Novavax Submits EUA Application to FDA for COVID-19 Vaccine Booster

Novavax has submitted an Emergency Use Authorization (EUA) application to the FDA for its protein-based COVID-19 vaccine as an adjuvanted booster dose for adults 18 years and older.

The EUA application was supported by results from clinical studies that showed the booster dose produces robust and significant antibody responses, the company said.

“It’s important for people to have a choice as they evaluate how to stay protected against COVID-19, and boosters are an invaluable tool to build upon immunity obtained from previous vaccinations,” said Novavax CEO Stanley C. Erck.

The FDA granted Novavax’s COVID-19 vaccine emergency authorization in July as a two-dose primary series for adults 18 years and older.