Novavax Inc. (NASDAQ: NVAX) said Monday it received a crucial status for its Covid-19 vaccine candidate as the pandemic drags on and coronavirus cases once again soar across the country.
The Gaithersburg company has earned fast-track designation from the Food and Drug Administration for NVX-CoV2373, a coronavirus vaccine candidate in late-stage development. It means the biotech can submit parts of its application on a rolling basis for a speedier review by the agency, and gives Novavax more direct and frequent access to the FDA.
The 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,” Dr. Gregory Glenn, president of research and development for Novavax, said in a statement. “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.”
The vaccine candidate is now in phase 3 clinical trials in the United Kingdom, with the potential for data early in the first quarter of 2021. It’s also on track to start late-stage studies in the U.S. and Mexico by the end of November after some delays. Data from these trials, if positive, could support required regulatory approvals to eventually administer the product to the public.
The program is funded with a total $2 billion, including $1.6 billion from the federal government’s Operation Warp Speed, $60 million from the Department of Defense and up to $338 million from the Coalition for Epidemic Preparedness Innovations, or CEPI.
Novavax’s share price reached a high of $101 Monday morning on the news, a 12.4% spike from its $89.86 close Friday. The stock was trading up more than 3% at $92.71 by 1:30 p.m.
Novavax secures fast-track status in a pivotal stage of the Covid-19 vaccine race, as other companies also advance candidates — and stand to reach the market earlier if successful in the clinic. New York pharmaceutical giant Pfizer Inc. (NYSE: PFE) and German biotech BioNTech SE (NASDAQ: BNTX) disclosed Monday their coronavirus vaccine candidate has shown to be more than 90% effective in early data from its late-stage trial.
It also comes as Novavax expands its footprint and continues to hire in Montgomery County, and after it restarted work on its seasonal flu vaccine program in October after temporarily pausing it earlier in 2020 to focus exclusively on Covid-19 clinical trials.
Novavax is set to report earnings Monday after the closing bell.
