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Thinking critically about COVID-19 vaccines

| Tuesday, November 2, 2021

The case for COVID-19 vaccine mandates rests on the assertion that vaccination is not just a private benefit for the recipient, but a public one necessary to prevent transmission onto others. As more data emerges on the shots’ waning efficacy, leakiness and safety problems, it is becoming clear that the primary benefit of vaccination is the reduction of severe illness and that recipients face a nontrivial risk of side effects. The scientific and moral case for vaccine mandates continues to fall apart.

A trio of Israeli preprints demonstrates significant declines in vaccine efficacy over time. A time-from-vaccine preprint analysis of 1.3 million fully vaccinated Israeli adults enrolled in an Israeli HMO determined, “Individuals who were vaccinated in January 2021 had a 2.26-fold increased risk for breakthrough infection compared to individuals who were vaccinated in April 2021.” Another study looked at infection rates among time-stratified cohorts and found “a strong effect of waning immunity in all age groups after six months.” And a third analysis found significantly higher rates of infection among those who received their second dose at least 146 days before their PCR test.

Because of the waning nature of immunity, estimates of vaccine efficacy largely depend on the study period. A paper published in The NEJM showing 88% efficacy for Pfizer against symptomatic COVID-19 among US health care personnel had a study period of fewer than four months that ended in May. A study by Israeli government researchers published in The Lancet demonstrating 95% efficacy against infection had an analysis period ending April 3. A widely-touted UK paper showing 88% efficacy against symptomatic Delta infection only analyzed data going through May, before the UK experienced a summer surge. The randomized, placebo-controlled trial that was instrumental in gaining approval for the Pfizer shot had a cutoff date of March 13, 2021 and was almost entirely unblinded by six months.

Papers analyzing more recent data show lower vaccine efficacy. A preprint study of individuals in the Mayo Clinic Health system in Minnesota found that the efficacy of the Pfizer shot dropped to 75% against hospitalization and 42% against infection by July. A Pfizer-funded retrospective cohort study published in the Lancet found that vaccine effectiveness against hospitalization remained at a high 93% up to 6 months, but protection against infection declined from 88% to 47% after 5 months. A follow-up on the aforementioned Israeli government Lancet research shows that vaccine efficacy dropped to 41% against symptomatic infection while keeping a high 88% against hospitalization. Research from the Imperial College London found vaccine efficacy against infection of 64% between May 20 and June 7, and 49% between June 24 and July 12. A study of Qatari residents published in The NEJM that extended into September 2021 found the efficacy of the Pfizer vaccine declined to 20% after five to seven months.

Not only can vaccinated individuals be quite easily infected, but they can easily transmit the virus as well. A technical briefing published by Public Health England found similar mean lowest Cycle Threshold (Ct) values for vaccinated and unvaccinated individuals infected with the Delta Variant, indicating that once vaccinated individuals are infected, there is “limited difference in infectiousness.” A preprint paper from Oxford and UK government researchers found that vaccinated individuals become similarly infectious to unvaccinated individuals after three months. Concern over the infectiousness of breakthrough cases prompted the CDC to renege on its mask-wearing recommendations for vaccinated individuals.

Real-world evidence demonstrates the inability of the vaccine to serve as a strong bulwark against infection and transmission, undermining the justification provided for vaccine mandates. A study led by S. V. Subramanian of the Harvard School of Public Health and published in the European Journal of Epidemiology found “no discernible relationship” between a country’s vaccination rate and new COVID-19 cases in the last seven days. Recent surveillance reports published by the UK show higher rates of infection for vaccinated individuals than in unvaccinated individuals for every age group over 30 (see page 13). Responding to this data, Dr. Jay Bhattacharya of the Stanford School of Medicine succinctly stated the case against vaccine mandates: “There is a lot to learn from this graph, but most obviously, the COVID-19 vax does not stop infection. The vax provides a private benefit (protection vs. severe disease), but limited public benefit (protection vs. disease spread). So what is the argument for mandates?”

With approximately 40% of the country having already been infected with SARS-CoV-2, natural immunity is the elephant in the room of vaccine mandates. Reams of data have demonstrated that natural immunity is at least as robust and long-lasting as vaccine-induced immunity. This includes a preprint analysis of employees of the Cleveland Clinic that found no reinfection among unvaccinated, previously-infected individuals, and a preprint Israeli study that found 13-fold increased risk of vaccine breakthrough infection over reinfection. Researcher Paul Alexander has compiled a list of over 70 papers demonstrating the efficacy of natural immunity. Any potential benefit of vaccination for the already infected, especially those that are young and healthy, would involve an absolute risk reduction so small as to make the intervention pointless.

There are numerous safety concerns regarding the COVID-19 vaccines. Passive surveillance systems like VAERS cannot demonstrate the cause-effect relationship, and adverse events are underreported, so their use should be limited to determining patterns and safety signals. There has been a dramatic uptick in reports to VAERS for a wide array of conditions. Of particular concern for college-aged men: myocarditis, an inflammation of the heart muscle. An analysis of VAERS reports presented at the CDC’s Advisory Committee on Immunization Practices June 23 meeting found an incidence of myocarditis far higher than expected background rates in the days following a second dose. A supposed “risk-benefit” discussion presented later that day purports to demonstrate that the benefits of vaccination for young men far outweigh the costs, by dishonestly comparing all negative COVID-19 outcomes to one vaccine side effect (myocarditis), assuming estimates of vaccine efficacy that no longer apply (as shown above), and relying on adverse event rates from VAERS, which does not capture the full incidence of side effects. In its letter to BioNTech approving its Comirnaty vaccine, the FDA acknowledged that “the pharmacovigilance system that FDA is required to maintain … is not sufficient to assess these serious risks [of myocarditis and pericarditis].” It is truly bizarre that an agency that stresses the limitations of VAERS would then attempt a detailed risk-benefit analysis using VAERS data. A review of two million vaccine recipients published in JAMA Network found a trend of post-vaccine myocarditis, particularly among young men, “at higher incidence [than the CDC VAERS analysis], suggesting vaccine adverse event underreporting.” A large retrospective analysis of data from Israel’s Clalit Health Services published in The NEJM found the “risk was substantially higher … in the vaccinated group than in the unvaccinated group for myocarditis.” In the study, COVID-19 infection was associated with an even higher risk of myocarditis, though importantly, post-vaccine myocarditis was particularly concentrated among young men (91% male, median age 25). Moreover, as the researchers note, “When a person decides to become vaccinated, this choice results in a probability of 100% for the vaccination, whereas the alternative of contracting SARS-CoV-2 infection is an event with uncertain probability.” This observation is particularly pertinent when considering vaccination of the prior infected: Why force a nontrivial risk of a vaccine-induced adverse event on individuals already possessing robust, long-lasting immunity? 

It is difficult to overstate the magnitude of the fight over the COVID-19 vaccines. Millions of Americans are being forced to undergo a medical intervention that for many of them is completely unnecessary and will cause more harm than good. With the FDA advisory panel’s illogical and immoral approval of COVID-19 vaccines for children as young as 5 years old, it is time to finally draw the line. If we don’t win this fight, we will no longer have a country worth fighting for. 

Adam Morys

Oct. 27

The views expressed in this Letter to the Editor are those of the author and not necessarily those of The Observer.

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