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Novavax Nuvaxovid™ COVID-19 Vaccine Granted Provisional Registration in Australia for Use in Adolescents Aged 12 Through 17
Nuvaxovid™ is the first protein-based COVID-19 vaccine available for use in adolescents aged 12 through 17 in AustraliaGAITHERSBURG, Md., July 26, 2022
About this update from Novavax, Inc.
[{"type":"text","content":"Nuvaxovid™ is the first protein-based COVID-19 vaccine available for use in adolescents aged 12 through 17 in AustraliaGAITHERSBURG, Md., July 26, 2022 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced the Australian Therapeutic Goods Agency (TGA) has granted expanded approval for provisional registration of 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) to adolescents aged 12 through 17.\n\"Today's provisional registration of Nuvaxovid for adolescents is timely with Australia's current winter surge of COVID-19 and the return to schools,\" said Stanley C. Erck, President and Chief Executive Officer, Novavax. \"We are committed to reducing the burden of COVID-19 and believe that our vaccine, developed using an innovative approach to traditional technology, may help increase the adolescent vaccination rate.\"\nThe provisional registration was based on data from the ongoing pediatric expansion of PREVENT-19, a pivotal Phase 3 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 trial, 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 trial 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-C...