Two major FDA vaccine regulators to leave this fall

The FDA is also expected to tackle the issue of emergency authorization of coronavirus vaccines for children under 12 in the near future....


The FDA is also expected to tackle the issue of emergency authorization of coronavirus vaccines for children under 12 in the near future.

Last week, the agency fully approved the Pfizer-BioNTech vaccine for people 16 and older, a major move that has spurred a series of vaccination mandates in businesses, universities, hospitals and elsewhere.

This decision and a host of others fell to the teams led by Dr Gruber and Dr Krause, working under the direction of Dr Marks.

The FDA reviews data from vaccine manufacturers on safety and efficacy, and sometimes makes decisions with input from the external advisory committee of vaccine experts. The agency’s decisions are followed by recommendations from the Centers for Disease Control and Prevention, after hearing its own panel of external experts.

Dr Gruber and Dr Krause have both been with the agency for 30 years and have extensive experience reviewing vaccines, including against Ebola. The office they lead evaluates annual flu shots, including target strains for each year’s release, and it was central to the FDA clearance of three coronavirus vaccines, which also include a single dose vaccine from Johnson & Johnson.

Their office also guides manufacturers on the types of studies they should conduct to evaluate new vaccines, and then reviews the data on them. FDA underwent enormous pressure last fall by Trump administration officials to relax or scuttle the standards he set for emergency vaccine authorizations, but which prevailed when the guidelines were released. Dr Stephen M. Hahn, commissioner of the FDA under President Donald J. Trump, said on Tuesday that Dr Gruber and Dr Krause “have stuck together and amassed incredible resources and obtained clearances in record time.”

“They set the gold standard” for vaccine reviews, said Dr Luciana Borio, the agency’s former acting chief scientist under President Barack Obama. During the pandemic, she added, “they have bowed their heads and organized their team to do this work under tremendous pressure, but are doing it in a rigorous, expedited and flexible manner.”

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Newsrust - US Top News: Two major FDA vaccine regulators to leave this fall
Two major FDA vaccine regulators to leave this fall
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