EU gives marketing authorization for Novavax updated 2024-2025 Nuvaxovid COVID vaccine
Gaithersburg: Novavax, Inc., a global company advancing protein-based vaccines with its Matrix-M adjuvant, has announced that the European Commission has 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.1.1 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 U.S. Food and Drug Administration (FDA), EMA and the World Health Organization to target the JN.1 lineage this fall.2-5
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