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FDA Authorizes Updated COVID-19 Vaccine Formulations for Better Protection Against Current Variants

Web Exclusives - FDA Approvals

On October 3, 2023, the FDA amended the emergency use authorization (EUA) of the Novavax COVID-19 Vaccine, Adjuvanted for use in individuals aged ≥12 years to include the 2023-2024 formula. Individuals are eligible for 1 dose if they are aged ≥12 years and previously received a COVID-19 vaccine (and have not already been vaccinated with a recently updated mRNA COVID-19 vaccine). Individuals are eligible to receive 2 doses if unvaccinated.

These vaccine updates address the currently circulating variants to deliver better protection against the serious outcomes of COVID-19, such as hospitalization and death. In line with the sum of the evidence and the FDA expert advisors’ input, the monovalent Novavax COVID-19 Vaccine, Adjuvanted now includes the spike protein from the SARS-CoV-2 Omicron variant lineage XBB.1.5 (2023-2024 formula).

“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,” he noted.

To support this change to the 2023-2024 formula of the Novavax COVID-19 Vaccine, Adjuvanted, the FDA evaluated manufacturing data, as well as nonclinical immune response data suggesting that the vaccine offers protection against the currently circulating variants of COVID-19. Other supporting data included the FDA’s evaluation of the 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, along with postmarketing data. The data collected with these Novavax COVID-19 vaccines are relevant to Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 formula), because the vaccines are manufactured via a similar process.

According to the FDA, the Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 formula) has satisfied the statutory criteria for issuing an EUA, and for individuals aged ≥12 years, the vaccine’s benefits outweigh its risks.

Owing to the FDA’s authorization of the 2023-2024 formula, the Novavax COVID-19 Vaccine, Adjuvanted (Original monovalent) is no longer authorized for use in the United States.

The Novavax authorization comes on the heels of the FDA’s September 11, 2023, approvals and authorizations of ModernaTX’s and Pfizer’s updated mRNA COVID-19 vaccines for 2023-2024. These vaccines were updated to target the current COVID-19 variants more closely and to improve protection against the serious consequences of COVID-19; they now include a monovalent (single) component that corresponds to the Omicron variant XBB.1.5.

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Last modified: November 16, 2023