FDA Grants Emergency Use Authorization for Novavax,COVID-19 Vaccine, adjuvanted (NVX-CoV2373)
Novavax, Inc. announced that the Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) has received emergency use authorization (EUA) from the FDA to provide a two-dose primary series for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and over.
"Patients and providers in the U.S. now have access to a protein-based COVID-19 vaccine backed by data that have demonstrated efficacy, safety, and tolerability," said Karen Kotloff, M.D., Professor of Pediatrics, University of Maryland School of Medicine, Associate Director of Clinical Studies at the Center for Vaccine Development and Global Health, COVID-19 Prevention Network co-lead for the PREVENT-19 trial. "Offering more vaccine technologies and options in our vaccination portfolio, including those built upon technologies that have been successfully used for years, will hopefully help to increase our country's vaccination rate."
The FDA EUA was based on data from the pivotal Phase III clinical trial, PREVENT-19, which enrolled approximately 30,000 participants aged 18 years and over in the U.S. and Mexico. In the trial, the Novavax COVID-19 Vaccine, Adjuvanted demonstrated 90.4% efficacy (95% confidence interval [CI], 83.8% to 94.3%; P<0.001) with a reassuring safety profile. among participants 18 through 64 years of age, solicited adverse reactions (ar) following administration of any dose of the novavax covid-19 vaccine, adjuvanted were injection site pain tenderness (82.2%), fatigue malaise (62.0%), muscle pain (54.1%), headache (52.9%), joint pain (25.4%), nausea vomiting (15.6%), injection site redness (7.0%), injection site swelling (6.3%), and fever (6.0%).
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