Two of the FDA's top vaccine regulators, Marion Gruber and Phil Krause, are leaving the agency, which was first reported by BioCentury.
Why it matters: The FDA appears to be increasingly rudderless at a crucial time in the pandemic. The agency still has no permanent commissioner and now is losing two highly regarded vaccine experts all while officials weigh full approval of the COVID-19 vaccines for adults, initial authorization for kids, and booster shots for many.
State of play: Gruber is retiring in October, and Krause is leaving in November, according to a memo from Peter Marks, a top drug director at the FDA. Gruber and Krause weren't immediately available for comment.
What they're saying: The departures shocked people throughout the industry, considering the FDA still has consequential decisions to make about the COVID-19 vaccines and that Gruber and Krause are considered top experts in this field.
- Luciana Borio, a former top FDA scientist, said on Twitter the agency is "losing two giants who helped bring us many safe and effective vaccines over decades of public service."
Between the lines: The Biden administration left a bad taste within the science community last month after officials said booster doses of the mRNA vaccines would be available for Americans starting Sept. 20, pending FDA evaluation of data.
- But many vaccine researchers thought the Biden administration neutered the FDA by saying boosters were going to happen on a specific date, even though the FDA's review had barely begun.
