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Novavax Nuvaxovid™ COVID-19 Vaccine Receives Expanded Emergency Use Authorization in Taiwan for Use in Adolescents Aged 12 Through 17
GAITHERSBURG, Md., Sept. 16, 2022 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing
About this update from Novavax, Inc.
[{"type":"text","content":"GAITHERSBURG, Md., Sept. 16, 2022 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that the Taiwan Food and Drug Administration (TFDA) has granted expanded emergency use authorization (EUA) 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\"In Taiwan, we have seen strong use of our protein-based COVID-19 vaccine in adults and are pleased to expand availability to adolescents aged 12 through 17 as we prepare for more time spent indoors during the fall and winter months and possible COVID-19 surges,\" said Stanley C. Erck, President and Chief Executive Officer, Novavax. \"We believe that our vaccine, developed using an innovative approach to traditional technology, may help increase adolescent vaccination rates.\"\nThe EUA is 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 75 sites in the U.S., to evaluate the safety and effectiveness of Nuvaxovid. In the pediatric expansion, Nuvaxovid achieved its primary efficacy endpoint with clinical efficacy of 78.29% (95% CI: 37.55%, 92.45%) overall at a time when the Delta variant was the predominant circulating SARS-CoV-2 strain in the U.S. The efficacy analysis was supported by assessment of antibody titers that were shown to be higher in adolescents than in young adults.\nPreliminary safety data from the pediatric expansion showed the vaccine to be generally well-tolerated. Serious and severe adverse reactions (AR) 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. Among participants 12 through 17 years of age, solicited ARs following administration of any dose of the vaccine were injection site pain/tenderness (75.0%), headache (56.9%), fatigue/malaise (57.9%), muscle pain (49.0%), nausea/vomiting (19.9%), joint pain (16.2%), fever (16.9%), injection site swelling (8.0%), and injection site redness (7.5%). Most were m...