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Novavax Nuvaxovid™ COVID-19 Vaccine Granted Expanded Conditional Marketing Authorization in the European Union for Use as a Booster for Adults Aged 18 and Older
Nuvaxovid™ is now authorized in the EU for use in adults aged 18 and older as a booster regardless of previous vaccine historyGAITHERSBURG, Md., Sept. 12,
About this update from Novavax, Inc.
[{"type":"text","content":"Nuvaxovid™ is now authorized in the EU for use in adults aged 18 and older as a booster regardless of previous vaccine historyGAITHERSBURG, Md., Sept. 12, 2022 /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 approved the expanded conditional marketing authorization (CMA) of Nuvaxovid™ (NVX-CoV2373) COVID-19 vaccine in the European Union (EU) as a homologous and heterologous booster for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) for adults aged 18 and older. The approval follows the recommendation made by the European Medicines Agency's Committee for Medicinal Products for Human Use on September 1, 2022.\n\"We are pleased to offer the first protein-based vaccine as both a primary series and booster in the European Union,\" said Stanley C. Erck, President and Chief Executive Officer, Novavax. \"As we continue to explore best practices for managing COVID-19 long term, we have ongoing trials further exploring Nuvaxovid's efficacy and safety as a booster and preclinical data has indicated that our vaccine induces immune response against Omicron variants, including BA.4/5.\"\nThe expanded CMA was based on data from Novavax' Phase 2 trial conducted in Australia, from a separate Phase 2 trial conducted in South Africa, and from the UK-sponsored COV-BOOST trial. As part of the Phase 2 trials, a single booster dose of Nuvaxovid was administered to healthy adult participants approximately six months after their primary two-dose vaccination series of Nuvaxovid. The third dose produced increased immune responses comparable to or exceeding levels associated with protection in Phase 3 clinical trials. In the COV-BOOST trial, Nuvaxovid induced a robust antibody response when used as a heterologous third booster dose.\nIn the Novavax-sponsored trials, following the booster, local and systemic reactions were generally short-lived with a median duration of approximately two days. The incidence of Grade 3 or higher events remained relatively low. Safety reporting of reactogenicity events showed an increasing incidence across all three doses of Nuvaxovid, reflecting the increas...