A Public Letter to FDA Commissioner, Dr. Janet Woodcock: Safety Error In The February 10, 2021 CDC Guidance Update on COVID-19 Vaccination.
Today, 2/15/2021, I submitted the following e-mail to FDA commissioner, Dr. Janet Woodcock.
My e-mail of concern and warning was prompted by the language used in the CDC’s February 10, 2021 revised “Interim Clinical Considerations for Use of mRNA COVID-19 Vaccines Currently Authorized in the United State”.
It is my expert professional opinion, as an American physician and Immunologist, that indiscriminate vaccination of persons previously, or currently, infected with SARS-CoV-2 poses a risk of harm to these individual. Therefore, as I have delineated for FDA Commissioner, Dr. Janet Woodcock, the language of the guidance provided by the CDC, as well as the FDA warning label on the Pfizer and Moderna vaccines, likely poses a danger to public health.
With this letter, I have again requested that Dr. Woodcock help her colleagues at FDA and CDC, as well corporate executives at Pfizer and Moderna, to amend and modify the language of their guidance and warning labels — in order to protect those infected who are likely at risk of harm from indiscriminate COVID-19 vaccination.
Please read the following with care and share with all concerned citizens of the United States and other nations.
— — — — — Forwarded message — — — — -
From: Hooman Noorchashm <email@example.com>
Date: Mon, Feb 15, 2021 at 8:47 AM
Subject: Re: WARNING To Pfizer — The Danger of Indiscriminate Vaccination of The Recently Infected With Your COVID-19 mRNA Vaccine.
To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>
Cc: firstname.lastname@example.org <email@example.com>, Marks, Peter <Peter.Marks@fda.hhs.gov>, Gruber, William C <Bill.Gruber@pfizer.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>, firstname.lastname@example.org <email@example.com>, Kamp, Jon <firstname.lastname@example.org>, mark.maremont <email@example.com>, Loftus, Peter <firstname.lastname@example.org>, email@example.com <firstname.lastname@example.org>, Amy.Marcus@wsj.com <Amy.Marcus@wsj.com>, Alison Motluk <email@example.com>, Kris Mamula <firstname.lastname@example.org>, Michael Paasche-Orlow <MichaelXXXXXX@XXXXX.org>, Thomas Greene <email@example.com>, Tucker Greene <firstname.lastname@example.org>, June MD, Carl H <cXXXXX@XXXXXXX.edu>, Caplan, Arthur <arthurXXXXXXX@XXXXXXX.org>
Dear Dr. Woodcock,
I have reviewed the Feb.10, 2021 update to the CDC’s “Interim Clinical Considerations for Use of mRNA COVID-19 Vaccines Currently Authorized in the United States”:
In this document, it is stated that:
“Data from clinical trials indicate that mRNA COVID-19 vaccines can safely be given to persons with evidence of a prior SARS-CoV-2 infection. Vaccination should be offered to persons regardless of history of prior symptomatic or asymptomatic SARS-CoV-2 infection. Viral testing to assess for acute SARS-CoV-2 infection or serologic testing to assess for prior infection for the purposes of vaccine decision-making is not recommended.”
This statement is dangerous to public health in the United States and the science underlying it, is weak — at best. I’ve delineated the reasons why I am stating this in prior letters to Drs. Bill Gruber and Albert Bourla of Pfizer, as well as to yourself and Dr. Marks. Though the clinical trials that preceded the vaccine EUA did include a number of patients with prior or asymptomatic infections, the numbers of such subjects were too small to elucidate a well powered safety signal. Additionally, it is nearly certain that the subset of recently or currently infected patients who were elderly and frail with underlying cardiovascular disease were almost entirely excluded from the trial. It is a simple fact that FDA, Pfizer and Moderna do NOT know whether the vaccine is safe in such vulnerable persons with recent or prior SARS-CoV-2 infections. Therefore, the above statement from the CDC is dangerously misleading or entirely false.
The document goes on to state:
”Vaccination of persons with known current SARS-CoV-2 infection should be deferred until the person has recovered from the acute illness (if the person had symptoms) and criteria have been met for them to discontinue isolation.”
