Top Trump FDA official Brenner hits pause on Novavax Covid-19 vaccine decision [View all]

Source: Politico

04/02/2025 02:05 PM EDT


A top FDA official directly intervened in an agency review of Novavax’s Covid-19 vaccine, pausing the approval process to ask for more data on the shot, according to four people familiar with the decision granted anonymity to discuss the approval status.

Dr. Sara Brenner, FDA’s Principal Deputy Commissioner, took the highly unusual step, cutting against longstanding precedent at the agency designed to shield scientific assessments from political interference. Typically, political FDA appointees follow the advice of career staff tasked with reviewing reams of data on drugs and vaccines seeking approval.

The move comes amid HHS Secretary Robert F. Kennedy Jr.’s decision to force out the top official responsible for reviewing such vaccines, Dr. Peter Marks, and put his deputy Julie Tierney on administrative leave.

An HHS official granted anonymity to discuss the FDA’s review of the shot denied that Brenner asked for more information, and noted that Dr. Scott Steele was named acting director of the Center for Biologics Evaluation and Research on Tuesday. That office is tasked with reviewing vaccine applications. The FDA did not immediately respond to a request for comment. The agency’s press office was among the thousands of job cuts Tuesday.

Read more: https://www.politico.com/news/2025/04/02/top-trump-fda-official-brenner-hits-pause-on-novavax-vaccine-decision-00266623