FDA official Marks taking on responsibilities to lead vaccine office

 Peter Marks, a high-ranking official at the Food and Drug Administration (FDA), took on responsibilities to lead the agency’s vaccine office on Monday as the office prepares for the retirement of two others who had publicly cast doubt on the need for COVID-19 boosters.

An FDA spokesperson said the agency elevated Marks to acting director of the Office of Vaccines Research and Review “to prepare for the upcoming retirement of two senior members of the team” in the fall.

“This will facilitate a smooth transition and ensure that the important vaccine work the team is undertaking to end of this devastating pandemic can continue to move forward seamlessly,” the spokesperson said in a statement. 

“A smooth transition is particularly important given the critical regulatory submissions that the Office of Vaccines Research and Review will need to work through as a team over the coming months that will affect the health of nearly every American,” the statement continued.

Since 2016, including throughout the pandemic, Marks has provided oversight for the vaccine office’s reviews as the director of the Center for Biologics Evaluation and Research. 

The leadership shift comes after the office’s director, Marion Gruber, and her deputy, Philip Krause, announced their plans to retire following the FDA’s defense of the Biden administration’s booster strategy. 

Marks announced his transfer in an email to staff obtained by The Hill, saying it allowed for Gruber and Krause to “take care of close-out activities prior to departing and help to assure a smooth transition.”

Gruber plans to retire at the end of October, while Krause intends to leave in November.

The two scientists have not discussed why they decided to leave the agency, but they joined a paper published in The Lancet earlier this month that argued current evidence does not back up giving booster shots to the general adult population.

"Current evidence does not, therefore, appear to show a need for boosting in the general population, in which efficacy against severe disease remains high," they wrote in the paper. 

The paper appeared in The Lancet as the Biden administration advocated for booster shots to be widely available starting on Sept. 20, as long as the FDA offered approval, despite divided views among experts.

FDA and Centers for Disease Control and Prevention (CDC) experts recently reviewed the evidence for a third Pfizer-BioNTech shot. The FDA granted emergency use authorization for third shots of Pfizer’s vaccine to be giving to people aged 65 and older, those at high risk of severe complications from COVID-19 and those at high risk of infection due to their occupations.

A CDC advisory panel last week backed recommending a third dose for those groups, except those with certain jobs. But CDC Director Rochelle Walensky overruled that exception, advising booster shots for workers considered at risk of COVID-19 because of their jobs, in addition to those aged 65 and older and those with underlying medical conditions.

The FDA’s vaccine office is expected to make more decisions on COVID-19 vaccine shots in the upcoming weeks and months as it considers whether to allow those ages 5 to 11 to get the Pfizer-BioNTech vaccine and whether boosters should be recommended for other vaccine recipients. 

https://thehill.com/policy/healthcare/574196-fda-official-taking-on-responsibilities-to-lead-vaccine-office