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.
In November, they revealed in an op-ed in the Washington Post, alongside Paul Offit, a prominent member of VRBPAC, that they had significant questions about the utility of vaccine boosters for healthy, younger adults, saying the case “is not strong — and those shots would do more good elsewhere.”
The newly revealed emails, in particular a message from Gruber raising concerns about the FDA’s review process, may help explain their sudden departures.
While the vaccines had already been given to millions of Americans under an emergency authorization, some holdouts had said they were waiting for full approval before getting the shots.
And governments and employers were awaiting full approval as a step needed to mandate the shots.
The vaccines have proven to be safe, and evidence shows that they have saved large numbers of lives. A handful of possible side effects have been identified, including risk of myocarditis in some young men.
But despite their good track record, there remains hesitancy among a minority of Americans about getting vaccinated …