The U.S. Food and Drug Administration (FDA) granted emergency use authorization (EUA) to Novavax COVID-19 vaccine Adjuvanted (NVX-CoV2373) “for the prevention of Coronavirus Disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 through 17 years of age.”
“This authorization follows a rigorous analysis and evaluation of the safety and effectiveness data conducted by the FDA,” said the agency’s roundup.
The Maryland-based biotech company announced on its website that FDA’s decision on EUA “was based on data from the ongoing pediatric expansion of 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.”
“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,” said Stanley C. Erck, President, and Chief Executive Officer of Novavax.
The trial results showed that “the vaccine achieved its primary efficacy endpoint with clinical efficacy of 78.29% overall” at a time when the Delta variant was the predominant circulating strain in the U.S.
“The efficacy analysis was supported by an assessment of antibody titers that were shown to be higher in adolescents than in young adults,” Novavax’s release added, pointing out that “safety data from the pediatric expansion showed the vaccine to be generally well-tolerated.”
CDC recommendation pending
Novavax COVID-19 Vaccine, Adjuvanted will be available for use in adolescents upon the policy recommendation for use from the Centers for Disease Control and Prevention (CDC).
Erck pointed out that “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.”
Experts hope that Novavax’s protein-based vaccine will be more acceptable to unvaccinated adults and adolescents who have refused jabs made with Pfizer’s and Moderna’s mRNA vaccine technology or are allergic to some of their vaccines’ components.
