The US Food and Drug Administration (FDA) has delayed granting full approval to the Novavax Covid-19 vaccine despite it being on track to be cleared until Tuesday afternoon. The agency is seeking more data on the vaccine, a person familiar with the situation told CNN.
The move comes as the FDA has made changes in its leadership, with Dr. Scott Steele taking over as acting director of the Center for Biologics Evaluation and Research, which oversees vaccine regulation. Former director Dr. Peter Marks was forced out after citing “efforts being advanced by some on the adverse health effects of vaccination” that he called “concerning.”
Novavax’s vaccine has been subject to emergency use authorization since 2022, but full approval would make it available beyond an emergency declaration and provide additional reassurance to people seeking the vaccine. The company said it had responded to all of the FDA’s information requests by April 1, when the agency was set to issue a decision.
The delay is not due to political considerations, according to the FDA’s press office, but rather scientific review. A spokesman for the Health and Human Services Department told CNN that the FDA’s independent review process is based solely on ensuring safety and efficacy.
Robert F. Kennedy Jr., a longtime anti-vaccine advocate, has made false claims about vaccines in the past. The Novavax vaccine uses traditional protein-based technology, which is different from the newer mRNA vaccines from Pfizer/BioNTech and Moderna.
Source: https://edition.cnn.com/2025/04/02/health/novavax-covid-vaccine-fda-delay/index.html