July 9, 2020 -- Novavax was awarded $1.6 billion by the U.S. government through Operation Warp Speed to deliver 100 million doses of a COVID-19 vaccine as early as late 2020.
The vaccine candidate, NVX-CoV2373, consists of a stable, prefusion protein manufactured using Novavax's proprietary nanoparticle technology and Matrix-M adjuvant.
Under the agreement, Novavax will rapidly ramp up large-scale manufacturing and transition into ongoing production, including storage and distribution of large quantities of the vaccine as needed. The funding will support late-stage clinical studies to determine the safety and efficacy of the vaccine candidate, including a phase III clinical trial with up to 30,000 participants beginning in the fall of 2020. Funds will also support the company's plans to file for licensure with the U.S. Food and Drug Administration.
The agreement also includes a follow-on agreement for additional production and procurement support to meet Operation Warp Speed's vaccine production goal.
Preliminary results for phase I/II clinical trials are expected at the end of July and immunity, safety, and efficacy studies are expected to begin shortly. These trials are supported with $388 million from the Coalition for Epidemic Preparedness Innovations. The Department of Defense is also investing $60 million to advance clinical development of NVX-CoV2373.