Two senior FDA vaccine companies step down

The outside of the Food and Drug Administration headquarters can be seen in White Oak, Maryland.

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Two senior Food and Drug Administration officials responsible for reviewing Covid-19 vaccine applications will leave the federal agency in the fall, a agency spokesman confirmed Tuesday.

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

“Thank you Marion and Phil for everything you have contributed and continue to contribute to the agency, and thank you to each of you for everything you do every day,” said Dr. Peter Marks, the FDA’s chief vaccine regulator, in the letter.

The news was previously reported by the biotech website BioCentury.

Their announced plans to leave come as the Biden government prepares to offer Covid vaccine booster shots to the general public in the week of September 20th. Some health professionals viewed the move as premature and political, especially because the FDA has not yet finalized its review of the data on boosters.

Endpoints News, a biotech industry publication, reported that officials are leaving the company frustrated that the Centers for Disease Control and Prevention and their advisory committee are involved in decisions they believe will be left to the FDA should.

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

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