FDA Approves Novavax's COVID-19 Vaccine For Use In Adolescents - Novavax (NASDAQ:NVAX)

The FDA has granted expanded use authorization for Novavax Inc's NVAX COVID-19 vaccine in adolescents aged 12 through 17. The move comes immediately after New Zealand approved the shot for the same group.
The FDA EUA decision was based on data from the ongoing pediatric expansion of the Phase 3 PREVENT-19 trial of 2,247 adolescents.
In pediatric expansion, the vaccine achieved its primary efficacy endpoint with clinical efficacy of 78.29% overall when the Delta variant was the predominant circulating SARS-CoV-2 strain in the U.S.
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The efficacy analysis was supported by the 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.
No new safety signal was observed.
The next step for the vaccine is a policy recommendation from the Centers for Disease Control and Prevention.
In July, the FDA 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.
Price Action: NVAX shares are up 0.36% at $36.35 during the premarket session on the last check Monday.
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