The FDA is also expected to soon consider whether to approve 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 sparked a series of vaccine mandates at companies, universities, hospitals and elsewhere.
That decision and a host of others fell to teams led by Dr. Gruber and Dr. Krause, who under Dr. Marks worked.
The FDA reviews vaccine manufacturers’ data on safety and efficacy, sometimes making 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 hearing from its own outside panel of experts.
Both Dr. Gruber as Dr. Krause has been with the agency for 30 years and has long experience evaluating vaccines, including for Ebola. The agency they lead evaluates annual flu vaccines, including which strains are each year’s release targets, and it played a pivotal role in the FDA’s approval of three coronavirus vaccines, including a single-dose injection from Johnson & Johnson.
Their office also guides manufacturers through the types of studies to conduct to evaluate new vaccines, and then reviews the data on them. The FDA came under tremendous pressure last fall from Trump administration officials to water down or lower the standards it had set for emergency authorizations for vaccines, but got the upper hand in publishing the guidelines. dr. Stephen M. Hahn, the FDA commissioner under President Donald J. Trump, said on Tuesday that Dr. Gruber and Dr. Krause “stood together and accumulated great resources and got the authorizations done in record time”.
“They set the gold standard” for vaccine assessments, said Dr. Luciana Borio, the former acting chief scientist at the bureau 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, accelerated and flexible form.”