Two High F.D.A. Vaccine Regulators to Depart This Fall

The FDA is also expected to address the question of whether to approve coronavirus vaccines for children under the age of 12 in an emergency shortly.

Last week, the agency fully approved the Pfizer BioNTech vaccine for people ages 16 and older, a major decision that prompted a number of vaccine mandates in businesses, universities, hospitals, and elsewhere.

These and many other decisions were made by the teams headed by Dr. Gruber and Dr. Krause under the direction of Dr. Marks too.

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

Both Dr. Gruber and Dr. Krause have been in office for 30 years and have many years of experience in testing vaccines, including those against Ebola. The office they head evaluates annual flu vaccines, including the strains each annual version targets, and played a pivotal role in the FDA’s approval of three coronavirus vaccines, including a single-dose vaccination from Johnson & Johnson.

Their office also guides manufacturers on the types of studies to conduct to evaluate new vaccines and then reviews the data on them. The FDA came under tremendous pressure from Trump administration officials last fall to dilute or sink the standards it set for approving emergency vaccines, but prevailed when the guidelines were released. Dr. Stephen M. Hahn, the FDA commissioner under President Donald J. Trump, said Tuesday that Dr. Gruber and Dr. Krause “held together and put together amazing resources and got the permits in record time”.

“They’re setting the gold standard” for vaccine review, said Dr. Luciana Borio, the agency’s former acting chief scientist under President Barack Obama. During the pandemic, she added, “They lowered their heads and organized their team to do this work under tremendous pressure, but in a rigorous, expedited and flexible form.”

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