Today, February 13, 2021, I wrote the following email of warning to Drs. Bill Gruber and Albert Bourla, executive leaders of the COVID-19 vaccine development program at Pfizer.
It is my sincere hope that these gentlemen along with the other executives and risk managers at Pfizer will have the clarity and foresight to urgently act on my recommendation: to amend their vaccine warning label with FDA, so as to mitigate against the risk of potential harm to the recently or currently infected “class” of persons being considered for vaccination.
At present, it is a certainty that a large proportion of the infected are being vaccinated indiscriminately in the US and abroad — it is my serious concern that such persons are at risk of disease and harm triggered by the vaccine’s powerful immunological effect.
Please read the below email and share with all concerned citizens.
— — — — — Forwarded message — — — — -
From: Hooman Noorchashm <email@example.com>
Date: Sat, Feb 13, 2021 at 10:31 AM
Subject: WARNING To Pfizer — The Danger of Indiscriminate Vaccination of The Recently Infected With Your COVID-19 mRNA Vaccine.
To: <firstname.lastname@example.org>, Gruber, William C <Bill.Gruber@pfizer.com>
Cc: Woodcock, Janet <Janet.email@example.com>, Marks, Peter <Peter.Marks@fda.hhs.gov>, Thomas Greene <firstname.lastname@example.org>, Tucker Greene <email@example.com>, Constant, Gerri S <firstname.lastname@example.org>, hornblowers <email@example.com>, Stark, Karl <firstname.lastname@example.org>, Sutton, Charlotte <CSutton@inquirer.com>, Grady, Denise <email@example.com>, Kamp, Jon <firstname.lastname@example.org>, mark.maremont <email@example.com>, <firstname.lastname@example.org>, <Amy.Marcus@wsj.com>, Loftus, Peter <email@example.com>, Karen Weintraub <firstname.lastname@example.org>, Kris Mamula <email@example.com>, Alison Motluk <firstname.lastname@example.org>, Caplan, Arthur <email@example.com>, Michael Paasche-Orlow <MXXXXXXXX@XXX.org>, June MD, Carl H <cXXXX@XXXXX.edu>
Dear Drs. Bourla and Gruber,
I write this public letter of warning to Pfizer, again, as an American immunologist and physician, regarding a potential dangerous use of the Pfizer COVID-19 mRNA vaccine in a specific “class” of persons.
This letter is to warn you and Pfizer’s executive and risk management leadership that a very specific and growing “class” of subjects may be exposed to a risk of harm following administration of the Pfizer COVID-19 vaccine.
It follows that, no matter how powerful you believe federal vaccine exemptions protecting Pfizer from liability are in the vaccine space, you will still want to: A) guard your corporation from any potential liability, and B) act in good faith to secure the health and lives of ANY persons who might be at added risk from your product. Therefore, I am certain that it is in Pfizer’s best interest to act upon my recommendation here, in collaboration with FDA, urgently.
We are in an unprecedented time, when a powerful and immunogenic vaccine from your company (and Moderna) is being deployed into millions of persons daily across the world in the midst of a pandemic outbreak. By definition, in this scenario many vaccine subjects fall in the “class” of the recently or currently infected at the time they are vaccinated. This is a vastly different scenario compared to population level vaccination programs in non-pandemic times, where a very small proportion, if any, of the vaccinated population is infected with the target microbe at the time of immunization.
The trouble is that a large proportion of the recently or currently infected during the present pandemic are asymptomatic or have had very mild symptoms by the time they are vaccinated. So, effectively, indiscriminate vaccination of the population in the US and abroad risks delivering your vaccine into the arms of a large “class” of people harboring viral antigens in their bodies’ tissues at the time of vaccination.
The trouble with indiscriminately vaccinating this “class” of people is NOT that your vaccine is intrinsically ineffective or unsafe. Rather, it is that your vaccine’s high level of efficacy in activating an immune response is highly likely to trigger an antigen specific immunological attack on the subject tissues harboring SARS-CoV-2 antigens from a recent or current infection.
