Omicron Emerges, But Delta Still Reigns
The big pandemic news recently has been the emergence of the Omicron, or B.1.1.529, variant. On its own, Delta was doing a great deal of damage, especially in more northern states, but Omicron is clearly more contagious.
As of Dec. 11, Omicron accounted for just 2.9% of infections in the U.S., according to the Centers for Disease Control and Prevention (CDC). One week later – just one week – the proportion jumped to 73%. This CDC bar chart shows the change graphically.
Even before dominance of Omicron, however, Delta, which emerged in the spring and represented nearly 100% of cases by July, had caused U.S. cases to rise 20% over the two weeks ending Dec. 20 to a daily average of 143,000. Hospitalizations have risen 14% and deaths 3% to an average of 1,300.
All these figures are well below records set last January, when daily average cases hit 251,000; hospitalizations, 137,000; and deaths, 3,300. A year ago, no Americans were vaccinated, but this year attitudes and policies have softened and many safeguards have been dropped. Today, there are ominous portents that the weeks ahead will be difficult.
For example, in 2020, U.S. cases began climbing around Oct. 1 as people began moving indoors as the weather cooled. Interior spaces are where COVID spreads. But both October and November 2021 have been warm – the third-warmest autumn in 127 years. Cases started rising slowly in mid-November. So it may be little solace that daily cases on Dec. 20 were one – third below their level of a year earlier.
Particularly alarming is that cases are increasing all over the country. In only 11 states have infections declined over the past two weeks.
Still, the striking geographic distribution of the past month persists, as you can see from this heat map of hospitalizations per 100 beds for the week ended Dec. 17.
The map is taken from the excellent Community Profile Report that is produced weekly by the CDC and the Office of the Assistant HHS Secretary for Preparedness and Response (ASPR). The darkest red indicates that more than 20% of hospital beds are occupied by COVID patients; light green indicates 1% to 3%. With the exception of Utah and Arizona, the reddest parts of the map are in the Northeast and Upper Midwest, the coldest parts of the country in late November and early December.
The top three states for COVID cases per 100,000 population are in New England, and the top 14 states are all north of the Mason-Dixon Line. By contrast, the six states with the fewest cases per 100,000 are all in the South – and, as we have noted before, there is no correlation right now between cases and vaccinations.
For example, in Louisiana, which has the lowest case rate among the states – 11 per 100,000 , compared with a U.S. average of 37 – just 50% of residents are fully vaccinated, compared with the U.S. average of 61%. (“Fully” means two shots of Pfizer-BioNTech or Moderna or one of Johnson & Johnson.)
Rhode Island and Maine are tied with the highest rates of full vaccination in the U.S., at 75%, but they also rank first and third for the most daily average COVID cases as of Dec. 15. The eight states with the highest COVID infection rates all have vaccination rates at or above the U.S. average.
What does this mean? Certainly, vaccination helps (see the last section of this newsletter), but spending time outdoors appears to be an even more important factor in determining how many people come down with the disease. More focus, it would seem, should be placed at protecting indoor spaces from airborne spread of the SARS-CoV-2 virus.
Defending Against the Virus in the Interior Spaces Where It Spreads Easiest
Omicron, the 15th letter in the Greek alphabet is racing through America. Open questions are whether it is more virulent than Delta and whether it responds as well to vaccinations. We will get to those issues below, but, first, it’s important to understand that at least one form of mitigation works as well against either variant, or any variant to come.
That defense against COVID-19 involves deploying devices that make interior air clean and safe. The most effective technology is relatively inexpensive and straightforward, but, unfortunately, it is not well understood.
Recognize that virus that causes COVID is relatively easy to deactivate.
The microbiological hierarchy of disinfection, as accepted by the U.S. Environmental Protection Agency and scientific experts, puts “enveloped viruses” like SARS-CoV-2 at the very bottom – that is, most susceptible to disinfection. With the proper technology, it is easier to render harmless the virus that causes COVID-19, with its lipid, or fatty, envelope, than it is to deactivate fungi, bacteria, or non-enveloped viruses such as the highly contagious norovirus that causes vomiting and diarrhea.
Shortly after COVID began to spread, there was widespread interest in ventilation, which generally means the exchange of inside for outside air through an air-conditioning or heating system that is equipped with a filter.
But, as we reported in the last issue of this newsletter experts have come to realize that this technology is insufficient. An article in the October issue of the ASHRAE Journal, a publication of the American Society of Heating, Refrigerating and Air-Conditioning Engineers, acknowledged that HVAC systems are ineffective in fighting pathogens like SARS-CoV-2. mold indoors.
In analyzing a restaurant simulation, Zhiqiang Zhai, a professor of Civil, Environmental and Architectural Engineering at the University of Colorado at Boulder and winner of ASHRAE’s Distinguished Science Award, and three colleagues write:
It is evident that if purely using the CA [that is, central air-conditioning with filtration], only a small fraction of the particles can be discharged through the ceiling exhausts. Most of the particles are spread out indoors and ultimately deposited on the occupants, tables, ground and walls.
The danger to occupants from HEPA [high-efficiency particulate air] filters placed on HVAC systems, write Zhai and his colleagues, is that some pathogens “do not get entrained into the return air vents and may float around in a given space.” In other words, this is not the right solution to contaminated indoor air.
Adding eight air purifier units “can clean 28% of the particles.” A table purifier placed in the center of each table in the room – only a few feet away from each occupant -- “can handle almost 80% of the particles, while slightly increasing the deposition on the tables compared to floor units.” But, clearly, sticking an air purifier in front of nearly every person in a room is impractical and expensive.
For filters to work, pathogens need to find them. If they have to travel large distances, that connection is elusive. But better answers exist. For example, ActivePure, a Dallas-based company, has developed an Advanced Photocatalysis technology, cleared by the Food & Drug Administration, that is capable of safely suffusing an occupied indoor space with the same oxidative particles found to clean the atmosphere naturally.
In the C-Suites: ‘If We’re Going to Live With This,
How Do We Live With It Safely?’
ActivePure’s chief medical and scientific advisor, Dr. Deborah Birx, who was formerly the White House coronavirus coordinator, recently spoke to an audience assembled at New York’s Hudson Yards by the Building Owners and Managers Association, or BOMA.
In an interview with the business news site Bisnow on Dec. 14, Birx assured executives:
The workplace in general, because of the modifications that have been done and because of the opportunities that now exist to even improve on those modifications,..is not only fairly safe, but can become increasingly safer.
She referred to her own experience – “out and working the entire time, traveling, in states, in airports, in hotels, in meetings, and I haven’t gotten infected. So it’s clear you can mitigate against infection.”
Businesses, she said, need “to empower people with the information that they have the confidence about where the virus spreads and how the virus spreads and where it doesn’t spread and what can be done to prevent it."
It is “the private sector [that] has to help convey to the American people what a safe environment looks like. I think that’s where the information is going to have to come from," Birx said. "Because the federal messages have been less clear and less leading."
The Bisnow article noted that the top 10 office markets in the country hit 40% of pre-coronavirus occupancy in December, the highest figure since the pandemic began. ActivePure’s chief commercial officer, Amy Carenza, also speaking at the BOMA forum, said that the company is working more with office owners as occupancy increases. More corporate executives, she said, now realize that COVID-19 is going to be a presence for years.
"What is happening now is that C-suites across America are saying, ‘If we stay home, we’ll be home forever,'" Carenza was quoted in the article as saying. "I think there is a lot of introspection happening across C-suites, but it’s happening from a standpoint of, number one, we’re going to have to learn to live with this, and then, number two, if we’re going to live with this, how do we live with it safely?"
What We Know and Don’t Know About Omicron
Dr. Tedros Adhanom Ghebreyesus, the director general of the World Health Organization, said in a news briefing on Dec. 14 that “Omicron is spreading at a rate we have not seen with any previous variant.” The W.H.O.’s Africa region, which excludes Egypt and six other nations in the continent’s north and northeast, recorded about 196,000 new cases in the first week of December, nearly double the figure from the week before.
Where did Omicron come from? “Viruses like SARS-CoV-2 continuously evolve as changes in the genetic code (genetic mutations) occur during replication of the genome,” says the CDC. These changes produce variants, which have one or more mutations that differentiate them from others. Omicron has 34 “spike protein substitutions,” meaning that it has significant physical differences and probably other characteristics from Delta.
The CDC ranks variants. The lowest level is “Variants Being Monitored.” There are nine of these, from Alpha to Mu, with none posing a threat. The next level is “Variants of Interest,” of which there are currently none. Next is “Variants of Concern.” Here, there are two: Delta and Omicron. The most alarming category, “Variants of High Consequence,” is currently unpopulated. Its characteristics include “a significant reduction in vaccine effectiveness, a disproportionately high number of infections in vaccinated persons, or very low vaccine-induced protection against severe disease.”
Significant research on Omicron, at this early date, is sparse. One of the largest studies, though not peer-reviewed, was released on Dec. 14 by Discovery Health, South Africa’s largest health insurance administrator. It is a real-world analysis of 78,000 positive test results, 19,000 of which were attributed to Omicron infections from Nov. 15 to Dec. 7.
The study found that a two-dose vaccination with Pfizer-BioNTech provided just 33% protection against COVID-19 infection but 70% protection against hospitalization. “While protection against hospital admission reduced from the highs of 93% in South Africa’s Delta-driven wave, 70% is still regarded as very good protection,” according to a press release by Discovery Health. Protection for those ages 60 to 69 drops to 67% and for those 70 to 79, to 60%.
The release quoted the president of the South African Medical Research Council, Glenda Gray, as saying, “We are extremely encouraged by the results of Discovery Health’s analysis…. The Pfizer-BioNTech vaccine provides good protection against severe disease and hospitalization.”
Also, for individuals who were previously infected, “the risk of reinfection with Omicron is significantly higher, relative to other variants.” For Beta, the variant responsible for South Africa’s second wave, the relative reinfection risk is 60%; for Delta, 40%.
The risk of hospitalization for those with COVID infection by Omicron is, however, 29% lower than during South Africa’s first wave early 2020. Furthermore, says the study, “hospitalized adults currently have a lower propensity to be admitted to high-care and intensive-care units, relative to prior waves.”
Children were 51% less likely to test positive for COVID than adults during the Omicron period, and they continue to have a low incidence of severe complications following COVID-19, says the study. But the data indicate that children under age 18 have a 20% higher risk for hospital admission for Omicron than with previous variants.
Vaccine Efficacy Against Omicron Is Vastly Increased by Boosters
New research on vaccine effectiveness against Omicron has produced some disturbing – and some reassuring -- results.
A study released Dec. 14 by Wilfred F. Garcia-Beltran of Massachusetts General Hospital, Kerri J. St. Denis of the Ragon Institute in Cambridge, Mass., and 15 colleagues examined sera (liquid separated from blood) from 239 individuals who had received a full series of Pfizer BioNTech, Moderna, or Johnson & Johnson vaccines; 71 of them also received boosters. The sera were then tested against the Omicron variant.
The researchers reported, “Remarkably, neutralization of Omicron was undetectable” in most of those who were fully vaccinated but unboosted, even if the vaccinations were completed just three months earlier. But those who were “boosted with mRNA vaccines exhibited potent neutralization of Omicron. ”The researchers also found that Omicron “is more infectious than any other variant tested.” They write:
Taken together, we demonstrate that Omicron drastically escapes vaccine-induced immunity after primary vaccination series with mRNA-1273 (Moderna), BNT162b2 (Pfizer- BioNTech) or Ad26.COV2.S (Johnson & Johnson/Janssen) and exhibits increased infectivity in vitro, raising the potential for increased transmissibility. Of note,…Omicron breakthrough infections may result in attenuated disease severity in vaccinees due to cellular and innate immunity.
However, neutralization remains the leading correlate of protection from infection, and this study demonstrates that receiving a third dose of an mRNA- based vaccine effectively yields a potent cross-neutralizing response against SARS-CoV-2 Omicron, likely through increasing breadth and cross-reactivity of neutralizing antibodies.
Previously, we reported on the waning of vaccine potency, which, after all, is the reason the CDC changed its policy and now says that “Everyone Ages 16 and Older Can Get a Booster Shot.” A large study of 843,000 Israelis who were aged 50 or older found that “participants who received a booster at least 5 months after a second dose of BNT162b2 had 90% lower mortality due to Covid-19 than participants who did not receive a booster.” The study, published Dec. 8 in the New England Journal of Medicine, covered August and September, before the emergence of Omicron.
Boosters work, no doubt, but the U.S. and other countries have had a tough enough time getting their residents to take a single vaccine shot. So far, only 56 million of the 203 million Americans who are fully vaccinated have also had a booster. Will Americans, or others in the world, continue to get booster after booster? And if they don’t, will mutations produce more troubling variants?
Which Countries Are Most Resilient in the Face of COVID?
The Bloomberg news service has been ranking countries for a year according to their “resilience” to COVID-19. The latest list, published Nov. 30, has the United Arab Emirates (UAE) in first place, followed, in order, by Chile, Finland, Ireland, Spain, Turkey, Canada, Sweden, France, and Denmark. The U.S. ranks 13th of the 53 countries that were rated, with the U.K. 12th, Japan 15th, Italy 27th, Mexico 43rd, and the Philippines last.
Criteria include vaccine doses per 100 population, with Chile leading at 211 (the U.S. is at 138); lockdown severity (less is better); flight capacity; case and death rates; GDP growth forecast; universal health care coverage; and community mobility, with smaller declines being better (the U.S. is down 15%; Chile, just 4%).
What we found significant was how much the ratings change. For example, Germany fell from third in September to 32nd in November. The U.S. rose 13 places from October to November. Japan was second a year ago and 15th in the latest ranking. Chile was in the bottom half of the rankings for 10 months, then soared in October and November. Canada, Denmark and Norway seem to have the best long-term track records, but, clearly, few countries have cracked the code and deal with the pandemic consistently well.
Advice to Dentists for Safer Air
“Controlling Pathogens in Your Air” was the title of a thorough article in the trade publication Dentistry Today on Dec. 10. It looked carefully at the dangers of airborne transmission of pathogens, especially SARS-CoV-2, and at the benefits and deficits of different kinds of mitigation.
One section of the piece, titled “New Adjunctive Technologies,” discussed devices that “variously offer the capture of micro-organisms and their destruction in the device and/or in the air.” The article urges dentists to ask several questions about these adjunctive devices:
First and foremost, do you need one, does it work, and is it safe? Is the device FDA-cleared or being marketed…under the FDA Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers during the COVID-19 public health emergency or neither? Is it CARB-certified (which is needed in California)? Other factors include whether there are independent studies demonstrating efficacy against micro-organisms.
Another consideration is the availability of information from studies in healthcare settings supporting efficacy. Does the device operate episodically or continuously, including safely when the room/area is occupied?
The piece then looks at specific devices, spending by far the most space on the first, the ActivePure Medical Guardian, which, the article notes, “is cleared by the FDA as a Class II Medical Device and is CARB-certified…. The technology is an advanced form of the one developed and used in the NASA Space Program and included in the Space Foundation Technology Hall of Fame.”
The Medical Guardian, says the article, “utilizes a patented process that includes a UV light source in the device and titanium dioxide as a photocatalyst that is used to produce gaseous hydrogen peroxide and other oxidizers. These then exit the device and enter the air. The oxidizers interact with and disrupt bacterial and fungal cell membranes, as well as the outer shell of viruses. This leads to microbial kill.”
The piece also notes testing results for the Medical Guardian, including a trial at the University of Texas Medical Branch, using the SARS-CoV-2 virus. “The test protocol was designed to deliver 29 ft per minute of air movement (the lowest setting). Within 3 minutes, a ≥2.87 to ≥3.38 log reduction was found, which equates to a ≥99.87% to ≥99.96% reduction in the concentration of SARS-CoV-2. It was noted that the actual reduction may have been 99.99% or greater since the level of detection was reached.”
In a second independent study, “the test micro-organisms were Staphylococcus epidermidis, Erwinia herbicola, RNA MS2 and DNA Phi X174 bacteriophages, Aspergillus niger, andBacillus subtilis. These are proxy/surrogate micro-organisms for known pathogens, among them, respectively, Staphylococcus aureus; Yersinia pestis (black plague); influenza virus and norovirus; HCV, HCB, and HIV; Stachybotrys chartarumand (a toxic black mold); and Bacillus anthracis (anthrax). Three test trials were conducted as well as a control trial. The results showed an overall average net log reduction of 4.8 ±0.74, representing a greater than 99.99% reduction.”
The article concludes by stating that “understanding of airborne transmission has …come into sharper focus, and during COVID-19, a layered approach has been recommended,” including ventilation and newer devices. When dentists are looking at the latter, says the article, “careful review and due diligence are needed to determine…efficacy, safety, and applicability.” Good advice.
The Characteristics of Breakthrough Infections
The Health System Tracker, a valuable resource devised by Peterson-KFF, published some fascinating data on Dec. 15 about breakthrough infections using a data set of 120,000 COVID-19 admissions between June and September, with Delta dominant.
Among the findings:
The authors write, “Despite the widespread availability of COVID-19 vaccines, in September, COVID-19 was the second-leading cause of death in the U.S. overall and the first-leading cause of death among people ages 35 to 54.”
Breaking Bad: How Well Are Vaccines Working?
Health officials are growing concerned that more fully vaccinated Americans are becoming hospitalized with breakthrough COVID. Anthony Fauci, director of the National Institute for Allergy and Infectious Disease, said Nov. 16 in an interview, “What we’re starting to see now is an uptick in hospitalizations among people who’ve been vaccinated but not boosted…. It’s a significant proportion.”
Just how large a proportion is hard to say because of outdated and inadequate reporting. The Centers for Disease Control and Prevention (CDC) reports that hospitalization rates for vaccinated Americans rose by a factor of five between July 17 and Aug. 28. Incredibly enough, the CDC has not published any data since – a hiatus of more than two and a half months. On Aug. 28, some 4.5 vaccinated persons per 100,000 were hospitalized – far fewer than the rate of 83.6 per 100,000 among the unvaccinated. Still, the increase among the vaccinated is worrisome.
