Novavax Files Final Data to FDA, Lays Groundwork for COVID-19 Vaccine EUA Request in a Month

Vials labeled "COVID-19 Coronavirus Vaccine" and a syringe are seen in front of displayed Novavax logo in this illustration taken on Feb. 9, 2021. Dado Ruvic/Illustration/Reuters

Novavax says that it has submitted the final round of data on its COVID-19 vaccine to the U.S. Food and Drug Administration (FDA) in anticipation of filing a request to the agency for emergency use authorization (EUA) in a month.

The final data is related to the vaccine’s manufacturing processes, and its submission is the final prerequisite for the EUA application.