FDA OKs Updated Novavax COVID Shot

The FDA granted emergency use authorization (EUA) for an updated Novavax COVID-19 vaccine to protect against hospitalization and death from circulating variants.

The protein-based shot represents a non-mRNA option for the 2024-2025 season, and follows the agency’s recent approvals and authorizations of the updated Moderna (Spikevax) and Pfizer-BioNTech (Comirnaty) vaccines.

“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, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research in the announcement.

“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,” he added.

Unlike the mRNA vaccines which target the KP.2 strain of SARS-CoV-2, the monovalent protein-based vaccine targets the JN.1 strain. As of August 31, variants KP.3.1.1, KP.2.3, KP.3, and LB.1 have the highest prevalence in the U.S., according to the CDC’s COVID data tracker.

The FDA assessed manufacturing and nonclinical data to support the change to the 2024-2025 formula, the agency said. The updated vaccine is manufactured using a similar process as previous formulas of this vaccine. The FDA determined that the updated vaccine 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 ages 12 years and older.

With this authorization, the previous 2023-2024 version of the protein-based COVID-19 vaccine is no longer authorized for use in the U.S.

Individuals ages 12 years and older previously vaccinated with a prior season’s mRNA COVID-19 vaccine or with two or more doses of the protein-based vaccine are eligible to receive one dose of the protein-based vaccine, at least 2 months after the last dose.

Individuals who have been vaccinated with only one dose of any Novavax COVID-19 vaccine are eligible to receive one dose of the updated vaccine at least 3 weeks after the previous dose. Unvaccinated individuals can get two doses, spaced 3 weeks apart.

Immunocompromised individuals can receive an additional dose of vaccine administered at least 2 months following the last dose of an updated COVID-19 vaccine. Additional doses can be administered at the discretion of the healthcare provider.