Two senior FDA vaccine regulators are stepping down

Two senior Food and Drug Administration officials responsible for reviewing Covid-19 vaccine applications are leaving the federal agency this fall, an agency spokesperson confirmed Tuesday.

Marion Gruber, director of the FDA’s Office of Vaccines Research & Review, and deputy director Phil Krause will exit the agency in October and November, respectively, according to a letter shared with CNBC by FDA spokeswoman Stephanie Caccomo.

“Thank you so much to Marion and Phil for all that they have contributed and continue to contribute to the agency, and thanks so much to each of you for all that you do every day,” FDA top vaccine regulator Dr. Peter Marks said in the letter.

The news was reported earlier by the biotech website BioCentury.

Their announced plans to depart come as the Biden administration prepares to begin offering Covid vaccine booster shots to the general public the week of Sept. 20. Some health experts saw the move as premature and political, especially because the FDA hasn’t finished reviewing data on boosters yet.

Endpoints News, a biotech industry publication, reported that the officials are leaving because they’re frustrated that the Centers for Disease Control and Prevention and its advisory committee are involved in decisions they think should be up to the FDA.

The final straw was when the White House got ahead of the agency on booster shots, according to Endpoints News, citing a former senior FDA leader.

When asked at a briefing later Tuesday whether the departures will affect trust in the FDA, White House Covid czar Jeff Zients said the decision to distribute boosters was made by a number of senior health officials, including acting FDA Commissioner Dr. Janet Woodcock.

“As our medical experts laid out, having reviewed all the available data, it is in their clinical judgment that it is time to prepare Americans for a booster shot,” he said.