Under an agreement reached with global biopharmaceutical companies Sanofi and GSK, the U.S. government will pay as much as $2.1 billion for development and delivery of 100 million doses of a vaccine to combat COVID-19.
It’s the largest agreement yet negotiated by Operation Warp Speed and it all hangs on the companies’ recombinant protein-based vaccine, which has not begun trials. The technology involved was originally used by Sanofi to create an influenza vaccine, and will now be supplemented by GSK’s established pandemic adjuvant technology.
“The global need for a vaccine to help prevent COVID-19 is massive, and no single vaccine or company will be able to meet the global demand alone,” Thomas Triomphe, executive vice president and global head of Sanofi Pasteur, said. “From the beginning of the pandemic, Sanofi has leveraged its deep scientific expertise and resources to help address this crisis, collaborating with the U.S. Department of Health and Human Services to unlock a rapid path toward developing a pandemic vaccine and manufacturing at large scale. With our partner GSK, we expect our Phase 1/2 study for the recombinant adjuvanted approach to start in September.”
A separate Phase 3 study is expected to begin by the end of the year. Both companies are also moving to scale-up manufacturing to produce as much as 1 billion doses per year, on the expectation that positive results in these studies could yield U.S. regulatory approval within the first half of 2021.
More than half of the government’s investment will be used to support clinical trials and other developmental aspects, but the rest will go toward the scale-up. Sanofi will receive the bulk of the funding. By funding the manufacturing effort, the federal government will own the doses that result from the demonstration project, which will take place in parallel with the clinical trials. Those doses could then be used in further clinical trials or, with approval from the U.S. Food and Drug Administration, distributed as part of a COVID-19 vaccination campaign.
“The portfolio of vaccines being assembled for Operation Warp Speed increases the odds that we will have at least one safe, effective vaccine as soon as the end of this year,” HHS Secretary Alex Azar said. “Today’s investment supports our latest vaccine candidate, an adjuvanted product being developed by Sanofi and GSK, all the way through clinical trials and manufacturing, with the potential to bring hundreds of millions of safe and effective doses to the American people.”
An additional option in the contract will allow the U.S. government to purchase an additional 500 million doses.