Novavax COVID vaccine Adjuvanted gets USFDA emergency use authorization 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."

NVX-CoV2373 is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. The vaccine was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax' patented saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19.

The FDA EUA decision was based on data from the ongoing pediatric expansion of the Phase 3 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. Safety data from the pediatric expansion showed the vaccine to be generally well-tolerated.

The next step for the vaccine is a policy recommendation for use from the Centers for Disease Control and Prevention (CDC). Doses of the Novavax COVID-19 Vaccine, Adjuvanted are available for use in adolescents upon the CDC's recommendation.

In July 2022 the U.S. FDA had granted EUA for a two-dose primary series in adults aged 18 and older, followed by a recommendation from the CDC Advisory Committee on Immunization Practices, and endorsement from the CDC.