FDA Approves Updated Novavax COVID-19 Vaccine for Current Variants

The U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for a revised version of the Novavax COVID-19 vaccine. This updated vaccine is designed to more effectively target the currently circulating variants of the virus, thereby offering enhanced protection against severe outcomes such as hospitalization and death. This new formulation is available for individuals aged 12 and older and includes a monovalent component aimed at the Omicron variant JN.1 strain of SARS-CoV-2.

Peter Marks, M.D., Ph.D., who is the director of the FDA's Center for Biologics Evaluation and Research, highlighted the significant positive impact that COVID-19 vaccines have had on public health. He emphasized that vaccination remains the most effective method for preventing COVID-19 and encouraged eligible individuals to get the updated vaccine. Marks noted that this newly authorized vaccine meets the FDA's rigorous standards for safety, effectiveness, and manufacturing quality, making it a valuable addition to the available COVID-19 vaccines.

This EUA follows the FDA's recent approvals and authorizations of updated mRNA COVID-19 vaccines for the 2024-2025 period, produced by ModernaTX Inc. and Pfizer Inc.

Key points to note include:

- Individuals aged 12 years and older who have never been vaccinated against COVID-19 are eligible for two doses of this updated Novavax vaccine, administered three weeks apart.
- Those who have received only one dose of a previous Novavax COVID-19 vaccine can receive one dose of the updated version, at least three weeks after their previous dose.
- Individuals who have been vaccinated with a prior formula from another manufacturer or with two or more doses of an earlier Novavax vaccine can receive a single dose of the updated vaccine at least two months after their last COVID-19 vaccine dose.

The FDA evaluated the manufacturing and nonclinical data to support the changes made to the 2024-2025 formula. The updated vaccine is produced using a similar process to previous formulations. Recipients of this updated vaccine may experience side effects similar to those reported with earlier versions of the Novavax COVID-19 vaccine, as outlined in the provided fact sheets.

The FDA concluded that the benefits of the updated Novavax COVID-19 vaccine outweigh its known and potential risks for individuals aged 12 and older. Consequently, the authorization for the Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) has been rescinded in favor of the new 2024-2025 formula.

Novavax Inc., based in Gaithersburg, Maryland, will be responsible for manufacturing the updated vaccine. The agency remains committed to ensuring the safety, effectiveness, and quality of vaccines and other medical products.

Additional resources and information about the updated COVID-19 vaccines for the fall of 2024 and other related issues can be found through the FDA's resources.

The FDA operates under the U.S. Department of Health and Human Services, ensuring public health by regulating human and veterinary drugs, vaccines, medical devices, and other products. The agency also oversees the safety and security of the nation's food supply, cosmetics, dietary supplements, and products that emit radiation, as well as the regulation of tobacco products.