Civil Defense Perspectives, vol. 35 #5
It appears that President Trump bet everything on a vaccine to be achieved at “warp speed.” And many others have suspended normal life and hunkered down awaiting the arrival of the silver bullet that will defeat the virus.
Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases (NIAID), stated at a conference at Yale University that masks and social distancing would be needed, and people would not be able to go wherever they wanted, before the end of 2021—even if a vaccine was approved in December 2020.
CDC Director Robert Redfield, M.D., in testimony before a Senate appropriations committee, said, “I might even go so far as to say that this face mask is more guaranteed to protect me against COVID than when I take a COVID vaccine, because the immunogenicity may be 70%…. And if I don’t get an immune response, the vaccine is not going to protect me. This face mask will” (https://tinyurl.com/y4xbopnh).
Monica Gandhi, M.D., M.P.H., of the University of California at San Francisco said that universal masking could become a form of “variolation” that would generate immunity (NEJM, 10/29/20, https://tinyurl.com/y4bf9c8l). In other words, the mask reduces the inoculum so that a person is more likely to develop natural immunity without getting very sick.
Awesome biotechnology is enabling rapid development of novel vaccine platforms, which, it is hoped, will enable containment of emerging epidemics as well as COVID-19 (see p 2).
Surviving Epidemics: a History
Pestilence has been a constant threat throughout human history. Sometimes, entire populations have been virtually wiped out, but spread was limited by geographic isolation. Isolating infected persons (leper colonies, tuberculosis sanatoria, quarantines), vector control (swamp drainage, DDT, other insecticides, rodent control), and sanitation have saved millions. Prophylactic antibiotics have protected exposed people from tb or meningitis.
Vaccinators have claimed that vaccines are the greatest public health development in history and have saved “untold millions.” Looking at a visual history of the great pandemics (https://tinyurl.com/r4xhshy), the only one that was arguably defeated by vaccination was smallpox. There was no vaccine against the influenza pandemic of 1918-1920, which killed as many as 50 million people. (The annual toll from smallpox was around 400,000.) Constant influenza vaccination campaigns have not eliminated annual outbreaks.
The elimination of smallpox involved aggressive worldwide efforts to identify every case. The disease was readily diagnosed by the rash and the odor. COVID-19, with many asymptomatic victims and manifestations often indistinguishable from a common cold or influenza-like illness, is far more challenging.
The modern smallpox vaccine emerged in the 19th century. The World Health Organization (WHO) eradication campaign lasted from 1958-1977. Smallpox is said to be the only human disease ever to be eradicated.
Will COVID-19 be the second? With factories in production even before approval and military resources to deliver vaccine and –80° freezers for mRNA vaccines, it shouldn’t take 20 years.
The COVID Vaccine Race
Bill Gates, whose foundation is the biggest funder of vaccines in the world, writes: “One of the questions I get asked the most these days is when the world will be able to go back to the way things were in December before the coronavirus pandemic. My answer is always the same: when we have an almost perfect drug to treat COVID-19, or when almost every person on the planet has been vaccinated against coronavirus.”
He observes that the fastest a vaccine has ever been made is 5 years, and the goal for COVID is 18 months. The technology is vastly different: “Rather than injecting a pathogen’s antigen into your body, you instead give the body the genetic code needed to produce that antigen itself. When the antigens appear on the outside of your cells, your immune system attacks them—and learns how to defeat future intruders in the process. You essentially turn your body into its own vaccine manufacturing unit.” He writes that the platform works and that it generates immunity. It is “a bit like building your computer system and your first piece of software at the same time” (tinyurl.com/ydyrrx6m).
The first vaccine approval will be followed by “chaos and confusion,” writes Carl Zimmer (NY Times 10/12/20, https://tinyurl.com/y6km7gan). It will certainly not be an “on-off” switch. For testing, AstraZeneca, Johnson & Johnson (J&J, Janssen), and Moderna are using the government’s “harmonized approach” and the NIH network of clinical testing sites. Pfizer is running independent tests, and apparently expects an emergency use authorization (EUA) from the Food and Drug Administration (FDA) soon. Vaccinators able to administer a tray of 975 shots from Pfizer over a short period are being sought, according to a town hall presented by the Arizona Medical Association.
