Novavax’s COVID-19 Vaccine Candidate Gets FDA Fast Track Status

As Novavax gears up to put its investigational COVID-19 vaccine through a phase 3 U.S. trial this month, the FDA has granted the candidate a Fast-Track designation in order to speed up its regulatory review process.

While all COVID-19 vaccines are getting accelerated reviews by the agency at this time — making the Fast-Track designation a technical change — it makes sponsors eligible for more frequent meetings with the FDA’s reviewers and for “rolling reviews” in which the agency does not wait to see a completed submission but will review a completed section of an application.

The Fast-Track designation “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, Novavax’s president of research and development.

The Gaithersburg, Md., vaccine firm’s late-stage study for its candidate, NVX-CoV2373, will begin by the end of November and will enroll up to 30,000 participants in the U.S. and Mexico, the company said. The company had planned to initiate the trial sooner but had to push back its start date due to manufacturing delays.

The vaccine is currently being evaluated in an ongoing phase 3 UK study. Enrollment for that trial is slated to wrap up by the end of the month, and interim data could be released as soon as the first quarter of 2021, according to Novavax.

Other vaccine candidates have been granted FDA Fast-Track status in order to accelerate their review times, including Moderna’s mRNA-1273 and Pfizer/BioNTech’s BNT162b2, the latter of which is currently leading in the race for an FDA Emergency Use Authorization and eventual approval (see related story). — James Miessler