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# Two Top CBER Vaccine Officials Leaving FDA
- URL: https://www.fdaweb.com/two-top-cber-vaccine-officials-leaving-fda/
- Published: 2021-08-31T12:00:00.000Z
- Updated: 2026-09-14T17:12:34.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5150047

Two senior CBER vaccine officials are leaving FDA over the next couple of months — untimely departures that signal trouble with how the agency and Biden Administration are handling Covid-19 vaccine reviews and approvals. CBER Office of Vaccines Research and Review (OVRR) director **Marion Gruber** plans to retire 10/31, and OVRR deputy director **Philip Krause** will be leaving in November, according to an [email ](http://www.fdaweb.com/download.php?file=Personnel%5FAnnouncement.pdf)from CBER director **Peter Marks**. Gruber has been at FDA for 32 years, whereas Krause has been there for about 11 years.

Marks’ email makes no mention as to why both officials have decided to simultaneously announce their departures at this critical time when the agency is diligently working to grant full approval to Covid-19 vaccines, authorize their use more broadly in the pediatric population, and allow booster shots that are being planned to begin this fall.

A [report from *Endpoints News*](https://endpts.com/breaking-in-a-major-blow-to-vaccine-efforts-senior-fda-leaders-stepping-down-report/?ref=fdaweb.com) senior editor **Zachary Brennan** indicates that the officials have been “frustrated by CDC and its *Advisory Committee on Immunization Practices for making decisions on issues that should be reserved for FDA.” A* former FDA official said he’s heard they’re upset with Marks for not insisting that those decisions be retained inside FDA, the report said. Presumably, they were upset with the advisory committee’s vote earlier this month to recommend booster shots for immunocompromised individuals. The final straw reportedly was the White House getting ahead of FDA’s review and announcing that booster shots for all others might be available by the week of 9/20.

The officials’ departures are getting some attention on Twitter. Former FDA acting chief scientist **Luciana Borio** said the agency was “losing two giants who helped bring us many safe and effective vaccines over decades of public service.” And former Biomedical Advanced Research and Development Authority director **Rick Bright** said the two officials are the true leaders of CBER vaccine reviews and a huge loss. “Dr. Gruber is much more than the director,” he added. “She is a global leader and visionary mastermind behind global clinical regulatory science for the flu, ebola, Mers, Zika, sars-cov-2, and many others.”

Marks’ email said Gruber will officially retire 10/31 and Krause will be leaving in November. He said a search for Gruber’s replacement will begin imminently. In the interim, he will serve as acting OVRR director and will announce details about the acting deputy director shortly.