FDA grants Emergency Use Authorization for Novavax COVID-19 vaccine, adjuvanted for adolescents aged 12 through 17

"Having more vaccine options for use in both adults and adolescents, like the Novavax COVID-19 Vaccine, Adjuvanted will hopefully help increase vaccination rates, particularly as we prepare for ongoing surges of COVID-19 with the start of fall and the back-to-school season," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "We hope that our vaccine, developed using an innovative approach to recombinant protein vaccine technology, may have a special role in adolescent vaccination based on parents' and caregivers' familiarity with protein-based vaccines used in other disease areas."

The FDA EUA decision was based on data from the ongoing pediatric expansion of the Phase III PREVENT-19 trial of 2,247 adolescents aged 12 through 17 years across 75 sites in the U.S., to evaluate the safety and effectiveness of the Novavax COVID-19 Vaccine, Adjuvanted. In pediatric expansion, the vaccine achieved its primary efficacy endpoint with clinical efficacy of 78.29% (95% CI: 37.55%, 92.45%) overall at a time when the Delta variant was the predominant circulating SARS-CoV-2 strain in the U.S. The efficacy analysis was supported by assessment of antibody titers that were shown to be higher in adolescents than in young adults.