FDA Issues Emergency Use Authorization for Novavax COVID-19 Vaccine, Adjuvanted

FDA announced that it had issued an Emergency Use Authorization (EUA) for the Novavax COVID-19 Vaccine, Adjuvanted on July 13, 2022 for individuals 18 and older. Unlike the currently approved vaccines, the Novavax vaccine utilizes traditional protein-based technology in lieu of messenger RNA technology.

Similar to the Pfizer-BioNTech and Moderna vaccines, the Novavax vaccine is administered as a two-dose primary series three weeks apart. The vaccine contains SARS-CoV-2 spike protein and Matrix-M adjuvant; adjuvants are incorporated into some vaccines to enhance the immune response of the vaccinated individual. The spike protein in this vaccine is produced in insect cells, while the Matrix M-adjuvant contains saponin extracts from the bark of the Soapbark tree that is native to Chile.

“Authorizing an additional COVID-19 vaccine expands the available vaccine options for the prevention of COVID-19, including the most severe outcomes that can occur, such as hospitalization and death,” said Robert M. Califf, Commissioner, FDA, in an agency press release. “Today’s authorization offers adults in the United States who have not yet received a COVID-19 vaccine another option that meets [FDA’s] rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization. COVID-19 vaccines remain the best preventive measure against severe disease caused by COVID-19, and I encourage anyone who is eligible for, but has not yet received a COVID-19 vaccine, to consider doing so.”