PREVENT-19 Adolescent Data Published in the Journal of the American Medical Association Network Open
The full results from the pediatric expansion of Novavax’s Phase 3 PREVENT-19 trial were published in the Journal of the American Medical Association Network Open. The expansion evaluated the safety and effectiveness of Novavax’s COVID-19 prototype vaccine (NVX-CoV2373) in adolescents aged 12 through 17 years across the U.S.
In the trial, the vaccine achieved its primary effectiveness and efficacy endpoints at a time when the Delta variant was the predominant circulating SARS-CoV-2 strain. Non-inferior neutralizing antibody responses compared to young adults in the adult main study were demonstrated, which was the key regulatory endpoint for authorization. Safety data showed the vaccine to be generally well-tolerated. The most common adverse reactions observed were injection site tenderness/pain, headache, myalgia, fatigue and malaise. There was no increase in reactogenicity in younger (12 to <15 years old) adolescents compared to older (15 to <18 years old) adolescents. No new safety signals were observed in the placebo-controlled portion of the study.
Results from the expansion were announced in February 2022 and the manuscript was previously posted to the medRxiv preprint server in September 2022. To date, the vaccine has been authorized in more than 30 markets around the world for use in this population.