FDA Authorizes “Updated” Novavax COVID-19 Vaccine
Improved vaccine includes Omicron variant’s spike protein and can offer enhanced protection in the 2023–2024 flu season
The U.S. Food and Drug Administration recently 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. 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.
The updated vaccine addresses currently circulating variants to provide better protection against the serious consequences of COVID-19, including hospitalization and death. Consistent with the totality of the evidence and input from the FDA’s expert advisors, the Novavax COVID-19 Vaccine, Adjuvanted, a monovalent vaccine, has been updated to include the spike protein from the SARS-CoV-2 Omicron variant lineage XBB.1.5 (2023–2024 formula).
This authorization follows the FDA’s recent approvals and authorizations of updated mRNA COVID-19 vaccines for 2023–2024 manufactured by ModernaTX Inc. and Pfizer Inc.
“The COVID-19 vaccines have saved countless lives and have prevented serious outcomes of COVID-19 caused by the SARS-CoV-2 virus,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research. “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 emergency use authorization. As we head into the fall season and transition into 2024, we strongly encourage those who are eligible to consider receiving an updated COVID-19 vaccine to provide better protection against currently circulating variants.”
Safety and effectiveness of the vaccine
The FDA evaluated manufacturing data to support the change to the 2023–2024 formula of the Novavax COVID-19 Vaccine, Adjuvanted. Additionally, the FDA evaluated nonclinical immune response data suggesting that the vaccine provides protection against the currently circulating COVID-19 variants.
The agency also relied on its evaluation of safety and effectiveness data from clinical trials of Novavax COVID-19, Vaccine, Adjuvanted (original monovalent) and investigational monovalent and bivalent Novavax COVID-19 adjuvanted vaccines, as well as postmarketing data. The data accrued with these Novavax COVID-19 vaccines are relevant to the Novavax COVID-19 Vaccine, Adjuvanted (2023–2024 Formula) as the vaccines are manufactured using a similar process.
The FDA has determined that the Novavax COVID-19 Vaccine, Adjuvanted (2023–2024 Formula) has met the statutory criteria for issuing 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. The EUA is granted to Novavax Inc. of Gaithersburg, MD.
As part of recent action, the Novavax COVID-19 Vaccine, Adjuvanted (original monovalent) is no longer authorized for use in the US.
- This press release was originally published on the U.S. Food and Drug Administration website