On Nov. 21, the Wall Street Journal reported that its own analysis found that “there have been more than 1.89 million cases and at least 72,000 hospitalizations and 20,000 deaths among fully vaccinated people in the U.S. this year.” The cases are concentrated among older people and those with underlying health conditions. Recent data from South Carolina, for example, found that 79% of people hospitalized with breakthrough infections had at least one additional health condition, the Journal reported. In the intensive-care unit, that proportion increased to 88%. Also, a data set from Epic Health Research Network found that “80% of breakthrough deaths among the vaccinated are in people ages 65 and older.”
The CDC did find that unvaccinated persons had a 6.1 times greater chance of becoming infected with SARS-CoV-2 and an 11.3 times greater chance of dying from COVID than vaccinated persons, but, again, these data are old. The last update was Sept. 3, and, judging from the graphic below, the gap between infection rates is narrowing.
In addition, the data come from only 16 jurisdictions, and they do not segregate statistics for the elderly, who are more apt to have breakthrough disease. Also, many vaccinated people, especially, develop only mild symptoms and confirm they have COVID by using a home-testing kit. But then they do not report the disease to their own physicians or to local authorities. The statistics are just not very good.
It is clear, however, that two-dose vaccination with the Pfizer or Moderna vaccine or one dose of Janssen is far from complete protection, and we are seeing the consequences in high community spread. In Michigan, for example, “28% of hospitalizations and 24 percent of deaths, between Oct. 7 and Nov. 5, were among fully vaccinated individuals,” reports Politico Pro.
In an incident in Canada recently, 15 hockey players in a league for men over age 50 became sick with COVID and one, who had no prior health problems but was age 75, died. All were fully vaccinated, according to a Canadian Broadcasting Corporation report, which also said the rink followed disease protocol.
Dr. Richard Gould, the York region's acting medical officer of health, said the source of the outbreak may have been a vaccinated player who was infected while playing. "Vaccines reduce our risk of infection and serious illness by a tremendous amount," said Gould. "But nothing is 100 per cent effective, unfortunately, and that's proved to be the case in this situation."
Evidence is strong that a booster shot significantly increases immunity, though there is debate still about who should get the vaccinations. On Nov. 19, the U.S. Food & Drug Administration (FDA) amended its Emergency Use Authorization to expand the use of booster doses of Pfizer-BioNTech and Moderna vaccines to individuals over age 18 at least six months after their primary vaccination series (and two months after their Janssen shot).
The CDC reports that, as of Nov. 19, some 34 million Americans had received booster shots. That is about one-tenth of the total U.S. population and one-sixth of those who are “fully” vaccinated (that is, have at least two Pfizer or Moderna shots, or one Janssen). The pace has picked up, and more Americans are now getting boosters (about 700,000 a day on average for the preceding week) than are getting first or second shots (about 600,000).
Is There a Correlation Between High Vaccination Rates and Low Infection Rates?
As the months pass, it has become clear that the correlation between COVID vaccination rates and disease rates is far from tight.
On Nov. 19, five of the seven states with the highest number of cases per 100,000 also had rates of full vaccination at or above the U.S. average. For example, Minnesota, where cases are triple the national average, had a vaccination rate of 62%, compared with 59% overall in the United States. Some of the states with the lowest case rates also have the lowest vaccination rates. Mississippi, Alabama, Georgia and Louisiana – which rank 45th through 48th in cases – all have vaccination rates well below the U.S. average.
Similar anomalies are found around the world. Germany, for example, at 68%, has one of the highest proportions of fully vaccinated residents globally, yet COVID cases there soared on Nov. 15 to a seven-day daily average of 39,000, a new record – and more than twice the total on the same date a year earlier, before vaccines became available. Germany’s case rate is 45 per 100,000 population, compared with 26 per 100,000 for the United States
Cases in the U.K., with a fully vaccinated rate of 69%, are about half the level of those in the U.S., whose population is five times that of the United Kingdom. A Nov. 2 article in Nature stated:
The United Kingdom was hit by three million infections between July and October this year — comparable to when the country was under a strict lockdown in late 2020. This is despite 79.5% of those aged 12 years and older having received two vaccine doses as of 31 October.
Raging COVID cases prompted the CDC on Nov. 15 to place Iceland, with a vaccination rate of 81%, on its list of highest-risk travel destinations. Iceland’s daily case rate is 46 per 100,000, or 70% higher than that of the U.S. And last week, Austria, with a vaccination rate of 65% and a daily case rate over 100 per 100,000, ordered all unvaccinated persons to stay home except to purchase food or go to work.
In other countries, however, higher vaccination rates do correlate with lower infection rates. In Canada, for instance, with a fully vaccinated rate of 76%, case rates are just 7 per 100,000, roughly the same as Italy, where the vaccination rate is 73%, and Spain, where the vax rate is 80%, one of the highest in the world.
These comparisons are crude, of course. The case rates are snapshots, and infections rise and fall in surges, which don’t occur at the same time in all states and countries. Case rates depend on testing volume, which also varies widely by country. In addition, it does appear that hospitalization and death rates are closely tied to vaccinations. For example, despite the sharp rise in cases, the death rate per 100,000 population in Germany is well below that of the United States. In Spain, with one-seventh the U.S. population, only 23 people are dying per day, compared with 1,100 Americans.
On the road from pandemic to endemic, the purpose of COVID vaccination is to prevent serious disease and death. Some governments, however, have misled populations about the ability of vaccines to prevent asymptomatic or mild disease or to spread it widely.
Also, vaccines have to be seen as only one layer of protection against COVID, not a panacea. Where community spread is high, masks and social distancing are advisable, and every interior space where people congregate should have the best protection against pathogens spread through aerosols, as we’ll now see.
ASHRAE Article: HVAC Plus Filtration Can’t Provide Sufficient Protection, Even With Portable Filter Devices Added
In an important and surprising development, an article in the official publication of the ventilation trade association acknowledges that HVAC systems are ineffective in fighting pathogens like SARS-CoV-2. This remarkable admission points the way toward better methods of mitigating viruses, bacteria, and mold indoors.
The piece in the ASHRAE Journal, a publication of the American Society of Heating, Refrigerating and Air-Conditioning Engineers, reveals serious deficiencies in the use of ventilation systems coupled with filtration in fighting COVID-19, even if those systems are supplemented by numerous portable air filtration devices.
Zhiqiang Zhai, a professor of Civil, Environmental and Architectural Engineering at the University of Colorado at Boulder and winner of ASHRAE’s Distinguished Science Award, and three colleagues were responsible for the comprehensive study.
For ASHRAE to admit the lack of effectiveness of HVAC system is particularly significant. The organization has been influential in encouraging such systems as the answer to COVID mitigation in interior spaces, where aerosols can linger for hours. But the article by Zhai, et al., shows the severe limitations of that approach, even when smaller devices are used as supplements.
In analyzing a restaurant simulation, the researchers write, “It is evident that if purely using the CA [that is, central air-conditioning with filtration], only a small fraction of the particles can be discharged through the ceiling exhausts. Most of the particles are spread out indoors and ultimately deposited on the occupants, tables, ground and walls.”
Adding eight air purifier units “can clean 28% of the particles while increasing the deposition (48%) on the surrounding walls due to the downward extraction flow to the units. A table purifier placed in the center of each table in the room – only a few feet away from each occupant, an impractical and expensive proposition – “can handle almost 80% of the particles, while slightly increasing the deposition on the tables compared to floor units.” The researchers write that simulations for a large ballroom “demonstrated similar performance.”
Zhai and his collaborators also underscore problems with HVAC systems that go beyond ineffectiveness against COVID. Such filters, they write, “may increase the pressure drop, which may make them impractical for some applications.” In other words, the more powerful the filter that is attached to an HVAC system, the more airflow is restricted, causing a drop in pressure. “This in turn,” says the article, “could compromise the comfort of occupants…[and] could call for more frequent filter change, causing increased recurring operational costs.”
Counteracting the pressure drop from filtration requires more energy, which, as Michael Dorsey, co-founder of the Center for Environmental Health, noted in an article in Newsweek in July, is a “recipe for driving up CO2 emissions, and simultaneously runs afoul of long-standing guidance for green buildings practices.”
Dorsey points out that the International Energy Agency has stated that “the single biggest behavior change we'll need to reduce CO2 emissions is cutting our energy use for space heating, a move that could save 457 million metric tons of CO2. We can save another 95 million metric tons by addressing the cooling side of air conditioning.”
The danger to occupants from HEPA filters placed on HVAC systems, write Zhai and his colleagues, is that some pathogens “do not get entrained into the return air vents and may float around in a given space.” In other words, this is not the right solution to contaminated indoor air.
For filters to work, pathogens need to find them. If they have to travel large distances, that meet-up is elusive. The researchers did find that adding multiple air purifiers on the floor and on tables can increase the removal of particles. But in the tests, these portable devices had to be “placed between every two occupants,” hardly the kind of regime for most businesses, schools, and other buildings.
The ASHRAE research involved simple portable air purifiers with a HEPA filter, but more sophisticated purifiers work much better. For example, ActivePure, a Dallas-based company, has developed an Advanced Photocatalysis technology, cleared by the Food & Drug Administration, that is capable of safely suffusing an occupied indoor space with the same oxidative particles found to clean the atmosphere naturally. Research by independent organizations shows that the technology is considerably more effective than filters alone.
Most of ActivePure’s devices themselves carry a HEPA filter and are widely used throughout the world, including by the Philadelphia School District and the Boch Center in Boston.
The importance of the ASHRAE article cannot be underestimated. As was the case with masks, many of those responsible for safety of employees, students, and customers are confused about the best way to mitigate the spread of the SARS-CoV-2 virus and other pathogens indoors, where contaminated aerosols do the most damage.
Now, what ASHRAE is saying in its official publication is that ventilation plus is not enough – even with the addition of a practical number of portable purification devices. What’s needed is advanced air purification devices, which can be installed at relatively low cost either in existing HVAC systems (without loss of pressure) or in free-standing units. This is a critical step in the evolution of the battle against the pandemic.
‘This Hope Appeared Overly Optimistic, and It Seems More So Now’
The lead article in the New England Journal of Medicine on Nov. 11 recounted the disappointing record of vaccines in what some anticipated would be the elimination of COVID-19. A reconsideration is necessary, writes Arnold S. Monto, a University of Michigan professor of public health and Acting Chair of the FDA’s Vaccines and Related Biological Products Advisory Committee.
“The initial data on inapparent SARS-Cov-2 infection strengthened the hope that, at a certain level of vaccination, transmission would cease completely,” writes Dr. Monto. “To many of us, this hope appeared overly optimistic, and it seems even more so now.”
Eliminating a disease through herd immunity, he writes, “works best when the agent has a low transmissibility.” It seemed at first that ending COVID-19 was “theoretically possible, because the original 2002 SARS virus ultimately disappeared.” But that virus “did not transmit as well as even the initial strain of SARS-CoV-2,” and the Delta strain transmits at a rate about 2.5 times higher.
Those hopes to which Dr. Monto referred quickly vanished. As Yasmin Tayag wrote in The Atlantic on Nov. 8:
Many Americans had thought that the shots were a ticket to normalcy—and at least for a while, that’s precisely what public-health experts were telling us: Sure, it was still possible for vaccinated people to get COVID-19, but you wouldn’t have to worry much about spreading it to anyone else. Interim guidance shared by the CDC in March stated that these cases “likely pose little risk of transmission,” and a few weeks later, CDC Director Rochelle Walensky said that “vaccinated people do not carry the virus.”
Unwitting vaccinated people, many not taking proper precautions, can spread the disease and create debilitating illness and death in unvaccinated people or in vaccinated people who are older or have comorbidities. (Vaccinated people, however, are not as likely to spread the virus as unvaccinated people.) Combine this spread with two other factors, and you can understand why cases are rising.
The first factor is simply the weather, which is driving people who live in the Northern Hemisphere indoors, where it is far easier to become infected. In Michigan for instance, cases have jumped 78% in the two weeks ending Nov. 19. Despite a fully vaccinated rate of 72%, tied with three other New England states for the highest in the U.S., Maine now has a case rate of 58 per 100,000, the seventh-highest in the nation. Conversely, Florida, where outdoor activities are in full swing, now has the lowest case rate among the 50 states, at 7 per 100,000.
Cases have risen 29% in the past two weeks in the U.S., with most of the increases occurring in the northern tier of the Midwest, the Plains states, and New England. Cases are also increasing in Germany, France, and Canada but falling sharply in Australia, where it is now spring.
The second factor is that the effectiveness of vaccines wanes over time – dramatically.
The Rapid Waning of Vaccine Effectiveness
The threat of waning was highlighted in the disturbing results of a new study by Barbara Cohn of the Public Health Institute of Oakland, California, and colleagues, published Nov. 4 in the journal Science.
The extensive research examined the experience of 780,000 Veterans Health Administration subjects who used the Pfizer-BioNTech, Moderna, and Janssen vaccines over the period Feb. 1, 2021, to Oct. 1, 2021. This period includes the emergence of the Delta (B.1.617.2) variant, which overwhelmed all others by July and, according to the CDC, is as transmissible as chickenpox.
The research found that the effectiveness against infection for the three vaccines dropped over the period from an average of 87.9% to just 48.1%. The Janssen vaccine’s effectiveness fell from 86.4% to just 13.1%. In other words, it was only slightly better than not being vaccinated at all. The other vaccines dropped significantly as well: Pfizer, from 86.9% to 43.3%; Moderna, from 89.2% to 58%.
The V.A. study was far more extensive than previous research that produced similar results. For example, two studies (one by Broxvoort, et al.; the other by Tartof, et al.) conducted among Kaiser Permanente patients in South California found that vaccine effectiveness against infection dropped from 95% at 14-60 days after vaccination to 79% at 151-180 days after vaccination for those ages 18-64 and a far larger decline – from 80% at one month to just 43% at five months – for those aged 65 and older. The V.A. study also notes that “declines in protection against infection with Delta have been observed in Israel, the U.K., and Qatar.”
The Israeli study, by Yair Goldberg and colleagues, was published in the New England Journal of Medicine on Oct. 27. It looked only at the Pfizer-BioNTech vaccine and found that immunity waned rapidly after receiving a second dose. Among persons aged 60 and older, the rate of infection in the July 11-31 period was 60% higher among those fully vaccinated in January 2021 than among those fully vaccinated in March. Just two months later!
The waning was even worse for protection against severe disease, which was 80% more likely in those who were vaccinated earlier.
The newly published Veterans Administration research found that effectiveness against death did not decline as much as effectiveness against infection. Compared to unvaccinated Veterans,” said the study, “those fully vaccinated had a much lower risk of death after infection.” Still, the rate of effectiveness against death among those 65 and over infected when Delta has been dominant was low enough to be concerning: 73% for Janssen, 75.5% for Moderna, and 70.1% for Pfizer.
One answer to waning vaccine effectiveness is the booster shot, but boosters have their limits. Can entire populations get a third shot after six months (or less) and another and another and another? The V.A. researchers conclude:
Our findings on increased risk of death following breakthrough infection provide further support for continuing efforts to discover and implement effective interventions to prevent infection in all persons, including those who have been fully vaccinated.
“Viral evolution,” warn Cohn and her colleagues, “may result in more lethal or infectious variants, or variants that escape protection [from] the vaccine.”
Vaccination by itself is not enough. It is a vital layer of protection, but only a single layer – an adjunct, for example, to cleaner, safer air in interior spaces, which we will examine below.
Reducing Confusion Over Masks, Droplets and Aerosols
The battle against COVID-19 is a work in progress. Take masks. Today, the CDC has relatively clear guidance: “Everyone 2 years of age or older who is not fully vaccinated should wear a mask in indoor public places,” and, even if you are vaccinated, you should wear a mask “in an area of substantial or high transmission.”
But at the start of the pandemic, confusion reigned among policy makers. In his new book, Uncontrolled Spread, former Food & Drug Administration Commissioner Scott Gottlieb writes that, before COVID hit, “masks had never been viewed as a standard part of the response to a pandemic.” In fact, the Obama Administration, in the pandemic plan it provided to the Trump Administration, did not “even mention masks a single time.”
In their book, Nightmare Scenario, Washington Post reporters Yasmeen Abutaleb and Damian Paletta write that many on the White House coronavirus task force “were skeptical that masks would make a difference.” They quote a Tweet from Surgeon General Jerome Adams on Feb. 29, 2020: “Seriously people – STOP BUYING MASKS! They are NOT effective in preventing general public from catching #Coronavirus.”
“The CDC,” wrote Gottlieb, “raised concerns that masks would end up encouraging consumers who wore them to touch their face more, and in turn make them more likely to spread infection through fomites,” that is, objects that carry infection. The CDC “initially told a major airline that their flight attendants couldn’t wear masks” because of worries that personnel did not “know how to properly fit” them and instead would spread would increase.
“These concerns,” wrote Gottlieb, “were based, in part, on the CDC’s flawed premise that more of the early transmission was being driven by droplets and contaminated surfaces rather than aerosolization.”
Droplets are heavy enough to drop, but aerosols float. As Kimberly Prather of the Scripps Institute of Oceanography, an expert on aerosols, and several colleagues explained in a letter to Science magazine:
Viruses in droplets (larger than 100 µm) typically fall to the ground in seconds within 2 m of the source and can be sprayed like tiny cannonballs onto nearby individuals. Because of their limited travel range, physical distancing reduces exposure to these droplets. Viruses in aerosols (smaller than 100 µm) can remain suspended in the air for many seconds to hours, like smoke, and be inhaled….
Individuals with COVID-19, many of whom have no symptoms, release thousands of virus-laden aerosols and far fewer droplets when breathing and talking. Thus, one is far more likely to inhale aerosols than be sprayed by a droplet, and so the balance of attention must be shifted to protecting against airborne transmission.
But guidance by the CDC and the World Health Organization was based on the erroneous view that droplets were mainly responsible for spread. It took a revolt of experts, which we have related in previous newsletters, to change the minds of the policy makers.
With evident reluctance, the CDC did change its guidance, and it now lists aerosols first among the “three principal ways” that people are exposed to “respiratory fluids carrying SARS-CoV-2,” the virus that causes COVID-19.
In addition, it took the World Health Organization (WHO) more than a year to admit that aerosols are the main mode of transmission. On April 30, 2021, the WHO website was revised to read:
The virus can spread from an infected person’s mouth or nose in small liquid particles when they cough, sneeze, speak, sing or breathe. These particles range from larger respiratory droplets to smaller aerosols.
