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| - Pharma giants Sanofi and GSK will receive up to $2.1 billion from the US government for the development of a COVID-19 vaccine, the companies said Friday, as the world continues to be ravaged by the coronavirus epidemic. The United States had identified a vaccine candidate under development by Sanofi and GSK for its "Operation Warp Speed," which aims to rapidly secure millions of vaccine doses. The firms aim to combine a Sanofi-developed antigen, which stimulates the production of germ-killing antibodies, with GSK's adjuvant technology, a substance that bolsters the immune response triggered by a vaccine. The American money, they said in a statement, will "help fund the development activities and secure scale-up of Sanofi's and GSK's manufacturing capabilities in the United States... resulting in a significant increase in capacity." "The US government will provide up to $2.1 billion, more than half of which is to support further development of the vaccine, including clinical trials, with the remainder used for manufacturing scale-up and delivery of an initial 100 million doses of the vaccine," they said. "The US government has a further option for the supply of an additional 500 million doses longer term," they added. The United States is the country the worst hit by far by the coronavirus outbreak, with over 150,000 deaths of the global toll of more than 667,000. Sanofi, based in France, and GSK of Britain announced in April that they were joining forces on a COVID-19 vaccine they hoped to make available in the second half of 2021. They said Friday that clinical trials are slated to start in September, with a Phase 3 study under way by the end of 2020. "If the data are positive, the companies can request US regulatory approval in the first half of 2021. In parallel, Sanofi and GSK are scaling up manufacturing of the antigen and adjuvant to produce up to one billion doses per year globally," they said. Alex Azar of the US Department of Health and Human Services (HHS) said the portfolio of vaccines being assembled under Operation Warp Speed "increases the odds that we will have at least one safe, effective vaccine as soon as the end of this year." The latest investment holds the "potential to bring hundreds of millions of safe and effective doses to the American people," the statement quoted him as saying. But the companies said discussions were also under way with the European Commission and other governments "to ensure global access to a novel coronavirus vaccine." The partners intended to supply "a significant portion of total worldwide available supply capacity" in 2021 and 2022 to an initiative seeking to ensure equitable global access to COVID-19 tests, treatments and vaccines. Thomas Triomphe, head of the Sanofi Pasteur vaccine division, said the global need for a vaccine was "massive, and no single vaccine or company will be able to meet the global demand alone." Sanofi CEO Paul Hudson drew the ire of French officials in May when he suggested any COVID-19 vaccine would be offered first to the US government, which has been investing in its development. Under pressure, he later indicated it would be available to everyone at the same time. mlr/js/cdw
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