FDA Authorizes Novavax’s COVID-19 Vaccine

The FDA has granted Emergency Use Authorization (EUA) to Novavax’s COVID-19 vaccine.

Unlike the Pfizer and Moderna products, Novavax’s vaccine does not use messenger RNA technology. Instead, it delivers a small amount of the SARS-CoV-2 spike protein along with an adjuvant that boosts the immune response.

The two-dose regimen is administered 21 days apart. Early last month, the FDA’s Vaccines and Related Biological Products Advisory Committee overwhelmingly voted to recommend the vaccine for emergency use in individuals 18 years and older (DID, June 8).

“Today’s authorization offers adults in the United States who have not yet received a COVID-19 vaccine another option that meets the FDA’s rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization,” said FDA Commissioner Robert Califf.

The federal government has already secured 3.2 million doses of the Novavax vaccine. — Selma Khenissi