Updated Novavax COVID-19 Vaccine Authorized by FDA to Protect Against Current Variants

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The US Food and Drug Administration (FDA) on Tuesday amended the emergency use authorization (EUA) for the Novavax COVID-19 vaccine, adjuvanted, for use in individuals aged ≥12 years of age to include the 2023-2024 formula that more closely matches currently circulating SARS-CoV-2 variants.¹

In an October 3, 2023, press release, the FDA stated that the COVID-19 vaccine has been updated to include the spike protein from the XBB.1.5 strain “to provide better protection against serious consequences of COVID-19, including hospitalization and death.”¹

The protein-based COVID-19 vaccine represents a non-mRNA option for the 2023-2024 season, following the FDA’s authorizations and approvals of Pfizer and Moderna's mRNA vaccines last month for persons aged ≥6 months.

For the current Novavax authorization, individuals aged ≥12 years previously vaccinated with a COVID-19 vaccine (and who have not already received a dose of a recently updated mRNA vaccine) are eligible to receive 1 dose of the adjuvanted protein-based vaccine; unvaccinated individuals can get 2 doses, according to the FDA.¹

"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," said Peter Marks, MD, PhD, director of the FDA's Center for Biologics Evaluation and Research, in the statement. "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."¹

After reviewing manufacturer and nonclinical immune response data as well as older clinical trial data supporting the original Novavax vaccine authorization, the FDA determined that the vaccine met “the statutory criteria for issuance of an EUA,” and that the benefits of the updated COVID-19 shot outweigh its risks in persons aged ≥12 years.¹

The agency also noted that with the amended EUA, the original monovalent Novavax COVID-19 vaccine is no longer authorized for use in the US.¹

"COVID-19 is once again on the rise with infections and hospitalizations increasing, so it's important that individuals get vaccinated to protect themselves and their loved ones," said John Jacobs, president, chief executive officer, Novavax, in a company press release. “In the coming days, individuals in the U.S. can go to pharmacies, physicians' offices, clinics and various government entities to receive an updated Novavax vaccine."²

References:

• FDA authorizes updated Novavax COVID-19 vaccine formulated to better protect against currently circulating variants. FDA. Press release. Published October 3, 2023. Accessed October 4, 2023. https://www.fda.gov/news-events/press-announcements/fda-authorizes-updated-novavax-covid-19-vaccine-formulated-better-protect-against-currently
• Novavax 2023-2024 COVID-19 vaccine now authorized and recommended for use in the US. Novavax. Press release. Published October 3, 2023. Accessed October 4, 2023. https://ir.novavax.com/press-releases/2023-10-03-Novavax-2023-2024-COVID-19-Vaccine-Now-Authorized-and-Recommended-for-Use-in-the-U-S