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Illustration: Aïda Amer/Axios

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.

Go deeper

FDA approves AstraZeneca COVID drug for people with immune problems

Photo: Qilai Shen/Bloomberg via Getty Images

The Food and Drug Administration issued an emergency use authorization for an AstraZeneca COVID-19 antibody drug for people with compromised immune systems.

Why it matters: The drug, Evusheld, is the first antibody therapy authorized in the U.S. to prevent coronavirus symptoms before virus exposure.

Dan Primack, author of Pro Rata
Dec 8, 2021 - Health

Ex-FDA chief: COVID jabs could become as common as flu shots

Photo by Alex Edelman-Pool/Getty Images

Former FDA commissioner Stephen Hahn tells Axios that Americans may eventually require annual COVID vaccination boosters, although acknowledges that right now it's just his "best guess."

Why it matters: COVID jabs could become as routine as flu shots.

Dec 8, 2021 - Health

Nearly all U.S. cases of Omicron are mild, CDC director says

U.S. Centers for Disease Control and Prevention Director Rochelle Walensky. Photo: Stefani Reynolds/Pool via Getty Images

Of the more than 40 known cases of the Omicron variant in the U.S., nearly all are mild, Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky said Wednesday in an interview with AP.

Why it matters: Concern has ramped up with health experts forecasting a rise in Omicron cases. Over three-quarters of U.S. patients had been vaccinated, and one-third had gotten their booster shots, according to Walensky.

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