Application to the FDA for Emergency Use Authorization for Novavax COVID-19 vaccine, adjuvanted as a booster in adults aged 18 and older
Novavax, Inc. announced that it submitted an application to the FDA for Emergency Use Authorization (EUA) of its protein-based COVID-19 Vaccine, Adjuvanted for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) as a homologous and heterologous booster in adults aged 18 and older
"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 Stanley C. Erck, President and Chief Executive Officer, Novavax. "Based on the data presented to the FDA's VRBPAC and the CDC ACIP, we believe our vaccine offers a broad, long-lasting immune response against a range of variants."
This application for EUA is supported by data from Novavax' Phase III PREVENT-19 trial conducted in the United States and Mexico, and from the UK-sponsored COV-BOOST Phase II trial.