– The U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for an updated version of the Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula). This updated vaccine has been specifically formulated to target the currently circulating Omicron variant JN.1 strain of SARS-CoV-2, aiming to provide enhanced protection against severe consequences of COVID-19, including hospitalization and death.

The updated vaccine is authorized for use in individuals aged 12 years and older. It includes a monovalent (single) component that corresponds to the Omicron variant JN.1 strain, ensuring that the vaccine more closely aligns with the variants presently in circulation.

“The COVID-19 vaccines have had a tremendous positive impact on public health, and vaccination continues to be the most effective method for COVID-19 prevention,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “COVID-19 continues to be a very real risk for many people, and we encourage individuals to consider getting an updated COVID-19 vaccine when eligible. 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.”

This EUA for the Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) follows the FDA’s recent approvals and authorizations of updated mRNA COVID-19 vaccines for the 2024-2025 season, manufactured by ModernaTX Inc. and Pfizer Inc.

• Eligibility for Unvaccinated Individuals: Individuals aged 12 years and older who have never received any COVID-19 vaccine are eligible to receive two doses of this updated vaccine, administered three weeks apart.

• Eligibility for Partially Vaccinated Individuals: Those who have received only one dose of any Novavax COVID-19 vaccine are eligible to receive one dose of the updated Novavax COVID-19 vaccine at least three weeks after the previous dose.

• Eligibility for Fully Vaccinated Individuals: Those who have been vaccinated with a prior formula of a COVID-19 vaccine from another manufacturer or with two or more doses of a prior Novavax COVID-19 vaccine are eligible to receive a single dose of the updated Novavax COVID-19 vaccine at least two months after the last dose of a COVID-19 vaccine.

The FDA evaluated manufacturing and nonclinical data to support the update to the 2024-2025 formula. The updated vaccine is produced using a similar process to previous versions. Individuals who receive the updated vaccine may experience side effects similar to those reported with earlier versions of the vaccine, as detailed in the provided fact sheets.

The FDA has determined that the updated Novavax COVID-19 vaccine meets the statutory criteria for EUA, concluding that the known and potential benefits of the vaccine outweigh its known and potential risks for individuals aged 12 years and older.

As part of this authorization, the previous Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) is no longer authorized for use.

The FDA granted the EUA for the updated Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) to Novavax Inc., based in Gaithersburg, Maryland.