FDA Advisory Committee Recommends Novavax’s COVID-19 Vaccine

The FDA’s Vaccines and Related Biological Products Advisory Committee voted almost unanimously yesterday for Emergency Use Authorization (EUA) of a two-dose primary series of the Novavax COVID-19 vaccine.

The 22-member expert voted 21 in favor of the EUA with one abstention — by Bruce Gellin, of the Sabin Vaccine Institute in Washington, D.C. Gellin explained that he abstained because of the lack of a conditional “yes” voting option, citing the risk of myocarditis associated with the vaccine.

Novavax’s COVID-19 vaccine uses a traditional protein-based technology to deliver the SARS-CoV-2 spike protein to the immune system, unlike the messenger-RNA-based vaccines from Pfizer and Moderna. The company claims the proven approach, which has been used in numerous previous vaccines, is a safe way to gain protection against COVID-19.

Other committee voters also spoke, explaining why they voted yes. Michael Nelson, an immunologist at the University of Virginia, said the Novavax COVID-19 vaccine fills an unmet need for those who are hesitant or hypersensitive towards the available mRNA COVID-19 vaccines. He also mentioned how the Novavax vaccine could be easier to store and possibly benefit the supply chain. Nelson suggested, however, that the risk of myopericarditis should be listed in the EUA.

Jay Portnoy, professor of pediatrics at the University of Missouri — Kansas City School of Medicine, noted that vaccine hesitancy has more to do with ideology than the technology used in a given vaccine and expressed skepticism that those who are vaccine hesitant would opt for the Novavax vaccine.

The committee vote does not finalize the FDA’s decision, but the agency is expected to approve the EUA (DID, June 6). — Selma Khenissi