Novavax announced that the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (U.K.) granted full marketing authorization for its prototype COVID-19 vaccine Nuvaxovid™ (NVX-CoV2373) for individuals aged 12 and older for active immunization to help prevent COVID-19.
Authorization was based on two Phase 3 trials, PREVENT-19 conducted in the U.S. and Mexico and a Phase 3 trial in the U.K., as well as a Phase 2a/b trial in South Africa. In these trials, Novavax demonstrated the efficacy and safety of its prototype vaccine as a primary series in individuals aged 12 and older, and the immunogenicity and safety of the vaccine as a booster in individuals aged 18 and older.
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