A Letter of Warning To FDA And Pfizer: On The Immunological Danger Of COVID-19 Vaccination In The Naturally Infected.

On January 26, 2021, Dr. Albert Bourla, Pfizer CEO, along with his colleague Dr. William Gruber, Pfizer’s SVP of Vaccine Clinical Research and Development, received this letter of warning regarding the potential immunological danger of vaccinating the recently convalescent or asymptomatic carriers of SARS-CoV-2 — especially in the elderly and the frail with cardiovascular disease.

Dear Reader, it is my sincere hope that this public letter might stimulate FDA, Pfizer and Moderna leaders to think critically and quickly about the immunological danger the COVID-19 vaccine might pose to those persons naturally infected by SARS-CoV-2 — most especially to those infected who are recently convalescent, asymptomatic carriers, the elderly and frail or those with significant cardiovascular risk factors.

I want to be clear that my warning here is based on a near definitive scientific Immunological prognostication. It is a “prognostication” in that I have put it forth in the absence of clear “evidence” of it being a material risk — as of January 2021. The reason I now this prognostication is critically important is that we are dealing with an evolving 11-month old national health emergency with many unknowns, and a vaccine that is only several weeks old — and it was approved for mass scale use on an Emergency basis. And, in a setting where it is critical to quickly vaccinate as many citizens as possible to achieve herd immunity against SARS-CoV-2, in the best interest of global and national security.

An Interview Discussing #ScreenB4Vaccine

I want to be very clear that I am an ardent supporter of President Biden’s plan to vaccinate 150 Million Americans in 100 days. And that my letter is not to be abused by political, uninformed or conspiratorial forces attempting to dissuade the American public from being vaccinated — nor by those whose binary approach to the PRO-vaccine position renders them incapable of grasping the problem of “minority harm”.

I do believe that it is the civic duty of every American who can reasonably and safely be vaccinated, to do so as soon as is possible — in order that we save our nation from this pandemic peril that is threatening our very existence.

(Update 1/28/2021: You may read a simple safety approach you can take to keep yourself and your loved ones maximally safe when undergoing COVID-19 vaccination. Please click HERE to read — Help convince the FDA and Pfizer leaderships to act now. Please click HERE for instructions on how to send a personalized call to action to FDA and Pfizer. They are listening to your voice on this issue now. Please listen to THIS PODCAST interview for the full perspective).

Here is my initial email of warning to FDA regulators, Pfizer leaders and the press:

From: Hooman Noorchashm <noorchashm@gmail.com>
Date: Tue, Jan 26, 2021 at 10:02 AM
Subject: COVID-19 VACCINE WARNING — Vaccine Directed Immune Response In Asymptomatic Carriers And The Convalescent
To: Woodcock, Janet <Janet.woodcock@fda.hhs.gov>, Marks, Peter <Peter.Marks@fda.hhs.gov>
Cc: June MD, Carl H <XXXXX>, Michael Paasche-Orlow <XXXXX>, Gruber, William C <Bill.Gruber@pfizer.com>, <albert.bourla@pfizer.com>, Constant, Gerri S <gsconstant@cbs.com>, hornblowers <hornblowers@cbsnews.com>, Stark, Karl <kstark@inquirer.com>, Sutton, Charlotte <CSutton@inquirer.com>, Kamp, Jon <jon.kamp@wsj.com>, mark.maremont <mark.maremont@wsj.com>, Loftus, Peter <peter.loftus@wsj.com>, <jared.hopkins@wsj.com>, <betsy.mckay@wsj.com>, Peter Lurie <plurie@cspinet.org>, Kris Mamula <kmamula@post-gazette.com>, Karen Weintraub <weintraubkaren@gmail.com>, Caplan, Arthur <arthur.caplan@nyulangone.org>,

Dear Drs. Woodcock and Marks,

I write here to present a warning and a, nearly certain, prognostication to you as our lead FDA regulators and public health experts.

As you know, the SARS-CoV-2 virus has tropism for the vascular endothelium, among other tissues and organs. This fact was captured in a Lancet paper published in April 2020:

https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)30937-5/fulltext

As you also know it appears that the ACE-2 receptor on endothelium is the portal for viral entry into endothelial cells — and it seems that endothelial injury from the virus or from the inflammatory reaction it incites, is the reason why many COVID-19 patients experience thromboembolic complications.

Dr. Willaim Gruber, Pfizer’s SVP of Vaccine Clinical Research and Development, received this email of warning.

So it is a matter of certainty that viral antigens are present in the endothelial lining of blood vessels in all persons with active or recent SARS-CoV-2 infection — irrespective of whether they are symptomatic or convalescent.

