FDA hires new vaccine director, a year after two senior leaders quit in protest

After almost exactly a year since the FDA’s top two vaccine leaders left in protest over boosters-for-all, the FDA has now named former Merck VP David Kaslow as its new director of CBER’s Office of Vaccines Research and Review.

Peter Marks

Kaslow will replace acting director Peter Marks (who is also head of CBER) after he had to step in to replace Marion Gruber, who resigned suddenly alongside her deputy Philip Krause in late 2021 after they disagreed with the agency’s booster strategy.

After quitting with little explanation after decades at the agency, Gruber and Krause (whose Twitter bio now reads “not anti-booster”) penned a Washington Post op-ed in which they said they didn’t “think boosters for all are necessary, even with the emergence of the omicron variant.” They also co-authored an article in the Lancet discussing the available vaccine data, saying it “did not support widespread boosting.”

Marion Gruber

Nevertheless, the boosters-for-all strategy went forward, and data now suggest that the third shot did save lives.

But that focus on equal access to vaccines globally, which Gruber and Krause also discussed early on, will likely play a role in Kaslow’s approach considering his recent work at the nonprofit PATH, which focuses on health equity, and where he served most recently as CSO.

Kaslow brings with him more than 35 years of experience in vaccine R&D, including more than a decade at the nonprofit PATH, as well as a VP and head of vaccine integration and management at Merck, and founder of the Malaria Vaccine Development Unit at NIH, where he spent 13 years.

Kaslow will assume his new role on October 11 at a key moment for the agency as the current round of bivalent booster shots for Covid-19 are being distributed, as key human data begins to trickle in on these vaccines from Pfizer/BioNTech and Moderna, and as the next round of flu shots (2023) will go before VRBPAC.

“David has been an incredible leader to the PATH team for the entirety of his decade-long tenure. His work has led to thousands of improved lives and many more averted illnesses and deaths,” Nikolaj Gilbert, president and CEO of PATH, said in a statement. “His expertise and scientific acumen are outshined only by his compassion, respect for his colleagues within and outside PATH, and his reputation as a principled leader and public health advocate.

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