URGENT FDA COMMUNICATION: J&J, Pfizer, Moderna COVID-19 Vaccine Clotting Complications AND The Naturally Immune.
The following urgent e-mail was submitted to Drs. Janet Woodcock and Peter Marks at the United States Food and Drug Administration on April 16, 2021.
Here, I present FDA with the rationale for delaying vaccination of Americans who are naturally infected and immune to SARS-CoV-2 in light of the emerging and accumulating evidence that the COVID-19 vaccines pose a risk of blood clots in a minority subset of persons treated.
On this public record, I am urgently informing the leadership of FDA and CDC that excluding those with natural immunity to COVID-19 from indiscriminate vaccination will: 1) reduce the absolute number of vaccine associated complications in America and 2) increase the speed to achievement of herd immunity by preventing the unnecessary administration of our currently limiting vaccine resources to persons already immune against SARS-CoV-2.
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From: Hooman Noorchashm <firstname.lastname@example.org>
Date: Fri, Apr 16, 2021 at 1:06 PM
Subject: URGENT COMMUNICATION — J&J, Pfizer, Moderna COVID-19 Vaccine Clotting Complications AND The Naturally Immune
To: Woodcock, Janet <Janet.email@example.com>, Marks, Peter <Peter.Marks@fda.hhs.gov>, Tierney, Julia <Julia.Tierney@fda.hhs.gov>
Cc: McNally, Kelly <firstname.lastname@example.org>, Constant, Gerri S <email@example.com>, hornblowers <firstname.lastname@example.org>, Sutton, Charlotte <CSutton@inquirer.com>, Stark, Karl <email@example.com>, Grady, Denise <firstname.lastname@example.org>, Kamp, Jon <email@example.com>, mark.maremont <firstname.lastname@example.org>, <Tom.Burton@wsj.com>, Avril, Tom <email@example.com>, <firstname.lastname@example.org>, Loftus, Peter <email@example.com>, Knowles, Joseph <firstname.lastname@example.org>, <Doug.Lankler@pfizer.com>, <email@example.com>, Gruber, William C <Bill.Gruber@pfizer.com>
Drs. Woodcock and Marks,
As it is now increasingly clear that the COVID-19 vaccines are all likely to have a non-negligible risk of thromboembolic complications, it is critically important that FDA and CDC take immediate steps to mitigate against this specific risk of harm.
As you know, it remains my prognostication that the risk of such thromboembolic complications (Not just CST, but all thromboembolic disease) is heightened in recently infected persons. Therefore, I had previously proposed, and continue to endorse, a #ScreenB4Vaccine framework for risk minimization to American citizens and residents in potential harm’s way in the midst of this outbreak.
But, irrespective of whether my risk prognostication about indiscriminate vaccination of the the recently infected turns out to be true or not, simply the fact that these vaccine are now known to cause a risk of catastrophic thromboembolic complications makes it critically important for FDA and CDC to minimize the probability of such harm on a population level. I believe that a #ScreenB4Vaccine framework will continue to serve this goal by eliminating the need for UNNECESSARY vaccinations in those persons already naturally immune — as you know upwards of 20–30% of Americans are already naturally immune.
Your agency MUST, therefore, consider that by excluding the naturally immune from indiscriminate vaccination, not only are you reducing the probability of iatrogenic harm from a vaccine mediated thromboembolic complication, you will also be increasing the speed to herd immunity by not WASTING vaccine doses on Americans very likely to be already immune.
My respectful suggestion is that you not continue to ignore the #ScreenB4Vaccine safety device I’ve proposed to you for protecting the American people from iatrogenic harm using these new COVID-19 vaccines — specifically, in persons who, at best, do not need them and, at worst, may be at an increased risk of harm from indiscriminate vaccination.
The ball is in your court Dr. Woodcock — and, in my opinion, at stake is the credibility of your entire agency before the American public.
I will tell you with certainty that if you move towards implementation of a nationwide #ScreenB4Vaccine clinical vaccine safety protocol, not only will you save many lives from harm, but you will have catapulted the nation towards herd immunity with all due urgency by not wasting vaccine doses in persons who do not benefit from them. I know, with certainty, that by so doing, you will earn the sustained trust that Americans must maintain in our government.
I write in friendship, in defense of US public health and in the name of Dr. Amy Josephine Reed of Yardley, PA.
Hooman Noorchashm MD, PhD.