Thirty-two-year FDA veteran Marion Gruber is leaving her position as director of FDA's Office of Vaccines Research & Review (OVVR) in October, and her deputy, Dr. Philip Krause, who has worked in the OVVR for 10 years, is leaving in November. According to The Defender,1 Gruber and Krause:

"… reportedly said they don't believe there is data to support the Biden administration's push to offer COVID booster shots later this month …

However, a former senior FDA leader told Endpoints News, Gruber and Krause are departing because they're frustrated the Centers for Disease Control and Prevention (CDC) and its advisory panel — the Advisory Committee on Immunizations and Practices (ACIP) — are involved in decisions they think should be up to the FDA.

The source said he heard Gruber and Krause were upset with [FDA's Center for Biologics Evaluation and Research, CBER, director Dr. Peter] Marks for not insisting those decisions be kept inside the FDA, and with the White House for getting ahead of FDA on booster shots."

"The news, first reported by BioCentury, is a massive blow to confidence in the agency's ability to regulate vaccines," Endpoints News said.2 Former director of Biomedical Advanced Research and Development Authority (BARDA) Rick Bright called the resignations a "huge global loss."