FDA Grants Fast Track Designation to Novavax’s COVID-19 Vaccine Candidate

Novavax announced on Nov. 9, 2020 that FDA has granted fast track designation to its COVID-19 vaccine candidate, NVX-CoV2373.

According to a company press release, the vaccine will enter into a Phase III clinical trial in the United States and Mexico by the end of November, which could potentially support global authorization and approval of the vaccine. NVX-CoV2373 is currently being evaluated in a Phase III clinical trial in the United Kingdom, which is expected to be fully enrolled by the end of November with results expected during the first quarter of 2020.

“The FDA’s decision to grant fast track designation for NVX-CoV2373 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 M. Glenn, MD, president of Research and Development, Novavax, in the press release. “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 US and globally.”