Breaking: Novavax COVID-19 Vaccine Authorized for Use

The FDA has amended the emergency use authorization (EUA) for the Novavax COVID-19 vaccine, adjuvanted, for use in individuals aged 12 years of age or older, according to an agency news release.¹ This updated vaccine targets currently circulating variants, providing better protection against COVID-19-related hospitalization and death.

According to a Novavax press release,2 the EUA was based on nonclinical data demonstrating that the Novavax COVID-19 vaccine “induced functional immune responses against XBB.1.5, XBB.1.16, and XBB.2.3 variants; additional nonclinical data demonstrated that the vaccine induced neutralizing antibody response to newly emerging subvariants, including BA.2.86, EG.5.1, FL.1.5.1, and XBB.1.16.6. Robust T-cell responses against EG.5.1 and XBB.1.16.6 were also noted.

“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 of the FDA’s Center for Biologics Evaluation and Research.¹ “Today’s authorization provides an additional COVID-19 vaccine option that meets the FDA's standards for safety, effectiveness, and manufacturing quality…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.”

Novavax president and CEO John C. Jacobs stressed the importance of vaccination, noting that COVID-19 infections and hospitalizations are once again increasing. The authorization of the Novavax COVID-19 vaccine “means people will now have the choice of a protein-based non-mRNA option to help protect themselves against COVID-19,” Jacobs said.²

As with earlier Pfizer-BioNTech and Moderna updates, the Novavax COVID-19 vaccine, adjuvanted (original monovalent) is no longer authorized for use in the United States.

Who's Eligible?

The Novavax COVID-19 vaccine, adjuvanted, can be used in the following patient populations:

• Individuals aged 12 years and older who were previously vaccinated with a COVID-19 vaccine, and who have not already received a recently updated mRNA COVID-19 vaccine
• Unvaccinated individuals aged 12 years and older may receive 2 doses.

Doses will be available at national and local retail pharmacies and physicians’ offices in the coming days.

References

1. FDA authorizes updated Novavax COVID-19 vaccine formulated to better protect against currently circulating variants. News release. FDA. October 3, 2023. Accessed October 3, 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. News release. Novavax. October 3, 2023. Accessed October 3, 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