Nuvaxovid COVID 19 vaccine is filed in the European Union for expanded conditional marketing authorization.- Novavax.

This request for expanded CMA is supported by 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 NVX-CoV2373. 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, NVX-CoV2373 induced a robust antibody response when used as a heterologous third booster dose.

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 NVX-CoV2373, reflecting the increased immunogenicity seen with a third dose.

Medically attended adverse events, potentially immune-mediated medical conditions, and severe adverse events occurred infrequently following the booster dose and were balanced between vaccine and placebo groups..