Updated 2024-2025 Nuvaxovid COVID-19 Vaccine (NVX-CoV2705) receives authorization in the EU – Novavax

9 October 2024-Novavax, Inc. announced 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).

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. In clinical trials, the most common adverse reactions associated with Novavax’s prototype COVID-19 vaccine (NVX-CoV2373) included headache, nausea or vomiting, muscle pain, joint pain, injection site tenderness, injection site pain, fatigue and malaise. Novavax’s vaccine is also authorized for use in the U.S., and is in line with guidance from the FDA. Novavax COVID 19 Vaccine Adjuvanted (2024-2025) Formula has not been approved in the US but authorized for Emergency Use to prevent COVID 19 for use in individuals  12 years and older.