Issue No. 6

In this issue:

• We should expect safe air in our buildings the way we expect safe food in our supermarkets, say 39 scientists in a manifesto. Who’s to blame for current failures?
• Former Surgeon General offers questions to get answered before purchasing systems to mitigate COVID spread.
• COVID liability claims are expected to hit businesses.
• How do different states treat COVID liability?
• Ventilation-Plus policy in schools beats masking in preventing COVID.
• Few who are eager to get a shot remain unvaccinated as herd immunity seems out of reach.
• “The emergence of variant strains is arguably the greatest threat to control” the pandemic.

​Scientists Issue Tough Manifesto on Improving Interior Air

“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.

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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:

1. Does the technology inactivate the COVID virus, and is it proven effective against pathogens in air and on surfaces? 
2. Is it continuously active, and can it adapt to your specific spaces? 
3. Is it safe to use in spaces occupied by people and pets? 
4. Has the technology been cleared by the U.S. Food & Drug Administration (FDA)? 
5. Has the system proven its effectiveness in real-world settings, and how does the manufacturer stand behind product claims with field testing and data? 

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.
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‘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.”

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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.”

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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.”

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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.

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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.

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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.

For more information visit www.COVIDsolutionsbulletin.com.