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Novavax Announces Positive Results of COVID-19 Vaccine in Pediatric Population of PREVENT-19 Phase 3 Clinical Trial
- PREVENT-19 pediatric expansion in adolescents aged 12 through 17 achieved primary effectiveness endpoint demonstrating comparability to adult population -
About this update from Novavax, Inc.
[{"type":"text","content":"- PREVENT-19 pediatric expansion in adolescents aged 12 through 17 achieved primary effectiveness endpoint demonstrating comparability to adult population\n- Trial demonstrated 82% clinical efficacy against Delta variant\n- Immune responses were about two-to-three-fold higher in adolescents than in adults against all variants studied\n- Vaccine was well-tolerated with no safety signals identified\n- Novavax plans to supplement global regulatory filings with pediatric data in Q1 2022\n- Company to host investor conference call today from 4:30 - 5:00 pm ET\n GAITHERSBURG, Md., Feb. 10, 2022 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that NVX-CoV2373, its recombinant nanoparticle protein-based COVID-19 vaccine, achieved its primary effectiveness endpoint in the pediatric expansion of its PREVENT-19 pivotal Phase 3 trial and demonstrated 80% efficacy overall at a time when the Delta variant was the predominant circulating strain in the U.S. The study enrolled 2,247 adolescents aged 12 through 17-years across 73 sites in the U.S. to evaluate safety, effectiveness (immunogenicity), and efficacy, with an emphasis on ensuring well balanced racial and ethnic representation among participants.\n\"We are encouraged by the results in this adolescent population given the ongoing need for alternative vaccine options for COVID-19,\" said Filip Dubovsky, MD, Chief Medical Officer, Novavax. \"We believe the Novavax vaccine offers a differentiated technology and option for this younger population given its established protein-based technology already used in other vaccines, and the positive responses demonstrated against variants.\"\nThe primary PREVENT-19 pivotal Phase 3 trial conducted in adults aged 18 years and older, results of which were published in The New England Journal of Medicine (NEJM), enrolled approximately 30,000 participants in the U.S. and Mexico. NVX-CoV2373 achieved 90.4% efficacy overall and demonstrated a reassuring safety and tolerability profile. Serious and severe adverse events in adults were low in number and balanced between vaccine and placebo groups. The most common adverse reactions observed in adults during clinical studies (frequency category of very common ≥1/10) were he...