Even moderately effective vaccines will be a huge help in reducing COVID-19, Zimmer writes—but only if enough people take them, and only if they realize they could still get sick. (The FDA’s goal of 50% has an error range of ±15%.) “We’ll have to continue to use a mask for some of these vaccines,” said Dr. Poland of the Mayo Clinic. “Vaccine hesitancy” could be a big problem, say Arizona public health officials. As few as 50% of U.S. adults are committed to receiving a COVID vaccine, states Howard Bauchner, editor-in-chief of the JAMA Network (JAMA 10/6/20).
One survey showed that only 44% would willingly get the vaccine, and if it only reduces disease incidence by 50%, it is “unlikely to achieve the herd immunity that many consider necessary to ‘reopen the country’” (JAMA 10/6/20).
Vaccine advocate Paul Offit, M.D., said that hesitancy was “somewhat understandable,” given the “frightening” language used to describe vaccine development. Terms such as “warp speed” may suggest that haste might trump safety considerations. He offered advice on how to reassure people about that, while saying that “fear [of the virus] works” to “convince people that vaccination is wise” (https://tinyurl.com/yx8mhwbu).
On Nov 9, Pfizer announced a success rate >90% “in the first 94 [of 44,000] subjects who were infected by the new coronavirus and developed at least one symptom (tinyurl.com/y4xbynb6). “Success” means reducing mild cold symptoms, not deaths or infections (https://tinyurl.com/y2nos9p9).
Federal Vaccine Allocations Top $9 Billion
Seven companies are each receiving $1–$2 billion to manufacture 100 million or more doses (https://tinyurl.com/yy7ff7dm). Sanofi Pasteur and GSK’s vaccine delivers the SARS-CoV-2 spike protein via a baculovirus that normally infects insect cells. Pfizer and BioNTech’s vaccine uses messenger RNA that codes for spike protein, packaged inside tiny balls of fat. Novavax uses moth cells to make spike proteins, which are attached to a synthetic particle and injected with a saponin adjuvant (tinyurl.com/y53xyomh). Janssen uses an uncommon human adenovirus to deliver antigen. AstraZeneca and Oxford use a chimpanzee virus. Not having seen it before, human immune systems have not developed antibodies to this virus. Moderna’s vaccine, like Pfizer’s, uses mRNA. The mRNA vaccines must be stored at –80°C (Pfizer) or –20°C (Moderna) and last only days in the refrigerator. Merck and its collaborator IAVI use a vesicular stomatitis virus, engineered to be harmless, to express spike proteins. This virus was used as part of the Ebola vaccine licensed in December 2019. Unlike others, the Merck vaccine is to be administered orally and is said to require only a single dose.
COVID-19 vaccines designed by Astra-Zeneca, Janssen, and and Novavax will be manufactured by Emergent BioSolutions, formerly Bioport, the sole supplier of anthrax vaccine. This vaccine allegedly caused many severe chronic illnesses in U.S. troops.
“The Pentagon is locked in a dependent relationship with BioPort Corp.,” said Rep. Christopher Shays (R-Conn.) in 1999. Emergent now controls many biodefense products (it acquired smallpox vaccine in 2017) and supply lines. “It has strategically placed itself to be, let’s just say, the company that can’t fail” (https://tinyurl.com/y37t4fcz).
Threshold for Approval
These vaccine candidates are all based on new technologies. In the phase 3 trials, only about 150-160 people will have to fall ill with COVID-19 to be able calculate the effectiveness of the vaccine. The FDA has said it will approve any vaccine that is shown to be safe and to prevent infection or severe symptoms in at least half of those who are vaccinated (tinyurl.com/yy7ff7dm).
How safe does a vaccine need to be? One out of every three people had side effects from the smallpox vaccine bad enough to keep them home from school or work, according to Gates, and “a small—but not insignificant—number developed more serious reactions” (op. cit.). That was about 1 in 1,000 serious reactions and 1 in 1 million deaths in primary vaccinees in the 1960s (https://tinyurl.com/y4lmjafd).
