GAITHERSBURG, MD.

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 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…

Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that European Medicines Agency (EMA) has begun its evaluation of an application for conditional marketing authorization (CMA) for Novavax’ COVID-19 vaccine, which will be marketed in the European Union under the brand name Nuvaxovid™. EMA’s statement […]

SK bioscience submits application for NVX-CoV2373, the first protein-based COVID-19 vaccine candidate for BLA, to South Korea’s MFDS Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, and SK bioscience, Co. Limited (SK bioscience), a biotechnology company in South Korea, today announced the submission of a Biologics […]

– Submission to New Zealand’s Medsafe marks the first protein-based COVID-19 vaccine submitted for authorization to regulatory authorities in New Zealand – All modules required for regulatory review of Novavax vaccine, including CMC data, are now complete for Medsafe Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today…

Filing marks first protein-based COVID-19 vaccine submitted to MHRA for authorization All modules required for regulatory review, including CMC data, are now complete Submission based on Phase 3 data from ~45K patients demonstrating high efficacy and well-tolerated safety, including against variants Submissions to additional global regulatory authorities including EU, Canada and Australia expected soon Novavax, Inc. […]

Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that Vivek Shinde, M.D., Vice President, Clinical Development, will deliver a presentation during the World Vaccine Congress Europe 2021. A topic of discussion will be Novavax’ COVID-NanoFlu™ Combination Vaccine, which combines the company’s recombinant…

– Pivotal Phase 3 trial achieved all primary endpoints, demonstrating non-inferiority to a leading U.S.-licensed quadrivalent influenza vaccine – NanoFlu™ vaccine candidate induced significantly enhanced cell-mediated immune responses – NanoFlu was well-tolerated with a comparable safety profile Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious…

Novavax and Serum Institute of India file regulatory submission for World Health Organization Emergency Use Listing of Novavax’ recombinant nanoparticle protein-based COVID-19 vaccine Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, with its partner, Serum Institute of India Pvt. Ltd. (SII), today announced a regulatory […]