various air flow conditions. The science and engineering behind this is massive and applies across the spectrum of systems from rockets and jet aircraft to simple HVAC systems. It is obvious that a virus is very small and will be suspended in the air for a very long time. It is also obvious that a virus will be viable for a long time while floating in the air. Simple animal studies would have shown this with the COVID-19 virus. Why was the public not shown the animal studies on a daily basis is a key question that will be asked for hundreds of years. To claim this is just wrong.
But from the beginning, the way the disease was spreading around the world did not fit this theory well. In February 2020, after an infected person was found to have boarded the cruise ship Diamond Princess, hundreds of people trapped on board for weeks were infected, including 567 of the 2,666 passengers, who were largely confined to their rooms and delivered food by masked personnel - hard to explain solely with droplet-driven transmission. (Hitoshi Oshitani, a Japanese virologist who played an important role in his country's response to the epidemic, said it was this ship outbreak that helped convince him this was airborne - and it's why Japan planned around airborne transmission assumptions from as early as February 2020.)
Then there were the many superspreader events around the world that defied droplet explanations. In March 2020 in Mount Vernon, Wash., 61 pandemic-aware people showed up to a choir practice and sang with some distance between them in a large space, were provided hand sanitizer and left the doors open, reducing the need for people to touch the handles. But 53 of them were confirmed or strongly suspected to have contracted Covid-19 anyway, and two died. Long-distance transmission was being documented as well: One study from China in April 2020, clearly documenting transmission from beyond one meter, had video evidence showing the initially infected person had not come very close to those he infected, and there were no common surfaces touched.
Epidemiological studies and examples kept pouring in, too, all of them showing that Covid-19 was spreading primarily indoors and clusters were concentrated in poorly ventilated spaces. And when outdoor transmission did occur, it was often when people were in prolonged close contact, talking or yelling, as with construction workers on the same site.
TA12: It was known as early as 2003 that SARS-1 was airborne when the New England Journal of Medicine published a paper on the transmission of a SARS outbreak that occurred on a flight from Hong Kong to Beijing on March 15, 2003 [3]. These other studies just confirmed what was already known.
The disease was also greatly overdispersed, sometimes being not very contagious and other times dramatically so. Large-scale studies showed that more than 70 percent of infected people did not transmit to any other person, while as few as 5 percent may be responsible for 80 percent of transmissions through superspreading events. Despite databases documenting thousands of indoor superspreader incidents, I’m not aware of a single confirmed outdoor-only case of superspreading.
None of this could be explained easily if the disease were primarily transmitted between people through respiratory droplets and contact routes, as the W.H.O. had said, since those larger, heavier particles would behave the same indoors as outdoors, would be largely indifferent to ventilation and would not be conducive to so much superspreading.
Finally, it was clear from early on that people who weren’t yet sick or coughing or sneezing - which produce a lot more droplets - were transmitting and that things correlated with aerosol emissions like talking, yelling and singing were associated with many of the outbreaks.
Amid the growing evidence, in July, hundreds of scientists signed an open letter urging the public health agencies, especially the W.H.O., to address airborne transmission of the coronavirus.
TA13: They were being ignored along with all the other studies and empirical data.
That month, after the open letter, the W.H.O. updated its guidance to say that short-range aerosol transmission from infected people in poorly ventilated spaces over time cannot be ruled out but went on to say that the detailed investigations of these clusters suggest that droplet and fomite transmission could also explain human-to-human transmission within these clusters and that close contact could still be the reason, especially if hand hygiene was not performed and masks were not used when physical distancing was not maintained.
TA14: It was not until this systems analysis from 2020 was provided to the media that it was finally admitted that the virus is airborne. That is because this systems analysis provided easily understood numbers that no one could refute. Other engineers and scientists were signing petitions but not providing the easily understood numbers that anyone could access and understand. Within one day of transmitting this analysis to the media, the media started to finally report that the virus is airborne. The gig was up as they say.
Evidence kept accumulating. Transmission was documented in adjacent rooms in a quarantine hotel where people never interacted. Several hospital workers were proved to have been infected despite strict contact and droplet precautions. Viable virus was found in air samples from hospital rooms of Covid-19 patients who hadn’t had aerosol-generating procedures and in an air sample from an infected person's car. The virus was found in exhaust vents in hospitals, and ferrets in cages connected only via shared air infected each other. And so on.
