Risk Evaluation of anaphylaxis with the Pfizer-BioNTech COVID-19 vaccine

A Drug Safety Physician’s Message to Dr. Peter Marks (U.S. Food and Drug Administration) Regarding Risk Evaluation of Anaphylaxis with the Pfizer-BioNTech COVID-19 Vaccine

Carol Taccetta, M.D., F.C.A.P

Click to read full letter with references

ORIGINALLY EMAILED 22 DECEMBER 2020and published at Pandata.

Please note: the views expressed here are my personal opinions and do not reflect the views of former or current employers or any professional organizations to which I belong.

Dear Dr. Marks,

Although initially trained and board-certified as a clinical pathologist, I have been working as a physician in the pharmaceutical industry for over two decades. Most of my experience has been in drug safety. I need to share that, for many years, I have had nothing but the utmost respect for the FDA and their decisions. Of all my interactions with the FDA, I am most proud of serving as a Sponsor’s Responsible Medical Officer…