Two senior FDA officials resigned over a disagreement with the Biden White House on Covid booster shots.
Marion Gruber, director of the agency’s Office of Vaccines Research and Review, and her deputy director, Phil Krause, will leave in October and November, according to a statement to CNBC.
The two FDA officials were angry that the CDC and Advisory Committee on Immunization Practices (ACIP) was making decisions on the Covid boosters that fall under the responsibility of the FDA.
Gruber and Krause resigned after the Biden Admin decided to approve the Covid booster program without the FDA’s approval.
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The first Covid booster shot will be available to the public the week of September 20.
Joe Biden also discussed with Fauci requiring Covid boosters every 5 months.
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.
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.