The update also states that the virus can spread “in poorly ventilated and/or crowded indoor settings, where people tend to spend longer periods of time.”
Learning to Live Safely with COVID
“In the end, all pandemics burn out,” states a thoughtful article titled, “How the world learns to live with covid-19,” in the Oct. 16 issue of The Economist. “Eventually, sufficient numbers of people develop immunity so viruses can no longer find new hosts at the rate they need to sustain their growth. And yet only one human disease, smallpox, has ever been completely eradicated.”
What has happened to the others, such as influenza, cholera, or Hepatitis B? They “slowly became endemic, part of the landscape of disease around the world, checked but not eliminated by vaccines and medical treatments.” And “checked” may be too strong a word. Influenza killed 50,000 Americans in 2019; Hepatitis B killed 820,000 people worldwide that year.
That, inevitably, is the fate of COVID-19. Eradication is impossible. “Every country,” says The Economist, “will have to learn to live with the disease.” We would revise that to say that we have to learn to live safely with COVID. We will always have to take measures.
Also, endemicity, as it’s called, doesn’t happen overnight. “The world’s collective level of immunity to COVID is nowhere near that of other endemic respiratory diseases.” The Economist cites Ali Ellebedy, an immunologist at the Washington University School of Medicine in Missouri, who says that “it will take decades for humanity to reach a comparable level of immunity to covid.”
Even in a best-case scenario, older people and those with an array of co-morbidities – former Secretary of State Colin Powell, who had multiple myeloma and died Oct. 18 from COVID, fit both categories – will still be vulnerable, even if immunized, to contracting disease from others, even if also immunized.
The Economist’s conclusion: “The coming years, then, will be characterized by a slow process of cyclical decline that runs in tandem with a broadening and deepening of immunity to infection.”
Learning to live safely with COVID does not mean acquiescence. It means using technology to take continuous, effective actions – such as sanitizing indoor air – to guard against the spread not only of the SARS-CoV-2 virus but of other pathogens. And it means a recognition that the best we can hope for is that “slow process of cyclical decline.”
Cyclical Decline Remains Elusive
Right now, however, cyclical decline is far from evident. COVID-19 cases have surged in rough cycles. In 2020, a summer surge began in the U.S. in early June and peaked in late July at a seven-day moving average of 67,000 daily cases. Infections bottomed in September at about 35,000 daily cases. The fall-winter surge began a month later, peaking at 260,000 cases in early January and falling to 15,000 in June 2021.
But this year’s summer surge was far worse last year’s, peaking at over 170,000 cases. Deborah Birx – the former White House coronavirus coordinator who is now chief medical and scientific advisor to ActivePure, a Dallas-based developer of technology that inactivates pathogens in the air and on surfaces – has noted that the U.S. is carrying many more cases into the winter than last year. On Sept. 30, 2020, the daily case count was 43,000; at the same date this year, it was 111,000.
A year ago, precisely no one was vaccinated. Today, 191 million Americans have received a full course of vaccines, or 57% of the total population; another 14 million have received a booster shot. Worldwide, 2.9 billion people are fully vaccinated or 40% of the population. But, when it comes to infections, the preventative power of vaccines has been counterbalanced by the Delta variant’s ability to spread at more than twice the rate of previous variants – and by its virulence in attacking people who are not vaccinated. Delta became the dominant strain in the U.S. in late June, and by the end of July, it accounted for 97% of U.S. COVID infections; today, 99.6%, according to the Centers for Disease Control and Prevention (CDC). The other counterbalancing factor is that the efficacy of vaccines wanes. A large study of patients in Veterans Administration hospitals, released this month, found that vaccine protection declined from 92% in March to 54% in August.
Caseload cycles appear to be geared to weather. In the summer, Americans, especially in the South, move indoors to escape the heat, and indoors is where the SARS-CoV-2 virus spreads most easily. In June and September, the months of low infection, temperatures are conducive to outdoor activity nearly everywhere in the United States, but as fall wears on, people in Northern states move indoors to escape the cold.
Southern Decline in Disease Outpaces Northern Growth, But for How Long?
Overall in the U.S., we seem to be in a period when the decline in cases in Southern states is outpacing the rise in cases in Northern states. For example, in Louisiana, daily average cases fell from 5,800 in mid-August, to just 460 on Oct. 26. Missouri over the last two months has experienced a decline of two-thirds; Mississippi and Texas, four-fifths. In the North, meanwhile, surges are occurring in such states as Vermont, which set a record on Oct. 13, registering about half-again as cases than last January’s peak. Colorado cases on Oct. 20 were up 16% in two weeks; South Dakota, up 35%.
For the U.S. as a whole: The Department of Health and Human Services incidence map, which shows the case rate by county, is almost entirely red.
Still, infections have dropped by 23% in the past two weeks, and states where the surge in infections was especially disturbing in mid-September, like Ohio, Wisconsin and Indiana, have seen dramatic declines. In other states, such as Montana, sharp increases have leveled off.
One reason may be that the cold weather simply hasn’t arrived yet. As the website Yale Climate Connections on Oct. 18:
The first half of autumn 2021 came in as the warmest on record for a broad set of towns and cities spanning much of the northern tier of the United States. From Bismarck to Buffalo, millions of people have experienced a September and early October milder than any observed in almost 150 years of record keeping.
For example, Buffalo, Chicago, Duluth, Fargo, and many other cities broke records for average high temperatures during the period Sept. 1-Oct. 15.
Dr. Birx said on Oct. 18 in a webinar that included members of the Michigan Assisted Living Association (MALA) and public officials, “The current case load, even though decreasing, raises significant concern for the fall and winter 2021. Planning and preparing now is critical.”
Cases vs. Hospitalizations vs. Deaths
As COVID-19 slowly transitions from pandemic to endemic, infections may remain high but severe cases that lead to hospitalization and death are expected to decline – mainly because of vaccinations and better treatments. During the peak of this year’s summer surge, there were two and a half times as many daily cases of COVID as during the peak of last year’s. But hospitalizations rose only by one-third and deaths by one-half.
More and more evidence points to the effectiveness of vaccines against death. A study published in the The Lancet earlier this year by three researchers – Aziz Sheikh, Chris Robertson, and Bob Taylor – examined records of 1.6 million adults in Scotland who underwent testing during the period when the Delta variant was prevalent in the community. It showed the beneficial effect of vaccines on hospitalization. Then on Oct. 20, in correspondence with the New England Journal of Medicine, the researchers reported a further analysis of the dataset – this time on deaths.
They found that, among persons aged 16 to 39, no deaths at all were reported among 13,000 people who were fully vaccinated with the Pfizer-BioNTech or AstraZeneca vaccines, compared with 17 deaths among the 35,000 who were unvaccinated. Among those aged 40 to 59, there was one death for every 145 unvaccinated subjects and one death for every 722 vaccinated subjects. For those 60 or older, effectiveness against death was 90% for Pfizer and 91% for AstraZeneca.
What we cannot expect from any vaccine is preventing vaccinated people from spreading disease to unvaccinated people – or even to immune-compromised vaccinated people. That is clearly happening with Delta, and it may be the main reason we are seeing so many infections – and such persistent mortality.
Digression on Deaths
The subject of deaths is worth a digression on the true danger of COVID-19. The Economist has developed a model based on excess deaths (that is, the observed increased in mortality beyond what would normally be expected if the pandemic did not exist), which gives a more accurate picture of how many people COVID-19 is killing a day, worldwide.
Official figures understate deaths for several reasons, including the exclusion from the rolls of victims who did not test positive for the disease before dying, “which can be a substantial majority in places with little capacity for testing.” In addition, “the pandemic has made it harder for doctors to treat other conditions and discouraged people from going to hospital, which may have indirectly caused an increase in fatalities from diseases other than covid-19.”
While the official global death count on Oct. 18 was 6,600 daily deaths, The Economist’s analysts estimate that actual deaths were closer to 30,000, with a 95% confidence interval between 15,000 and 40,000. Excess deaths have fallen by more than half from the high of 70,000 in May.
Nearly two years after the initial COVID-19 outbreak, the FDA has given full approval to one vaccine (Pfizer-BioNTech) and emergency authorization to two others (Moderna and Johnson & Johnson). In addition, the FDA has approved Viklury, an intravenous anti-viral drug developed by Gilead for hospitalized adults and some children, and has given emergency authorization to several monoclonal antibody treatments for mild and moderate cases of the disease and, in one case (Regeneron) as a prophylactic for people who may have been exposed to COVID but haven’t contracted it yet.
On Oct. 1, Merck and Ridgeback announced that their investigational oral antiviral called Molnupiravir “reduced the risk of hospitalization or death by approximately 50%” compared to a placebo for patients with mild or moderate disease. And Pfizer and BioNTech have presented data to the FDA, which was released Oct. 22, showing that its vaccine was 90% effective in preventing symptomatic COVID-19 in children ages 5 to 11. A meeting of advisors to the FDA on whether to approve the vaccine for kids that young is scheduled for Oct. 26.
In short, enormous progress has been made in a short time, but there is still a great deal we don’t know about the disease in an epidemiological, or public health, sense. For example, how much does the waxing and waning of infections depend on seasonality and how much on the penetration of vaccines? How dangerous is spread from vaccinated to unvaccinated people? How important is masking and social distancing – in real, concrete terms?
Public health experts have not adequately answered practical questions, such as whether children in school should be masked all day or whether, even in a community without widespread disease, people should go to a concert hall where they are surrounded by 2,000 music lovers, some of whom are inevitably unvaccinated. What are the odds of becoming infected inside a restaurant as opposed to sitting outside? The question of who should get a booster shot is still murky, and a CDC panel only on Oct. 21 recommended that Americans can choose among the three vaccine offerings for their booster, no matter which company developed their first and second shots.
The Japanese Mystery, or Is It?
Puzzles abound. An apparent one is that “Japan has become a stunning, and somewhat mysterious, coronavirus success story,” as Mari Yamaguchi of the Associated Press wrote on Oct. 17. Daily cases on Aug. 25 were 23,000; on Oct. 20, they were 434. Only 10 people died from COVID on Oct. 20 in Japan, a country with about 40% of the population of the United States, where, on that same date, 1,700 people died.
In Japan, “the bars are packed, the trains are crowded, and the mood is celebratory, despite a general bafflement over what, exactly, is behind the sharp drop,” wrote Yamaguchi. “Japan, unlike other places in Europe and Asia, has never had anything close to a lockdown, just a series of relatively toothless states of emergency.”
So what’s the answer? It appears to be an aggressive vaccination campaign that pushed rates from 15% in early July to 68% three months later. In other words, nearly half the Japanese population is living with the effects of fresh (that is, less than three months old) vaccine inside their bodies. In the U.S., by contrast, vaccinations peaked in mid-April at nearly 3 million doses per day and are now down to one-fourth that level. So, for vast numbers of Americans, vaccinations were administered six to ten months ago and effectiveness has waned.
Within a few months, Japan, too, may experience a waning, which is why this Reuters headline is poignant: “Japan's dip in COVID-19 cases baffles experts; winter 'nightmare' still a risk.”
Some Certainties About COVID Spread Do Exist
There are things we do know about the virus for certain: that it is especially deadly for those who are old or have compromising conditions and that it spreads easiest indoors. As a result, ventilation plus technology that can continuously deactivate pathogens – not just filter them – is critical as a layered defense against the virus, especially in nursing homes and assisted-living facilities.
At the same Oct. 18 webinar at which Dr. Birx spoke, John LaRochelle, a veteran of the giant services firm Sodexo and now president of Lighthouse Environmental Infection Protection, discussed the challenges and opportunities of the pandemic for assisted-living facilities. He pointed out that “tragedy leads change” – in this case, a complete reassessment of the dangers of all kinds of infection in settings like nursing homes.
LaRochelle warned that there will be other pandemics as well as an increase in antibiotic-resistant bacteria and the spread of insect-to-human and animal-to-human diseases. Disinfection efforts, he said, often fail because treatments are difficult for humans to deploy. What is required is not merely ventilation but a layer of continuous, enhanced disinfection that is automatic – that doesn’t require daily or hourly human intervention. He cited ActivePure’s advanced photocatalysis technology, which is FDA-cleared and, he noted as an example, reduced Staphlococcus Epidermis Gram-positive bacteria by 99.9999% within 60 minutes after treatment.
‘Who Wants to Go Back to a Building That Isn’t Healthy’
In an Atlantic article on Oct. 3, Joseph Allen, an associate professor at the T.H. Chan School of Public Health, reminded readers that, if they are in a typical office, home, or school, “about 3 percent of the air you breathed in recently came out of the lungs of the people in the room with you right now.” And that air can be contaminated with SARS-CoV-2, which spreads almost entirely indoors, or other pathogens.
“How many pathogens you take in,” Allen writes, “depends on one factor in particular: how much fresh air is coming into the building….. Before the coronavirus pandemic, the interior designers and HR professionals who decide how offices look paid little attention to ventilation. Allen’s point in the piece is that “the cool new [office] amenity won’t be a foosball table. It’ll be something we should have had all along—clean air.”
He concludes, “COVID-19 has prompted a universal awakening about the power of our buildings to make us sick or keep us well. At this point, really, who wants to go back to a building that isn’t healthy?”
That statement is certainly correct, and it reflects the comment of LaRochelle above about tragedy leading to change for the better. But ventilation is not the only way to provide safe air in offices or other interior spaces. In fact, because good ventilation requires very frequent exchanges of air, it can be a very expensive, energy-intensive way to sanitize the air and a way that harms the environment.
There’s another problem with ventilation. As Allen admits, “Bringing in more outdoor air should be good for cognition, but outdoor air is polluted with particles that hurt cognition.” His answer is filtration. “By capturing pollutants before people inside have to breathe them, buildings can give people the benefits of outdoor air without the downside.”
But filters are inefficient. They have to wait for pathogens to drift to them in order to capture them. Allen does not mention a much better technology: an advanced photocatalytic process that deactivate pathogens swiftly in interior air without creating ozone or volatile organic compounds.
The Same Winter/Summer Pattern We Saw Last Year Re-Emerges
As we expected, COVID-19 cases have dropped sharply in recent weeks in the Southern states that were hotspots in July and August. In Florida, new infections fell from a daily seven-day average of about 22,000 in mid-August to 5,500 on Sept. 29; in Mississippi, from 3,600 to 1,100; in Louisiana, from 6,000 to 1,000. Because testing has risen back to the January 2021 levels all over the country, these case rates paint a more accurate picture of the ups and downs of infections in the South.
Meanwhile, however, cases are climbing in more northerly states like Wisconsin (up 33% in the past 14 days), Alaska (up 84%), North Dakota, Minnesota, New Hampshire, Maine, and Vermont.
This is the same pattern we saw a year ago. As the weather cools off, people in the South go outdoors while in the North residents go indoors, and indoors is where the SARS-CoV-2 virus spreads more readily and rapidly.
Vaccination rates undoubtedly affect infection rates. We noticed last week that all 10 states with the highest number of COVID cases per 100,000 residents had fully vaccinated rates that are below the national average of 55%, while 9 of the 10 states with the lowest COVID case rates had fully vaccinated rates above the national average. But, with the Delta variant now responsible for 99% of infections, vaccinations don’t tell the whole story.
For the U.S. as a whole, the daily average of COVID cases on Sept. 29 for the seven preceding days was 113,000, down 26% from two weeks earlier and less than half the all-time record set in January. Hospitalizations have peaked, and deaths appear to have reached an apex as well. But all this is likely to be temporary.
The short history of COVID indicates that winter is the cruelest season because nearly all of America moves inside. What’s disturbing is that some of the cooler states are already far ahead of their case rates from last year. For example, Wisconsin on Sept. 25, 2021, had a seven-day average of 3,300 infections, a one-third increase over the same date last year. In Montana, cases are triple where they were a year earlier; in Minnesota, more than double. In Vermont, there were 194 average daily cases on Sept. 29; precisely a year earlier, there were just 4.
Even worse, hospitalization rates have increased, evidently because of Delta. In Idaho, hospitalizations reached a new high of more than 700 deaths daily in the last week of September. The record set during the last peak in January was 471. Deaths also set a record.
The CDC has appropriately called for “layered prevention strategies” against COVID-19. One of those layers, masking, received further validation from a study of Arizona schools published in the CDC’s Morbidity and Mortality Weekly Report (MMWR) on Sept. 24. Led by Megan Jehn of Arizona State University, the researchers examined infection rates in 999 schools in Maricopa and Pima Counties, which account for about three-quarters of the state’s population.
Of the schools, 519 had mask requirements and 480 did not. Between July 15 and Aug. 31, some 191 “school-associated outbreaks occurred.” Of those, 16 were in schools with early mask requirements, 62 in schools with mask requirements enacted a median of 15 days after school started, and 113 happened in schools without mask requirements. “The odds of a school-associated COVID-19 outbreak in schools with no mask requirement,” concluded the researchers, “were 3.7 times higher than those in schools with an early mask requirement.”
An Effective Layer of Protection Against Airborne SARS-CoV-2
Another layer that more and more schools – as well as health facilities, offices, theaters, and homes – are installing is a combination of ventilation (that is, the replacement of interior air with less dangerous outdoor air) plus a means of removing SARS-CoV-2 from interior air and surfaces. Ventilation itself is not enough, and the inadequacy of ventilation plus filters like HEPA was recently demonstrated in the Marin County investigation that was reported in the Aug. 27 edition of MMWR and that we related in a Sept. 14 COVID Solutions Bulletin Extra.
In that case, an unvaccinated teacher, apparently reading without a mask infected 55% of a class of masked students. The room had significant ventilation from open windows on two sides, plus “portable high-efficiency particulate air filters.” Those mitigation strategies failed, and it’s not hard to see why. A filter can capture pathogens only if pathogens flow into it, and many do not. A CDC study published in July, for example, found in a simulation that a HEPA filter reduced aerosol exposure by only 65%. But research shows that technology such as Advanced Photocatalysis attacks and inactivates pathogens that filters miss.
Photocatalytic oxidation, or PCO, is a general term for a technology that works by shining an ultraviolet bulb onto a coated surface, causing a reaction that turns oxygen and water in the air into the same oxidizing particles found naturally in the atmosphere. These particles then react with viruses and bacteria, inactivating them.
