FDA Grants Emergency Authorization to Novavax's Updated COVID-19 Vaccine for Ages 12 and Up, Including Omicron

This article first appeared in our sister brand, Contemporary Pediatrics.

Novavax’s updated COVID-19 vaccine, which includes the 2023 to 2024 formula, adjuvanted for individuals aged 12 years and up, has been authorized by the FDA after the agency amended the emergency use authorization (EUA). Addressing currently circulating variants, the monovalent vaccine is updated to include the spike protein from the SARS-CoV-2 omicron variant lineage XBB.1.5 (2023-2024 formula), the agency stated in a press release.¹

Those 12 years and older are eligible to receive 1 dose if they have been previously vaccinated with a COVID-19 vaccine or if they have not already been vaccinated with a recently updated mRNA COVID-19 vaccine.¹ Unvaccinated individuals are eligible to receive 2 doses of the Novavax COVID-19 Vaccine. The authorization is based on the evaluation data presented to the FDA.¹ This included nonclinical immune response data, suggesting protection against variants that are currently circulating, including response for XBB.1.16, XBB.2.3. The vaccine, according to nonclinical trial data, induced neutralizing antibody responses to subvariants including BA.2.86, EG.5.1 FL.1.5.1 and XBB.1.16.6. It also demonstrated CD4+ polyfunction cellular (T-cell) responses against EG.5.1 and XBB.1.16.6.²

Since the vaccine was manufactured using a similar process as the original monovalent, investigational monovalent, and bivalent Novavax COVID-19 adjuvanted vaccines, the FDA was able to rely on evaluations it made on the safety and effectiveness from previous clinical trial data. Overall, the federal agency determined that the updated vaccine met the criteria for an EUA and that the known potential risks outweighed the known potential benefits for this indication. The Novavax COVID-19 Vaccine Adjuvanted (Original monovalent) is no longer authorized for use in the United States.¹

“The COVID-19 vaccines have saved countless lives and have prevented serious outcomes of COVID-19 caused by the SARS-CoV-2 virus,” said Peter Marks, MD, PhD, director, Center for Biologics Evaluation and Research, FDA. “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. As we head into the fall season and transition into 2024, we strongly encourage those eligible to consider receiving an updated COVID-19 vaccine to provide better protection against currently circulating variants.”¹

According to Novavax, the company’s updated vaccine is the only protein-based, non-mRNA option in the United States. It expects thousands of locations across the country will have doses available in the “coming days,” including CVS Pharmacy and Rite Aid, following the release of vaccine batches by the Center for Biologics Evaluation and Research.²

References:

1. FDA authorizes updated Novavax COVID-19 vaccine formulated to better protect against currently circulating variants. FDA. Press release. 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

2. Novavax 2023-2024 COVID-19 vaccine now authorized and recommended for use in the US. Novavax. Press release. 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