Novavax Says EU Grants Marketing Authorization For Updated 2024-2025 Nuvaxovid COVID-19 Vaccine

(RTTNews) - Novavax, Inc. (NVAX) announced Wednesday that the European Commission granted Marketing Authorization for Novavax's updated 2024-2025 Nuvaxovid COVID-19 Vaccine (recombinant, adjuvanted) (NVX-CoV2705), dispersion for injection, for use in individuals aged 12 and older for the prevention of COVID-19 in the European Union (EU).

This decision follows the positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA).

The authorization was based on non-clinical data that showed Novavax's updated vaccine provides 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's vaccine is also authorized for use in the U.S., and is in line with guidance from the U.S. Food and Drug Administration (FDA), EMA and the World Health Organization to target the JN.1 lineage this fall.