Peter Marks, MD, PhD
Director, FDA Center for Biologics Evaluation and Research (CBER)
Led FDA's biologics center during COVID-19 vaccine authorization and surveillance.
Timeline appearances (9)
- analysis
Szarfman raises COVID-19 vaccine safety monitoring concerns with CBER Director Marks.
- analysis
Szarfman presents RGPS to Marks and other CBER officials, calling MGPS not state of the art.
- analysis
Szarfman shares DuMouchel's RGPS analysis showing 49 examples of extreme masking with senior FDA officials.
- internal
Forshee forwards Szarfman's mortality findings to Marks, expressing concern about her interpretation.
- internal
Anderson asks Marks that Szarfman refrain from using FDA email or communicating findings using CBER VAERS data.
- internal
Marks tells Cavazzoni that Szarfman has been asked to cease and desist on her vaccine analysis.
- oversight
Sen. Johnson writes to Collins, Walensky, Woodcock, Marks, and Shimabukuro about federal safety surveillance systems and reports of adverse events following COVID-19 vaccination.
- publication
Walinsky circulates Szarfman's preprint to FDA officials weighing Moderna's pediatric COVID-19 vaccine appeal.
- publication
Forshee notifies Marks and Anderson that FDA officials are addressing issues with Szarfman's published paper.
Quotes (2)
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"create erroneous conflicts that feed in to anti-vaccination rhetoric"
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"Ana Szarfman[] has decided on her own to do vaccine analysis using VAERS as part of her work at FDA. She is, however, not doing this in collaboration with our CBER statisticians, and quite to the contrary, has been asked to cease and desist, because the strategy that she is using could create erroneous conflicts that feed in to anti-vaccination rhetoric."