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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