I am writing to warn that it is an almost certain immunological prognotication that if viral antigens are present in the tissues, any tissues, of subjects who undergo vaccination, the antigen specific immune response triggered by the vaccine will target those tissues and cause inflammation and damage beyond the local anatomic site of vaccine placement.

Dr. Janet Woodcock, acting FDA commissioner, received this email warning of the potential immunological danger of vaccinating recently convalescent or asymptomatic carriers of SARS-CoV-2.

Most pertinently, when viral antigens are present in the vascular endothelium or other layers of the blood vessel, and especially in elderly and frail with cardiovascular disease, the antigen specific immune response incited by the vaccine is almost certain to do damage to the vascular endothelium. Such vaccine directed endothelial damage is certain to cause blood clot formation with the potential for major thromboembolic complications, at least in a subset of such patients. If a majority of younger more robust patients might tolerate such vascular injury from a vaccine immune response, many elderly and frail patients with cardiovascular disease almost certainly will not.

Therefore, it is my respectful request that FDA, in collaboration with Pfizer and Moderna, immediately and at the very minimum, institute clear recommendations to clinicians that they delay or avoid immunization in any recently convalescent patients, as well as, any “known or suspected” symptomatic or asymptomatic carriers — and to actively screen as many patients with high cardiovascular risk as is reasonably possible, in order to detect the recent or current presence of SARS-CoV-2, prior to vaccinating them.

Dr. Peter Marks, Chief of FDA’s Center for Biological Evaluation and Research, is the lead regulator responsible for ensuring proper evaluation of efficacy and safety for all vaccine products.

A potential reasonable solution, especially in the nursing home setting, would be to use antibody screening as a surrogate means of excluding/delaying vaccination in persons who might have been exposed to the virus and have viral antigens lingering in their tissues.

The goal of maximally and quickly vaccinating the population is the correct and laudable public health goal. It will save many lives and likely our nation — certainly population level vaccination will save far more lives than any given vaccine related complication might compromise. But, in the present national emergency, simply because we know that the majority of citizens in our society will benefit from vaccination cannot justify a regulatory and corporate failure to robustly mitigate against known and rationally prognosticated dangers to the minority subset of persons at risk of harm.

As an immunologist with a good understanding of how antigen specific immune responses could cause organ and tissue specific damage, I am recommending to you, as our lead FDA regulators, not to gloss over the real possibility that vaccinating persons with pre-existing SARS-CoV-2 viral antigens in their tissues could cause that subset of people grave immunological harm — and especially the frail with cardiovascular disease.

Additionally, if the immunological risk I am prognosticating herein is in reality material, over the next months as millions more Americans are immunized, it will become quite visible to the public.

Can you imagine if the public, without having received any real warning from FDA, becomes aware of an increasing number of such vascular/thromboembolic complications following vaccination? What do you suppose will happen to the level of “vaccine hesitancy” then? And, what kind of accountability do you think the public will demand from our experts and federal regulators — especially if they knew, or should have known, that this immunological danger might exist?

The aim of benefiting the majority of our public and saving the nation from this pandemic by quick and aggressive vaccination is an ethically sound one — but where we know of real or likely risks of harm and mortality, we ought to robustly mitigate the risks to those in potential harms way. So doing is the only reasonable, ethical, and likely legal option you can pursue as public health regulators — for in America, we no longer sacrifice the lives of minority subsets of people for the benefit of the majority. In America we specialize in ethically balancing majority good with the defense of the rights of individuals to life, liberty and property.

Drs. Woodcock and Marks, a professor of mine in medical school used to tell his students “the eyes do not see what the mind does not know”….Thromboembolic complications, within days to weeks following activation of a vaccine induced antigen specific immune response, in elderly frail vasculopaths, will not register as classical “vaccine related complications”….Nor will inflammatory COVID-19 like diseases triggered by vaccination of the infected. But SARS-CoV-2 is a virus with tropism for the vascular endothelium and many other tissues….So, our Pfizer and Moderna vaccines could easily direct an antigen specific immune attack to the very target organs and tissues harboring viral antigens from recent or current infection.

I ask that you carefully and wisely consider my immunological prognostication and warning here — FDA, Pfizer and Moderna ought not miss this projected risk of harm to what is a daily increasing proportion of the population during this ongoing pandemic. Vaccinating patients with occult SARS-CoV-2 infections or lingering viral antigens, is a clear and present potential danger to the health of these patients.

With respect and in friendship,

Hooman Noorchashm MD, PhD.

Update 1/28/2021: You may read a simple safety approach you can take to keep yourself and your loved ones maximally safe when undergoing COVID-19 vaccination. Please click HERE to read.

Hooman Noorchashm MD, PhD is a physician-scientist. He is an advocate for ethics, patient safety and women’s health. He and his 6 children live in Pennsylvania.