The French drugmaker Sanofi said Friday that it had secured an agreement of up to $2.1 billion to supply the US federal government with 100 million doses of its experimental coronavirus vaccine, the largest such deal announced to date.. This multiagency effort, known as Operation Warp Speed, is placing bets on multiple vaccines and is paying companies to manufacture millions of doses before clinical trials have been completed.
“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, the company’s vaccine division, said in a statement.
Also on Friday, the European Union said it was working on a deal with Sanofi to buy up to 300 million doses of potential vaccines to distribute to citizens in its 27 member countries. The announcements came two days after a deal with the British government to supply up to 60 million doses of the vaccine. Financial details of those deals were not disclosed.
Under the US deal, Sanofi and its partner, the British pharmaceutical company GlaxoSmithKline, will receive federal funding to pay for clinical trials as well as for manufacturing the vaccine. Sanofi said the deal also includes an option for the company to supply an additional 500 million doses. The company expects to begin clinical trials to test for safety in September, followed by late-stage efficacy trials before the end of this year. Sanofi said it could apply for regulatory approval in the first half of next year.
If the vaccine is successful, it would be made available to Americans at no cost, other than what providers charge to administer it, the federal government said in a statement.
The head of Operation Warp Speed, Moncef Slaoui, is a former GSK executive who as of May held just under $10 million in GSK stock. Slaoui’s financial ties to some of the companies that are pursuing coronavirus vaccines have raised questions about conflicts of interest.
Slaoui is not a federal employee, instead working under a $1 contract that exempts him from federal rules that would require him to list his outside positions, stock holdings and other potential conflicts. Slaoui said in an interview in May that he was determined to avoid any conflicts of interest, but that his GSK stock represented his retirement from 29 years at the company, and that he had told federal officials he would not take the job if he had to sell it.
Sanofi and GSK did not say how much of the federal money would go to each company, only that Sanofi would receive the most. GSK did not comment on whether Slaoui had recused himself from negotiations over the deal. A senior administration official said that all agreements were negotiated by federal “acquisition professionals” and that Slaoui did not play a role in the negotiations.
A handful of other vaccine candidates are already in late-stage clinical trials, and some, such as AstraZeneca and Moderna, have said a vaccine could be ready before the end of this year.
Sanofi’s coronavirus vaccine relies on a protein-based technology that the company already uses to produce an influenza vaccine. It is similar to a technique used by another company, Novavax, that will receive up to $1.6 billion from the defense department and the Department of Health and Human Services to develop its experimental vaccine. GSK is supplying the Sanofi vaccine with an adjuvant, an ingredient used in many vaccines that boosts the immune response.
Sanofi is also developing a separate vaccine in partnership with Translate Bio that uses so-called messenger RNA to provoke an immune response in the body. That vaccine is expected to enter clinical trials in the fall.
As a French company, Sanofi has had to carefully navigate the geopolitics of vaccine development. In May, the company’s chief executive, Paul Hudson, faced backlash after he said the United States would get the largest number of doses because they were investing the most.
The remarks caused the company to backpedal, explaining that “We have always been committed in these unprecedented circumstances to make our vaccine accessible to everyone.”
Katie Thomas c.2020 The New York Times Company
from Firstpost World Latest News https://ift.tt/3k0gIO1
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