Why Key People Quit Over COVID Vaccines

January 24, 2023 03:43 PM ESTUpdated 04:03 PM Coronavirus
FDA emails show how vaccine leader questioned 'hyper-accelerated' 2021 review of Pfizer shot
Zachary Brennan
Senior Editor

The FDA’s top vaccine official raised concerns that a sharply accelerated process to review and formally approve Pfizer’s Covid-19 vaccine would undermine public confidence in the shots, leading to a series of vigorous exchanges between her and the agency’s senior leaders.


Phil Krause

The emails, contained in a public records disclosure posted by the FDA, shed new light on an episode in late 2021 when Marion Gruber, director of the FDA’s Office of Vaccines Research and Review and a 32-year veteran of the agency, abruptly announced her decision to leave the agency. Her deputy, Phil Krause, who had been at FDA for more than a decade, also announced his departure, 10 days after the vaccines were formally approved.

In November, they revealed in an op-ed in the Washington Post, alongside Paul Offit, a prominent member of VRBPAC, that they had significant questions about the utility of vaccine boosters for healthy, younger adults, saying the case “is not strong — and those shots would do more good elsewhere.”

The newly revealed emails, in particular a message from Gruber raising concerns about the FDA’s review process, may help explain their sudden departures. While the vaccines had already been given to millions of Americans under an emergency authorization, some holdouts had said they were waiting for full approval before getting the shots. And governments and employers were awaiting full approval as a step needed to mandate the shots.

The vaccines have proven to be safe, and evidence shows that they have saved large numbers of lives. A handful of possible side effects have been identified, including risk of myocarditis in some young men. But despite their good track record, there remains hesitancy among a minority of Americans about getting vaccinated, and the use of updated boosters has been limited as the most severe consequences of the pandemic have faded for most of the public.



Peter Marks

Gruber, in a July 21 email to Center for Biologics Evaluation and Research (CBER) chief Peter Marks and FDA Acting Commissioner Janet Woodcock, said she was worried about reviewing Pfizer’s vaccine package in less than a third of the usual time.

“Our concern is that a review that is hyper-accelerated beyond the already very rapid September 15 target date,” Gruber said in the email. She raised concerns that the accelerated review would be less thorough, and was “more likely to undermine confidence in the vaccine (and, indeed, in the FDA’s credibility) than to increase it.” Gruber also said she disagreed with a decision to have Marks oversee the review process.

Marks, in a follow-up email to Woodcock shortly after, said that he expected the communication to end up in the public record, and urged Woodcock to push back, adding that he understood that FDA staff were exhausted, but that there was “a lack of urgency and responsiveness to the public health imperative to save lives that seems to be felt by some in leadership of the Office of Vaccines.” He called it “highly disappointing.”

The FDA declined to comment directly on the emails.

“We want to make clear that at no time was there disagreement about whether to license (approve) Comirnaty,” said CBER spokesman Paul Richards, referring to Pfizer’s vaccine.  “Agency staff were under immense pressure to complete the review of the BLA as rapidly as possible, without sacrificing FDA’s standards for review.”

Endpoints News wasn’t able to contact Gruber and Krause.

Endpoints is publishing the emails here, including Gruber’s message to Marks and Woodcock.




Here is Marks’ response to Woodcock.



[The subtext of Peter Marks' response is, "You know they're breaking our rice bowl."]