A Letter of Warning to CDC Director and CDER Chief at FDA: On The 2020 Influenza Vaccine During The COVID-19 Pandemic
The following email of warning was sent to Dr. Redfield, CDC Director, and Dr. Janet Woodcock, Chief of the FDA’s Center for Drug Evaluation and Research (CDER), on May 9, 2020. In addition to these CDC and FDA leaders, prominent members of the press in the United States were CC’d, in order that the press also be informed of the potential risk of the 2020 Influenza vaccine during the COVID-19 pandemic.
It is my hope that the press and our federal public health agencies will be responsive to the warning raised in this public letter — given the potential catastrophic risk the 2020 Influenza vaccine may pose by triggering progression of COVID-19 disease in asymptomatic carriers of the SARS-CoV-2 virus.
From: Hooman Noorchashm <noorchashm@gmail.com>
Date: Sat, May 9, 2020 at 7:59 PM
Subject: WARNING — Fall 2020 Influenza Vaccine in Young Asymptomatic SARS-CoV-2 Carriers
To: Woodcock, Janet <Janet.woodcock@fda.hhs.gov>, <XXXX@cdc.gov>
Cc: Constant, Gerri S <gsconstant@cbs.com>, Kamp, Jon <jon.kamp@wsj.com>, Levitz, Jennifer <jennifer.levitz@wsj.com>, Grady, Denise <grady@nytimes.com>, <betsy.mckay@wsj.com>, <Amy.Marcus@wsj.com>, <amy.dockser@wsj.com>, <joseph.walker@wsj.com>, Murray, Matt <Matt.murray@wsj.com>, Sutton, Charlotte <csutton@philly.com>, Stark, Karl (kstark@phillynews.com) <kstark@phillynews.com>, Charles Ornstein <Charles.Ornstein@propublica.org>, Grewal, Renmeet <renmeet.grewal@fda.hhs.gov>, Peter Lurie <plurie@cspinet.org>, Brian Fitzpatrick <XXXXXX@gmail.com>, Knowles, Joseph <joseph.knowles@mail.house.gov>, McCabe, Michael <michael.mccabe@mail.house.gov>, Alison Motluk <alison.motluk@gmail.com>, hornblowers <hornblowers@cbsnews.com>, <mcruibal@fbi.gov>, Stahl, Stephanie S <stahl@kyw.com>, Maiken Scott <mscott@whyy.org>
Honorable Drs. Woodcock and Redfield,
Here I write for the record to warn the leadership of FDA’s CDER and CDC of a potential high morbidity/mortality risk associated with activation of COVID-19 disease in young asymptomatic SARS-CoV2 carriers this coming Fall 2020.
As you know, millions of Americans (and many more globally) will be receiving the Influenza Vaccine, as per CDC guidelines, in the Fall and early winter of 2020. This guideline may appear to be sound clinical judgement since it would be a terrible scenario if an Influenza epidemic is superimposed on the COVID-19 pandemic. Nonetheless, I write here to warn extreme caution in considering liberal delivery of the 2020 Influenza vaccine during the COVID-19 pandemic.
Specifically, because the subclinical presence of SARS-CoV-2 in asymptomatic carriers is a well documented fact, and particularly in younger and pediatric patients, it is of critical importance for FDA and CDC to determine whether the 2020 Influenza vaccine might trigger activation of COVID-19 disease in such persons.
In the following opinion article, I’ve delineated the serious concern, specifically regarding children and young adults, in a manner accessible to the general public:
I trust that scientists at FDA and CDC also fully understand the basic immunological principle of “bystander immunological activation”, which is operational in both the laboratory setting and clinical diseases — with some very clear example from the basic science and clinical literature. Therefore, in the setting of the COVID-19 pandemic when millions of Americans will certainly be asymptomatic carriers of the SARS-CoV-2 virus by the Fall 2020, it is ABSOLUTELY necessary for the American population to be protected from the potential for iatrogenic COVID-19 disease activation through a “bystander” effect from the 2020 Influenza vaccine. This risk is NOT only theoretical as you know — with many example of disease activation following iatrogenic vaccination.
With this public email to your offices, I ask that CDC and FDA immediately move to determine whether a dangerous pathogenic interaction between the Influenza vaccine and the SARS-CoV-2 virus might occur — or to mitigate against the possibility.
My respectful suggestion for mitigation, at minimum, be that the 2020 Influenza vaccine ONLY be administered to patients whose SARS-CoV-2 antigen screen is negative — in particular in the pediatric and young adult subsets of patients.
I trust that you will take the content of this letter of warning to your agencies seriously and immediately engage the appropriate personnel within your agencies to address the potential dangerous interaction between the 2020 Influenza vaccine and the SARS-CoV-2 virus.
With respect,
Hooman Noorchashm MD, PhD.
