Vaccine Safety Is A Critical Consideration During the COVID-19 Pandemic.

It’s very simple for high level professionals and scientific thought leaders to advocate for the mainstream, utilitarian “majority benefit” part of the COVID-19 vaccine strategy, presumably to combat vaccine hesitancy — but this is not an effective strategy. Because it’s much more difficult to relinquish professional hubris and to carefully and empathically address real and prognosticated potential for “minority harm”, and the safety concerns of the 20–30% of the American population, whose trust can be earned.

We are in the midst of a viral pandemic, where nearly 1% of the general population is at risk of being killed by the SARS-CoV-2 virus. That number works out to potentially over 3 million Americans dead.

Already over 500,000 Americans are dead from COVID-19, since March 2020— and more are susceptible to or are dying already.

So, without a question, achievement of herd immunity using an effective vaccine capable of generating protective IgG antibodies and priming T-cells against SARS-CoV-2, is the key to preventing infections and containing the pandemic.

In my opinion as a physician, Immunologist and public health advocate, knowing the mRNA vaccine technology used and having reviewed the clinical trial results for the COVID-19 vaccine, I know that the Pfizer and Moderna vaccines are two of the most powerful vaccines ever made by humankind.

It’s almost certain that these vaccines are going to be highly effective against the strains of the SARS-CoV-2 virus they’ve been designed against.

Of course, the efficacy of any given vaccine in controlling a pandemic by creating herd immunity depends on its efficient and rapid administration to a large enough swath of the population — BEFORE the pandemic virus manages to mutate its way away from the vaccine sequence.

But in a democratic republic, like the United States, vaccinating the population requires willingness, and buy-in from the people. It requires trust!

And these days, trust is lacking in America.

So, “vaccine hesitancy” on the part of the American people, when it comes to the COVID-19 vaccine, is a clear and present national health security threat to the United States.

Two problems are the source of vaccine hesitancy in America:

1. The public’s under-education about the fundamental principles of Immunology, vaccine science and viral immunity.
2. An absence of trust in the FDA and the medical establishment to take safety and “minority harm” seriously enough.

On the topic of deficient public education about the principles of immunology, the problem may be too rigid to resolve quickly. The fact that so many Americans are unwilling to accept the fundamentals of science is a problem that pervades other domains of our civil life — everything from environmental preservation, to climate change to public health. America has under-invested in public education for too long — and this pandemic and all the recent social upheavals in America are showing our nation’s deficit in public education.

Suffice it to say here, the science of immunology tells us, without a question, that when a human person makes protective IgG antibodies against a Coronavirus and mounts a primed T-cell response against it, that person is very highly likely to be protected from infection and illness caused by the virus. And, vaccine science tells us that vaccines (and especially the COVID-19 mRNA vaccines) are capable of stimulating just these immune responses. These vaccine are powerful and effective defensive weapons in this pandemic. That, is a matter of scientific certainty.

But the topic of trust, in vaccine safety, is a critical one. Because, the subset of the population whose vaccine hesitancy is primarily caused by safety concerns for themselves and their loved ones, are actually reasonably well educated and thoughtful. And if I had to guess, such people make up a good 20–30% of the American public. So, it is absolutely critical to understand the sources of these folks’ concerns about vaccine safety — and to rationally address them.

In my own discourse about vaccine safety, I’ve come across a few very well decorated physicians, scientists, legal “experts”, and politicians whose level of hubris and intellectual rigidity about the safety of the COVID-19 vaccines is striking — and dangerous. Because these are the professionals whose hubris is fueling mistrust and vaccine hesitancy on the part of the 20–30% of Americans, who are amenable to reasoned discourse and whose trust can be earned. In as much as such professionals are fueling vaccine hesitancy in this pandemic, they are a threat to US national security — no matter the validity of their past narrative in forcefully advocating for public vaccination program or their correct understanding of the vaccine’s utilitarian benefit. Today, these professionals are posing a greater threat to public health by those they criticize, because they are sustaining hesitancy on the part of the slice of America amenable to reason and to being reassured.

I’d like to work towards earning the people’s trust as a professional with a good understanding of why thee vaccines are critical for our national security.

So, let’s dissect the vaccine safety problem with care, here.

Certainly, any persons who have had a prior serious complication or adverse reaction to any vaccination ought to be excluded from getting the COVID-19 vaccine. Instead, such people ought to focus on behavioral preventive actions like mask wearing and distancing, to avoid contracting COVID-19. These prior problems could include severe allergic reactions, debilitating neurological consequences, or severe inflammatory responses to vaccination. Certainly such persons should NEVER be forced to take a vaccine.

It’s important to recognize that rapid implementation of a large scale vaccine treatment program clearly requires a clinical trial, as Pfizer and Moderna performed. Such trials are generally and mainly designed to evaluate and demonstrate efficacy in, and benefit to, the majority, with respect to the targeted pathogen — as was clearly demonstrated and is bearing out in the case of the COVID-19 mRNA vaccines. Clinical trials are by definition dominantly focused on proof of utilitarian benefit and efficacy.

