The Trump administration on Friday announced a new deal with Sanofi and GlaxoSmithKline to support clinical trials and the manufacturing of 100 million doses of an investigational coronavirus vaccine.
The companies said the U.S. government will provide up to $2.1 billion for development, manufacturing and delivery.
The federal government would own the doses of the vaccine, which could be used in clinical trials or be distributed if it gets authorization from the Food and Drug Administration.
“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,” said Health and Human Services Secretary Alex Azar.
The federal government will also have the ability to acquire up to 500 million additional doses.
Adjuvants are materials in some vaccines that can help create a stronger immune response.
The companies are not as far along in vaccine development as others; Sanofi expects to start a Phase 1-2 study in September and a Phase 3 study by the end of the year.
If the data are positive, the companies said they can request regulatory approval in the first half of 2021.
The deal is part of the administration’s “Operation Warp Speed” — an effort to facilitate the delivery of 300 million doses of a vaccine by January 2021.
“There may be, and you may have heard of, some great vaccine candidates that will be hitting the market in January of 2022. Operation Warp Speed is not interested in investing in those,” a senior administration official said on Thursday.
“We have a very firm set of guidances from the president of the United States, which is deliver vaccines to the American people by year-end or early 2021,” the official said. “So those are the ones we’re investing in.”
Sanofi is also working on another vaccine candidate with Translate Bio, but said they don’t anticipate winning approval for that product until the second half of 2021 “at the earliest.”
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