Two of FDA’s Top Vaccine Experts Leaving the Agency

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A pair of the U.S. Food and Drug Administration (FDA)’s top vaccine experts are leaving the agency. Marion Gruber, director of the agency’s Office of Vaccines Research & Review (OVRR) is leaving at the end of October. Phil Krause, OVRR’s deputy director, is exiting in November. Gruber has been with the agency for 32 years, and Krause for more than a decade.

Luciana Borio, former acting chief scientist of the agency, noted on Twitter, “FDA is losing two giants who helped bring us many safe and effective vaccines over decades of public service.”

Peter Marks, Director of the FDA’s Center for Biologics Evaluation and Research, issued a letter to staff announcing the departures. In it, Marks noted that Gruber’s “contributions throughout her career have been immeasurable, but never more so than during the COVID-19 pandemic. Her leadership in the Center’s efforts to authorize three COVID-19 vaccines, and more recently to approve one of those vaccines, ensured that the vaccines met the high standards the public has come to expect from FDA, and has positively impacted the public health in the United States and across the globe.”

Of Krause, Marks noted, “I can’t thank Phil enough for his extraordinary commitment and effort in helping guide OVRR during the ongoing public health emergency. He has also served a key role in our interactions to address critical vaccine-related issues with our public health counterparts around the world. His keen insight and experience in addressing a wide variety of challenges will truly be missed.”

Marks plans to act as the OVRR director while the agency begins an official search for a replacement.

In a statement to Reuters, Stephanie Caccomo, spokesperson for the FDA, said the agency is “confident in the expertise and ability of our staff to continue our critical public health work, including evaluating COVID-19 vaccines.”

There was no indication of why Gruber or Krause are departing.

On August 27, President Joe Biden, speaking with Israeli Prime Minister Naftali Bennett, indicated the administration was considering dosing COVID-19 booster shots at five months after primary immunizations. This is a shortened timetable. Initially an eight-month period was discussed, which then moved to six.

“We’re considering the advice you’ve given that we should start earlier,” Biden said, noting that public health officials were debating the timeline. “Should it be as little as five months, and that’s being discussed.”

There have been concerns expressed by regulators that the Biden Administration is pushing ahead with booster shots without sufficient data and oversight by regulators. The White House announced a plan to start dosing boosters on the week of September 20, but that would appear to circumvent decision-making by the FDA and the U.S. Centers for Disease Control and Prevention (CDC).

Approval for the boosters is expected around September 6.

Rick Bright, former director of the Biomedical Advanced Research and Development Agency, tweeted, “These two are the leaders for Biologic (vaccine) review in the U.S. They have a great team, but these two are the true leaders of CBER. A huge global loss if they both leave.”

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