But efficacy to the majority is no guarantee of safety for the minority. And most civilized human beings agree that safety considerations and mitigation of harm to the minority, in any society, are the true measures of that society’s civility, intelligence and resilience.

It is a fact that mitigation of safety hazards to minority subsets of susceptible people is by definition more elusive and complex than implementation of a practice that benefits the majority. Specifically, because to intelligently identify and mitigate against specific safety hazards, clinical trial design needs to include a sufficiently powered subset of patients in whom safety is of concern. If such potentially susceptible subsets of persons are either excluded from the trial or are unknown at the time of a clinical trial, product safety cannot be assessed in them and will remain unknown.

Regarding the COVID-19 vaccines, as FDA knows and has acknowledged, the Pfizer and Moderna clinical trials of the mRNA vaccines did NOT contain a sufficiently powered subset of elderly and frail institutionalized subjects with cardiovascular disease AND prior or recent SARS-CoV-2 infections. These trials didn’t even include a sufficiently powered subset of younger and healthier persons with asymptomatic or recent SARS-CoV-2 infections to properly assess safety in younger infected folks. Therefore, the subset of infected patients, many of whom do not even have autonomy of consent in the elderly and institutionalized subset, are being subjected to indiscriminate large scale (i.e., on the order of millions of persons) vaccinations — in a setting where FDA and CDC also know and have acknowledged that vaccination of “known” infected persons should be avoided — because it is a potential safety hazard .

So, since mitigation of harm to minority subsets of patients is a more complex issue, and especially because the United States is committed to vaccinating the majority of the population in under 6 months, it becomes a REQUIRED regulatory position to maximally and tightly mitigate against all real and rationally projected safety hazards in the COVID-19 vaccination space.

To this end, I have respectfully recommended that the FDA commissioner’s office along with Pfizer and Moderna executives immediately take the following urgent actions:

1) Amend the FDA and CDC warning language to avoid or delay COVID-19 vaccination in persons with “KNOWN OR SUSPECTED” COVID-19 infection, respectively.

2) Amend FDA and CDC guidances to delay vaccination of persons with known IgG positive antibody titers against SARS-CoV-2 — in order to free up the limited vaccine doses for persons who are not immune — as such persons with IgG titers are highly likely to be well immune already.

3) Encourage physicians and medical directors, especially in institutional setting where patients with compromised or absent autonomy of consent are cared for, to screen their patients for presence of IgG and SARS-CoV-2 antigens — in order to avoid immunization of the elderly and frail with underlying diseases, who have already been infected.

If only a few hundred thousand persons per year were being exposed to this potential risk of harm from indiscriminate vaccination of those with occult SARS-CoV-2 infection, perhaps FDA could delay and deliberate about safety risks for months.

But, when the United States’ National health security policy is dictating that the majority of the population be treated with a new vaccine in under 6 months — and when an entire subset of persons with a rational and scientifically based risk factor were almost entirely excluded from clinical trials, we are dealing with an entirely different beast. Because, by the time “evidence” of vaccine harm to this subset of persons, the systemic harm may just be a fait accompli.

I do believe that FDA and CDC’s public health leaders have the ability and duty to protect Americans with known or occult SARS-CoV-2 infections from the potential harm they are likely to be at from indiscriminate vaccination — and that this duty is of particular gravity in the case of the elderly and frail with underlying cardiovascular disease who do not themselves have complete autonomy of consent to knowingly choose their course of care.

Of course as the recent tragic case of Dr. J. Barton Williams of Memphis, TN demonstrates, the elderly and frail with pre-existing SARS-CoV-2 infections are not necessarily the only ones in harms way from indiscriminate vaccination — younger patients with prior infections are likely at risk too. Dr. Williams was 36 years old at the time of his death.

In the end, to minimize vaccine hesitancy, the medical and scientific community needs to be far more humble and must drop its intolerable hubris. When citizens are concerned about the safety of themselves and their loved ones, no matter what degree of majority benefit we believe or know to be scientifically likely and no matter the nature of the emergency, there is no place for elitist hubris or mockery. Certainly, in a democratic republic we cannot allow ourselves to use the force of the state to mandate vaccination on the people against their willful consent. But what can and MUST be done is to provide high quality public education about the principles of science. Certainly, physicians, scientists and cogent regulators must realistically and empathically focus on both real and rationally prognosticated safety concerns and fears a large subset of hesitant citizen harbor.

Without respecting and properly engaging the 20–30% of the American population, whose vaccine hesitancy is born out of safety fears for themselves and their loved ones, we stand no chance of succeeding with the vaccine strategy against the COVID-19 pandemic.

It’s time for physicians, scientists and regulators of integrity and reason to accept that no matter the majority benefit imparted by utilitarian medical treatments — we ignore or downplay real, prognosticated or perceived fears of “minority harm” at peril to public health. No event is a clearer demonstration of this public health principle than the present pandemic emergency, wherein our very national security might depend on successful participation of ALL citizens in a safe vaccination program.