The FDA has fast-tracked Novavax's COVID-19 vaccine, which is currently in late-stage development, the drugmaker said Nov. 9.
Granting fast-track designation means the FDA will expedite its review of the vaccine in order to come to an approval decision quicker.
"The FDA’s decision to grant fast track designation for [Novavax's vaccine] reflects the urgent need for a safe and effective vaccine to prevent COVID-19, and we look forward to working closely with the agency to accelerate access to this vaccine," said Gregory Glenn, MD, Novavax's president of research and development. "While the regulatory review of this clinical program will be expedited, Novavax remains committed to a data-driven and scientifically rigorous approach in demonstrating safety and efficacy, which we believe will support confidence in the vaccine in the U.S. and globally."
Novavax said it plans to start its phase 3 trial of the vaccine in the U.S. and Mexico by the end of November. It's already started a phase 3 trial in the U.K., which it said it expects to be fully enrolled by the end of November. Results are expected as soon as early first quarter 2021.
Novavax has received about $2 billion for its global COVID-19 vaccine program, with almost $1.7 billion coming from the U.S., the drugmaker said.
Read Novavax's full news release here.