An Early Warning To FDA: On Indiscriminate COVID-19 Vaccination In Children With Recent or Asymptomatic SARS-CoV-2 Infections.
Today, 4/11/2021, I submitted the below email of concern to the FDA commissioner, Dr. Janet Woodcock, and her colleague, Dr. Peter Marks.
This email was prompted by my full recognition of the critical importance and urgency of efficiently and safely vaccinating pediatric populations against COVID-19 in the near future.
However, I am extremely concerned that indiscriminate deployment of these powerfully effective COVID-19 vaccines in children, who are either asymptomatically infected or were recently infected, might trigger a hazardous systemic inflammatory response.
In my opinion, this potential danger to our children MUST be fully mitigated by FDA, CDC and every practicing pediatrician and concerned regulator.
But because of the FDA’s unwillingness to acknowledge the potential danger of vaccinating recently infected adults, I am concerned that the same level of regulatory laxity is at work in the pediatric space. But, as any parent in America will acknowledge, the cost of a federal regulatory error in the pediatric space will be unforgivable.
I will reiterate my professional opinion and immunological prognostication that indiscriminate vaccination of the recently or concurrently infected, in the midst of an outbreak, is a potentially critical and dangerous public health error — this holds in the adult space, but especially so in the pediatric space, where the stakes are, arguably, far higher.
Given that there is still time before the COVID-19 vaccines are deployed in American children, it is my hope that FDA and the vaccine manufacturers will address the warnings and prognostication I have raised with integrity and scientific cogency in defense of US public health.
Here is my e-mail to Drs. Woodcock and Marks:
— — — — — Forwarded message — — — — -
From: Hooman Noorchashm <noorchashm@gmail.com>
Date: Sun, Apr 11, 2021 at 10:28 AM
Subject: FDA COMMUNICATION — Pediatric COVID-19 Vaccination
To: Woodcock, Janet <Janet.woodcock@fda.hhs.gov>, Marks, Peter <Peter.Marks@fda.hhs.gov>
Cc: Constant, Gerri S <gsconstant@cbs.com>, McNally, Kelly <kelly.mcnally@foxnews.com>, hornblowers <hornblowers@cbsnews.com>, Stark, Karl <kstark@inquirer.com>, Grady, Denise <grady@nytimes.com>, Kamp, Jon <jon.kamp@wsj.com>, <betsy.mckay@wsj.com>, Loftus, Peter <peter.loftus@wsj.com>, Peter Lurie <plurie@cspinet.org>, Michael Paasche-Orlow <MicXXXXXXXXXXXX.org>, June MD, Carl H <XXXXXXX.edu>, <Tom.Burton@wsj.com>, Reyn Archer <reyn.archer@mail.house.gov>, <charlotte_pineda@marshall.senate.gov>, Knowles, Joseph <joseph.knowles@mail.house.gov>, Gruber, William C <Bill.Gruber@pfizer.com>, <albert.bourla@pfizer.com>, <Doug.Lankler@pfizer.com>, Tierney, Julia <Julia.Tierney@fda.hhs.gov>, <offit@XXXXXXX.edu>
Dear Drs. Woodcock and Marks,
As we anxiously await the arrival of efficacy and safety data justifying urgent use of COVID-19 vaccines in children, I am compelled to communicate a critically important concern with you — so that, perhaps, FDA can do better on the pediatric side, by ensuring robust and well mitigated safety of the vaccine in children.
First, for the benefit of those reporters CC’d here, I will state my categorical opinion as a physician-immunologist that it is critical for us to vaccinate children against COVID-19 with all urgency for three main reasons:
1) Thousands of children have been harmed by post-COVID-19 MIS-C inflammatory disease. This can and must be prevented by urgent vaccination,
2) Vaccine immunity is highly likely to prevent or dramatically reduce the risk of community transmission from children to other susceptible members of the community,
3) Prevention of natural infection in children will limit the virus’ ability to mutate new and potentially more virulent strains, which occurs in the naturally infected — including children.
So to be clear, childhood vaccination is critically important to pediatric health and to overall public health — and I look forward to urgently vaccinating my own children:
https://noorchashm.medium.com/heres-why-my-kids-will-get-the-covid-19-vaccine-asap-e6afb796e2df
However, it is also critically important, especially in children, to acknowledge that the vast majority of those infected will be asymptomatic carriers and that avoiding indiscriminate vaccination of these recently infected children with SARS-CoV-2 is HIGHLY likely to be critical for their safety.
As with adults, it is likely to be a very costly, yet totally avoidable error, in at least a minority subset of unsuspecting families, to indiscriminately use the COVID-19 vaccine in children with concurrent or recent COVID-19 infections.
Here, I write for your record at FDA and to inform you that, perhaps even more so than in adults, indiscriminate COVID-19 vaccination in children with recent or concurrent SARS-CoV-2 infections could be a hazardous, and even deadly, error in regulatory and clinical judgement. As of this writing, neither FDA nor CDC have adequately addressed or worked to mitigate against this potential danger to the lives of a minority subset of unsuspecting adult citizens. As I have detailed before, this is a serious error of omission and downplay on your agency’s part — and I hope you do not continue to make it as we begin to prepare for vaccination of pediatric populations in the near future.
Please recognize that the most dramatic difference between the COVID-19 vaccine campaign and any other in the history of vaccine campaigns in America is that we are rapidly deploying this highly effective vaccine in the midst of an outbreak when many millions are recently or concurrently (and asymptomatically) infected.
If America can put a rover on Mars, we can certainly mitigate against indiscriminate vaccination of the COVID-19 infected in the midst of a pandemic outbreak.
I write to you in friendship and in defense of US public health,
Hooman Noorchashm MD, PhD.
