The U.S. Food and Drug Administration (FDA) has delayed granting full approval of Novavax’s COVID-19 jab.

According to POLITICO, a top FDA official “directly intervened” in an agency review.

From POLITICO:

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.

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Per CNN:

The agency is seeking more data on the vaccine, said the source, who declined to be named because they weren’t authorized to speak publicly about the situation. The Wall Street Journal first reported that the FDA had missed its decision deadline.

The move came as the FDA named Dr. Scott Steele acting director of the Center for Biologics Evaluation and Research, which oversees vaccine regulation, days after former director Dr. Peter Marks was forced out. In his resignation letter, Marks cited “efforts being advanced by some on the adverse health effects of vaccination” that he called “concerning.”

US Health and Human Services Secretary Robert F. Kennedy Jr., a longtime anti-vaccine advocate, has falsely called vaccines for Covid-19 “the deadliest vaccine ever made” and more recently made misleading statements about the safety of the measles vaccine amid a deadly outbreak centered in West Texas.

The Novavax vaccine, which uses more traditional protein-based technology than the newer mRNA vaccines from Pfizer/BioNTech and Moderna, has been subject to emergency use authorization since 2022. But with FDA action, it would be the third vaccine against Covid-19 to receive full FDA approval. Full approval would make the vaccine available beyond an emergency declaration and could provide additional reassurance to people seeking the vaccine.

The company said Wednesday that it hadn’t received an official decision from the FDA but that April 1 was the date by which the agency had been set to issue the decision.

 

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