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FDA senior vaccine official Peter Marks is ending a months-long transition for two senior career vaccine officials who abruptly called on him to step down in late August.
Marion Gruber, director of the FDA’s Office of Vaccines Research & Review and the agency’s 32-year veteran, its deputy director Phil Krause, announced their departures and then voiced concerns over Covid booster injections -19 before and during a recent Covid-19 Booster Vaccine Advisory Committee.
“It’s important to allow Marion and Phil time to transition before they leave after so many years with our center,” Marks said in a note to CBER staff on Monday morning. “Therefore, I would like to inform you that effective today, September 27, I will assume the responsibilities of Interim Office Manager and Marion will hand over to me the supervision and management of office activities. “
The note follows a few hectic and at times confusing weeks where Gruber, who said she was leaving in October, and Krause, who said he was leaving in November, announced their departure from the FDA and then shared their concerns about the booster injections in the Lancet, and questioned Pfizer’s data at the FDA’s Vaccine Advisory Committee reviewing the recalls.
At the start of the question-and-answer session during the adcomm booster with Pfizer and the FDA, Gruber gave Krause the opportunity to ask Pfizer about the statistical models used in a real-world study in Israel.
Krause claimed there was a gap between the efficacy reported by Pfizer using a specific model, which said the 8-month efficacy fell to 58% from 61%, but the numbers calculated by a different mathematical process using cases per person-year yielded an efficiency of 93%. Those disparate numbers, Krause said, came from the same number of cases in a study by California-based healthcare company Kaiser Permanente.
Two former chief scientists of the FDA – Jesse Goodman and Luciana Borio – have raised concerns about the New York Times on Marks’ decision to name himself, Goodman calling him “extremely unusual and concerning.”
But other former senior officials have taken on additional roles as the FDA seeks a permanent replacement. Janet Woodcock was formerly the head of the CDER and the NDO ad interim, before becoming the interim commissioner, as the agency sought a permanent head of the NDO.
BioCentury also reported Monday that two other FDA vaccine reviewers quit their jobs following Marks’ announcement. FDA Director of Media Relations Stephanie Caccomo did not respond to a Terminal news request for verification of these two other departures.
Paul Offit, a vaccine expert and FDA adomm member who met to discuss boosters, told Endpoints he thinks Gruber and Krause are leaving because they don’t like the way. the recall process has taken place.
“They see their job as protecting the public from pharmaceutical company products that may not have been adequately tested and I think that’s what worries them about that,” Offit said.
Saad Omer, director of the Yale Institute for Global Health, added: “A lot of specialized expertise has been underutilized and that’s a problem.”
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