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European Commission Grants Conditional Marketing Authorization for Novavax COVID-19 Vaccine
Nuvaxovid™ COVID-19 Vaccine (recombinant, adjuvanted) is the first protein-based COVID-19 vaccine authorized for use in Europe Novavax and the European
About this update from Novavax, Inc.
[{"type":"text","content":"Nuvaxovid™ COVID-19 Vaccine (recombinant, adjuvanted) is the first protein-based COVID-19 vaccine authorized for use in Europe Novavax and the European Commission previously announced an advance purchase agreement for up to 200 million doses through 2023 Authorization follows positive recommendation by European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) GAITHERSBURG, Md., Dec. 20, 2021 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that the European Commission (EC) has granted Novavax conditional marketing authorization (CMA) for Nuvaxovid™ COVID-19 Vaccine (recombinant, adjuvanted) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. The authorization follows the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommendation today to authorize the vaccine (also known as NVX-CoV2373) and is applicable in all 27 European Union (E.U.) member states. \n\"We welcome today's European Commission decision reflecting the first authorization of a protein-based COVID-19 vaccine for the people of the E.U.,\" said Stanley C. Erck, President and Chief Executive Officer, Novavax. \"We thank the European Medicines Agency, the Committee for Medicinal Products for Human Use reviewers and the European Commission for their thorough assessment as we look forward to playing a critical role in helping to address the continued threat of COVID-19. We also thank the thousands of clinical trial participants, our partners and Novavax employees worldwide who have contributed to this historic milestone.\" \nClick here to view multimedia content that accompanies this press release. \nThe 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 3 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...