Updated Protein-Based COVID-19 Vaccine Now Authorized in the U.S.

For the first time, the U.S. government has authorized an updated protein-based COVID-19 vaccine.

Today, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) of the Novavax COVID-19 Vaccine, Adjuvanted for use in individuals 12 years of age and older, to include the 2023-2024 formula.

Novavax Inc.'s updated vaccine addresses currently circulating variants to provide better protection against the serious consequences of COVID-19.

Consistent with the totality of the evidence and input from the FDA's expert advisors, the Novavax COVID-19 Vaccine, Adjuvanted, a monovalent vaccine, now includes the spike protein from the SARS-CoV-2 omicron coronavirus variant lineage XBB.1.5 (2023-2024 formula).

The FDA confirmed it has determined that the Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula), has met the statutory criteria for issuance of an EUA and that the known and potential benefits of the vaccine outweigh its known and potential risks in individuals 12 years of age and older. 

This means individuals 12 years of age and older previously vaccinated with a COVID-19 vaccine (and who have not already been vaccinated with a recently updated mRNA COVID-19 vaccine) are eligible to receive one dose, and unvaccinated individuals receive two doses.

Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research, commented in a press release on October 3, 2023, "Today's authorization provides an additional COVID-19 vaccine option that meets the FDA's standards for safety, effectiveness and manufacturing quality needed to support EUA."

From an availability perspective, Novavax previously indicated it had produced about 20 million doses of the updated vaccine and stored them in the U.S., enabling expedited delivery to health clinics and pharmacies.

As part of today's action, the Novavax COVID-19 Vaccine, Adjuvanted (Original monovalent), is no longer authorized for use in the U.S. Additionally, global information about the Novavax COVID-19 Vaccine varies by country and is searchable at NovavaxMedInfo.com.