The Maryland-based biotechnology company, Novavax has been selected to be a part of the U.S. government program, Operation Warp Speed (OWS) that aims to begin delivering millions of doses of a safe, effective vaccine for COVID-19 in 2021.
The company that develops next-generation vaccines for serious infectious diseases, is in its late-stage phase-3 clinical trial and will get a funding of $1.6 Billion from the federal government.
As per the terms of the agreement, Novavax has to show that it can rapidly stand up large-scale manufacturing and transition into ongoing production, including the capability to stock up and distribute large quantities of vaccine NVX-CoV2373 when needed. The funding will also be used for late-stage clinical studies necessary to determine the safety and efficacy of the vaccine, including Phase 3 clinical trials with up to 30,000 subjects beginning in the fall of 2020.
Depending on the success of the candidate in clinical trials, Novavax will have to manufacture 100 million doses for the American people.
Based on the success of the candidate, there can be a follow-on agreement with the U.S. government for additional production and procurement to support OWS’s vaccine production goal.