There were quibbles with each study: Was the sampled virus infective enough? (It is hard to catch the viruses from the air without destroying them.) Could some fomite connection have been missed? Still, it kept getting harder to deny the role of aerosols as a major factor.
TA15: All irrelevant. The systems slang is called beating a dead horse.
Last October, the C.D.C. published updated guidance acknowledging airborne transmission, but as a secondary route under some circumstances, until it acknowledged airborne transmission as crucial on Friday. And the W.H.O. kept inching forward in its public statements, most recently a week ago.
Linsey Marr, a professor of engineering at Virginia Tech who made important contributions to our understanding of airborne virus transmission before the pandemic, pointed to two key scientific errors - rooted in a lot of history - that explain the resistance, and also opened a fascinating sociological window into how science can get it wrong and why.
First, Dr. Marr said, the upper limit for particles to be able to float is actually 100 microns, not five microns, as generally thought. The incorrect five-micron claim may have come about because earlier scientists conflated the size at which respiratory particles could reach the lower respiratory tract (important for studying tuberculosis) with the size at which they remain suspended in the air.
TA16: Still trying to explain away toxic choices from policy makers. The systems slang is called grasping for straws. Just stop already. You are beating a dead horse.
Dr. Marr said that if you inhale a particle from the air, it's an aerosol. She agreed that droplet transmission by a larger respiratory particle is possible, if it lands on the eye, for example, but biomechanically, she said, nasal transmission faces obstacles, since nostrils point downward and the physics of particles that large makes it difficult for them to move up the nose. And in lab measurements, people emit far more of the easier-to-inhale aerosols than the droplets, she said, and even the smallest particles can be virus laden, sometimes more so than the larger ones, seemingly because of how and where they are produced in the respiratory tract.
Second, she said, proximity is conducive to transmission of aerosols as well because aerosols are more concentrated near the person emitting them. In a twist of history, modern scientists have been acting like those who equated stinky air with disease, by equating close contact, a measure of distance, only with the larger droplets, a mechanism of transmission, without examination.
Since aerosols also infect at close range, measures to prevent droplet transmission - masks and distancing - can help dampen transmission for airborne diseases as well. However, this oversight led medical people to circularly assume that if such measures worked at all, droplets must have played a big role in their transmission.
Other incorrect assumptions thrived. For example, in July, right after the letter by the hundreds of scientists challenging the droplet paradigm, Reuters reported that Dr. John Conly, who chairs a key W.H.O. infection prevention working group, said that there would be many more cases if the virus was airborne and asked, Would we not be seeing, like, literally billions of cases globally? He made similar claims last month. And he is not the only member of that group to assert this, a common assumption in the world of infection control well into 2021.
However, Dr. Marr pointed out, there are airborne diseases, like measles, that are highly contagious and others, like tuberculosis, that are not. Moreover, while SARS-CoV-2 is certainly not as infectious as measles on average, it can be highly infectious in the superspreading events driving the pandemic.
Many respiratory viruses carried by aerosols survive better in colder environments and lower relative humidity, Dr. Marr said, again fitting the pattern of outbreaks around the world, for example, in many meatpacking plants. Plus, some activities produce more aerosols - talking, yelling, singing, exercising - also fitting the pattern of outbreaks globally.
Why did it take so long to understand all this?
TA17: It is all matter of system boundary. Are we talking about the general public or the United States Government and the President of the United States. The President of the United States disclosed their knowledge to journalist Bob Woodward on Feb. 7, 2020. No one told the public until September 09, 2020.
One reason is that our institutions weren’t necessarily set up to deal with what we faced. For example, the W.H.O.'s Infection Prevention and Control (I.P.C.) global unit primarily concentrates on health care facilities. Many of the experts they enlisted to form the Covid-19 I.P.C. Guidance Development Group were hospital-focused, and some of them specialized in antibiotic-resistant bacterial infections that can spread wildly in health care facilities when medical personnel fail to regularly wash their hands. So this focus made sense in a prepandemic world. Hospitals employ trained health care workers and are fairly controlled, well-defined settings, with different considerations from those of a pandemic across many environments in the real world. Further, in some countries like the United States, they tend to have extensive engineering controls to dampen infections, involving aggressive air-exchange standards, almost like being outdoors. This is the opposite of modern office and even residential buildings, which tend to be more sealed for energy efficiency. In such a medical environment, hand hygiene is a more important consideration, since ventilation is taken care of.
