On August 30, 2024, Novavax, Inc., a global company advancing protein-based vaccines with its Matrix-M adjuvant, announced the Novavax COVID-19 Vaccine, Adjuvanted (2024–2025 Formula) received EUA from the FDA for active immunization to prevent COVID-19 in individuals aged 12 years and older.

Novavax’s COVID-19 vaccine is the only protein-based option available in the United States for use in individuals aged 12 years and older to prevent COVID-19 viral infections. The Novavax vaccine is included in the recommendations issued by the CDC on June 27, 2024.

In June, the CDCs Advisory Committee on Immunization Practices voted unanimously in favor of a universal recommendation for the use of 2024–2025 COVID-19 vaccines authorized under EUA or approved by Biologics License Application in individuals aged 6 months and older, regardless of specific viral strains. As discussed at the June 2024 U.S. FDA Vaccines and Related Biological Products Advisory Committee meeting, there is a public health benefit to targeting JN.1, the parent strain of the most common currently circulating variants. Novavax filed for JN.1 in line with guidance from the FDA, European Medicines Agency, and the World Health Organization to target the JN.1 lineage this fall.

The EUA was based on nonclinical data showing that Novavax’s updated vaccine provides cross-reactivity against JN.1 and numerous JN.1 lineage viruses, including KP.2.3, KP.3, KP.3.1.1, and LB.1.

In clinical trials, the most common adverse reactions associated with Novavax’s prototype COVID-19 vaccine (NVX-CoV2373) included headache, nausea or vomiting, muscle pain, joint pain, injection-site tenderness, injection-site pain, fatigue, and malaise.

The manufacturer indicated that the vaccine’s prefilled syringes will be available in thousands of locations, including retail and independent pharmacies and regional grocers, following the Center for Biologics Evaluation and Research’s release of vaccine batches.

John C. Jacobs, president and CEO of Novavax, stated, “The authorization enables Novavax to launch our updated COVID-19 vaccine in the U.S. in pre-filled syringes, and we have worked hard to ensure consumers have access in thousands of locations nationwide. Our updated vaccine targets JN.1, the ‘parent strain’ of currently circulating variants, and has shown robust cross-reactivity against JN.1 lineage viruses, including KP.2.3, KP.3, KP.3.1.1 and LB.1.”

Novavax COVID-19 Vaccine, Adjuvanted (2024–2025 Formula), has not been approved or licensed by the FDA but has been authorized for emergency use under an EUA to prevent COVID-19 in individuals aged 12 years and older. The EUA of this product will remain in effect for the extent of the COVID-19 EUA declaration, justifying emergency use of the product unless the authorization is rescinded sooner.

More information on the Novavax COVID-19 Vaccine can be found at https://us-hcp.novavaxcovidvaccine.com/

The content contained in this article is for informational purposes only. The content is not intended to be a substitute for professional advice. Reliance on any information provided in this article is solely at your own risk.