Novavax Wins FDA Emergency Approval for 2024-2025 COVID-19 Vaccine Formula
Novavax, a global leader in protein-based vaccines, has announced that its updated COVID-19 vaccine, Adjuvanted (2024-2025 Formula) (NVX-CoV2705), has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). This authorization allows the vaccine to be used for active immunization against COVID-19 in individuals aged 12 and older.
The vaccine, which incorporates Novavax’s proprietary Matrix-M™ adjuvant, is specifically designed to target the JN.1 strain, the progenitor of several currently circulating variants. The EUA was granted based on non-clinical data demonstrating robust cross-reactivity against the JN.1 strain and its lineage viruses, including KP.2.3, KP.3, KP.3.1.1, and LB.1.
Pre-filled syringes of the vaccine will be made available at thousands of locations nationwide, including retail and independent pharmacies and regional grocery stores, following the release of vaccine batches by the Center for Biologics Evaluation and Research.
John C. Jacobs, President and CEO of Novavax, highlighted the importance of this milestone, stating:
“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. 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.”
The U.S. Centers for Disease Control and Prevention (CDC) has included Novavax’s vaccine in its recommendations issued on June 27, 2024, for the 2024-2025 COVID-19 season. This follows a unanimous vote by the CDC’s Advisory Committee on Immunization Practices in favor of a universal recommendation for COVID-19 vaccines for individuals aged six months and older.
Following the emergency authorization, Novavax has levelled the playing field with its primary COVID-19 vaccine competitors, Pfizer/BioNTech and Moderna, who received similar approvals from the FDA for their vaccines, Comirnaty and Spikevax, in late August 2023. However, in contrast to Pfizer/BioNTech and Moderna’s vaccines, Novavax’s vaccine does not utilize mRNA technology. Instead, it includes a recombinant form of a specific viral protein and its proprietary Matrix-M™ adjuvant to enhance immune response.
The EUA for Novavax’s COVID-19 vaccine will remain in effect as long as the COVID-19 EUA declaration is active unless it is revoked sooner. The vaccine has not yet received full FDA approval or licensure. For more information, please visit novavax.com
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