Two Top F.D.A. Vaccine Regulators Are Set to Depart During a Crucial Period
The F.D.A. is also expected soon to tackle the question of whether to authorize coronavirus vaccines on an emergency basis for children under 12.
Last week, the agency fully approved the Pfizer-BioNTech vaccine for people 16 and older, a major decision that spurred a series of vaccine mandates at corporations, universities, hospitals and elsewhere.
That decision and a host of others fell to teams led by Dr. Gruber and Dr. Krause, working under Dr. Marks.
The F.D.A. reviews data from vaccine manufacturers on safety and efficacy, and sometimes makes decisions with input from the outside advisory committee of vaccine experts. The agency’s decisions are followed by recommendations from the Centers for Disease Control and Prevention, after it hears from its own outside panel of experts.
Both Dr. Gruber and Dr. Krause have been at the agency for 30 years and have long experience reviewing vaccines, including for Ebola. The office they lead evaluates annual flu vaccines, including which strains each year’s version targets, and it had a central role in the F.D.A.’s authorization of three coronavirus vaccines, which also include a single-dose shot from Johnson & Johnson.
Their office also guides manufacturers on what kinds of studies they need to conduct to evaluate new vaccines, then reviews the data on them. The F.D.A. came under enormous pressure last fall by Trump administration officials to water down or scuttle standards it had set for vaccine emergency use authorizations, but prevailed in publishing the guidelines. Dr. Stephen M. Hahn, the F.D.A. commissioner under President Donald J. Trump, said on Tuesday that Dr. Gruber and Dr. Krause “stuck together and marshaled amazing resources and got the authorizations done in record time.”
“They set the gold standard” for vaccine reviews, said Dr. Luciana Borio, the former acting chief scientist at the agency under President Barack Obama. During the pandemic, she added, “they put their heads down and organized their team to do this work under tremendous pressure, but do it in a rigorous, expedited and flexible form.”
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