Novavax Nuvaxovid™ COVID-19 Vaccine Granted Expanded Provisional Approval in New Zealand for Adolescents Aged 12 Through 17

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[{"type":"text","content":"Nuvaxovid™ is New Zealand's only protein-based COVID-19 vaccineGAITHERSBURG, Md., Aug. 18, 2022 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that New Zealand's Medsafe has granted expanded provisional approval for Nuvaxovid™ (NVX-CoV2373) COVID-19 vaccine for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adolescents aged 12 through 17.\n\"We are pleased to offer a protein-based COVID-19 vaccine choice as a primary series to New Zealanders aged 12 and older and as a booster for adults 18 and older,\" said Stanley C. Erck, President and Chief Executive Officer, Novavax. \"Providing Nuvaxovid now for adolescents may help increase vaccination rates amidst rising cases of COVID-19.\"\nThe provisional approval 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 73 sites in the U.S., to evaluate the safety, effectiveness (immunogenicity), and efficacy of Nuvaxovid. In the pediatric expansion, Nuvaxovid achieved its primary effectiveness endpoint and demonstrated 80% clinical efficacy overall at a time when the Delta variant was the predominant circulating SARS-CoV-2 strain in the U.S.\nPreliminary safety data from the pediatric expansion showed the vaccine to be generally well-tolerated. Serious and severe adverse events were low in number and balanced between vaccine and placebo groups, and not considered related to the vaccine. Local and systemic reactogenicity was generally lower than or similar to adults, after the first and second dose. The most common adverse reactions observed were injection site tenderness/pain, headache, myalgia, fatigue, and malaise. There was no increase in reactogenicity in younger (12 to 30%. A secondary endpoint was the prevention of PCR-confirmed, symptomatic moderate or severe COVID-19. Both endpoints were assessed at least seven days after the second study vaccination in volunteers who had not been previously infected with SARS-CoV-2. In the trial, the Novavax COVID-19 vaccine achieved 90.4% efficacy overall. It was generally well-tolerated and elicited a robust antibody respons...

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