FDA Authorizes Updated Novavax COVID-19 Vaccine to Better Protect Against Currently Circulating Variants

FDA News Release

• For Immediate Release: August 30, 2024

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Today, the U.S. Food and Drug Administration granted emergency use authorization (EUA) for an updated version of the Novavax COVID-19 vaccine that more closely targets currently circulating variants to provide better protection against serious consequences of COVID-19, including hospitalization and death. The updated vaccine is authorized for use in individuals 12 years of age and older. It includes a monovalent (single) component that corresponds to the Omicron variant JN.1 strain of SARS-CoV-2. 

“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 authorization follows the FDA’s recent approvals and authorizations of updated mRNA COVID-19 vaccines for 2024-2025 manufactured by ModernaTX Inc. and Pfizer Inc.

What You Need to Know

• Individuals 12 years of age and older who have never been vaccinated with any COVID-19 vaccine are eligible to receive two doses of this updated vaccine, 3 weeks apart.
• Individuals who have been vaccinated only with one dose of any Novavax COVID-19 vaccine are eligible to receive one dose of the updated Novavax COVID-19 vaccine at least 3 weeks after the previous dose.  
• 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 formula of the Novavax COVID-19 vaccine are eligible to receive a single dose of the updated Novavax COVID-19 vaccine at least 2 months after the last dose of a COVID-19 vaccine.

The FDA assessed manufacturing and nonclinical data to support the change to the 2024-2025 formula. The updated vaccine is manufactured using a similar process as previous formulas of this vaccine. Individuals who receive this vaccine may experience similar side effects as those reported by individuals who received previous formulas of this COVID-19 vaccine and as described in the fact sheets. 

The FDA has determined that the updated Novavax COVID-19 vaccine has met the statutory criteria for issuance of an EUA, including that the known and potential benefits of the vaccine outweigh its known and potential risks in individuals 12 years of age and older. 

As part of today’s action, the Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) is no longer authorized for use.

The FDA granted the emergency use authorization of the Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) to Novavax Inc. of Gaithersburg, Maryland.