EU approves expanded conditional marketing for Nuvaxovid in COVID-19

The approval follows the recommendation made by the European Medicines Agency's Committee for Medicinal Products for Human Use on September 1, 2022.

The expanded CMA was based on data from Novavax' Phase II trial conducted in Australia, from a separate Phase II trial conducted in South Africa, and from the UK-sponsored COV-BOOST trial. As part of the Phase II 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 III 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.