Europe Authorizes Maryland's COVID-19 Booster for Adults

Maryland-based Novavax, Inc. announced yesterday that the European Commission (EC) had approved the expanded conditional marketing authorization of the Nuvaxovid™ COVID-19 vaccine in the European Union as a homologous and heterologous booster for active immunization to prevent COVID-19 in adults. 

Nuvaxovid has also been authorized in Japan, Australia, and New Zealand as a booster in adults and is actively under review in other markets.

The EC previously granted authorization for Nuvaxovid to prevent COVID-19 in December 2021 and in adolescents in July 2022.

"We are pleased to offer the first protein-based vaccine as both a primary series and booster in the European Union," commented Stanley C. Erck, President, and CEO, of Novavax, in a press release on September 12, 2022.

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

Note: The trade name Nuvaxovid™ has not yet been approved by the U.S. FDA.