On Jun. 23 2022, Novavax announced the filing of a Supplement to a New Drug Submission with Health Canada to expand the label of Nuvaxovid (NVX-CoV2373) COVID-19 vaccine for active immunization to prevent COVID-19 caused by SARS-CoV-2 to adolescents aged 12 through 17 years.

This request 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 years 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.