Marion Gruber, former director of the FDA’s Office of Vaccines Research and Review

FDA emails show how vac­cine leader ques­tioned 'hy­per-ac­cel­er­at­ed' 2021 re­view of Pfiz­er shot

The FDA’s top vac­cine of­fi­cial raised con­cerns that a sharply ac­cel­er­at­ed process to re­view and for­mal­ly ap­prove Pfiz­er’s Covid-19 vac­cine would un­der­mine pub­lic con­fi­dence in the shots, lead­ing to a se­ries of vig­or­ous ex­changes be­tween her and the agency’s se­nior lead­ers.

The emails, con­tained in a pub­lic records dis­clo­sure post­ed by the FDA, shed new light on an episode in late 2021 when Mar­i­on Gru­ber, di­rec­tor of the FDA’s Of­fice of Vac­cines Re­search and Re­view and a 32-year vet­er­an of the agency, abrupt­ly an­nounced her de­ci­sion to leave the agency. Her deputy, Phil Krause, who had been at FDA for more than a decade, al­so an­nounced his de­par­ture, 10 days af­ter the vac­cines were for­mal­ly ap­proved.

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