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# Woodcock Attempts to Quell CBER Dissent
- URL: https://www.fdaweb.com/woodcock-attempts-to-quell-cber-dissent/
- Published: 2021-09-01T12:00:00.000Z
- Updated: 2026-09-14T17:12:40.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5150060

In the wake of the departures of two senior CBER vaccine officials ([see earlier story](https://www.fdaweb.com/two-top-cber-vaccine-officials-leaving-fda/)), FDA acting commissioner **Janet Woodcock** has weighed in, pledging support and asserting confidence that she and the agency have in the Center’s ability to deliver safe and effective vaccines during the pandemic. 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, reportedly due to frustrations related to how the Biden Administration has gotten ahead of the agency in announcing Covid-19 booster vaccines’ availability.

The officials reportedly 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. Presumably, they were disturbed by the advisory committee’s vote last 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.

In an 8/31 email to CBER staff, Woodcock said: “I am confident in the team that will remain in place under Peter’s \[CBER director **Peter Marks**\] leadership. We have put together a plan that will allow us to continue prioritizing science, while meeting timelines that are important to ensuring the end of the devastating pandemic... These are difficult time, requiring extraordinary effort, and I want to take the opportunity to once again thank you for your perseverance and dedication. The issues are complex and the days are long, bur please know the work you all have done to date and will continue to do in the days, weeks and months ahead, will hopefully one day allow us to fully put Covid-19 behind us and better prepare us for future challenges.”

FDA observers are worried that the agency is losing some of its independence due to political pressure over the timing of Covid vaccine booster shots. FDA’s credibility took a hit during the Trump Administration when the former president pressured it to authorize a vaccine before the 2020 election and allow use of unproven Covid-19 treatments. It would again be demoralizing to current FDA staff if the Biden Administration overstepped its bounds further with Covid products under review, not to mention the affect on the public’s confidence, which is already shaken from misinformation and changing scientific knowledge related to Covid-19.  

A *Politico* [report](https://www.politico.com/news/2021/08/31/biden-booster-plan-fda-508149?ref=fdaweb.com) compiled from conversations with 11 current and former health officials describes growing exasperation with the administration’s “disjointed process for implementing its booster plan. Those sources said there is little coordination between federal health agencies, even as two top FDA officials try to guide the rollout.”

The administration’s Covid-19 czar, **Jeff Zients,** supported FDA and its regulatory “gold standard” shortly after the CBER officials’ departure news, according to the report. “\[The booster\] decision was made by and announced by the nation’s leading public health officials… and as our medical experts laid out having reviewed all the available data, it is in their clinical judgment that it’s time to prepare Americans for a booster shot,” he said. “We announced our approach to stay ahead of the virus and to be transparent on latest data.”

Additionally, heightened tensions between FDA regulators and top Biden administration officials remain as the agency begins to weigh making vaccines available to children under 12, whose bodies react differently to both the virus and the vaccines, *Politico* notes. “FDA will have to decide whether the rising number of cases in kids warrants making shots available to them on an emergency basis, before the lengthier approval process, which is more likely to detect any rare side effects,” the report says.