Two High-Level FDA Vaccine Officials Stepping Down Soon: Spokeswoman

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Md., on Aug. 29, 2020. Andrew Kelly/Reuters

Two senior Food and Drug Administration (FDA) vaccine regulators are planning to leave the agency in the coming weeks, said the FDA on Tuesday.

The regulator is “confident in the expertise and ability of our staff to continue our critical public health work, including evaluating COVID-19 vaccines,” FDA spokeswoman Stephanie Caccomo said in a statement to news outlets in confirming the planned departures of Dr. Marion Gruber, the head of the FDA’s Office of Vaccines Research and Review (OVRR), and Gruber’s deputy, Dr. Philip Krause.

FDA acting Director Janet Woodcock confirmed to medical news website Endpoints News of their departures and said she wishes them well in their future endeavors.

Jeffrey Zients, the White House COVID-19 team coordinator, told reporters in a virtual briefing that the booster decision was made by “the nation’s leading public health officials,” including Dr. Anthony Fauci and Dr. Rochelle Walensky.

The OVRR, according to the FDA, is the division responsible for regulating all vaccines, including COVID-19 shots, intended for human usage, including reviewing applications for new vaccines.

The Epoch Times has contacted the FDA for comment.

According to a memo that was sent by Peter Marks, the head of FDA’s Center for Biologics Evaluation and Research (CBER) that oversees OVRR, and obtained by The Epoch Times, Gruber is leaving on Oct. 31. Krause is leaving sometime in November, the memo said.

Marks said in the memo that he would serve as the OVRR’s acting director while the FDA carries out a search for who should lead the division.

The memo did not provide a reason for why Gruber and Krause are leaving.

A LinkedIn profile for Gruber shows she worked for the FDA for 32 years and served as the OVRR’s director for about a decade. Krause, meanwhile, has worked for the FDA for about 11 years, according to his profile.

Former high-level FDA employees said their departure would be a blow to the agency’s vaccine regulation efforts.

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

“These two are the leaders for Biologic (vaccine) review in the US. They have a great team, but these two are the true leaders of CBER. A huge global loss if they both leave,” Rick Bright, who formerly directed the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority, said on Twitter.

He added that “Gruber is much more than the director,” adding she is a “visionary mastermind behind global clinical regulatory science for flu, Ebola, Mers, Zika, Sars-Cov-2, many others.” SARS-Cov-2 refers to the CCP (Chinese Communist Party) virus, which causes COVID-19.