Novavax has been chosen to participate in Operation Warp Speed, a U.S. government program that seeks to begin delivering millions of doses of a safe, effective vaccine for COVID-19 next year.
The Maryland based company has received $1.6 billion from the federal government to complete late-stage clinical development, including a Phase 3 clinical trial; establish large-scale manufacturing; and deliver 100 million doses of NVX‑CoV2373, its COVID-19 vaccine candidate, as early as late 2020.
Countries, including the U.S., are under a program called "Operation Warp Speed," where work is beginning to stockpile millions of doses of different shots, in hopes at least some will prove usable.
In addition to Novavax, Regeneron Pharmaceuticals has received $450 million through Operation Warp Speed to make and supply its COVID-19 vaccine candidate, REGN-COV2. The agreement supports continued manufacturing so that the product could be made available immediately in the U.S. if clinical trials are successful and the U.S. Food and Drug Administration grants Emergency Use Authorization or product approval.
REGN-COV2 is currently in two Phase 2/3 clinical trials for the treatment of COVID-19 and in a Phase 3 trial for the prevention of COVID-19 infection.
About 15 vaccine candidates are in various stages of human testing worldwide but the largest studies -- including 30,000 people each -- needed to prove if a shot really protects are set to begin in July. First up is expected to be a vaccine created by the NIH and Moderna Inc., followed closely by an Oxford University candidate.
Centers for Disease Control and Prevention Director Dr. Robert Redfield said the public health institute is already planning how to prioritize who is first in line for the scarce first doses and how they’ll be distributed.
But a vaccine is at the very least many months away.