Novavax : CHMP Recommends Approval Of Its COVID-19 Booster Vaccine

(RTTNews) - Novavax Inc. (NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, said that Nuvaxovid (NVX-CoV2373) COVID-19 vaccine has been recommended for expanded conditional marketing authorization or CMA in the European Union as a homologous and heterologous booster for active immunization to prevent COVID-19 caused by the SARS-CoV-2 for adults aged 18 and older.

The Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency based its opinion on results from two Phase 2 trials, and the UK-sponsored COV-BOOST trial.

Nuvaxovid has also been approved in Japan, Australia, and New Zealand as a booster in adults aged 18 and older, and is actively under review in other markets.

The European Commission previously granted CMA for Nuvaxovid in adults aged 18 and older in December 2021. In addition, the Commission granted CMA for Nuvaxovid to prevent COVID-19 in adolescents aged 12 through 17 in July 2022.

The trade name Nuvaxovid has not yet been approved by the U.S. Food and Drug Administration.

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