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Key vaccine leaders departing FDA as COVID-19 booster questions linger

Two key vaccine leaders will leave the FDA this fall, just as the agency faces key decisions over COVID-19 booster shots and as variants take a bite out of the shots’ efficacy.

FDA Office of Vaccines Research and Review Director Marion Gruber, Ph.D. and Deputy Director Phillip Krause, M.D. will depart the agency. Both have been with the agency for decades and have been pivotal in the United States’ effort to authorize COVID-19 vaccines to fight the pandemic. The news was first reported by Biocentury.

Gruber will leave the agency on Oct. 31 and Krause’s last day will be sometime in November, according to a letter shared by the FDA with Fierce Pharma. The letter was signed by Peter Marks, M.D., Ph.D., director of the Center for Biologics Evaluation and Research, under which the vaccine research office sits.

Marks will serve as acting director of the OVRR for now as a search begins for a new chief. An acting director will be announced later.

“[Gruber’s] contributions throughout her career have been immeasurable, but never more so than during the COVID-19 pandemic,” Marks said. “Her leadership in the centre’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 U.S. and across the globe.”

Marks continued: “Marion’s departure is a huge loss for CBER and FDA.”

For his part, Krause was responsible for liaising with public health officials around the world to “address critical vaccine-related issues,” according to Marks.

“His keen insight and experience in addressing a wide variety of challenges will truly be missed,” the letter said.

The departures are the latest high-profile officials to leave the key federal agency that still lacks a permanent leader. Janet Woodcock is leading the agency on an acting basis and will not be considered for the commissioner job permanently.

Nevertheless, the FDA expressed confidence that the vaccine work would go on.

“We are confident in the expertise and ability of our staff to continue our critical public health work, including evaluating COVID-19 vaccines,” an FDA spokesperson said.

Gruber and Krause are leaving the agency following criticism of the White House’s decision to leap frog over the agency to recommend COVID-19 booster shots. The move to start boosters next month has been blasted by the World Health Organization, which questions the data to support the need for a third shot—especially as poorer nations continue to struggle with getting first shots to people.

Pfizer and BioNTech, which manufacture the only fully-approved COVID-19 vaccine called Comirnaty, sent booster data to the FDA earlier this month, but the agency has yet to make a call on the matter. Neither has the Centers for Disease Control and Prevention.