Another dynamic we’ve seen is something that is not unheard-of in the history of science: setting a higher standard of proof for theories that challenge conventional wisdom than for those that support it.
As part of its assessment of the virus's spread, the W.H.O. asked a group of scientists last fall to review the evidence on transmission of the coronavirus. When reviewing airborne transmission, the group focused mostly on studies of air samples, especially if live virus was captured from the air, which, as mentioned above, is extremely hard. By that criterion, airborne transmission of the measles virus, which is undisputed, would not be accepted because no one has cultivated that pathogen from room air. That's also true of tuberculosis. And while scientists, despite the difficulties, had managed to capture viable SARS-CoV-2 in three studies that I’m aware of, the review noted that the virus was detected only intermittently in general, disputed whether the captured live virus was infective enough and ultimately said it could not reach firm conclusions over airborne transmission. The lead author and another senior member of the research group previously said they believed transmission was driven by droplets.
The skepticism about airborne transmission is at odds with the acceptance of droplet transmission. Dr. Marr and Joseph Allen, the director of the Healthy Buildings program and an associate professor at Harvard's T.H. Chan School of Public Health, told me that droplet transmission has never been directly demonstrated. Since Dr. Chapin, close-distance transmission has been seen as proof of droplets unless disproved through much effort, as was finally done for tuberculosis.
Another key problem is that, understandably, we find it harder to walk things back. It is easier to keep adding exceptions and justifications to a belief than to admit that a challenger has a better explanation.
The ancients believed that all celestial objects revolved around the earth in circular orbits. When it became clear that the observed behavior of the celestial objects did not fit this assumption, those astronomers produced ever-more-complex charts by adding epicycles - intersecting arcs and circles - to fit the heavens to their beliefs.
In a contemporary example of this attitude, the initial public health report on the Mount Vernon choir case said that it may have been caused by people sitting close to one another, sharing snacks and stacking chairs at the end of the practice, even though almost 90 percent of the people there developed symptoms of Covid-19. Shelly Miller, an aerosol expert at the University of Colorado Boulder, was so struck by the incident that she initiated a study with a team of scientists, documenting that the space was less full than usual, allowing for increased distance, that nobody reported touching anyone else, that hand sanitizer was used and that only three people who had arrived early arranged the chairs. There was no spatial pattern to the transmission, implicating airflows, and there was nobody within nine feet in front of the first known case, who had mild symptoms.
Galileo is said to have murmured, And yet it moves, after he was forced to recant his theory that the earth moved around the sun. Scientists who studied bioaerosols could only say, And yet it floats.
So much of what we have done throughout the pandemic - the excessive hygiene theater and the failure to integrate ventilation and filters into our basic advice - has greatly hampered our response. Some of it, like the way we underused or even shut down outdoor space, isn’t that different from the 19th-century Londoners who flushed the source of their foul air into the Thames and made the cholera epidemic worse.
Righting this ship cannot be a quiet process - updating a web page here, saying the right thing there. The proclamations that we now know are wrong were so persistent and so loud for so long.
It's true that as the evidence piled on, there was genuine progress and improvement, especially as of late. Even before the change in language last week, for example, the W.H.O. published helpful guides on ventilation, first in July and updating it in March. Recently, though the organization's documents have lagged, more of its officials have started giving advice compatible with aerosol transmission, emphasizing things like close mask fit - which matters little for droplet transmission - and ventilation - which matters even less. All this is good, but nowhere near enough to change the regulations and policy bundles that had already been put in place around the world.
And the progress we’ve made might lead to an overhaul in our understanding of many other transmissible respiratory diseases that take a terrible toll around the world each year and could easily cause other pandemics.
So big proclamations require probably even bigger proclamations to correct, or the information void, unnecessary fears and misinformation will persist, damaging the W.H.O. now and in the future.