Common versions of PCO, however, create ozone and nasty secondary byproducts like formaldehyde, while proprietary versions of PCO that were developed later and are more advanced actually remove them. As a result, the CDC recommends a careful review of manufacturer data, including third-party research results. The U.S. Food & Drug Administration (FDA) clearance process requires proof that dangerous compounds are not formed during a device’s operation. For example, the advanced PCO technology of ActivePure, a Dallas-based manufacturer that recently installed thousands of devices in the Philadelphia public schools, provides a rare instance of FDA clearance in this field
Vaccination Potency Pre- and Post-Delta
More and more data have accumulated to show that the Pfizer and Moderna vaccines were effective at preventing the majority of infections and severe disease, as shown by hospitalization data before the Delta variant became widespread in the United States. Times have changed. Delta is “more than 2x as contagious as previous variants,” according to the CDC, and “some data suggest the Delta variant might cause more severe illness than previous variants in unvaccinated people.” Delta began appearing around April in the U.S., was found in a majority of cases the week of June 26 and in nearly all cases by the end of July. It now represents about 99% of infections.
A study published Sept. 24 in MMWR looked at 1,682 fully vaccinated subjects and 2,007 control patients between March and August and found that the Moderna vaccine was 93% effective against COVID-19 hospitalization; the Pfizer-BioNTech vaccine, 88%; Johnson & Johnson, 71%. And a study of about 5,000 health care workers, found vaccines “highly effective under real-world conditions.” Published in the New England Journal of Medicine on Sept. 22, the research concluded that, for complete vaccination, effectiveness at preventing infection was 88.8% with Pfizer-BioNTech and 96.3% with Moderna. But the study covered only the period from December 2020 to May 2021, so it missed Delta almost completely and undoubtably these numbers are now significantly lower.
Because the advantages of vaccination in preventing all infections have been blunted by Delta, it’s unlikely that the U.S. can avoid a winter surge. The recent past is not encouraging. The summer surge this year proved worse than last year’s. The lesson here is that, even with more than half of American fully vaccinated, we’re going to have to learn to live with COVID-19, at least for the near future and increase mitigation and safety indoors.
Meanwhile, despite the advent of boosters, vaccinations are on the decline. The daily seven-day average for shots (of any kind: first, second or third) at the start of September was 954,000; on Sept. 23, it was 683,000 (the peak day, in April, was 3.4 million). The New York Times calculates that, at the current rate, 85% of all Americans (including children) will have received at least one shot by June 13, 2022. By then, of course, the potency of initial vaccinations for those who received their shots at the peak vaccination period – February to May of this year – will have declined, perhaps significantly.
Vaccinations Decline in Effectiveness Over Time
The issue of arresting that decline through boosters has preoccupied Washington lately. On Sept. 24, Rochelle Walensky, the director of the Centers for Disease Control and Prevention (CDC) took the unusual step of overruling a recommendation by an agency advisory panel and instead endorsed booster shots for a wide range of Americans, including those in jeopardy because of their jobs, like health care workers, waiters and teachers. The advisory panel had backed boosters only for adults 65 and older and younger people at high risk because of underlying health conditions, excluding those with job-related and institutional risk.
The decision by the CDC Director comes on the heels of revelations that the effectiveness of vaccines against infection may drop sharply over time – again, probably because of the virulence of the Delta variant.
An article in the journal Nature on Sept. 17 stated:
Immunological studies have documented a steady decline of antibody levels among vaccinated individuals. Long-term follow-up of vaccine trial participants has revealed a growing risk of breakthrough infection. And health-care records from countries such as Israel, the United Kingdom and elsewhere all show that COVID-19 vaccines are losing their strength, at least when it comes to keeping a lid on transmissible disease.
That’s without accounting for the Delta threat either — and it’s clear that vaccine–induced antibodies do a worse job at recognizing SARS-CoV-2 variants compared with the ancestral strain of the virus. What remains unclear, however, is to what degree the immune system’s safeguards that protect vaccinated people against severe disease, hospitalization and death might be fading as well.
Research published as a preprint in mid-September by Nick Andrews of Public Health England and colleagues, using a sample of 4 million subjects, produced disturbing results. Vaccine effectiveness against infection for the Pfizer-BioNTech vaccine (with the brand name Comirnaty), which previous studies found in the 95% range a few weeks after the second dose, fell to 69.7% at 20 weeks and beyond; the AstraZeneca vaccine (Vaxzevira) fell to 47.3%. The “waning of vaccine effectiveness was greater for 65+ year-olds compared to 40 to 64 year-olds,”wrote the researchers.
What’s Happening to the Elderly?
That is an understatement. For this older group, effectiveness at 20-plus weeks against symptomatic infection from the Delta variant for the Pfizer-BioNTech vaccine dropped to just 55.3%; for AstraZeneca, 36.6%. Those figures compare to 69.1% and 49.4%, respectively 14 weeks after the second dose, so protection appears to decline rapidly.
In addition, the study found that longer intervals between first and second doses – around 8 to 12 weeks – “provide higher serological responses and increased vaccine effectiveness compared to the licensed 3-week interval for mRNA vaccines, thus potentially providing their populations with better longer-term protection. This is supported by our findings comparing short and long intervals in 80+ year olds in the current analysis.”
The researchers also found “that waning was greatest among individuals in clinical risk groups, suggesting that this group should be prioritized for boosters” – which is exactly what the CDC has now done.
Another study, headed by the CDC’s Srinivas Nanduri and Tamara Pilishvili, that sheds some light was published by MMWR on Aug. 18. Its subjects were residents of 14,917 nursing home and long-term care facilities, and it compared three periods: pre-Delta (March 1 to May 9), intermediate or partial Delta (May 10-June 20), and Delta (June 21-Aug. 1).
The results were dramatic and did not vary much between PfizerBioNTech and Moderna. Here are the combined data for the effectiveness at preventing infection of two doses of the two vaccines:
In other words, Delta produced a decline of nearly one-third in potency.
A separate study, by Kristina L. Bajema of the CDC and colleagues, published Sept. 17, covered a mixed pre- and post-Delta period, Feb. 1 to Aug. 6, and looked at COVID hospitalization rates at five Veterans Administration Medical Centers. The researchers found that, for persons aged 65 and older, vaccine effectiveness at preventing hospitalization was 79.8% compared to 95.1% for those under 65 – a major difference. The study noted that in past research “lower vaccine effectiveness among older adults had not previously been observed” and speculated that one reason might be that this study covered, in part, a period when Delta was rampant.
Comment Letters Criticize OSHA Proposal on Filters
With seniors especially vulernable, institutions with a proportion of elderly, including assisted-living facilities, are particularly in need of the best protection against the interior spread of COVID. But a recent proposal by the federal Occupational Health and Safety Administration (OSHA) aimed at health facilities is attracting serious criticism in part because it adds a burden to those institutions that seems unwarranted.
OSHA wants to improve ventilation and augment HVAC systems with MERV-13 (a measure of Minimum Efficiency Reporting Value) filters. We reported on this proposal in our last newsletter.
OSHA, a division of the U.S. Labor Department, has gained attention lately as the vehicle for the Biden Administration’s proposal to require workers at U.S. companies with more than 100 employees to be vaccinated.
On June 21 – months before the Biden vaccination proposal – OSHA published a broad Emergency Temporary Standard (ETS), with numerous requirements for dealing with COVID-19, in the Federal Register and asked for comments. Among the 460 comment letters were several that raised questions about the ventilation-plus-filters regulation.
Specifically, the regulations require….
.…employers who own or control buildings or structures with an existing heating, ventilation, and air conditioning (HVAC) system(s) must ensure that…all filters are rated Minimum Efficiency Reporting Value (MERV) 13 or higher, if compatible with the HVAC system(s). If MERV-13 or higher filters are not compatible with the HVAC system(s), employers must use filters with highest compatible filtering efficiency for the HVAC system(s). 1910.502(k)(1)(iii).
One of the comment letters, from Stacey Hughes, executive vice president of the American Hospital Association, called the emergency standard “vague, contradictory, and not necessarily helpful due to critical issues with MERV-13 [filters] when applied in a medical environment.” In a key excerpt, the letter stated:
The ETS requirements, by simply requiring hospitals to increase the filtration requirements without a system-by-system analysis and an understanding of potential performance of that filtration, could be harmful. This is because increasing filtration could have downstream impacts to the system that could alter the designed pressure relationships, causing the system to be out of balance, and potentially exposing immunocompromised individuals and others to harmful conditions.
In a joint comment letter, two Connecticut state legislators – Sen. Paul Formica, Senate Republican Leader Pro Tempore, and Democratic Rep. Jonathan Steinberg, House chair of the legislature’s Public Health Committee – agreed that “OSHA’s concern for the dangers of interior spread of the SARS-CoV-2 virus is absolutely warranted” but wrote that its “is misguided – both for health and economic reasons.” The legislators added:
In our view, the best course of action is an exemption stating that health care facilities are not required to install MERV-13 filters if they adopt proven anti-viral technology. Unlike filters, this technology inactivates the SARS-CoV-2 virus and other pathogens immediately and thoroughly.
The technology can be installed on existing HVAC systems or as stand-alone units. OSHA could simply state that antiviral devices that use FDA-cleared technology, such as those deploying advanced photocatalysis, may be used in lieu of MERV-13 filters in fulfillment of the ETS….
In recent years, critical health technologies have advanced significantly, and we believe the OSHA should adjust the ETS as a consequence. Antiviral devices, used in venues as diverse as California state hospitals, Philadelphia public schools, and Major League Baseball locker rooms, inactive virus that causes COVID-19 and can provide financial relief to health providers as they work hard to comply with protocols regarding interior air.
The Texas Assisted Living Association cited the costliness and impracticality of the promulgated regulations and said they were at odds with Texas Law and would have serious unintended consequences. The letter stated:
Suggestions to operate the HVAC to pull in the maximum allowable amount of outside air could easily cause problems for communities in Houston and along the Gulf Coast. Forcing HVAC systems to run at maximum capacity in hot, humid conditions will break down equipment faster and develop environments habitable to mold growth.
Jonathan Ellen, M.D., former head of Johns Hopkins All Children’s Hospital, wrote, “As a former hospital CEO, I know how important it is to have high-quality air filtration. But, we are always mindful of costs that make providing care more expensive.” He continued:
The system you’ve outlined would impose an undue financial burden on health care facilities because it would require the purchase of expensive equipment that would continue to generate high ongoing costs throughout the lifetime of the appliances. And we already know that the average age of hospital infrastructure is rising, with many facilities simply incapable of taking on broad-scale new technologies.
And if they’re too expensive or cumbersome to operate, many facilities will just avoid implementing effective filtration altogether, leaving patients, providers, and the public even more at risk.
Ellen wrote that cost-effective anti-viral devices “would effectively accomplish the same aims at a fraction of the cost, enabling more places like nursing homes and smaller hospitals to afford them.”
Other letters critical of the ventilation and filtering requirements, citing high expenses, came from US Renal Care and CareSpring Health Care Management, Kentucky and Ohio elder care facilities.
The agency will have to address these criticisms before rendering a final judgment. The idea of an exemption for facilities that install active anti-viral devices (especially with FDA clearance), as the Connecticut legislators and other commenters recommended, appears to be the best answer.
The Marin County Case
An Infected Teacher Reads to Her Class, and 55% of Students Come Down with COVID. Masking, Ventilation and HEPA Filters Weren’t Enough.
“On May 25, 2021, the Marin County Department of Public Health (MCPH) was notified by an elementary school that on May 23, an unvaccinated teacher had reported receiving a positive test result for SARS-CoV-2, the virus that causes COVID-19.”
So begins one of the most fascinating and important investigations we’ve read during this pandemic. It appeared in the Aug. 27 edition of the CDC’s Morbidity and Mortality Weekly Report (MMWR).
The report – whose lead author was Tracy Lam-Hine of the MCPH and the University of California at Berkeley School of Public Health – focused on the behavior of the elementary school teacher, the high level of student masking and distancing in the classroom, and the frightening rate of infection among those students.
But there is another lesson here that the report does not explore but that deserves serious attention: the inadequacy of CDC-recommended measures to remove SARS-CoV-2 from interior air.
Marin, California, a suburb of San Francisco, is the 14th richest county in the nation. Some 75% of its residents are fully vaccinated – the highest rate in the state and one of the highest in the country.
The unnamed, unvaccinated teacher was reading aloud to students and “reportedly unmasked” even though the school required it. The teacher also “became symptomatic on May 19 with nasal congestion and fatigue” but continued working through May 21. The students, it appears, were masked, and parents of those infected “suggested that students’ adherence to masking and distancing guidelines in line with CDC recommendations was high in class.” Desks were all spaced six feet apart.
Between May 23 and 26, all but two of the 24 students were tested for COVID, and 12 of them came up positive – a 55% rate. Eight of the 12 were symptomatic, including four of the five students in the first row (the fifth tested positive as well). In the second row, three of four students tested received positive results, as did two of four in the fifth row, despite being 30 feet away from the teacher. The case provides a powerful example of how the SARS-CoV-2 virus can linger in the air, drifting far from its original source.
In another classroom, separated from the first by a large outdoor courtyard, 14 students were tested, and six received positive results. Several students in other grades, siblings of those in the original classroom, were later found to be infected, as were four parents (only one of whom was unvaccinated). In all, there were 27 cases, all apparently stemming from the index case involving the teacher.
The rapid spread of the virus throughout the classroom occurred before the Delta variant, which is twice as contagious as previous variants, became established as dominant in the United States. In late May, Delta (B.1.617.2) accounted for only about 5% of cases.
But how exactly did the spread occur in the teacher’s classroom? Below is a diagram from the MMWR report:
In the school, the report notes, “All classrooms had portable high-efficiency particulate air filters and doors and windows were left open.” In fact, as you can see from the diagram, the room was receiving a good deal of cross-ventilation. Ventilation plus high-efficiency particulate air (HEPA) filters is what the Centers for Disease Control and Prevention (CDC) recommends for interior spaces.
A single case is not dispositive, of course, but the CDC should take careful note of the Marin County experience, and a reconsideration of its advice may be in order. The CDC says it bases its recommendations on guidance from ASHRAE, the American Society of Heating, Refrigeration, and Air-Conditioning Engineers, a trade group dominated by the HVAC industry.
The question that CDC, other government agencies, and facilities managers should explore is whether ventilation (either via open windows or HVAC systems) combined with a passive filtration system like HEPA is the best means of mitigating indoor pathogens like SARS-CoV-2. The Marin experience shows that it is not.
The CDC recommends a “layered approach,” and that is certainly correct. Ventilation is necessary but not sufficient. Filters, on the other hand, present problems, the main one being that they are passive. They sit there waiting for pathogens to come to them. But not all pathogens do. Some continue to float in the air, and ventilation, as we saw in Marin, blow them all over an enclosed space. It’s almost certain that some pathogens won’t flow to where the HEPA unit is placed (in this case at the front of the room). In the back two rows, at a minimum of 24 feet away from the teacher, 37.5% of students tested positive.
The alternative to passive filtration is active antiviral elimination – that is, a system that sends particles throughout a space at high speed to deactivate pathogens chemically. Some of these systems also have deficiencies, including production of toxic byproducts like formaldehyde as well as ozone. More advanced versions, including one called Advanced Photocatalysis, developed by the Dallas firm ActivePure, create more efficient reactions, reducing rather than creating byproducts. In trials involving rooms that were already equipped with filter systems, Advanced Photocatalysis was found to reduce the level of pathogens by more than 50%.
CDC is correct to advocate a layered response to COVID, but each of those layers needs to work with maximum effectiveness. Yes, the teacher should have been vaccinated, but it is clear that a large segment of the U.S. population will never be vaccinated. Yes, the teacher should have been wearing a mask, but all of the students evidently were and masking every minute of a workday or school day is nearly impossible. Yes, the teacher should have reported a possible infection right away, but as we enter the cold and flu season, not every runny nose equals COVID. Yes, ventilation is necessary, but large banks of windows were open on a California spring.
The layered element that needs addressing is one that supplements ventilation. In the case of Marin, mitigation was passive and demonstrably ineffective. Mitigation, it seems logical to conclude, needs to be active: seek and deactivate. The CDC and everyone concerned about limiting the damage of COVID would do well to look beyond HVAC industry guidance, as school systems in Philadelphia and throughout the country are currently doing.
The Late-Summer Surge Is On
In mid-June, the U.S. was registering just 12,000 new cases of COVID-19 a day. On Aug. 14, the seven-day average had reached 130,000 in a surge that looks similar to that of last summer – except that this time the magnitude is greater (the surge of summer 2020 topped out at 67,000), and more young people are getting sick. This year’s late-summer surge is particularly disturbing because more than half the population is fully vaccinated, compared with zero a year ago. The disparity is almost certainly the result of the Delta variant, which is twice as transmissible as the original Wuhan strain of SARS-CoV-2, according to the American Society for Microbiology.
If the U.S. pattern in 2020 holds again this year, we can expect daily cases to start declining soon, then picking up again in mid-September and climbing to another peak in January or February. These ups and downs appear correlated to interior activity, with Americans in the South moving indoors in July to escape the heat, and those in the North going inside in the fall to escape the cold. Right now, it’s hot almost everywhere, and, according to the Centers for Disease Control (CDC), 2,691 counties are experiencing a “high” level of community transmission, compared with 200 counties deemed “low” or “moderate.” With just a few exceptions, the low and moderate counties are all in the northern part of the United States. Below is the CDC’s community-spread map as of Aug. 9, with low and moderate in blue and yellow, respectively.
Consider Florida, where COVID hospitalizations just set a record. Florida has 6% of the U.S. population but is responsible for 18% of all COVID cases, and Florida’s case positivity rate is an astounding 18.9%, up from 3.6% just a month earlier. The rate for children aged 12 to 18 is 20.1%. Low overall vaccination rates don’t explain Florida’s surge. According to the latest report from Florida’s Department of Health, some 63% of Floridians have had at least one shot, compared with 58% nationwide, and 53% of Floridians are fully vaccinated, compared with 50% nationwide. In addition, 85% of Floridians over age 85 have received at least one shot.
