Business
U.S. FDA Grants Emergency Use Authorization for Novavax COVID-19 Vaccine, Adjuvanted for Adolescents Aged 12 Through 17
Novavax' vaccine is the first protein-based COVID-19 vaccine authorized in the U.S. Doses of the Novavax COVID-19 Vaccine, Adjuvanted are now available and
About this update from Novavax, Inc.
[{"type":"text","content":"Novavax' vaccine is the first protein-based COVID-19 vaccine authorized in the U.S. Doses of the Novavax COVID-19 Vaccine, Adjuvanted are now available and primary series immunizations for adolescents can begin once a policy recommendation from the CDC is receivedGAITHERSBURG, Md., Aug. 19, 2022 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that the Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) has received expanded emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) to provide a two-dose primary series for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adolescents aged 12 through 17.\n\"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.\"\nThe 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.\nSafety data from the pediatric expansion showed the vaccine to be generally well-tolerated. Serious and severe adverse reactions (AR) were low in number and balanced between vaccine and placebo groups, and not considered related to the vaccine. Local...