FDA Authorizes Novavax COVID-19 Vaccine in Adolescents

The FDA has expanded its Emergency Use Authorization (EUA) of Novavax’s COVID-19 vaccine to include adolescents between the ages of 12 and 17 years old.

The EUA allows this age group to receive a two-dose primary series of the vaccine.

The agency’s decision was based on data from an ongoing late-stage clinical trial in which the vaccine demonstrated efficacy of 78.29 percent at a time when the Delta variant was the predominant variant in the U.S.

Unlike the messenger RNA-based vaccines from Pfizer-BioNTech and Moderna, the Novavax vaccine is based on recombinant nanoparticle technology.