Two senior FDA vaccine regulators are stepping down

The outside of the Food and Drug Administration headquarters is seen in White Oak, Md.

Al Drago | CQ Roll Call | Getty Images

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 the office’s 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 BioCentury, and later followed by other outlets, including Stat News.

Their announced plans to depart come as the Biden administration prepares to begin offering Covid vaccine boosters shots to the general public the week of Sept. 20. Some in the science community saw the move by the administration 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.