Novavax Inc., a biotechnology company based in Gaithersburg, Maryland, has received $1.6 billion from the federal government to develop, test and manufacture its COVID-19 vaccine candidate.
Novavax received the award through the government program Operation Warp Speed, which aims to begin delivering millions of doses of a safe, effective vaccine for COVID-19 in 2021, the company said in a news release Tuesday.
Maryland Gov. Larry Hogan said it is the largest grant yet from Operation Warp Speed.
As part of the grant agreement, Novavax must establish large-scale manufacturing and transition into ongoing production, including the capability to stockpile and distribute large quantities of its vaccine, NVX-CoV2373, when needed.
The grant will fund late-stage clinical studies, including a Phase 3 clinical trial with up to 30,000 subjects beginning in the fall of 2020, according Novavax.
“Adding Novavax’ candidate to Operation Warp Speed’s diverse portfolio of vaccines increases the odds that we will have a safe, effective vaccine as soon as the end of this year,” said U.S. Health and Human Services Secretary Alex Azar. “Today’s $1.6 billion investment supports the Novavax candidate, depending on success in clinical trials, all the way through to manufacturing 100 million doses for the American people.”
Phase 1 and 2 of Novavax's clinical trial began in May with 130 healthy participants ages 18 to 59 in Australia. Those phases were funded by the Coalition for Epidemic Preparedness Innovations.