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FDA’s director and deputy director of its Office of Vaccines Research & Review resign

The departure of director Marion Gruber and deputy director Philip Krause is unexpected

FDA building

The Food and Drug Administration (FDA) has announced the departure of both the director of its Office of Vaccines Research & Review, Marion Gruber, and the deputy director, Philip Krause.

Gruber – a 32-year veteran of the FDA – will retire at the end of October, while Krause will leave in November. The Center for Biologics Evaluation and Research head, Peter Marks, said he would stand in as acting OVRR director and the “search for the next office director will begin immediately”.

Former director of the Biomedical Advanced Research and Development Authority (BARDA), Rick Bright commented: “Dr Gruber is much more than the Director. She is a global leader. Visionary mastermind behind global clinical regulatory science for flu, Ebola, Mers, Zika, Sars-cov-2, many others.”

The sudden departure of the two most significant vaccines leaders at the FDA in the middle of the COVID-19 crisis – and with the spread of the Delta variant in the US – has stirred conjecture that it was the Biden administration’s vaccine booster plan that prompted the move.

The FDA’s former acting chief scientist Luciana Borio said the pair were initially frustrated by the involvement of Centers for Disease Control and Prevention (CDC) and Advisory Committee on Immunization Practices (ACIP) in COVID-19-related decision-making, but it was the White House’s announcement to offer booster shots to people eight months after they received their second shot that proved to be the final straw.

“FDA is losing two giants who helped bring us many safe and effective vaccines over decades of public service. A huge global loss if they both leave,” said Borio.

It is reported that the two vaccine heads believed there was enough insufficient data to justify offering COVID-19 booster shots and that the announcement, amplified by President Biden, put too much pressure on the FDA to authorise them quickly.

Last week the White House had to roll back comments made by President Biden that the administration was considering allowing people to get a booster shot sooner than eight months after their second vaccine.

During an Oval Office meeting with Israeli prime minister Naftali Bennett, President Biden said: “We were going to start mid-September, but we’re considering the advice you’ve given that we should start earlier. The question raised is should it be shorter than eight months? Should it be as little as five months? That’s being discussed.”

White House press secretary, Jen Psaki, clarified that the administration’s original eight-month proposal was unchanged.

Article by
Hugh Gosling

1st September 2021

From: Regulatory



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