On Jun. 23 2022, Novavax announced that the Nuvaxovid (NVX-CoV2373) COVID-19 vaccine had been recommended for expanded conditional marketing authorization (CMA) in the European Union (EU) for adolescents aged 12 through 17. The Committee for Medicinal Products for Human Use (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 (immunogenicity), 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.