Swissmedic granted conditional Marketing Authorization for Novavax COVID-19 vaccine

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On Apr. 13, 2022, Novavax announced that Swissmedic had granted Novavax conditional marketing authorization (CMA) for Nuvaxovid COVID-19 Vaccine (recombinant, adjuvanted) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older.

The vaccine, also known as NVX-CoV2373, was the first protein-based vaccine to be authorized for use in Switzerland.

The Swissmedic decision was based on the totality of preclinical, manufacturing and clinical trial data submitted for review. This includes two pivotal Phase 3 clinical trials: PREVENT-19, which enrolled approximately 30,000 participants aged 18 years and older in the U.S. and Mexico was published in the New England Journal of Medicine (NEJM); and a trial with almost 15,000 adult participants in the U.K. also published in NEJM.

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Source: Novavax
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