Scientists have responded. In just the past few weeks, there has been a flood of articles published about airborne transmission in leading medical journals. Dr. Marr and other scientists told me the situation was very difficult until recently, as the droplet dogma reigned. I co-wrote one of those papers, published in The Lancet last month, arguing that aerosols may be the predominant mode of transmission for SARS-CoV-2, a step farther.
I’ve seen our paper used in India to try to reason through aerosol transmission and the necessary mitigations. I’ve heard of people in India closing their windows after hearing that the virus is airborne, likely because they were not being told how to respond. Plus, there are important questions for what this means for higher-risk settings, like medical facilities.
The W.H.O. needs to address these fears and concerns, treating it as a matter of profound change, so other public health agencies and governments, as well as ordinary people, can better adjust.
The past year has revealed how crucial the agency is, despite being hampered by chronic underfunding, lack of independence and attempts to turn it into a political football by big powers. Like other public health organizations, many of its dedicated staff members work tirelessly under difficult conditions to safeguard health around the world. Maintaining its credibility is essential not just for the rest of this terrible pandemic but in the future.
It needs to begin a campaign proportional to the importance of all this, announcing, We’ve learned more, and here's what's changed, and here's how we can make sure everyone understands how important this is. That's what credible leadership looks like. Otherwise, if a web page is updated in the forest without the requisite fanfare, how will it matter?
TA18: The rest is irrelevant. There is no excuse.
TA19: It is sad that the New York Times published this opinion piece without a follow up comparison of the history of events and its own findings. There was only 1 reference that was needed and that was the documented evidence of what the President of the United States disclosed in a phone call to a journalist and published in the New York Times [2]. In systems we look for consistency. In large complex systems sometimes it is difficult to get external consistency but loss of internal consistency is viewed as a very bad or broken system.
The analysis provided in the opinion piece above is an example of a narrow specialty providing critical data and information but it is not a systems analysis that considers all the data and information. That is why the above analysis is wrong and dangerous because it is being used by some stakeholders to game the situation in a particular direction; in this case to deflect blame and stop accountability. This is a classic example of why systems thinking, practices, and engineering must be reintroduced into the society.
This generation will not come out of the COVID-19 disaster until they begin to build a world based on something other than exclusive self interest. They still have all the history and technologies to get them out of this disaster. However, the clock is ticking and they immediately need to roll up their sleeves and get to work because it will take years to implement everything in the infrastructure that needs to happen. If they do it right they can make a better world for their kids and grand kids. If they do it wrong it will be a massive tragedy that will result in a new dark age lasting several hundred years. You don't allow a civilization to spread disease, sickness, and death without paying a severe price.
This will be a topic of study for hundreds of years.
References:
[1] Why Did It Take So Long to Accept the Facts About Covid, The New York Time, May 07,2021. webpage https://www.nytimes.com/2021/05/07/opinion/coronavirus-airborne-transmission.html, May 2021. Why Did It Take So Long to Accept the Facts About Covid
[2] Trump Admits Downplaying the Virus Knowing It Was Deadly Stuff, New York Times, September 09, 2020. webpage https://www.nytimes.com/2020/09/09/us/politics/woodward-trump-book-virus.html, September 10, 2020. Trump Admits Downplaying the Virus Knowing It Was Deadly Stuff
[3] Transmission of the severe acute respiratory syndrome on aircraft. The New England Journal of Medicine, December 18, 2003. webpage https://www.nejm.org/doi/pdf/10.1056/NEJMoa031349, March 2020. Transmission of the severe acute respiratory syndrome on aircraft.
This analysis is in Part 3. The tables were very large and flooded this webpage. Once again using the systems perspective has surfaced out of the box findings that must be considered.
Go to Return to Life Part 3 - International Perspective.
Full Research Links
COVID-19 Return to Life (2020 to 2021 March research)
>>> COVID-19 Return to Life Part 2 (Started March 2021)
COVID-19 Return to Life Part 3 (Started September 2021)
This research is being performed using the memex. The memex was first conceived in 1945 in a paper called As We May Think. Since 1945 generations of engineers and scientists have worked tirelessly to make the memex a reality and you know it as the Internet. Its original purpose was to Educate and perform Research. E-commerce and social media came much later and many that used the Internet for Research and Education have died. The memex is being used by healthcare providers around the world to deal with the COVID-19 disaster in real time. Please forward the information on this page to everyone everywhere.
