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European Union Authorizes Novavax Booster

The vaccine is available in adults 18 years and older.

Earlier this week, the European Commission (EC) announced it had approved the expanded conditional marketing authorization (CMA) of the Novavax, (Nuvaxovid, NVX-CoV2373) COVID-19 vaccine in the European Union as a homologous and heterologous booster.

“We are pleased to offer the first protein-based vaccine as both a primary series and booster in the European Union," Novavax CEO Stanley C. Erck, said in a statement. "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."

This expanded CMA stems from data from the company’s 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 the Novavax COVID-19 vaccine 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.

Back in August, Novavax announced it was seeking an FDA Emergency Use Authorization (EUA) for its COVID-19 vaccine as a booster. That application for this EUA is supported by data from the company’s phase 3 PREVENT-19 trial conducted in the United States and Mexico, and from the UK-sponsored COV-BOOST phase 2 trial. As part of an open-label booster phase of the PREVENT-19 trial, a single booster dose of the Novavax adjuvanted COVID-19 vaccine was administered to healthy adult participants at least 6 months after their primary two-dose vaccination series of the Novavax vaccine.

The third dose produced robust antibody responses comparable to or exceeding levels associated with the efficacy data in the primary series phase 3 clinical trials. In the COV-BOOST trial, the vaccine, induced a significant antibody response when used as a heterologous third booster dose.