The United States announced Friday it will pay French pharmaceutical company Sanofi and Great Britain’s GlaxoSmithKline up to $2.1 billion to test and produce 100 million doses of an experimental coronavirus vaccine.
More than half of the money will support further development and early-stage clinical trials to ensure it is safe and effective. The rest will pay for the first 100 million doses, with an option on 500 million more.
The majority of the $2.1 billion will go to Sanofi, which made the vaccine candidate. GlaxoSmithKline made a booster that improves how the body responds to it.
The deal is part of Operation Warp Speed, a White House-led initiative aimed at getting a vaccine to stop SARS-CoV-2, the virus that causes COVID-19. The Trump administration initiative has now spent more than $8 billion on experimental vaccines that may or may not make it across the finish line.
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They are being manufactured “at-risk” — before they’re licensed. If any of the vaccines aren’t approved, the stockpiled doses will be destroyed.
The companies are collaborating with the U.S. Department of Health and Human Services and the Department of Defense to scale up their manufacturing capabilities in the United States.
Sanofi’s experimental vaccine uses DNA and a never-released experimental vaccine against the SARS virus. Phase 1 and Phase 2 clinical tests of the candidate vaccine will begin in September, said Thomas Triomphe, global head of Sanofi Pasteur, Sanofi’s vaccine wing.
The potential vaccine could begin Phase 3 studies, the final phase before licensing, by the end of 2020. If it’s shown to be safe and effective, the companies anticipate seeking regulatory approval in the first half of 2021.
This is the fourth deal in which the federal government has committed to buy doses if companies develop successful coronavirus vaccines.
Under an agreement struck in May, British-Swedish firm AstraZeneca would receive $1.2 billion for 300 million doses. In July, a $1.95 billion deal was announced with U.S.-based Pfizer for 100 million doses. And Maryland-based Novavax announced in July it would receive $1.6 billion from the government to fund development, testing and 100 million doses of its vaccine candidate.
“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,” Health and Human Services Secretary Alex Azar said in a written statement.
The latest deal has “the potential to bring hundreds of millions of safe and effective doses to the American people,” he said.
Sanofi and GSK said they are committed to making the vaccine available globally and are building up manufacturing capabilities to produce up to 1 billion doses per year.
The DNA-based vaccine candidate is one of two the companies are working on. The other is a messenger RNA vaccine, the same type being developed by Moderna.
For the second one, they anticipate beginning Phase 1 testing by the end of 2020 and plan to have a vaccine ready to begin regulatory approval in the second half of 2021, the companies said.