The contract with Sanofi, shown, and GlaxoSmithKline was made under the auspices of the Trump administration’s ‘Operation Warp Speed.’
Photo: gonzalo fuentes/ReutersThe U.S. government will pay up to $2.1 billion to Sanofi SA SNY -0.10% and GlaxoSmithKline GSK 0.17% PLC to fund the development of a coronavirus vaccine and guarantee supply of 100 million doses, if proven safe and effective in clinical trials, the companies said Friday.
Paris-based Sanofi is leading development of the vaccine, the companies said, and plans to start initial clinical trials in September and move into late-stage studies by the end of this year.
If the studies are positive, the companies said they could seek U.S. regulatory approval in the first half of 2021.
The contract is the latest in a series of deals—potentially worth more than $8 billion—struck by the U.S. government aimed at accelerating development of Covid-19 vaccines and securing large supplies before potential product approvals.
The U.S. has reached deals worth over $1 billion each with vaccine makers including Pfizer Inc. and partner BioNTech SE, AstraZeneca PLC and its partner the University of Oxford, and Novavax Inc., a biotech company in Gaithersburg, Md. Each of the deals guarantees the U.S. 100 million doses or more, if the vaccines are approved by regulators.
The government is also helping to fund drugs that can treat infected patients. Regeneron Pharmaceuticals Inc. has received about $618 million to develop an antibody drug and provide the U.S. with thousands of doses, if the drug is authorized by regulators.
As in earlier deals, the contract with Sanofi and GlaxoSmithKline was made under the auspices of the Trump administration’s “Operation Warp Speed,” which aims to secure 300 million vaccine doses for the U.S. by January 2021.
The European Commission said on Friday it had reached a preliminary agreement with Sanofi for the sale of 300 million doses of a potential vaccine.
“Today’s step with Sanofi is a first important cornerstone of a much broader European Vaccines Strategy,” European Commission President Ursula von der Leyen said in a statement. “We are in advanced discussions with several other companies,” she added.
The companies said they would also “provide a significant portion of total world-wide supply” in 2021 and 2022 to an initiative led by the World Health Organization and other nongovernmental organizations to supply low- and middle-income countries with drugs, vaccines and other supplies to fight Covid-19.
Under the U.S. contract with Sanofi and GlaxoSmithKline, more than half of the $2.1 billion is earmarked for clinical trials and other development costs. The remainder will go toward scaling up manufacturing of the vaccine and delivery of an initial 100 million doses.
The U.S. also has an option to secure an additional 500 million doses over the long-term, Sanofi said.
The companies don’t yet know how many doses will be needed to be effective, a Sanofi spokeswoman said. Other leading vaccine makers are moving into Phase 3 studies using two-shot regimens.
Sanofi, which will receive the bulk of the U.S. funding, developed the vaccine candidate. London-based GlaxoSmithKline is responsible for making a so-called “adjuvant” substance that helps to make vaccines work better.
Sanofi earlier received about $30 million from the Department of Health and Human Services in February for early-stage development of the vaccine.
Also on Friday, Pfizer said it had reached a deal with Japan to provide the country with 120 million vaccine doses beginning in 2021. Financial terms weren’t disclosed.
—Noemie Bisserbe contributed to this article.
Write to Joseph Walker at joseph.walker@wsj.com
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