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Novavax Nuvaxovid™ COVID-19 Vaccine Approved in South Korea for Use in Adolescents Aged 12 Through 17
Novavax and partner SK bioscience will provide the first protein-based COVID-19 vaccine approved for use in adolescents aged 12 through 17 years in South
About this update from Novavax, Inc.
[{"type":"text","content":"Novavax and partner SK bioscience will provide the first protein-based COVID-19 vaccine approved for use in adolescents aged 12 through 17 years in South KoreaGAITHERSBURG, Md., Aug. 12, 2022 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that partner, SK bioscience, has received a Post Approval Change Application approval from the Korean Ministry of Food and Drug Safety (KMFDS) 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\"Today's approval in South Korea is an important step in ensuring broad global access to a protein-based vaccine option,\" said Stanley C. Erck, President and Chief Executive Officer, Novavax. \"We are pleased to collaborate with SK bioscience to offer our vaccine to adolescents aged 12 through 17 in South Korea.\"\nJaeyong Ahn, CEO of SK bioscience said, \"We are responding to the ongoing COVID-19 pandemic by expanding the use of Nuvaxovid for adolescents and as a booster. With CDMO manufacturing of global COVID-19 vaccines, including Nuvaxovid, we will do our best to promote human health in the world.\"\nThe 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 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","lengt...