Vaccines appear effective in reducing hospitalizations and deaths, but Delta leaves even people who have received shots vulnerable to infection, and the vaccinated can then pass the virus on to the unvaccinated. Research published in the New England Journal of Medicine on July 21 by Jamie Lopez Bernal of Public Health England and colleagues concluded, “Only modest differences in vaccine effectiveness were noted with the delta variant as compared with the alpha variant after the receipt of two vaccine doses. Absolute differences in vaccine effectiveness were more marked after the receipt of the first dose.” But a later study showed a big drop in effectiveness for the Pfizer vaccine even after two doses. (See more on both of these studies below.) Some 49% of Americans – and all young children – are not fully vaccinated, and they are particularly susceptible indoors, where the SARS-CoV-2 virus spreads more easily. Interior mitigation efforts have still not caught with the potency of the pathogen.
Learning To Live With COVID
The fact is that COVID-19 is not going away soon, and the world is learning to live with it as a long-term disease that requires adaptation, as much as we wish for eradication. Treatment has gotten better, and, while deaths are rising, at a seven-day daily average of 687 on Aug. 14, mortality is far lower than during previous peaks. But the point is that governments, businesses, and individuals are changing behavior as the effects of the virus change in their own communities.
The biggest change is that Centers for Disease Control (CDC) shifted its earlier guidance that people who have been vaccinated did not need to wear masks indoors. Instead, on July 28, the CDC urged vaccinated Americans to “Wear a mask in public indoor settings if they are in an area of substantial or high transmission.” A cascade followed.
The Wall Street Journal reported on Aug. 8 that “up until a few weeks ago, corporate leaders felt confident about what to expect this fall” as the COVID-19 pandemic receded. But “the swift, startling resurgence of swift, startling resurgence of COVID-19 cases and hospitalizations across the U.S. is causing corporate leaders to rip up playbooks for the next few months.” The Journal continued:
No longer is a September return a target for many companies. Some employers, such as banking giant Wells Fargo & Co. and managed-care company Centene Corp., have in recent days shifted return-to-office dates to October. Meanwhile, a range of other prominent companies now predict it will be 2022 until most workers return.
In a policy change, Tesla is now requiring masks at its giant battery facility even for workers who are vaccinated. The New York Auto Show, which was set to start Aug. 20, has been cancelled. New Orleans Jazz Fest, set for October, has now been pushed to the spring of 2022. And in a policy updated Aug. 5, the CDC issued guidance stating, “Due to the circulating and highly contagious Delta variant, CDC recommends universal indoor masking by all students (age 2 and older), staff, teachers, and visitors to K-12 schools, regardless of vaccination status.” Re-masking, however, is not popular, and some governors are disputing the CDC recommendation. Ron DeSantis of Florida has even threatened to withhold the salaries of local officials who mandate masks in schools.)
The rate of vaccinations started to increase in the U.S. in the third week of July, just as cases of COVID were rising. The daily average, as of Aug. 9, was 716,000, up from 507,000 on July 20 but still far below the 3.4 million mark set in early April. The New York Times projects that, at the current pace, 85% of Americans will have at least one shot by February 2022. That forecast may be pessimistic if attitudes change with two developments: first, the imminent full approval of the Pfizer-BioNTech vaccination by the U.S. Food & Drug Administration (FDA), and, second, requirements by more and more government agencies and businesses that workers and customers be vaccinated. The Pentagon, for example, announced Aug. 9 that all military members would have to receive shots starting in mid-September.
Still, surveys by the Kaiser Family Foundation indicate that 14% of Americans have said they will not get a vaccination, period. That proportion has not budged since polling began in December 2020, but the number of Americans saying they will “wait and see” or will get vaccinated “only if required” has declined. More important, even if the FDA gives approval, it will take many months to vaccinate all children, and, increasingly, they are the ones getting sick – though, on average, not nearly as sick as adults.
Mitigating Interior Spread
Living with COVID-19 becomes a less daunting prospect not just with the advent of vaccines but also with the knowledge that there are effective ways to mitigate interior spread. Surges, happening throughout the world, have multiple sources, but a major factor is the amount of time people are spending indoors without proper protection, including not merely sufficient ventilation but also anti-viral air purification, using such technologies as advanced photocatalysis.
The evidence that the SARS-CoV-2 virus could spread easily through aerosols was at first resisted by the World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC). But nearly a year ago, a group of 239 scientists appealed to the medical community and international organizations that there “is significant potential for inhalation exposure to viruses in microscopic respiratory droplets (microdroplets) at short to medium distances (up to several meters, or room scale), and we are advocating for the use of preventive measures to mitigate this route of airborne transmission.” Since then, the danger of respiratory spread, especially indoors, has been widely recognized.
OSHA’s Misguided New Standards
Unfortunately, there remains confusion even in government agencies over the best ways to protect people in interior spaces. A good example is recent activity by the Occupational Safety & Health Administration (OSHA), part of the U.S. Department of Labor.
On June 21, the agency issued a “final interim rule” (ETS) to an Emergency Temporary Standard (ETS) to protect healthcare workers against COVID in their workplaces, including hospitals, nursing homes, clinics, and physicians’ and dentists’ offices. Comments on the rule face a deadline of Aug. 20, and it could be enacted shortly afterwards. “For the first time in its 50-year history,” says the filing in the Federal Register, “OSHA faces a new hazard so grave that it has killed nearly 600,000 people in the United States in barely over a year.” OSHA notes that “the [Labor] Secretary must issue an ETS in situations where employees are exposed to a ‘grave danger,’” and COVID today clearly qualifies.
The ‘grave danger’ standard permits OSHA to issue regulations on facemasks, distancing, record-keeping, and more. But especially relevant is a rule on ventilation. It states:
Improving existing ventilation and ensuring optimal performance of ventilation is an effective way to reduce viral transmission in occupational populations. Work sites with existing heating, ventilation, and air conditioning (HVAC) systems can utilize improvements to, and maintenance of, high performance ventilation as part of a layered response for infectious disease control.
So far, so good. Ventilation, through HVAC systems, replaces indoor air with outdoor air, and outdoor air is cleaner and safer, thanks to the oxidation that naturally occurs through sunshine. But ventilation alone is not enough, as OSHA recognizes. The Interim Final Rule recommends that ventilation be “complemented by other measures.” Specifically, the regulations require….
.…employers who own or control buildings or structures with an existing heating, ventilation, and air conditioning (HVAC) system(s) must ensure that…all filters are rated Minimum Efficiency Reporting Value (MERV) 13 or higher, if compatible with the HVAC system(s). If MERV-13 or higher filters are not compatible with the HVAC system(s), employers must use filters with highest compatible filtering efficiency for the HVAC system(s). 1910.502(k)(1)(iii).
Problems of Ventilation Plus Filtration
OSHA recognizes that HVAC systems can’t eliminate pathogens simply by exchanging air. The solution, says the agency, is adding a MERV-13 filter. That filter, says the rule, “is at least 85-percent efficient at capturing particles from 1 µm to 2 µm in size.” (1 µm, or micron, is one-one-millionth of a meter.) But a study published in the International Journal of Environmental Research and Public Health estimates that “the minimum size of the respiratory particle that can contain SARS-CoV-2 is approximately 0.4 μm.” A MERV-13 filter captures only 66% of particles between 0.3 µm and 1 µm in size.
Filters placed on ventilation systems present other problems as well:
Also, it’s critical to understand just how much ventilation is necessary to clean interior air. Ventilation systems use a measurement called Air Changes per Hour (ACH), that is, the number of times an hour that the system brings in a volume of fresh air equal to the room volume. The American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE) recommends a minimum of 0.35 ACH for homes. Schools should be designed to have 3 ACH, but most fall short of that level in practice. The CDC recommends between 6 ACH and 15 ACH for hospitals.
But an “air change” does not immediately make interior air perfectly clean and safe. As fresh air comes in, it mixes with interior air, which can be contaminated. The entire mixture becomes diluted with some proportion of contamination still present, so increasingly large amounts of new air are needed in order to remove the same amount of contaminants as earlier injections of outside air. According to the CDC’s calculations, a room served by a system generating 4 ACH will still take 104 minutes to eliminate 99.9% of the room’s initial concentration of contaminants, and, of course, during that nearly two-hour period, many contaminated people can enter the room.
A Better Way to Augment Ventilation Systems
Many healthcare facilities managers have found a better way to augment their current HVAC systems: purchase relatively low-cost units that generate submicroscopic particles that flow immediately through the air and inactivate pathogens, even on surfaces. These units can either be placed on existing HVAC systems, without causing a pressure drop, or can stand alone.
For example, the Philadelphia School District (PSD) purchased 9,500 anti-viral air-purification devices last month from ActivePure, a Dallas-based company that uses a process called advanced photocatalysis. The FDA has granted clearance to the ActivePure Medical Guardian, which uses the same technology as the company’s other devices. Says a PSD release:
Unlike conventional filtration-based air purifiers, these purifiers work immediately and do not require capture or exposure time. They work by rapidly and continuously filling a room with virus-neutralizing particles to instantly break viruses down to their component parts, eliminating them on contact.
By contrast, the OSHA regulations appear to be misguided and antiquated, ignoring solutions that are both more effective in inactivating pathogens and more cost-effective. One reason may be that they are informed by ASHRAE, a trade association influenced by large HVAC companies. For example, the president and one of the four vice presidents are both executives of Trane, the Ireland-domiciled HVAC giant with a market capitalization of $46 billion.
The ventilation industry has failed to keep people safe indoors for decades now, but it is encouraging to see more attention paid to health rather than to just heating and cooling. Still, the limitations of ventilation in maintaining health need to be recognized. Kenneth and Gary Elovitz, two Massachusetts energy economists, wrote last year in HPAC Engineering, “The primary role of HVAC systems is to maintain comfort, usually measured by temperature, humidity, and odor control in the conditioned space.” Now, because HVAC systems move air, “there is interest in whether HVAC systems can play a role in managing infectious disease transmission.” But, they write, “HVAC systems cannot be the primary means of infectious disease control.” They conclude:
No practical amount of ventilation can be relied on or expected to protect occupants over long exposure times like the 6 or 8 hours people might spend together in an office or school classroom. Similarly, ventilation is unlikely to succeed as the prime means of protection for people in close contact in a small space like a private office.
Creating Outdoor Air Inside
Rather than a requirement that will lead to increasing the power of existing HVAC systems and attaching a filter, OSHA could allow an exemption for healthcare facilities that deploy modern technologies, such as advanced photocatalysis, an updated and improved version of photocatalytic oxidation, or PCO. As Fei He of Pohang University of Science and Technology in South Korea wrote recently in the journal Nature:
PCO is proposed as an ideal technology for air purification because it can degrade diverse air pollutants into non-toxic or less harmful forms using solar (or artificial) light under ambient conditions. The photocatalyst (PC) process has some intrinsic similarity to the self-cleaning mechanism in Earth’s atmosphere in that both are based on indirect (sensitized) photooxidation to generate in situ oxidants in air.
Rather than bringing outdoor air inside through a mechanism that consumes large amounts of energy, PCO recreates indoors the organic process that continuously occurs in outdoor air to cleanse the atmosphere. Each breath of outdoor air contains billions of oxidative particles, which are the atmosphere’s primary self-cleaning mechanism. These particles continuously break down pollutants. But without sunlight indoors, cleansing particles are normally missing from interior environments.
Advanced photocatalytic technology restores the naturally occurring oxidizer particles to levels that will inactivate pathogens. The technology improves on simple PCO with a proprietary reactor that speeds up the process and avoids the generation of ozone and volatile organic compounds that have plagued earlier versions of PCO.
The Missing Data on Delta
“Where the hell are the data?” said the headline on an Aug. 9 Axios report, which continued, “Biden administration officials are growing frustrated with the lack of internal visibility into data being collected by the CDC, particularly as they try to deal with Delta’s spread.”
It's true that U.S.-based research on the new variant is limited. But the study we referred to above, by Jamie Lopez Bernal of Public Health England, et al., published in the NEJM, does examine the effectiveness of vaccines against Delta in the United Kingdom. The Pfizer-BioNTech vaccine, administered in two doses, was 88% effective in preventing infection by Delta; the Astra Zeneca vaccine was 67% effective. This U.K. study did not test Moderna.
A new Mayo Clinic study, not yet published in a peer-reviewed journal but released as a pre-print on Aug. 6, had findings regarding the Pfizer vaccine that were at odds with the U.K. research. Both the Moderna and Pfizer vaccines were “highly effective” in earlier research by Mayo, with Moderna 86% effective against infection and 92% effective against hospitalization and Pfizer in the same range. But in July, with Delta rampant (a prevalence of 70%), Moderna’s effectiveness against infection fell to 76% and Pfizer’s to 42%.
Meanwhile, a South African study, taken during high Delta prevalence, found that the J&J vaccine, which was administered to 477,000 health care workers in the country, was 91% to 96% effective in preventing death and 71% effective in preventing hospitalization.
In a separate study, also published Aug. 6 in MMWR, researchers found that among “Kentucky residents who were previously infected with SARS-CoV-2 in 2020, those who were unvaccinated against COVID-19 had significantly higher likelihood of reinfection during May and June 2021,” when Delta was becoming widespread. If you had COVID before and did not get a vaccination, you were 2.3 times more likely to get COVID again, compared with those who were vaccinated.
The Kentucky study follows this report on July 14 in JAMA:
After an infection with SARS-CoV-2, most people—even those with mild infections—appear to have some protection against the virus for at least a year, a recent follow-up study of recovered patients published in Nature suggests. What’s more, this and other research demonstrates that vaccinating these individuals substantially enhances their immune response and confers strong resistance against variants of concern, including the B.1.617.2 (delta) variant.
The Dreaded Third Tier
Vaccines appear to be doing a good job battling the Delta variant, but, with unvaccinated people providing a breeding ground, the virus can be expected to continue to mutate. The U.S. Government has developed a three-tiered classification system for variants, and, so far, no COVID-19 variant is in the top tier, “variants of high consequence.” Such a variant, says an American Chemical Society website, “is defined by failure to be detected by diagnostics, significantly reduced susceptibility to vaccines or other therapies, and more severe clinical disease (i.e., increased hospitalizations) above the levels described for the lower tiers.”
The second tier, called “variants of concern” and home to the original SARS-CoV-2 virus discovered in Wuhan and the Delta variant, is bad enough, but, as we have seen, it is highly susceptible to vaccines. A mutation could, however, produce a variant that qualifies for the third tier. The good news is that the proper tools to fight interior spread should be able to inactivate any new variant as quickly and easily as they can the current COVID-19 virus and other pathogens, which, by the way, tend to be even more difficult to tackle than an enveloped RNA virus like SARS-CoV-2.
As U.K. Cases Spike, Can the U.S. Be Far Behind?
Public health officials in the U.S. are looking to the U.K. with trepidation. Cases of COVID-19 there have soared from a seven-day average of 2,000 on May 4 to 37,000 on July 15, and the curve keeps rising almost vertically. U.K. Health Secretary Sajid Javid said on July 12 that cases could rise to 100,000 a day in the coming weeks, breaking the record of 60,000 set in January. The culprit, of course, is the highly contagious Delta variant.
What is disturbing for Americans is that the U.K. has actually been more successful vaccinating its residents than the U.S. has been. Some 52% of the population in the U.K. is fully vaccinated, compared with 48% in the U.S., and 69% of residents have received at least one dose, compared with 66% in the U.S. And the U.K. isn’t the only country with a recent spike despite an above-average vaccination rate. In Spain, where 48% of the public is fully vaccinated, cases have jumped 252% in two weeks to levels similar to those in January. Italy, France, and Germany, where vaccination rates are slightly lower, are also seeing significant increases.
The question now is whether American cases will follow the same pattern – that is, heading for another peak just when we thought that vaccines were depressing the virus for good.
Currently, U.S. cases are on the rise in every state – more than doubling over the past two weeks. Levels are still relatively low compared to the U.K., but it’s hard to tell what’s really happening because daily testing has dropped by half since April. Cases are rising especially in the South, and hospitalizations are up sharply in the last two weeks: more than tripling in Florida and doubling in Arkansas, Louisiana, and Missouri. The red counties in the map below indicate counties where hospitalizations have risen at least 20% in a week.
So far, the dramatic rise in cases in the U.K. has not caused a similar increase either in deaths or hospitalizations. During the last surge, deaths topped 1,000 a day; currently, deaths are fewer than 40 a day, though increasing. A high proportion of those getting sick from the SARS-CoV-2 virus are young people, nearly all of whom have not been vaccinated. Young people are less likely to get very sick and die from COVID-19, but, of course, they can spread the infection to more vulnerable seniors.
Despite all the cases, the U.K. dropped almost its legal COVID restrictions on July 19. Nightclubs, for example, were allowed to open for the first time since March 2020, and legal requirements for masking in enclosed public spaces were removed. Venues with crowds are being encouraged to require passports proving vaccination. There’s a growing belief globally that COVID is not going away any time soon.
Dr. Birx Expresses Virus Worries to County Officials at DC Conference
In the U.S., we will know very soon whether a genuine surge is at hand or whether cases will rise, as they did in April, and then quickly fall again. Deborah Birx, the physician and research scientist who served as leader of the U.S. battle against global HIV/AIDS and then as Coronavirus Task Force Coordinator, is worried. She is particularly focused on what happens as Americans move indoors, as they are now doing in the South and Southwest as summer heat intensifies; then later when school openings begin in late August; and, finally, as temperatures cool and people crowd interior spaces all over the country.
Birx spoke July 9 at a conference center outside Washington to attentive local officials from throughout at the country who were hungry for information about the course of the virus. Her remarks came at a meeting of the National Association of Counties (NACo). Birx took a new role in March as chief medical and scientific advisor to ActivePure, the Dallas-based developer of technologies to make indoor air cleaner and safer. She is especially concerned about mitigating indoor spread, not just of the SARS-CoV-2 virus, but also of other respiratory pathogens.
County officials at the NACo conference were naturally focused on the American Rescue Plan, which became law in March and allocates $1.5 trillion in county-related funding (NACo provides a breakdown). Some $130 billion is going to help schools reopen in the fall, including by purifying classroom air. Separate funds can be used by state, county, large-city, and tribal governments for “prevention, mitigation or other services in congregate living facilities or schools” (again, including by purifying the air) and for the safety of air in “key settings like health care facilities.”
