European Union Authorizes Novavax Booster

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.