The clinical result of vaccinating the infected “class” of people could range from minor benign symptoms, to moderate signs of systemic inflammation, to severe inflammatory disease with end organ damage (e.g., COVID-19 inflammatory disease or vascular injury with thromboembolic events), or death within days to weeks of vaccination. As with any disease, a COVID-19 vaccine induced inflammatory process in the previously or currently infected “class” of patients will present along a spectrum — in other words, I am not stating that 100% of such patients would die. But, no matter the clinical manifestation following vaccine delivery in the “class” of persons, the disease will have directly resulted from the administration of your vaccine into such persons, who are very likely to be at unacceptably high risk from indiscriminate vaccination.
Now I recognize that my risk prognostication is not based on any currently visible data — being as this vaccine is literally weeks old in a pandemic that itself is only months old. Nonetheless, this warning is a scientifically sound risk prognostication, based on the fundamental principles of adaptive immunity and vaccine science, in an unprecedented scenario where a vast number of the treated persons will certainly be recently or currently infected at the time of vaccination. Therefore, Pfizer and its executives and risk managers simply cannot ignore the present formal warning.
I am particularly concerned about how elderly and frail patients with cardiovascular disease, in the herein described “class” of recently or currently infected persons, will react to their vaccination. I sincerely hope that you both share my concern — because many of these persons carry intellectual deficits that preclude them from providing proper informed consent to their vaccination within their institutional or home care settings.
Furthermore, front-line healthcare providers, though younger and perhaps less susceptible on an individual basis, are likely at higher risk of harm because a larger proportion of them are expected to be infected than in the general population — of course, the recent tragic case of the 38 year old, Dr. J. Barton Williams of Memphis, TN comes to mind.
As I have discussed with Drs. Bill Gruber and Peter Marks, the reality is that the clinical trials leading to the EUA for large scale deployment of your vaccine in the US did NOT include a large enough “class” of patients with recent or current infections. Certainly, in this class, elderly and frail persons with cardiovascular disease were almost entirely excluded from your trials. Therefore, it is a fact that neither Pfizer, nor FDA have any idea whether vaccinating this class of persons, and especially the elderly and frail, is safe. In truth, and irrespective of what federal legal protections Pfizer might enjoy in the vaccine space, both your company and these persons are at risk of liability or serious harm/death, respectively.
Therefore, my urgent and immediate plea with the executive leadership of Pfizer is that you immediately move to amend your vaccine label with FDA to include language that would emphatically delay, or avoid, vaccination of persons with “known or suspected” recent or current SARS-CoV-2 infections — and especially in the elderly and frail with cardiovascular disease.
As you know, I have proposed a mitigation strategy to FDA leadership and the public using the #ScreenB4Vaccine Hashtag. You may read about this at the following link, if you have not already:
I do not believe that applying my proposed mitigation strategy (i.e., #ScreenB4Vaccine) and robustly warning against indiscriminate vaccination of the recently or currently infected (i.e., amendment of your FDA label), will lead to “vaccine hesitancy”, as a few of my critics have charged — for two reasons: 1) the supply of the vaccine is currently far below the demand for it and will be so for the foreseeable future, so there is no shortage of persons who wish to get vaccinated, and 2) Pfizer and FDA’s move towards safety would actually have the opposite effect of that predicted by my critics: it will earn public trust with the subset of people, who are concerned about lax safety considerations in this emergency vaccine roll-out.
I do believe that by formally editing the warning language on your vaccine label to limit the possibility of indiscriminately vaccinating the recently or currently infected class of persons immediately, Pfizer will not only protect itself from potential legal liability — but, more importantly, you will have very likely protected the safety of this class of people, whose numbers are daily increasing during this pandemic.
I pray and hope that you will read my public message to you here in its entirety, and understand the critical importance of acting on the warning herein promptly — from both a legal and ethical perspective.
I write for the record.
Yours in friendship,
Hooman Noorchashm MD, PhD