Two Top FDA Vaccine Regulators Set to Split at a Crucial Time

The FDA is also expected to soon address the question of whether to allow emergency coronavirus vaccines for children under the age of 12.

Last week, the agency fully approved the Pfizer-BioNTech vaccine for people aged 16 and over, a key decision that has spurred a range of vaccine mandates at companies, universities, hospitals and elsewhere.

This decision and many others, Dr. Working under Marks, Dr. Gruber and Dr. It fell to teams led by Krause.

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

Both Dr. Gruber and Dr. Krause has been with the agency for 30 years and has long experience reviewing vaccines, including for Ebola. The office they manage evaluates annual flu vaccines, including release targets for which strains each year, and has played a central role in the FDA’s authorization of three coronavirus vaccines, including a single-dose vaccine from Johnson & Johnson.

Their offices also provide guidance to manufacturers on what types of studies they should do to evaluate new vaccines and then review data on them. FDA came under great pressure Last fall, Trump administration officials decided to dilute or lower the standards it had set for vaccine emergency use authorizations, but prevailed in issuing the guidelines. President Donald J. Trump’s FDA commissioner, Dr. Stephen M. Hahn said on Tuesday, Dr. Gruber and Dr. Krause said they “sticked together and queued up the great resources and got the permits in record time.”

President Barack Obama’s former acting chief scientist, Dr. They “set the gold standard” for vaccine reviews, said Luciana Borio. During the pandemic, he added, “They bent their heads and organized their teams to do this job under tremendous pressure, but they did it with precision, speed and flexibility.”

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