The U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to Novavax Inc.’s COVID-19 vaccine, Adjuvanted (2024-2025 Formula) (NVX-CoV2705), for individuals aged 12 and older. This authorization allows the vaccine to be used for active immunization to prevent COVID-19 in this age group.
Novavax’s vaccine has been included in the recommendations issued by the U.S. Centers for Disease Control and Prevention (CDC) on June 27, 2024. Following the release of vaccine batches by the Center for Biologics Evaluation and Research, pre-filled syringes will be available across thousands of locations, including pharmacies and grocery stores.
“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,” stated John C. Jacobs, President and Chief Executive Officer of Novavax.
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, including those authorized under EUA, in individuals aged six months and older, regardless of specific viral strains. This decision was based on non-clinical data showing Novavax’s updated vaccine provides protection against JN.1 and its related subvariants.
Novavax highlights that its vaccine is the only protein-based option available in the U.S. for individuals aged 12 and older seeking COVID-19 prevention. The company has confirmed that doses are expected to be available as early as the end of next week.
In August, Novavax revised its 2024 revenue guidance downward to a range of $700 million to $800 million, including revenue recognition from its agreement with Sanofi. This adjustment contrasts with the consensus estimate of $936.38 million. Previously, the company had projected combined revenue and Sanofi agreement payment to reach $970 million to $1.17 billion.
Following the news of the EUA, NVAX stock experienced a 3.30% increase, closing at $12.79 on Tuesday.
