Novavax Inc.

22/08/2024 | Press release | Distributed by Public on 22/08/2024 17:04

Novavax Continues to Work with the U.S. FDA on Authorization of 2024 2025 Formula COVID 19 Vaccine

Novavax filed for U.S. Emergency Use Authorization of our 2024-2025 formula COVID-19 vaccine (NVX-CoV2705) in June. We are working productively with the U.S. Food and Drug Administration (FDA) as they complete their review, including providing additional information as needed, and the FDA has committed to moving swiftly on regulatory authorization. We expect to have authorization in time for peak vaccination season.

In the U.S., product will be supplied in pre-filled syringes and after authorization, will be available in thousands of locations across the country, including retailers, regional grocers and independent pharmacies.

Our 2024-2025 formula COVID-19 vaccine targets JN.1, the "parent strain" of currently circulating variants, and 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. Upon authorization, Novavax's vaccine will be the only protein-based option available in the U.S. for use in individuals aged 12 and older to prevent COVID-19.