A Gaithersburg-based biotechnology company has been awarded a $1.6 billion contract to continue working on a COVID-19 vaccine.
The contract with Novavax — part of a government program called “Operation Warp Speed” — is for late-stage clinical development. It includes a Phase 3 clinical trial and large-scale manufacturing.
The contract calls for Novavax to deliver 100 million doses of its vaccine candidate — called NVX‑CoV2373 — as early as late 2020, according to a company press release posted Tuesday.
The Phase 3 clinical trial in the fall of 2020 would have up to 30,000 subjects, the press release said.
The U.S. Food and Drug Administration describes Phase 1 of a clinical trial as a look at safety and dosage, Phase 2 as a look at efficacy and side effects, Phase 3 as a look at efficacy and monitoring of adverse reactions and Phase 4 as a look at safety and efficacy. The number of people involved in the study increases with each phase.
“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,” U.S. Health and Human Services Secretary Alex Azar said in the press release. “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.”
Novavax said in the press release that a “Phase 1/2 clinical trial of NVX-CoV2373 in 130 healthy participants 18 to 59 years of age began in Australia in May. Preliminary immunogenicity and safety results are expected at the end of July, and the Phase 2 portion to assess immunity, safety, and COVID-19 disease reduction is expected to begin thereafter.”