European Commission grants conditional marketing authorization for Nuvaxovid COVID-19 vaccine.
The authorization follows the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommendation to authorize the vaccine (also known as NVX-CoV2373) and is applicable in all 27 European Union (E.U.) member states.
The EMA opinion and related EC decision is based on the totality of preclinical, manufacturing and clinical trial data submitted for review. This includes two pivotal Phase III clinical trials: PREVENT-19 which included 30,000 participants in the U.S. and Mexico, the results of which were published in The New England Journal of Medicine (NEJM); and a trial with 15,000 participants in the U.K., the results of which were also published in NEJM. In both trials, NVX-CoV2373 demonstrated high efficacy and an acceptable safety and tolerability profile. Novavax will continue to collect and analyze real-world data, including the monitoring of safety and the evaluation of variants, as the vaccine is distributed..
"Efficacy and Safety of NVX-CoV2373 in Adults in the United States and Mexico"- Lisa M. Dunkle, M.D., Karen L. Kotloff, M.D., Cynthia L. Gay, M.D., M.P.H., Germán Áñez, M.D., ,Veronica Garcia-Fragoso, M.D., et al., for the 2019nCoV-301 Study Group.10.1056/NEJMoa2116185. NEJM.
VOL. 385 NO. 13, SEP 23, 2021- Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine; P.T. Heath and Others.N Engl J Med 2021; 385:1172-1183.
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