Novavax COVID-19 Vaccine Recommended For Conditional Marketing Authorization In EU For Adolescents

(RTTNews) - Novavax Inc. (NVAX) said that the Nuvaxovid (NVX-CoV2373) COVID-19 vaccine has been recommended for expanded conditional marketing authorization in the European Union for adolescents aged 12 through 17. The Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency based its opinion on results from the Phase 3 PREVENT-19 clinical trial.

The CHMP recommendation was based on data from the ongoing pediatric expansion of PREVENT-19, a pivotal Phase 3 trial of 2,247 adolescents aged 12 through 17 across 73 sites in the U.S., to evaluate the safety, effectiveness, and efficacy of Nuvaxovid.

In the trial, Nuvaxovid achieved its primary effectiveness endpoint and demonstrated 80% clinical efficacy overall at a time when the Delta variant was the predominant circulating SARS-CoV-2 strain in the U.S.

The European Commission granted conditional marketing authorization for Nuvaxovid to prevent COVID-19 in people 18 years of age and over in December 2021.

In the 12 through 17 year-old population, emergency use authorization has been granted in India.