FDA delays full approval of Novavax Covid-19 vaccine even though it was on track for clearance

(CNN) — The US Food and Drug Administration has delayed granting full approval of Novavax’s Covid-19 vaccine despite it being on track to be cleared until Tuesday afternoon, a person familiar with the situation told 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.

“As of Tuesday, April 1, we had responded to all of the FDA’s information requests and we believe that our [Biologics License Application] is ready for approval,” Novavax said in a statement, noting that the application “included robust Phase 3 clinical trial data that showed our vaccine is safe and effective for the prevention of Covid-19.”

“We are confident our well-tolerated vaccine represents an important alternative to mRNA Covid-19 vaccines for the US,” Novavax said.

The FDA’s press office was put on administrative leave Tuesday as part of the HHS Reduction in Force effort. A spokesman for HHS told CNN, “The FDA’s independent review process for the Novavax vaccine, like all vaccines is based solely on ensuring safety and efficacy, not political considerations. Any delays are a result of scientific review.”

The-CNN-Wire
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