The county officials are trying conscientiously to find the most effective, safest technologies to mitigate SARS-CoV-2 and other pathogens, while also protecting the environment. But making the right choices is not easy. As we have previously noted, a good guide was provided in an article by former Acting Surgeon General Kenneth Moritsugu posited in an article we cited in our newsletter No. 6. The original piece appeared on the RealClearHealth site on May 20, and its aim was to help government and education officials, as well as owners of private businesses and facilities managers that have to decide the best way to mitigate the dangers of SARS-CoV-2 and other pathogens
‘She Saved Thousands of Lives’
Dr. Birx was highlighted in an article in the latest issue of the academic journal Regulation by David Harrington, the Himmelright Professor in Economics at Kenyon College. Harrington wrote:
During the final months of [Donald Trump’s] presidency, [Birx] spent most of her time on the road, traveling from state to state, meeting with governors, university presidents, public health officials, and reporters. She delivered an urgent message to everyone who would listen: COVID is surging; it’s insidious and dangerous; and people need to start guarding against it now.
Her travels create a unique opportunity to estimate whether people were heeding her advice. More specifically, the variation in where and when she made her recommendations can be compared to outcome variables such as whether people were wearing masks. As you’ll see, the evidence convinces me that she saved thousands of lives.
Harrington referred to Birx as a kind of “Johnny Appleseed,” travelling to “nearly every state on the continent, enduring “danger and drudgery,” and offering “hard recommendations wrapped in compliments.”
His research found that “Birx nudged 14.5% of those reluctant to wear masks to do so. If someone like her was just as successful in nudging people to get vaccinated, the hesitancy rate in states Trump won would decrease from 21% to 18%.”
The Biden Administration, wrote Harrington should consider having someone like Birx “visiting with governors and the American people to talk about receiving the COVID vaccine and taking care not to relax mitigation strategies too rapidly as the virus’s infection and death tolls fall…. An official filling the role Birx did last year would certainly be helpful.”
Harrington warns that “there is still elevated public health risk, exacerbated both by virulent new strains of the disease and a significant chunk of the public’s hesitancy (and in some cases outright opposition) to receiving one of the vaccines.”
For her part, Birx is continuing to talk to state, local, and university officials, both at venues like the NACo conference and on dozens of Zoom calls
A Respiratory Virus That Strikes Infants and Seniors Is Surging,
and It’s Not COVID
As masks come off, conventional respiratory infections are increasing. The Centers for Disease Control and Prevention (CDC) reports a huge spike, starting in mid-March, in cases of respiratory syncytial virus (RSV), which is especially dangerous for infants and older people.
Mask-wearing to protect against contracting COVID has been shielding us from other viruses, like the flu, as well. Now we are back where we started – in interior spaces where ventilation, even with filters, is inadequate protection.
Actually, we may be worse off. A July 8 article in The Guardian notes that hospital wards in New Zealand are being “flooded by babies with a potentially-deadly respiratory virus,” a reference to RSV. The reason is what’s called “immunity debt.” Children have not built up the usual protections because they “haven’t been exposed to a range of bugs due to lockdowns, distancing, and sanitizer, [so] their immune systems are suffering.”
The article points out that in New Zealand, “lockdowns last winter led to a 99.9% reduction in flu cases and a 98% reduction in RSV.” According to a May 2021 study of immunity debt by a group of French doctors, “This positive collateral effect in the short term is welcome, as it prevents additional overload of the healthcare system,” In the long term, however, says the Guardian article, “if bacterial and viral infections aren’t circulating among children, they don’t develop immunity, which leads to larger outbreaks down the line.”
Immunity debt will almost certainly lead not just to more infections but to confusion and deep concern when people come down with respiratory symptoms as the weather gets colder. They’ll wonder, even if they are vaccinated, whether they have COVID. One way to alleviate both the infections and the worries is by taking measures to reduce the spread of pathogens indoors through ventilation and air purification.
Climate Endangered as HVAC Systems Draw More Power to Mitigate COVID, Writes Former Sierra Club Board Member
In an opinion piece in Newsweek on July 14, Michael Dorsey, an environmental scientist and former director of the Sierra Club, warned of the dangers to the climate from ramping up HVAC systems and adding high-efficiency filters to them in an effort to mitigate threats of COVID-19 indoors.
Instead, Dr. Dorsey, who is also a former director of Dartmouth College’s Climate Justice Research Project and earned his PhD in natural resource and environmental policy at the University of Michigan, recommends “advanced photocatalytic,” or AP, processes as “better solutions” for cleaning interior air while avoiding increased energy use. He writes that the AP “methodology uses sub-microscopic particles in a super-charged state” to deactivate pathogens, “avoiding massive energy consumption” that is caused “by the process of sucking air through a filter or using harmful ultraviolet light.”
Dr. Dorsey takes aim at ASHRAE, the American Society of Heating, Refrigerating and Air-Conditioning Engineers, whose advice, he writes, “is a recipe for driving up CO2 emissions, and simultaneously runs afoul of long-standing guidance for green buildings practices.” ASHRAE has urged property managers to consider keeping their HVAC systems running 24 hours a day. The group also recommends applying filters, which can cause major pressure drops to systems, in turn necessitating more power to maintain ventilation levels.
The article cites a piece last year in the Wall Street Journal with the headline, “Why Covid-19 Makes It Harder for Cities to Fight Climate Change.” The article noted, “In a recent study, real-estate technology company Enertiv found that HVAC costs in office buildings increased 36% during the pandemic” because of increased energy use.
The Journal article also stated:
Landlords in some cities face not just higher energy bills, but also steep fines. In New York, the country’s largest office market, the city council last year passed a bill that set emission caps for buildings with a goal of reducing carbon emissions 40% by 2030, compared with 2005 levels. Starting in 2024, some building owners that fail to reduce emissions face fines of as much as millions of dollars a year.
On the other hand, said the article, paraphrasing Brenden Millstein, CEO of Carbon Lighthouse, a firm that helps building owners cut emissions, “landlords face potential lawsuits if tenants in their buildings become infected and a court determines that negligence has occurred,” so “the key is finding a balance.”
Dorsey sees that balance being achieved, not through enhancement of HVAC systems but through adding technology like AP, which was developed by ActivePure, a Dallas-based company. The U.S. Food & Drug Administration last year cleared ActivePure’s Medical Guardian, a device that uses the same technology as its other products, as a Class II Medical Device.
The Newsweek article concludes:
We can’t roll back 50 years of progress in sustainable building practices by simply telling property owners to run their HVAC systems more…. Advanced photocatalytic technologies can give us the best of both worlds. If we pursue a smart approach, we can emerge from COVID-19 healthier, reducing emissions and ultimately [becoming] more sustainable.
In Newsletter No. 5, we cited an article in HPAC Engineering by Gary and Ken Elovitz, a father and son team with Energy Economics, a venerable consulting firm outside Boston. The authors are skeptical of ventilation -- that is, the exchange of indoor for outdoor air through a heating and cooling, or HVAC, system – as the sole method of mitigating the spread of the SARS-CoV-2 virus, which causes COVID-19. They write:
The biggest danger for COVID-19 infection is close-range contact with infected people who are talking loudly or are otherwise exhaling heavily for at least several minutes. The HVAC system does not have much effect on those conditions.
The authors use the Wells-Riley equation, which uses “infectious particle concentration, exposure time, and outside air ventilation” to come up with a prediction of the “likelihood that a person will be infected by a virus.” (Academic research shows that, if anything, Wells-Riley underestimates risk.) Plugging in the numbers, the Elovitzes conclude:
No practical amount of ventilation can be relied on or expected to protect occupants over long exposure times like the 6 or 8 hours people might spend together in an office or school classroom. Similarly, ventilation is unlikely to succeed as the prime means of protection for people in close contact in a small space like a private office.
The authors write that “improved filtration can reduce the risk of transmission by reducing the concentration of infectious particles in the air.” But that reduction is by no means complete. They write that, on average, “MERV 13 filters might be 60% to 70% efficient at removing particles that contain viral material.”
Like Dr. Dorsey, the authors also warn that higher-efficiency filters “have higher pressure drop,” which means reduced air flow and heating and cooling capacity. Bringing an HVAC system back up to its pre-filter levels of air flow requires an increased “motor load” – that is, a bigger-capacity system, which will use more energy and pose a greater threat to the environment.
Study Finds Delta Variant ‘Highly Transmissible in Indoor Sports Settings’
The Tokyo Olympic Games begin on July 23, and, while spectators have been banned because of COVID-19 concerns, athletes are already testing positive. Indoor events could become breeding grounds.
On July 16, the CDC’s Mortality and Morbidity Weekly Reports (MMWR) presented an examination of an outbreak at a U.S. gymnastics facility caused by the B.!.617.2 Delta variant, which originated in India and has spread around the world. The study concluded that the variant is “highly transmissible in indoor sports settings and households.”
Researchers from the Oklahoma Department of Health found that 47 people were infected out of 194 people exposed in the April-May event, including both gymnasts and family members. Among the 133 gymnasts themselves, 26 were infected.
“Several potential risk factors for transmission were identified through household interviews and direct observations at facility A,” wrote the researchers, “including nonadherence to recommended quarantine and testing guidance; delayed recognition of infection because of mild symptoms or attribution of symptoms to other causes; not using masks among active participants, coupled with increased respiration during active sport participation.”
No doubt “increased respiration” will be hard to avoid when the Olympics begin. The researchers urged, in addition to vaccinations, “multicomponent prevention strategies (e.g., testing, symptom monitoring, and other setting-specific measures)…among persons participating in indoor sports and their contacts.”
There was no specific mention, however, of one of the best ways to prevent the spread of the virus indoors: steps to keep interior air clean and safe through, for example, ventilation coupled with advanced photocatalysis.
Public Health Leaders Urge Expanded Testing and Research
Writing in JAMA on July 15, three public health leaders took issue with the decision of the CDC in May to focus “its surveillance efforts only on breakthrough infections that resulted in hospitalizations or deaths, and ceasing to document [other] asymptomatic or symptomatic breakthrough cases.” (The term “breakthrough” refers to a COVID-19 infection in someone who has been vaccinated.)
The authors -- David Holtgrave, dean of the School of Public Health at the State University of New York at Albany; Sten Vermund, dean of the School Public Health at Yale; and Leana Wen, former health commissioner of Baltimore – wrote that the CDC “should once again add symptomatic infections to its surveillance efforts for breakthrough infections.” Recording these cases will help policy makers learn the extent of “suboptimal” vaccine protection. “Such symptomatic cases are relevant to the nation and should be reported by CDC.”
The authors point out that vaccinated people who are infected “may have more potential to transmit SARS-CoV-2 to others.” This is precisely the problem we may see at the Olympics or in the U.S. as school begins and people go back to office work.
Breakthrough infections currently happen at a low rate. For example, a study of 1,843 health care personnel, published in the MMWR in May, found that, of 623 case patients with a positive COVID test, only 19, or 3%, had received two vaccine doses. But, write the authors, “given the very large number of vaccinated persons in the U.S., even a small fraction of a large population can still represent a moderate number of cases.”
While finding and publicizing even the small proportion of breakthrough cases could alarm the public, if the CDC does not look for those cases actively, it will not have much authority when it asserts that the cases are rare. The authors, therefore, urge the CDC to step up testing of both vaccinated and unvaccinated Americans, which, as we noted above, has trailed off at an alarming rate.
Holtgrave, Vermund, and Wen also call for more research to understand why the case fatality rate (CFR) has been flat over the past six months. CFR is the number of COVID-19 related deaths divided by cases – in other words, the chances that, if you get infected, you will die. Since December 2020, “the CFR for the U.S. has hovered at approximately 1.7%” (actually, it rose a bit to 1.8% in the second week of July) despite the fact that, “given the array of tests, vaccines, and treatments now available, the CFR might be expected to be declining over time.”
The authors write that it’s important to learn whether people receive a diagnosis early in their illness and whether they have access to the right treatments. They urge expanded research into the role that income inequities and other social determinants play in treatment.
They conclude, “The nation’s confidence in the overall COVID-19 response is only as strong as its COVID-19 surveillance system, which should continue to persistently and rigorously look for trouble even if everyone hope there is little trouble to be found.”
Most Americans Still Not Fully Vaccinated
As Variants and Heat Rise Across Nation
The U.S. is unlikely to reach President Biden’s goal of having 70% of adults vaccinated for COVID-19 by July Fourth, but we’ll be close – an estimated 68%. The seven-day average for coronavirus cases has dropped to 11,672 as of June 24, the lowest figure in 15 months, and deaths are down to 314, or an average of six per state, a decline of more than 90% since the January peak.
But serious threats remain:
Dormant or Resurgent
We may not be getting good data, either. There has been a big decline in testing: just 500,000 on June 14, compared with 1.8 million on April 1. A lot more people could have COVID than we know, including people who have been vaccinated but have asymptomatic infections and can spread the disease further. In addition, the CDC is no longer tracking transient infections.
Also, understand that the proportion of Americans over age 18 with at least one shot, currently 66%, isn’t the whole story. The figure for all Americans who are fully vaccinated (two Pfizers or Modernas, or one J&J) is 45%. And in lightly vaccinated states, especially, cases are on the rise. According to CDC data, the states with the highest number of new cases per 100,000 over the past seven days are, in order: Missouri (far and away the worst), Wyoming, Utah, Nevada, Arkansas, Florida, Louisiana, and Colorado.
The essential question is whether the pandemic is dormant and will reemerge in the late summer and fall – when we will have a difficult time reviving mask-wearing and distancing measures -- or whether we have beaten it down for good. But when it comes to mitigating interior spread of the virus, it really doesn’t matter. Even if the SARS-CoV-2 bug leaves, there are many others that need addressing.
As COVID Falls, Other Illnesses Rise
As the pandemic is waning, a new and surprising problem is arising: Americans are getting sicker with non-COVID diseases. We know because of data gathered by California-based Kinsa, a young tech firm that has developed a network of two million smart thermometers that provide early-warning notice of illness around the country.
Kinsa recently took a close look at Texas, as a possible harbinger: “On March 10, 2021, as any other states braced for another wave of the epidemic, Texas took the bold steps of lifting mask mandates and removing other precautionary measures designed to slow the spread of COVID-19.”
COVID cases continued to decline after March 10 in Texas, although at a slightly slower rate than before. But something else happened:
Following the loosening of restrictions, Texas experienced the highest levels in Kinsa’s overall illness signal in more than a year, driven not by COVID, but by other common contagious illnesses like strep, RSV and even some flu, according to diagnostic data.
Especially alarming in Texas has been the sharp increase in RSV, or respiratory syncytial virus, which produces only mild symptoms that last about one or weeks in most people but can be dangerous to infants and the elderly. RSV positivity soared from 0.1% of tests in early April to over 5% by late May, according to Kinsa. The Centers for Disease Control (CDC) notes that “RSV is the most common cause of bronchiolitis (inflammation of the small airways in the lung) and pneumonia (infection of the lung) in children younger than one year of age in the United States.”
The precautions taken to prevent COVID also prevented other infectious diseases, but when those precautions were lifted, the other illnesses spiked. From late March to early May, for example, the total Texas population with a fever rose from 0.4% to 1.5%. “Though [it is] initially alarming to see so much illness,” writes Kinsa’s Matt Albasi, “this is simply a return to normal…. The road back to normal is paved with illness.”
While much of the media is missing this story, an article in STAT News last month predicted a resurgence in non-COVID viruses -- “perhaps a big one.” The piece, on May 27, quoted Ben Cowling, an infectious disease researcher at Hong Kong University saying, “When they come back there’s going to be vulnerability and probably greater levels of infections.”
In an Axios piece on June 7 with the headline “America’s Next Big Wave of Sick,” Ryan Langlois, associate professor in the microbiology and immunology department at the University of Minnesota, made the point that “you’ve lost one pathway to immunity, which is natural infection” from the previous flu season, when people were masked and socially distant and flu was at the lowest levels on record. "We’ve never been in this situation."
Improving Indoor Air as an Antidote
But should the road back to normal be “paved with illness”? While we can’t expect mask-wearing to persist, now appears to be the time for those responsible for schools, office buildings, hotels, restaurants, theatres and all indoor spaces to improve the quality and safety of indoor air. Two lessons from the COVID pandemic are that, first, this pathogen, like nearly all pathogens, spreads most effectively through indoor air, and, second, our indoor air is not nearly as clean and safe as it should be.
This unclean and unsafe air might be seen as an indictment of the ventilation industry, whose HVAC systems do a good job of keeping rooms at a comfortable temperature but, we are learning, have been inadequate to prevent disease.
These two lessons about interior air should also be seen in the context of a changing environment of public awareness. The pandemic has made people much more conscious of the air around them, and they are almost certain to demand its improvement – COVID or no. The good news is that the funds that the federal government is providing states and localities to battle airborne SARS-CoV-2 in schools and other buildings will also support combatting other pathogens.
If you deploy the right technology, the COVID virus, in fact, is among the easiest pathogens to inactivate because it is an enveloped virus with a vulnerable shell. Harder to kill are non-enveloped viruses, bacteria, and mold spores.
A Future 'New Norm' in India
India has had a rough spring, mainly because of variants and a lack of vaccinations, but in the past two weeks, new cases of COVID-19 have dropped 49%. The experience inspired Rachna Aggarwal to imagine a future world that’s changed because of the pandemic. In the venerable daily New Delhi-based national newspaper The Pioneer, Aggarwal wrote on June 21:
Air purification systems which regulate the PM [particulate matter] level of air are now passe; we must upgrade to technologies that can eliminate biological aerosol contents from the air…. The recent turn of events will bring in a ‘new norm’ wherein air quality certification will be required to gain people’s trust.
Will the public want to enter any building whose air isn’t trusted, in India or anywhere else? It’s doubtful.
‘Meeting Code’ Is Not Enough, Says Harvard’s Allen
Joseph Allen, an expert on interior environments at the Harvard T.H. Chan School of Public Health, puts the situation well, “If you’re still feeling uncomfortable or anxious, that’s totally understandable. “This pandemic has affected all of us in profound ways, and people are going to be ready to re-enter life again or re-enter interacting with people at different times.”
Quoted in a June 11 New York Times article, Allen advised, “One thing you can do before you go back to work is simply [to] ask them what they’ve done. And if you hear things like, ‘Yes, we’re meeting code,’ then that’s a flag that something’s not right. They should be going above and beyond the bare minimum ventilation and filtration rates.”
