Novavax, Inc. 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.
"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."
The 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.
In 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), potentially immune-mediated medical conditions, and severe AEs occurred infrequently following the booster dose and were balanced between vaccine and placebo groups.
Nuvaxovid has also been authorized in Japan, Australia, and New Zealand as a booster in adults aged 18 and older and is actively under review in other markets.
The EC previously granted CMA for Nuvaxovid to prevent COVID-19 in adults aged 18 and older in December 2021. Additionally, the EC granted expanded CMA for Nuvaxovid to prevent COVID-19 in adolescents aged 12 through 17 in July 2022.
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