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Novavax Announces Expanded Approval of Nuvaxovid™ COVID-19 Vaccine for Adolescents Aged 12 through 17 in Japan
Nuvaxovid™ is the first protein-based COVID-19 vaccine approved for use in adolescents in JapanGAITHERSBURG, Md., July 26, 2022 /PRNewswire/ -- Novavax, Inc.
About this update from Novavax, Inc.
[{"type":"text","content":" Nuvaxovid™ is the first protein-based COVID-19 vaccine approved for use in adolescents in JapanGAITHERSBURG, 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 that Nuvaxovid™ (NVX-CoV2373) COVID-19 vaccine received expanded manufacturing and marketing approval from the Japan Ministry of Health, Labour and Welfare (MHLW) for primary 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. Novavax has partnered with Takeda to develop, manufacture, and distribute Nuvaxovid in Japan.\n\"We are pleased to work with Takeda to offer Nuvaxovid™, a protein-based vaccine, to adolescents in Japan,\" said Stanley C. Erck, President and Chief Executive Officer, Novavax. \"As COVID-19 continues to surge in the country, this approval offers another option to help protect the health of the people of Japan and help bolster the vaccination rate.\"\nThe expanded approval 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","length":2948,"tagName":"div"}]