The article continued:
Although the ideal ventilation rate varies, in general, employers should maximize the amount of fresh air coming in from outdoors, he said. In a relatively small space — say, the size of a typical school classroom — employers should aim for four to six air changes per hour, meaning that the air inside the space is being completely refreshed every 10 to 15 minutes.
Few HVAC systems produce such vigorous air changes, and upgrading a system to do so, as well as to carry heavy-duty filters, means added power – and potentially added damage to the environment. One good solution is supplementing ventilation with air-cleaning technologies that can either be added to an HVAC system without causing a pressure drop or arrayed in stand-alone devices.
Confidence and Caution: ‘This is Not Just a COVID Thing’
In an article headlined, “Consumer expectations: Restoring confidence in the travel experience,” Adam Perkowsky of HotelBusiness.com wrote that hoteliers and guests are, of course, concerned about “air quality as it relates to the transmission of COVID-19 particles and other airborne pathogens.”
The piece quoted one industry expert as saying, “This is not just a COVID thing. The links between air quality and cognition and susceptibility for long-term disease are supported by years and years of research. The pandemic was an ignition switch to raise awareness that what we breathe matters—that indoor air quality is oftentimes a lot worse than outdoor air quality and that needs to be addressed.”
Actually, it is rare that indoor air quality is not worse than outdoor air quality. The aim of the best air purification systems is to produce chemical changes to render indoor air as clean as outdoor, which has the advantage of solar cleansing.
Unfortunately, while many devices make claims, few are effective and safe enough to have 501k FDA clearance as a Class II Medical Device. One that does have such clearance is the Medical Guardian, which deploys the same Advanced Photocatalysis (AP) technology used in all products made by Dallas-based ActivePure, whose corporate roots go back nearly a century. AP technology evolved from photocatalytic oxidation (PCO), a process which, unlike proprietary AP, can, in its more rudimentary early forms, generate ozone and volatile organic compounds (VOCs).
New purveyors of air-cleaning products are popping up, and the HotelBusiness article urges caution: “There are so many gimmicks out there. [There is a] need to separate fact from fiction as it relates to manufacturers’ claims on what their units can do.”
An article in a Missouri newspaper on June 21 noted that Kansas City schools purchased devices that rely on technology that involves emitting ions that cause particles in the air to cluster, which, the manufacturer says, makes them easier to trap in an HVAC system. The company behind the technology, says the article, “is facing a federal lawsuit filed by a consumer who bought one of its devices, alleging the company ‘continues to defraud consumers by concealing material information regarding the true performance’ of its products.” (The company says the suit is baseless.)
In another example, a study by researchers from Colorado State University, Portland State University and the Illinois Institute of Technology found that in chamber and field tests “an ionizing device led to a decrease in VOCs [such as] xylenes, but an increase in others, most prominently oxygenated VOCs (e.g., acetone, ethanol) and toluene, substances commonly found in paints, paint strippers, aerosol sprays and pesticides.”
A release issued by Colorado State about the study stated:
According to the EPA, exposure to VOCs has been linked to from eye, nose and throat irritation, headaches, loss of coordination and nausea, to damage to liver, kidney and central nervous system, and some organics can cause cancer in animals, some are suspected or known to cause cancer in humans. The study, published May 15 in the journal Building and Environment, mimicked real-world operating conditions for these ionization devices to test the effectiveness and potential to form chemical byproducts in environments similar to where we all live, work, and learn.
Former Surgeon General’s Advice
The reference to “real-world operating conditions” is important, and it reminds us of the set of five questions that former Acting Surgeon General Kenneth Moritsugu posited in an article we cited in our newsletter No. 6. The original piece appeared on the RealClearHealth site on May 20, and its aim was to help the many school, state, city and country administrators, as well as owners of private businesses and facilities managers that have to decide the best way to mitigate the dangers of SARS-CoV-2 and other pathogens.
Ventilation is part of the answer, but another layer of protection is needed. Here are the five questions from Dr. Moritsugu:
Survey Finds Big Mitigation Outlays With Limited Success
Reinforcing the need to ask the right questions is a recent survey of 430 facilities managers, reported June 23. It found that 60% improved their HVAC systems to battle COVID-19. But, according to a CleanLink article, “HVAC upgrades are quite expensive, typically costing more than $500,000 and in some cases as much as $5 million.” The survey found that managers “vastly underestimated” the cost of these improvements. The article continued:
Additionally, for an upgraded HVAC system to improve air quality, it must operate continuously while the building is occupied, which is very expensive. In other cases, businesses felt compelled to try relatively new and unproven ionization technologies, which are increasingly under attack from academics and government agencies for being ineffective and possibly dangerous.
The survey found that 60% of surveyed companies spent more than $500,000 upgrading or installing HVAC systems and that nearly all respondents took some kind of measure to stop interior spread. But, said the article, the survey found that the managers “often made subpar investments, spending millions of dollars with limited success.”
Said Paul de la Port, the CEO of Omni ClearAir, a commercial manufacturer of air purification systems and sponsor of the survey: “The noisy environment, lack of transparent and easily understood real-world efficacy data, and unscrupulous COVID-19 opportunists appear to have clouded the landscape so much that many businesses simply were unable to make informed investment decisions about indoor air quality solutions.”
He added, “What many businesses don’t realize is that HVAC systems, even when they can eliminate the virus, require large amounts of electricity to operate, so the long-term cost will be very burdensome and the resulting air often won’t be adequately cleaned.”
In this issue:
“We expect clean water from the taps. We expect to have clean, safe food when we buy it in the supermarket. In the same way, we should expect clean air in our buildings and any shared spaces,” said Lidia Morawska, an aerosol physicist at Queensland University of Technology in Australia. She was one of 39 scientists, including Joseph Allen of Harvard and William Bahnfleth of Penn State who, writing in Science magazine on May 14. called for a “paradigm shift” in the way policy makers and individuals think about the quality of indoor air.
In a New York Times article, Aporova Mandavilli called the Science magazine article “a manifesto of sorts” and noted, “The pressure to act on preventing airborne spread has recently been escalating.” She wrote: “Clean water in 1842, food safety in 1906, a ban on lead-based paint in 1971. The sweeping public health reforms transformed not just our environment, but expectations of what governments can do.”
COVID-19, of course, was the catalyst for this new interest in clean interior air, but the need for mitigating pathogens extends well beyond the end of the pandemic. The failure to address airborne dangers is not merely regulatory. Large companies engaged in ventilation bear a good deal of the blame as well because the technology exists to mitigate the problem. It is just not being applied. The Science manifesto states:
Airborne pathogens and respiratory infections, whether seasonal influenza or COVID-19, are addressed fairly weakly, if at all, in terms of regulations, standards, and building design and operation, pertaining to the air we breathe. We suggest that the rapid growth in our understanding of the mechanisms behind respiratory infection transmission should drive a paradigm shift in how we view and address the transmission of respiratory infections to protect against unnecessary suffering and economic losses. It starts with a recognition that preventing respiratory infection, like reducing waterborne or foodborne disease, is a tractable problem.
Questions for Officials (and the Rest of Us) to Ask Before Buying Devices to Mitigate the Spread of Airborne Virus
In the U.S., COVID-19 cases are falling, but more than 140,000 Americans were infected last week, and public health authorities have at last recognized that the main culprit is interior spread of the SARS-CoV-2 virus. The federal government is allocating billions of dollars to state and local government for mitigation efforts inside buildings.
The American Rescue Plan, signed into law March 11, includes $130 billion to help schools reopen in the fall. That money can go to such uses as reducing class sizes, purchasing personal protective equipment, and buying devices to prevent interior spread of the COVID-19 virus through the air.
On May 10, the U.S. Treasury specified the way that a separate tranche of $350 billion in Coronavirus State and Local Fiscal Recovery Funds under the Rescue Plan may be used by state, county, large-city, and tribal governments. One of those uses was “prevention, mitigation or other services in congregate living facilities or schools”; another was addressing the safety of air in “key settings like health care facilities.”
Imagine you’re a public school, university, or hospital administrator. Or a mayor, county executive, or governor. Or someone in charge of a childcare or senior facility or recreation center. The federal government has bestowed millions or billions of dollars on your office – a windfall of enormous importance. You want to spend a significant portion of the funds on protecting citizens against airborne and surface SARS-CoV-2 and other pathogens, but how do you decide which technology is best?
In a RealClear Health article on May 20, former Acting Surgeon General Kenneth Moritsugu, tackled the problem by providing a set of five questions that officials and other purchasers should be asking. Moritsugu is a retired Rear Admiral, a physician and public health administrator who was the first Asian-American to serve as Surgeon General.
“Demand for equipment that can help mitigate and prevent the spread of COVID has exploded,” he wrote, “but don’t buy in a panic. Ask the right questions and invest in the technologies that are best suited for the specific need, based on science and proven evidence. Good choices made today can help keep students and others safe from COVID-19 and other viruses, bacteria, and molds.”
Here are the questions that purchasers of equipment should ask:
Moritsugu notes that, “while improved ventilation systems can help, conventional air filters try to trap pathogens but may miss a large proportion of virus-sized particles. Look for technologies with filters that work at the viral level or deploy microscopic particles to search and destroy pathogens in the air and on surfaces rather than just trying to filter them out.”
He also points out that to “use ultraviolet (UV) light to deactivate COVID viruses, the light has to be so strong that it could damage the retina – which is why surgical theaters are cleared when UV is utilized. Other systems, especially those using outdated version of photocatalytic oxidation (PCO), generate ozone and toxic byproducts. Be sure to ask for data and evidence that a system is safe.”
That last point is critical. Very few devices are equipped with technology that has FDA clearance, and few companies that sell equipment can provide testing data. Be demanding. Lives are at stake.
‘A Wave of Liability Claims’ for COVID Infection Is Expected
An article published in Risk & Insurance, a trade journal, says that business interruption cases, which were popular in the early stages of the COVID pandemic, are being replaced by “a wave of liability claims [that] is rolling in.” Says the piece: “Though plaintiffs will have a tough time blaming businesses for exposure to the virus, [insurance] carriers are nonetheless prepping defense strategies and emphasizing risk mitigation to clients.”
The reporter, Kate Dwyer, writes, “Of course, the best way to limit exposure to liability claims and ensure an expeditious closure to any that do come forward is to keep premises as safe as possible.” She quotes Stephen Jones of Praedicat, a data firm, as predicting that “COVID-related liability litigation could reach roughly $19.6 billion, with another $1.4 to $3.8 billion in associated securities lawsuits.”
In a piece on Bloomberg Law’s Daily Labor Report, Chris Marr concurs: “Business groups fear [a] flood of lawsuits as yet unseen.”
Liability Shields in the States Vary Widely
Many states have offered protections to businesses through liability shields. While some of these laws are close to expiration, others are being extended as the disease continues to afflict Americans. Florida, Oklahoma, and West Virginia have even enacted shields with no expiration date.
The Florida law, signed March 29, is particularly favorable to businesses. If a business makes a “good faith effort to substantially comply with authoritative or controlling government-issued health standards or guidance at the time the cause of action accrued,” then the business is immune from liability. Under South Dakota’s law, plaintiffs can only bring cases if they get sick as a “result of intentional exposure with the intent to transmit COVID-19.”
About half of all states have extensive COVID liability shields. They are mainly in the South and Midwest, and nearly all have Republican legislatures. States with limited shields, or none at all, are concentrated in the Northeast and West Coast but also include Illinois, Minnesota, and Colorado, according to a Bloomberg Law analysis. Rhode Island, for example, extends ample protections to health care workers but “not all businesses are insulated,” writes attorney Samantha Vasques of the firm Locke Lord.
In a May 11 article, Vasques cites Tennessee’s law as typical. It…
…provides that individuals or businesses cannot be liable for loss, damage, injury, or death that arises from COVID-19 unless the party filing suit against them proves by clear and convincing evidence that they caused the injury by an act of omission constituting gross negligence or willful misconduct.
Marr quotes Thomas J. Mew, a plaintiffs-side employment lawyer in Atlanta as saying that places such as nursing homes face a bigger risk of litigation. “From a practical level,” he said, “it’s generally going to be challenging to prove that one contracted COVID-19 at a particular place,” especially one that a customer visits for only a few minutes or an hour.
Still, said Ashley Cuttino, a Greenville, S.C., lawyer, we are seeing virus-related liability suits. “We’re just not seeing tens of thousands of them.” Cuttino said that the shield laws are working to limit lawsuits “and get businesses reopened in a safe manner.”
Rumrill v. Princess Cruise Lines Ltd., filed in April 2020, was of the earliest cases. Cited in the Risk & Insurance article, it involved a couple that claimed they contracted COVID on a ship because of the cruise line’s “lackadaisical approach to safety.” A federal judge tossed out the case but let the plaintiffs amend their suit. Wrote Dwyer:
To build a stronger argument, the couple must demonstrate they were likely exposed on the ship given the exact date they began experiencing symptoms and the virus’s incubation period. Building that link between time of exposure, incubation period and symptom onset would be “a key fact necessary to render the causation allegations plausible, not merely possible,” the judge said, essentially laying the foundation for future plaintiffs’ arguments.
Dwyer concludes, “Insurers expect this type of claim to increase in frequency as restrictions continue to loosen and courts open back up.”
In Schools, a Policy of Ventilation-Plus Cuts COVID Cases
“To date, there have been no U.S. studies comparing COVID-19 incidence in schools that varied in implementing recommended prevention strategies,” such as mask wearing and improvements in air circulation and purification, write a dozen researchers from the Georgia Department of Public Health and the Centers for Disease Control and Prevention (CDC).
Those researchers set out to rectify that situation in a study published May 28 in Mortaility and Morbidity Weekly Report (MMWR), the indispensable publication of the CDC. Examining 169 schools with varying policies in Georgia between Nov. 16 and Dec. 11, 2020, they found that “COVID-19 incidence was 37% lower in schools that required teachers and staff members to wear masks and 39% lower in schools that improved ventilation.”
Researchers also look at schools that deployed “ventilation-plus” – that is, they augmented simple ventilation, which exchanges inside air for outside, with “methods to filter airborne particles with high-efficiency particulate absorbing (HEPA) filtration” or with or ultraviolet germicidal irradiation (UVGI). Ventilation-plus caused COVID-19 incidence to fall to 48% below incidence in schools with no air improvements. In other words, adding filtration or UVGI, increases the rate of mitigation over simple filtration by about one-fourth.
The authors conclude that “in rooms that are difficult to ventilate or have an increased likelihood of being occupied by persons with COVID-19 (e.g., nurse’s office), installation of HEPA filters or UVGI should be considered.”
Filtration is slow, and UVGI at high levels is dangerous for people. The research did not examine classrooms that used air cleaning or purification technology that goes beyond these methods, such as enhanced photocatalytic oxidation of the sort developed by ActivePure, a Dallas company that has installed its devices in many schools. This technology can inactivate much smaller particles, at much faster speeds, than filtration.
The authors urge “a multicomponent approach to school COVID-19 prevention efforts” and write that “universal and correct mask use among teachers and staff member and improved ventilation are two important strategies that could reduce SARS-CoV-2 transmission as schools continue, or return to, in-person learning.”
Adult Vaccinations in U.S. Seem to Be Hitting the Wall
More than half of U.S. adults are now fully vaccinated – a proportion exceeded only by Israel, Bahrain, and Chile and a remarkable achievement in just six months. But now, vaccinations are running into a brick wall. “Few who are eager to get a shot remain unvaccinated”: that’s the conclusion that the Kaiser Family Foundation is drawing from its latest survey, released May 28.
“Nearly all adults who are eager to get a COVID-19 vaccine now have already gotten at least one shot,” says KFF in a press release. The foundation’s latest polling shows that 62% of U.S. adults have gotten at least one dose – up just 6 percentage points from April. The share of those who say they want a shot “as soon as possible” dropped from 9% in April to 4% in April.
What’s particularly disturbing is that the proportion saying they will “definitely not” get a shot has been stuck at 13% in every monthly survey since January – and those saying “only if required” has been stuck at 7%. In other words, one-fifth of adults are adamantly opposed to COVID vaccination and haven’t changed their minds.
The proportion saying they will “wait and see” has dropped since January from 31% to 12%, but that number too seems to have stalled out. Also grim: KFF found that 40% of parents of children under 12 answered “definitely not” or “only if required” when asked if they would have their kids vaccinated.
Factors That May Accelerate Vaccinations
Two developments, however, could cause vaccinations to increase. First, Pfizer and BioNTech, developers of the first vaccine to receive Emergency Use Authorization from the U.S. Food & Drug Administration (FDA), last month asked for full authorization. The application process for a Biologics License normally takes about a year, but Pfizer is seeking a priority six-month review. Approval will allow the partners to market the vaccine directly to consumers.
It could also give greater confidence to vaccine-hesitant Americans whose reluctance, despite a flood of positive data, may be based on notion that they’re getting a treatment that has been given swift “emergency” approval rather than longer, more detailed consideration.
The second development is that more employers, schools, airlines, retailers, and other public institutions will start requiring vaccinations. But that change is far more likely to occur after full authorization of the vaccine. As the New York Times reported:
The University of California and California State University school systems, for instance, have announced that once coronavirus vaccines receive full F.D.A. approval, they will require students, faculty and staff members to be vaccinated. The U.S. military, which has seen many troops decline coronavirus vaccines, has said that it would not make them mandatory as long as they have only emergency authorization.
Still, anyone who is responsible for the safety of others should be aware that the U.S. is unlikely to reach herd immunity and as much as one-third of the population may never be vaccinated (the proportion today is 41%, according to Johns Hopkins University). In addition, Anthony Fauci, director of the NIH Institute for Allergy and Infectious Diseases, said on May 26 that booster shots will be needed as the effect of the initial vaccination wears off.
“Even with vaccination efforts in full force, the theoretical threshold for vanquishing COVID-19 looks to be out of reach,” said a recent article in the scientific journal Nature.
The COVID-19 virus or, at the very least, fears of its resurgence, will likely be with us for a long time.
The Problem of Virus Variants
Then, there is the problem of SARS-CoV-2 mutating into slightly different viruses that current vaccines cannot combat as effectively. “The emergence of variant strains is arguably the greatest threat to control of the Covid-19 pandemic,” says a piece in the May 20 issue of New England Journal of Medicine by Kathleen Neuzil of the University of Maryland School of Medicine.
