Novavax's Updated Covid-19 Vaccine Gets EUA Approval From FDA

(RTTNews) - Novavax, Inc. (NVAX), Friday announced that the Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) has received Emergency Use Authorization from the U.S. Food and Drug Administration for active immunization to prevent COVID-19 in individuals aged 12 and older.

Novavax's vaccine is included in the recommendations issued by the U.S. Centers for Disease Control and Prevention on June 27, 2024.

Pre-filled syringes of the vaccine will be available in thousands of locations, including retail and independent pharmacies and regional grocers, following the Center for Biologics Evaluation and Research release of vaccine batches.

"Today's 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," said John C. Jacobs, President and Chief Executive Officer, Novavax. "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."

In June, the CDC's 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 six months and older, regardless of specific viral strains.