by Oleg Burunov
Earlier this month, the Biden administration announced plans to administer coronavirus vaccine boosters, sparking turmoil within the Food and Drug Administration, which is yet to complete its own review on the issue.
Two senior US Food and Drug Administration (FDA) vaccine officials are due to leave the agency in the next several months, the FDA announced on Tuesday.
Marion Gruber, director the FDA’s Office of Vaccines Research and Review, plans to retire on 31 October, while her deputy, Philip Krause, is set to quit in November, according to Peter Marks, director of the agency’s Centre for Biologics Evaluation and Research (CBER).
Marks called Gruber’s departure a “huge loss”, citing her “immeasurable contributions” to the FDA. The CBER director also thanked Krause for his commitment and effort during the COVID-19 pandemic, adding that a search for the next vaccine office director “will begin imminently”.
FDA spokesperson Stephanie Caccomo, for her part, said in a statement that the agency remains “confident in the expertise and ability of our staff to continue our critical public health work, including evaluating COVID-19 vaccines”.
Luciana Borio, a former chief scientist with the agency, reacted to the news by tweeting that the FDA “is losing two giants who helped bring us many safe and effective vaccines over decades of public service”. Gruber has worked with the agency for 30 years, whereas Krause has been there for over a decade.
With no official reason given for the pair’s sudden departure, the biotech outlet Endpoints cited an unnamed former senior FDA official as saying that Gruber and Krause are quitting because “they’re frustrated that [the] CDC [Centres for Disease Control and Prevention] and their ACIP [Advisory Committee on Immunisation] are involved in decisions that they think should be up to the FDA”.
The two were also allegedly upset over CBER director Marks not standing up for them against the CDC. The last straw was the Biden administration’s recent decision to announce vaccine “booster” shot-related plans without consulting the FDA, according to the source.
The developments come as the FDA is weighing whether to authorise a potential third Pfizer shot for most Americans, amid the agency’s plans to evaluate the use of coronavirus vaccines in children.
Jeffrey Zients, coordinator of the White House’s COVID-19 task force, has meanwhile stressed that the Biden administration’s plan for additional doses remains “pending the FDA conducting an independent evaluation and CDC’s panel of outside experts issuing a booster dose recommendation”.