Turmoil at CBER: Peter Marks grabs control of FDA's Office of Vaccines ahead of 2 key career leader departures

28 Sep 2021
endpts.com
Vaccine
FDA’s top vaccine official Peter Marks is pulling the plug on a months-long transition for two top career vaccine officials who abruptly called it quits in late August. Marion Gruber, director of the FDA’s Office of Vaccines Research & Review and 32-year veteran of the agency, her deputy director Phil Krause, announced their departures and then raised concerns with Covid-19 booster shots ahead of and during a recent Covid-19 booster vaccine advisory committee. “It is important to allow both Marion and Phil to have time to transition before their departure after so many years with our Center,” Marks said in a memo to CBER staff on Monday morning. “Therefore, I want to let you know that beginning today, September 27, I will be assuming responsibilities as the Acting Office Director, and Marion will transition oversight and management of the activities of the office to me.” The memo follows a hectic and at-times confusing few weeks where both Gruber, who said she was leaving in October, and Krause, who said he was leaving in November, announced their departures from FDA, then raised concerns with the booster shots in the Lancet , and questioned Pfizer’s data at the FDA’s vaccine advisory committee reviewing the boosters. At the beginning of the Q&A session at the booster adcomm with Pfizer and the FDA, Gruber gave Krause the opportunity to question Pfizer on the statistical models used in a real-world study in Israel. Krause claimed there was a discrepancy between the efficacy Pfizer reported using a specific model, which said efficacy after 8 months fell to 58% from 61%, but numbers calculated through a different mathematical process using cases per person-years resulted in 93% efficacy. These disparate figures, Krause said, came from the same number of cases in a study by California health care company Kaiser Permanente. Two former FDA chief scientists — Jesse Goodman and Luciana Borio — raised concerns with the New York Times over Marks’s decision to name himself, with Goodman calling it, “extremely unusual and concerning.” But other former senior officials have taken on additional roles as the FDA looks for a permanent replacement. Janet Woodcock was at one time head of both CDER and OND on an acting basis, before becoming acting commissioner, as the agency looked for a permanent OND leader. BioCentury also reported Monday that two additional FDA vaccine reviewers quit their jobs as a result of Marks’s announcement. FDA media relations director Stephanie Caccomo did not respond to an Endpoints News request to verify those other two departures. Paul Offit, a vaccine expert and member of the FDA adcomm that met to discuss the boosters, told Endpoints he thought Gruber and Krause are leaving because they didn’t like the way the booster process played out. “They see their job as protecting the public from pharmaceutical companies’ products that may not have not been adequately tested and I think that’s what worries them about this,” Offit said. Saad Omer, director of Yale’s institute for global health, added, “A lot of specialized expertise has been underutilized and that’s a problem.”
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