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Novavax Receives Positive European Medicines Agency Recommendation for Conditional Marketing Authorization of its COVID-19 Vaccine
European Commission decision on conditional marketing authorization expected imminently Upon authorization, Nuvaxovid™ (also known as NVX-CoV2373) will be the
About this update from Novavax, Inc.
[{"type":"text","content":"European Commission decision on conditional marketing authorization expected imminently Upon authorization, Nuvaxovid™ (also known as NVX-CoV2373) will be the first protein-based COVID-19 vaccine available in Europe 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 Medicines Agency (EMA) has recommended granting a conditional marketing authorization for Novavax' COVID-19 vaccine (also known as NVX-CoV2373) to prevent COVID-19 in people from 18 years of age and older. Upon authorization, NVX-CoV2373 will be marketed in the European Union (E.U.) as Nuvaxovid™ COVID-19 Vaccine (recombinant, adjuvanted). \n\"Novavax appreciates the CHMP's positive opinion concerning our vaccine, and we look forward to a decision from the European Commission,\" said Stanley C. Erck, President and Chief Executive Officer, Novavax. \"An authorization from the Commission would deliver the first protein-based vaccine to the E.U. during a critical time when we believe having choice among vaccines will lead to increased immunization.\" \nThe EMA recommendation follows a positive CHMP opinion based on an expedited review of the totality of manufacturing, preclinical, and clinical trial data submitted by the company, with the conclusion that the vaccine meets the stringent criteria set by the E.U. for efficacy, safety and quality. This included data from two pivotal Phase 3 clinical trials: PREVENT-19, which enrolled almost 30,000 participants in the U.S. and Mexico, and achieved an overall efficacy of 90.4%, the results of which were published in the New England Journal of Medicine (NEJM)); and a trial with more than 14,000 participants in the U.K. that achieved an overall efficacy of 89.7%, the results of which were also published in NEJM. In both trials, NVX-CoV2373 demonstrated high efficacy and a reassuring safety and tolerability profile.\nNovavax and the European Commission announced an advance purchase agreement (APA) for up to 200 million doses of Novavax' COVID-19 vaccine in August 2021. This filing leverages Novavax' manufacturing partnership with Serum Institute of India (SII), the world's largest vaccine manufacturer by volume, which will supply initial doses ...