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Novavax Nuvaxovid™ COVID-19 Vaccine Recommended by CHMP for Expanded Conditional Marketing Authorization in the European Union as a Booster for Adults Aged 18 and Older
Authorization could allow Nuvaxovid™ to be used as a booster regardless of previous vaccine historyGAITHERSBURG, Md., Sept. 1, 2022 /PRNewswire/ -- Novavax,
About this update from Novavax, Inc.
[{"type":"text","content":"Authorization could allow Nuvaxovid™ to be used as a booster regardless of previous vaccine historyGAITHERSBURG, Md., Sept. 1, 2022 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that Nuvaxovid™ (NVX-CoV2373) COVID-19 vaccine has been recommended for expanded conditional marketing authorization (CMA) 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 Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its opinion on results from two Phase 2 trials, and the UK-sponsored COV-BOOST trial.\n\"This recommendation is a critical step towards being able to offer the first protein-based COVID-19 vaccine registered for use as both a primary series and booster regardless of previous vaccine history in the EU,\" said Stanley C. Erck, President and Chief Executive Officer, Novavax. \"As COVID-19 continues to evolve, we are committed to increasing global access to diversified vaccine options.\"\nThe CHMP recommendation 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 increased immunogenicity seen with a third dose. Medically attended adverse events (AE), p...