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Just how large a proportion is hard to say because of outdated and inadequate reporting.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.”
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.