One is left wondering: what about persons with unknown, or occult, SASR-CoV-2 infections at the time of their vaccination? If FDA, CDC, Pfizer and Moderna know that vaccination may pose a danger to the health of persons “known” to be actively infected with SAR-CoV-2, what about the asymptomatic or mildly symptomatic infected? Are they not at risk of harm? If not, where is the data to demonstrate this? What’s even more concerning and contradictory in the CDC guidance is the prior paragraph’s statement that, “Viral testing to assess for acute SARS-CoV-2 infection or serologic testing to assess for prior infection for the purposes of vaccine decision-making is not recommended.” In other words, FDA, CDC, Pfizer and Moderna recognize that a “known” infection with the virus poses a risk to the vaccinated, but none would recommend finding out who the infected actually are? This clear contradiction is striking and likely dangerous to public health — and it amounts to nothing more than guess work, as all know that vaccinating the infected is a risky proposition.
I am sure that you have read my analysis of the death of Dr. J. Barton Williams of Memphis, TN by now:
It is highly unlikely that this physician’s death is unrelated to his vaccination in the setting of a prior asymptomatic COVID-19 infection. This “anecdote”, should be a loud safety signal to you and to all FDA and CDC regulators — as well as to Pfizer and Moderna executives.
The FDA and CDC surveillance systems are too passive and subjective to detect safety signals with adequate granularity — this I know and understand deeply. Certainly when the entire mainstream of the US medical establishment and the mainstream press are prone to quickly label most post-vaccine complications and deaths as “unrelated” to the vaccine, it is highly likely that you will miss a safety signal in the midst of this enormous drive to vaccinate as many people as possible, as quickly as possible, in America.
Dr. Woodcock, the CDC recommendation discouraging antigen or serological screening prior to vaccination is a dramatic and illogical failure in safe regulatory guidance — because it will lead to blanket vaccination of persons with occult recent or prior SARS-CoV-2 infection. And the assumption that the previously infected, and especially the elderly and frail in this class, are safe from the vaccine is totally baseless and not rooted in reasonable data from a proper clinical trial — not to mention that it fully ignores the basic tenets of cellular immunological science.
I do understand all the real and political pressures FDA and CDC are under to maximally vaccinate the population as fast as possible. But reason and safety consideration must also prevail in the midst of this rush to national recovery using these effective vaccines.
My respectful suggestion is that you guide the CDC, FDA, Pfizer and Moderna to: 1) remove all language discouraging screening prior to vaccination — this must be left to the judgement of individual citizens and treating physicians, 2) amend CDC and FDA language to contraindicate or to delay COVID-19 vaccination in persons with known “OR SUSPECTED” infection, respectively, and 3) eliminate any language baselessly claiming that the vaccine is safe in the previously infected — the case of Dr. J. Barton Williams’ death ought to be a loud enough signal for you and your colleagues to delete such language: At best, we simply do NOT know if this is the case.
Dr. Woodcock, I write to you knowing that you understand fully that healthcare products and services that “benefit the majority” in society must be regulated so as to maximally mitigate against real or potential “minority harm”. The COVID-19 vaccination program is an unprecedented event, where because of the speed necessary to protect the nation, safety mitigations must be maximally deployed, both against known and potential risks — not ignored or glossed over. In this regard the regulatory language used by FDA, CDC, Pfizer and Moderna vis-a-vis indiscriminate vaccination of the recently or currently infected is abysmally unsafe and risks harming some of the most vulnerable citizens of our nation.
I am not certain if you read my communications in any degree of detail — or if the agency and administration’s political lens dictating “FAST VACCINATION”, is diminishing your clarity on the safety warning I have raised with you and Dr. Marks. All I will say in conclusion is that by the time the “evidence” emerges of this risk being material (or immaterial), it may already be too late for the minority harmed — If nothing, Dr. J. Barton Williams’ case MUST be instructive to you, as he will not be alone.
I write for the record — and in friendship to you and to US public health,
Hooman Noorchashm MD, PhD