Friday, the FDA granted Emergency Use Authorization to Novavax Inc.'s (NASDAQ: NVAX) COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) (NVX-CoV2705) 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 (CDC) on June 27, 2024.
Following the Center for Biologics Evaluation and Research's release of vaccine batches, pre-filled syringes of the vaccine will be available in thousands of locations, including retail and independent pharmacies and regional grocers.
"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," said John C. Jacobs, President and Chief Executive Officer, Novavax.
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.
The approval was based on non-clinical data that showed Novavax's updated vaccine provides protection and cross-reactivity against JN.1 and numerous JN.1 lineage viruses, including KP.2.3, KP.3, KP.3.1.1, and LB.1.
Novavax says its vaccine is the only protein-based option available in the U.S. for individuals aged 12 and older to prevent COVID-19.
Doses are on track to be available as early as the end of next week, the company said in an email to Reuters.
In August, Novavax lowered its 2024 revenue guidance to $700 million - $800 million, including revenue recognition of Sanofi (NASDAQ: SNY) Payment, compared to the consensus of $936.38 million.
Earlier, the company expected sales of $970 million - $1.17 billion in combined revenue and Sanofi agreement payment.
Price Action: NVAX stock is up 3.30% at $12.79 at the last check on Tuesday.