The Clear-Cut Ethics of COVID-19 Vaccination: A Civic Duty With Safety In Mind.
I was privileged to receive my first dose of the Moderna COVID-19 vaccine on January 11, 2021. My parents did too.
Other than my own mild sore left arm for about 24 hrs, none of us had other side-effects.
My parents had no complaints.
[After initial publication of this article, my parents and I went on to get our second shots of the Moderna vaccine on February 8, 2021 — without any significant issues. I felt a bit of malaise the next day, which resolved — my parents had no complaints. I got my second shot in my right arm — and it was certainly sore for about 24 hrs. But I found it interesting that my left arm, where I’d gotten my first dose of the vaccine, started aching again 24 hrs after my second shot. I guess my left arm remembered, and was “empathizing” with my right arm (?).]
I am an immunologist and physician with a solid grasp of the biology and immunology of this new class of mRNA vaccines. I can attest that these mRNA vaccines are two of the most powerful vaccines human beings have ever created. The science has been decades in the making.
From an immunological perspective, both these vaccine are effective at stimulating IgG antibodies and T-cell responses to the SARS-CoV-2 Spike protein. The data is clear and generated by some of our most reputable academic centers and clinicians in the US and abroad.
By definition, and in practice, these vaccines are proving highly effective against the current dominant strain of SARS-CoV-2. Specifically, because the mRNA vaccine is able to mimic a live infection, without being live or having any viral protein components itself. So, it is highly effective at stimulating the immune system well. The Immunological science guiding its efficacy is truly undeniable.
I also deeply grasp the epidemiology of the COVID-19 pandemic. As the virus roars through the world’s population, it is killing an overall 1–2% of the people it infects in aggregate. But it is also leaving 10–20% of the infected, permanently damaged — all things from strokes and heart attacks, to lung damage and the so-called COVID-19 “long haul” syndrome.
So though the majority of infected people recover well, up to 20% of the infected suffer gravely or die of natural infection. And though natural infection imparts immunity to the majority affected, it is not a viable way for the world to achieve herd immunity — unless, of course, the peoples of the world want destroy our modern ethics of human rights and to accepts millions of deaths within a short period of time.
The way to herd immunity is through efficient large scale vaccination using a good vaccine — this is undeniable science.
So the fact that the United States federal government and the National Institutes of Health, in collaboration with Pfizer and Moderna, have been able to develop these new mRNA vaccines within a year is nothing short of a miracle.
And because the emergency and large scale clinical trials performed by Pfizer and Moderna have, in fact, demonstrated good efficacy, there is no question that in the utilitarian public health equation, these vaccines could secure the common good — so long as the virus does not mutate its way away from the vaccine mRNA sequence and bypass it. The vaccine deployed quickly enough, could in theory, save the nation.
So, I believe that it is the deeply patriotic duty of every American who could safely undergo vaccination, to do so with all urgency and as soon as possible.
But I say all this also knowing that in a civil society, majority benefit and the common good afforded by utilitarian treatments and services ought to be balanced with the ethics of duty to individual people and minority subsets of people who may be in disproportionate harm’s way from such treatments and services.
When it comes to COVID-19 vaccine safety, I know that the aggregate of all adverse events and deaths that can be attributed to a “vaccine reaction”, will be several thousand times LOWER than the lives spared by an effective vaccine. This is a matter of scientific certainty. The vaccine will do far more good than it will do harm to our society.
Nevertheless, in a civil society, we must do all that is possible to mitigate against the risk of harm to all minority subsets of people.
There is very little doubt that the incidence of what we know as “vaccine allergy” is not higher for the COVID-19 mRNA vaccines than for any other of the vaccines in routine use across the US. Additionally, every vaccination center and provider is equipped to recognize and treat the classical signs of an allergic reaction. So, I do believe that we have done our best to mitigate against vaccine allergies and are operating in ethical airspace when it comes to classical vaccine reactions.
However, because SARS-CoV-2 is a new virus with a unique biology — and because it is a pandemic virus which is infecting a daily increasing number of people. We must be highly vigilant and we must mitigate against ALL real and prognosticated scientific risks.