The piece cites two recent peer-reviewed trials reported in the NEJM. They evaluated the performance of vaccines in battling the B.1.351 variant, first identified in South Africa. The variant “has shown evidence of increased transmissibility, a considerable reduction in neutralization by convalescent and postvaccination serum, and significantly decreased neutralization by monoclonal antibodies.”
One of the vaccines, AstraZeneca’s ChAdOx1 nCoV-19, “conferred no efficacy…against mild-to-moderate disease caused by the B.1.351 variant.” No severe cases were reported for either the vaccine or a placebo, so no conclusions could be drawn on that score. Overall, writes Neuzil, “the lack of efficacy against nonsevere disease…is disappointing,” especially because the AstraZeneca vaccine has “has highly favorable stability and storage characteristics, can be produced by multiple global manufacturers to supply billions of doses, and is well positioned for global vaccine distribution.”
The second vaccine, NVX-CoV2373, developed by Novovax, a biotech company based in Gaithersburg, Md., had an efficacy of 49.4% against symptomatic COVID-19 caused by the South African variant – a result that Neuzil characterized as “modest.” But Novovax reported that all five cases of severe disease occurred in the South Africa trial occurred in the placebo group, so the efficacy rate was 100%.
Neuzil also reported data from two other trials that included South African participants. The Johnson & Johnson vaccine (Ad26.COV2.S) “showed significant efficacy against moderate-to-severe disease” at 64%, “with higher efficacy against severe-to-critical disease,” at 82%. The second trial, which included only 800 South African participants, found no cases among those given the Pfizer-BioNTech vaccine (BNT162b2), compared with nine in the placebo group.
Some of these results are encouraging, but Neuzil writes that “SARS-CoV-2 will continue to replicate in humans, mutations with continue to occur, and variants of concern will continue to emerge.” New vaccines will almost certainly be needed to address difficult variants. While drug companies will become even more adept at developing them and “faster production timelines will facilitate the manufacturing of new vaccines,” distributing booster doses will still be an arduous process.
COVID Solutions Bulletin | a publication providing regular updates on new and existing technologies that can help stop the spread of COVID-19, and help clear the air to open America back up.
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The World Health Organization (WHO) and the U.S. Centers for Disease Control and Prevention (CDC) have both revised their guidance on how SARS-CoV-2, the COVID-19 virus, is transmitted. Earlier, the two organizations said the virus was contained in droplets, which would fall harmlessly to the ground of their own weight within a few feet. Now, WHO and CDC are acknowledging that the virus is carried in tinier aerosols, which, as the WHO put it, “remain suspended in the air,” carrying pathogens around a room.
This revision repeats what the CDC stated in November in a softer version – but then quickly retracted as what a spokesperson called an “error of process.” According to a Washington Post report at the time, the CDC originally said it was “possible” that SARS-CoV-2 could be airborne, spreading through “small particles, such as those in aerosols.”
A Long and Frustrating Road for Aerosol Experts
The issue of airborne spread has been controversial for nearly a year. For example, a July article by Lidia Morawska of the Queensland University of Technology in Australia and Donald Milton of the University of Maryland School of Public Health, titled “It’s Time to Address Airborne Transmission of Coronavirus 2019,” drew the support of 237 scientists in an open letter. The authors wrote:
There is significant potential for inhalation exposure to viruses in microscopic respiratory drop- lets (microdroplets) at short to medium distances (up to several meters, or room scale), and we are advocating for the use of preventive measures to mitigate this route of airborne transmission.
Then in November, Kimberly Prather of the Scripps Institute of Oceanography, an expert on aerosols, and several colleagues wrote a letter to Science magazine, with an excellent description of how the virus is spread:
Viruses in droplets (larger than 100 µm) typically fall to the ground in seconds within 2 m of the source and can be sprayed like tiny cannonballs onto nearby individuals. Because of their limited travel range, physical distancing reduces exposure to these droplets. Viruses in aerosols (smaller than 100 µm) can remain suspended in the air for many seconds to hours, like smoke, and be inhaled….
Individuals with COVID-19, many of whom have no symptoms, release thousands of virus-laden aerosols and far fewer droplets when breathing and talking. Thus, one is far more likely to inhale aerosols than be sprayed by a droplet, and so the balance of attention must be shifted to protecting against airborne transmission.
As we reported in the first issue of this newsletter, a group of 13 U.S. public health experts, including such members of President Biden’s own COVID task force as Rick Bright, the former director of the Biomedical Advanced Research and Development Authority, and Michael Osterholm, a highly regarded epidemiologist at the University of Minnesota, called for “immediate action to strengthen measures to limit inhalation exposure to SARS-CoV-2.
The 13 scientists wrote in a letter Feb. 16 to Rochelle Walensky, director of the Centers for Disease Control and Prevention (CDC); Administration COVID Coordinator Jeff Zients; and Anthony Fauci, director of NIH’s National Institute of Allergy and Infectious Diseases:
For many months it has been clear that transmission through inhalation of small aerosol particles is an important and significant mode of SARS-CoV-2 virus transmission… Numerous studies have demonstrated that aerosols produced through breathing, talking, and singing are concentrated close to the infected person, can remain in air and viable for long periods of time and travel long distances within a room and sometimes farther.
Linsey Marr, an expert on aerosols at Virginia Tech who also signed the Science letter, was quoted as saying:
It’s time to stop pussyfooting around the fact that the virus is transmitted mostly through the air. If we properly acknowledge this, and get the right recommendations and guidance into place, this is our chance to end the pandemic in the next six months. If we don’t do this, it could very well drag on.
A Momentous Shift
In a long opinion piece on May 7 the New York Times, with the headline, “Why Did It Take So Long to Accept the Facts About COVID,” Zeynep Tufekci expressed the view that the updates by WHO and CDC were momentous. “A few sentences have shaken a century of science,” she wrote. “These latest shifts challenge key infection control assumptions,…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.”
But she also pointed out that the two organizations gave the changes short shrift: “no news conference, no big announcement.” Perhaps they were embarrassed.
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. Our mitigations would have been much more effective, sparing us a great deal of suffering and anxiety.
Super-Spreader Events 32.6x More Likely Indoors Than Outdoors
It is now crystal-clear that the COVID problem is indoors, and the way to mitigate SARS-CoV-2 spread is through smart measures to make the air inside not just clean but safe. In addition, what we are learning about COVID applies as well to other viruses, bacteria, and mold.
The data are now overwhelming. A systematic review by Tomasso Celeste Bulfone of the the University of California at Berkeley and colleagues in the Journal of Infectious Diseases looked at studies of peer-reviewed papers that compared interior and outdoor infection. Their conclusion: “Less than 10% of reported [SARS-CoV-2] transmissions occurred in outdoor settings [and] less than 5% of cases were related to outdoor occupations…. The odds of transmission or super-spreading are much lower outdoors.”
Bulfone and the other researchers noted that, of 318 identified outbreaks involving three or more cases in China reported to local Municipal Health Commissions in a one-month period, all occurred in indoor environments. And a Japanese study found that “the odds of a primary case transmitting COVID-19 in a closed environment were 18.7 times greater…compared to outdoor setting. The odds of a single case spreading to 3 or more individuals, which they defined as a super-spreader event, in closed environments compared to open air was 32.6 [to 1].” Another study of 10,926 cases found that less than one percent of transmissions occurred outdoors.
An April 13 opinion piece in the Denver Post headlined, “The CDC finally admits it was wrong about surface transmission of COVID-19,” Alex Huffman, an associate professor of chemistry at the University of Denver who studies biological aerosols, wrote:
Respiratory aerosols can be inhaled no matter where you are in a room. If you are standing within a few feet from someone infected, you breathe in a high concentration of virus and the risk is highest. Even if you are standing on the other side of the room, the virus can still infect you. At first, most public health agencies wrongly assumed that COVID-19 was spreading primarily through touch or droplets,…but increasingly deep and wide evidence has shown that inhalation of these smaller aerosols drives the majority of COVID spread.
None of this is new. It was merely ignored. Early in the pandemic, Canadian journalist Jonathan Kay analyzed 58 separate COVID-19 "super spreader" events in 28 countries. Kay's study was published in the blog Quillette on April 20, 2020. Kay is admits that he is not an epidemiologist and that his data are “substandard,” but they were also enormously powerful and impossible to overlook.
He found that 19 of the events “involved parties or liquor-fueled mass attendance festivals of one kind or another, including…celebrations of weddings, engagements and birthdays. Fourteen super-spreader events occurred at religious services or funerals and six involved “face-to-face business networking.” None concerned casual or incidental contact. Except for three incidents at sports events, where people were packed tight and spreading virus by cheering, all the events were outdoors. “It is notable, for instance,” Kay writes, “that the notorious outbreak at an Austrian ski resort is connected to a bartender and not, say, a lift operator.” Kay concludes his article with these prescient words:
If the principal modes of COVID-19 transmission can be narrowed down in this way, it would provide an enormous boon to the policymakers who are now starting to think about restarting our economies. Fighting this disease will always be hard. But it will be harder still if we fail to develop a proper understanding of the precise way it attacks us.
At last, it seems, the world is recognizing the nature of the beast.
Ventilation Is 'Unlikely to Succeed as the Prime Means of Protection'
The question is how best to prevent airborne SARS-CoV-2 from continuing to infect people, especially as they go back to school and work.
According to an extensive article in HPAC Engineering, the definitive answer is not ventilation – that is, the exchange of indoor for outdoor air through a heating and cooling, or HVAC, system.
Gary and Ken Elovitz of Energy Economics in Newton Centre, Mass., write:
The biggest danger for COVID-19 infection is close-range contact with infected people who are talking loudly or are otherwise exhaling heavily for at least several minutes. The HVAC system does not have much effect on those conditions.
The Elovitzes’ main contribution is to deploy the Wells-Riley equation, which uses “infectious particle concentration, exposure time, and outside air ventilation” to come up with a prediction of the “likelihood that a person will be infected by a virus.” (Academic research shows that, if anything, Wells-Riley underestimates risk.)
After the authors plug in the numbers, they conclude:
No practical amount of ventilation can be relied on or expected to protect occupants over long exposure times like the 6 or 8 hours people might spend together in an office or school classroom. Similarly, ventilation is unlikely to succeed as the prime means of protection for people in close contact in a small space like a private office. However, short term, intermittent contact in large spaces like a trip to the supermarket is unlikely to spread infection.
The authors say that “improved filtration can reduce the risk of transmission by reducing the concentration of infectious particles in the air.” But that reduction is by no means complete. They write that, on average, “MERV 13 filters might be 60% to 70% efficient at removing particles that contain viral material.” The authors also warn that higher-efficiency filters “have higher pressure drop,” which means reduced air flow and heating and cooling capacity. Bringing an HVAC system back up to its pre-filter levels of air flow requires an increased “motor load” – that is, a bigger-capacity system, which will use more energy and pose a greater threat to the environment.
Current Standards, Writes Allen of Harvard, Are Set for Bare Minimums
In fact, as an April 16 JAMA article by Joseph Allen of the Harvard T.H. Chan School of Public Health and Andrew Ibrahim of the University of Michigan points out, “an important flaw exists in how most buildings operate in that the current standards for ventilation and filtration in indoor spaces, except for hospitals are set for bare minimums and not designed for infection control.”
This is an indictment of the ventilation industry, which for decades has put people in jeopardy indoors. But the immediate point that Allen and Ibrahim are making is that HVAC systems generally do not produce enough air changes per hour for good health. In other words, these systems already require more power without loading them down with filtration systems.
But to get back to the Elovitzes…. They are also skeptical of ultraviolet disinfection systems because “ultraviolet radiation can harm people.” As for bipolar ionization systems, some of them “produce ozone as a byproduct,” and “there are no industry standards or test protocols” for these systems, “so performance is not verified.”
They conclude, “There is no solid evidence that HVAC systems can be a primary means of control” of COVID-19 spread.
COVID-19 Mitigation Can Damage the Environment
As Allen and Ibrahim write, “Increasing air exchange rates involves trade-offs including the added costs of moving more air as well as heating or cooling this volume of air.
Writing last year in the Wall Street Journal, Konrad Putzier amplified this point: “Some building owners find that they face a choice between lowering their energy use and keeping tenants safer from infection.” The truth is, devices do exist that destroy the virus with little or no effect on energy use – and those devices can be used with good effect as complements to ventilation. But simply increasing ventilation or adding filters to HVAC systems can both dramatically increase expenses and threaten the global climate.
The Journal article noted that in a study last year, “real-estate technology company Enertiv found that HVAC costs in office buildings increased 36% during the pandemic.” And buildings and construction account for 39% of all energy-related carbon emissions.
Ventilation is sometimes cited as a way to chase away pathogens or capture them if a filter is added. But the minimum standards (for example, five to six air changes per hour for schools) set by the American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE) are rarely met, as Allen and Ibrahim note. And some researchers believe the rates are too low to be effective.
Doubling the amount of outdoor air “reduces the chance of infection by up to 35% in densely packed venues such as restaurants,” writes Dyani Lewis in the journal Nature, referring to a preprint of a study by Liangzhu Wang and colleagues at Concordia University. But even wearing a mask indoors is “more effective than changing the air.”
Another scientist quoted in the Nature article points out that “the environmental cost of increased ventilation should give people pause.” Large HVAC companies have a stake in encouraging school administrators and building owners to increase the size and power of their systems – and thus, energy consumption -- to produce more air changes per hour.
It’s important to note that “air change” does not mean a 100% exchange of interior air with clean outdoor air. Instead, as the CDC calculates, it will still take 104 minutes in a room with four air changes per hour to eliminate at least 99.9% of contaminants – unless, of course, an infected person enters the room during those 104 minutes.
ASHRAE urged property managers in April to consider keeping HVAC systems running for 24 hours a day and bringing in more outside air. Because outside air typically has to be heated in the winter or cooled in the summer, it uses up more energy than merely recirculating indoor air. HVAC systems certainly have their place in the battle against COVID when combined with devices that inactivate the virus in the air, but running an HVAC system 24/7 seems deeply irresponsible environmentally.
Worse Than We Thought
COVID may be even worse than we thought. A Research Letter in JAMA on April 2 calculates that between March 2020, and Jan. 2, 2021, the U.S. experienced 22.9% more deaths than were expected before the pandemic. The study, by Seven H. Woolf of the Virginia Commonwealth University Medical School and colleagues, looked not just at COVID-19 deaths but at all-cause mortality. In fact, COVID represented only 72.4% of U.S. excess deaths for the nine-month period.
What were the other major causes? Heart disease, Alzheimer’s disease and other dementia, and diabetes. The authors found that these excess deaths showed surges that corresponded to COVID surges, pointing to COVID as the reason the other diseases took more lives than expected.
The researchers speculate that these deaths could actually have been caused by COVID but the infection was undocumented so mortality was attributed to another disease. Another possibility – which the authors cited in an earlier JAMA piece – is that the pandemic caused illnesses such as heart disease and diabetes to go untreated or undetected. In addition, fear of COVID-19 may have caused patients to neglect their care, unable or unwilling to visit physicians’ offices or go to emergency rooms.
The authors identify Mississippi, New Jersey, New York, Arizona, Alabama, Louisiana, South Dakota, North Dakota, New Mexico and Ohio as the states with the higher per capita rate of excess death. “New York,” they write, “experienced the largest relative increase in all-cause mortality” at 38.1%, a daunting figure.
Will We Ever Get Heard Immunity?
As nearly everyone knows, the CDC on April 27 issued new guidance for the 33% of Americans who are fully vaccinated against COVID-19. The big change is that if you’re vaccinated, you can “participate in outdoor activities and recreation without a mask, except in certain crowded settings and venues.” But right around the same time, vaccinations started to slow. As of May 3, the number of shots per day had dropped 50% when compared to just three weeks earlier.
More than 70% of Americans over 65 are vaccinated, and clearly the shots are having an effect. Overall, cases of COVID have dropped from a late January seven-day average of 260,000 to 45,000 last week, and deaths have declined from a seven-day average of 3,263 to 693.
It appears, nevertheless, that COVID-19 is not going to disappear because of herd immunity – that is, resistance to the spread of the disease because a high proportion of the population has had a previous infection or vaccination. A sobering report by Apoorva Mandavilli on May 5 surveyed experts, who now believe that the herd immunity threshold is not attainable — at least not in the foreseeable future, and perhaps not ever.”
Instead, Mandavilli writes:
The virus will most likely become a manageable threat that will continue to circulate in the United States for years to come, still causing hospitalizations and deaths but in much smaller numbers. How much smaller is uncertain and depends in part on how much of the nation, and the world, becomes vaccinated and how the coronavirus evolves.
The problem is that the virus is changing quickly into variants that spread too easily, and, at the same time, “vaccination is proceeding too slowly.” The main variant spreading in the U.S., called B.1.1.7 and first identified in Britain, is about 60% more transmissible than the virus that was first identified.
As Mandavilli writes in the New York Times:
Polls show that about 30 percent of the U.S. population is still reluctant to be vaccinated. That number is expected to improve but probably not enough. “It is theoretically possible that we could get to about 90 percent vaccination coverage, but not super likely, I would say,” said Marc Lipsitch, an epidemiologist at the Harvard T.H. Chan School of Public Health.
Variants are developing globally because only 8% of people worldwide have received a single dose, and those mutated viruses will inevitably move to the United States. An Axios headline on May 7 referred to “The race to avoid a possible ‘monster’ COVID variant.”
Reporter Eileen Drage O’Reilly quoted Josh Schiffer, an infectious disease expert at Fred Hutchinson Cancer Research Center, as saying, “If there is a new variant that's terrible — that ruins 2022 and brings us back to very dark times — it's almost a guarantee that it's percolating in an area of the world that's getting hit very hard now," Schiffer says.
All the more reason to get interior pathogen mitigation right.
COVID Solutions Bulletin
Our mission is to educate people on innovative solutions to the COVID-19 crisis in America. We need to get back to work, to school, to play – to enjoying life. We can’t get there without thwarting the current pandemic and preparing for the possibility of other pathogens to come.
COVID Solutions Bulletin is a publication providing regular updates on new and existing technologies that can help stop the spread of COVID-19, and help clear the air to open America back up.