Virtually all recipients of the second dose of Moderna’s mRNA 1273 vaccine had a systemic reaction, mostly mild or moderate (NEJM 7/14/20). With some 60,000 subjects enrolled in vaccine trials, half receiving placebo, a risk of much less than 1 in 10,000 might well escape detection.
During the smallpox era, the overall case fatality rate in unvaccinated individuals was around 30%. The overall symptomatic fatality rate for COVID-19 is estimated at around 1.3% (Health Affairs 5/5/20, tinyurl.com/y2zgvo3q), ranging from <1% in persons under age 50 to around 15% in persons over age 80% (tinyurl.com/y66gzcuw). Because so many cases are asymptomatic, the infection fatality rate (IFR) is far lower, around 0.14% according to WHO (tinyurl.com/yxmlzomt). Thus, the risk: benefit ratio was far more in favor of vaccine in the smallpox era.
Smallpox Gone Forever?
Historical research demonstrates that smallpox occurred in severe outbreaks that were followed by the periods of inactivity. The mechanism of this sinusoidal pattern remains unknown.
Smallpox lesions were identified in Egyptian mummies from the 3rd century B.C. but not in earlier or later mummies. It might have caused the Antonine Plague (165–180 A.D.) and the Plague of Cyprian (251–266 A.D.). It re-emerged in Europe in the 6th and 7th centuries A.D., mysteriously disappeared until the 11th century, was almost absent for about 300 years, re-emerged again in 15th century, waxed and waned but wreaked havoc in the 18th century. Practiced first in Asia and Africa, variolation spread to the Ottoman Empire around 1670 and then to the rest of Europe within a few decades (https://tinyurl.com/y8qgddrp).
While vaccination supposedly caused its final demise (except in biowarfare factories), what “eradicated” smallpox during all those times when it was not active? What if vaccination merely speeded up the natural cycle of this disease? Certainly, Egyptians were not familiar with vaccination. Maybe our belief in the effect of vaccines is a post hoc ergo propter hoc fallacy.
George Bernard Shaw wrote: “During the last considerable epidemic at the turn of the century, I was a member of the Health Committee of London Borough Council, and I learned how the credit of vaccination is kept up statistically by diagnosing all the revaccinated cases (of smallpox) as pustular eczema, varioloid or what not—except smallpox.”
Monkeypox, a zoonosis caused by an orthopoxvirus with symptoms similar to but less severe than smallpox, is occurring with increasing frequency in Africa as smallpox vaccination ceased and immunity to poxviruses waned (tinyurl.com/yyt28uc6).
Notes on Transmission, Immunity and Vaccines
Natural immunity: According to a letter from health professionals to Belgian authorities (tinyurl.com/yxl2aje6), a strong immune system relies on normal daily exposure to microbes. Excessive hygiene can have a detrimental effect on our immunity.
Up to 60% of noninfected people have T-cells reactive to SARS-CoV-2, probably from past colds from related viruses (ibid.).
Transmission via objects (e.g. money, shopping carts) has not been proven (ibid.)
In 10 years, only three vaccines with >50% efficacy have been developed. Efficacy is very poor past age 75 (ibid.).
Immunopathology: Vaccines developed against SARS-CoV-1, including those using a spike (S) protein preparation, induced neutralizing antibodies and protection against infection, but challenge with the virus induced immunopathologic changes in the mouse lung. Caution is indicated with human vaccines (PLoS One 4/20/12, https://tinyurl.com/yx2wl8jr).
Safety: AstraZeneca and J&J vaccine trials were paused then restarted. One volunteer experienced transverse myelitis. A man in his 20s suffered a cerebral hemorrhage and transverse venous sinus thrombosis. The latter was attributed to a stroke unrelated to the vaccine (tinyurl.com/yx9wl75e). A 28-year-old AstraZeneca volunteer died; he had received the “placebo,” the established meningococcal vaccine (tinyurl.com/y3qabhvm).
Prevalence: About 13–14% of Americans have likely been infected with COVID-19. About 80% have probably been asymptomatic (https://tinyurl.com/y5dsukdb).