Normally, in non-emergency situations, clinical trials are done with the benefit of time — and all risks, including reasonable prognosticated/theoretical ones, are assessed in a trial setting before large scale deployment. If the prognosticated risk is found to be material from the trial data, it is mitigated against when the drug or vaccine is scaled up into the population.
The trouble with the Emergency nature of the COVID-19 mRNA vaccine trials is the problem of insufficient time to assess whether all rational theoretical risks are actually material with good statistical power.
This problem is even further exacerbated because the vaccine needs to be administered to the entire population of the United States within a few short months — because the prognosticated harm, if it is material, will likely only become visible in retrospect.
So the only ethical (and, likely, legally viable position) when confronted with a scientifically and clinically cogent theoretical health risk, in the emergency scenario we are now in, is to mitigate against the potential danger — not to ignore or to downplay the possibility because it is only a prognosticated one and there is no current “evidence” for it. If/when the evidence comes, it will already be too late — when the entire population is to be treated within months.
Of course, it goes without saying that creating mitigation in such a scenario requires scientific and clinical insight (and humility!) — such that we accept that in a civil and just society, the ethics of the utilitarian good alone do not justify leaving known or rational prognosticated health risks to minority subsets of people, unmitigated.
I have recently expressed just such a scientifically based theoretical safety risk to the leaderships of FDA, Pfizer and Moderna. You may read my letter of warning to FDA and Pfizer HERE.
I have also proposed a potential mitigation approach for this safety risk and written about it HERE.
Both FDA and Pfizer, including Drs. Peter Marks (FDA), Janet Woodcock (FDA) and Bill Gruber (Pfizer) have personally acknowledged receipt of my safety warning regarding the COVID-19 vaccines. And I do believe that the FDA leader fully grasp the magnitude of my raised concern. Of course, they are up against a tough problem with much too much political interference from all sides.
Unfortunately, after Mr. Robert F. Kennedy Jr’s publication, The Defender, elected to republish my FDA warning letter, I became the subject of a relentless and defamatory assault by a group of people who coin themselves “pro-vaccine” for having expressed my concern. To be clear, I have no formal association with Mr. Kennedy, other than the tremendous esteem I have for his late father. Nor did I consent to his publication of my writing. I am ok with all people reading my concern — because it is a scientifically based immunological prognostication about a danger than could compromise lives and could be thoughtfully mitigated against. To not state the problem and expose it to regulatory and public discourse, would have been supremely unethical. Mr. Kennedy’s publication of my letter, being that his public persona is that of a vaccine opponent, does not argue against my duty as a physician to inform the public of a potential harm I’ve prognosticated in good faith and based on careful consideration. It is my duty to have informed the FDA and the public.
You may read the adopted version of my letter in The Defender, HERE.
You may read the personal attack on me, which The Defender coverage incited, HERE.
You may read my response to this attack on my person, HERE.
Additionally, I would invite all citizens to visit my Twitter account and witness the surreal assault on my personal and professional standing, HERE.
The whole approach to me reminds me of the way in which “pro-Life” activists assault those who are defending the constitutional rights of women to elect the timing of motherhood. It’s simply obscene.
So, I want to be very clear on this record. I do believe that it is the patriotic duty of every American, who is a candidate and who can safely do so, to undergo vaccination with all urgency. And from an ethical perspective, I am fully aware of the utilitarian vaccine equation and that these vaccines, properly and quickly deployed, will save many more lives than those hurt or lost from vaccine complications.
But, again, in a civil society, we cannot allow ourselves, even in drastic emergencies, to lose sight of the fact that our utilitarianism must be calibrated as reasonably as possible — and mitigated to protect those souls, in minority subsets, whose lives may be in harm’s way from our utilitarian approach.
In this pandemic, and with these Emergency Authorized COVID-19 mRNA vaccines, we have no choice, ethically, but to mitigate against all real AND cogent scientifically prognosticated health risks to the people — especially because as many people MUST be vaccinated as is possible, as quickly as is possible now — to protect the nation and the world from peril.
I write in defense of the United States, my children’s home and mine, and in defense of the values she enshrines.
Hooman Noorchashm MD, PhD
February 1, 2021.
