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The pressure to create a coronavirus vaccine is growing during the day, but for a safe vaccine to enter the market, it takes time.

USA TODAY

The United States announced Friday that it will pay French pharmaceutical company Sanofi and UK 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 clinical trials at an early stage to ensure they are safe and effective. The rest will pay for the first 100 million doses, with an option for 500 million more.

Most of the $ 2.1 billion will go to Sanofi, which made the candidate for the vaccine. GlaxoSmithKline made an amplifier that improves the way 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 them to the finish line.

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They are being produced “at risk” – before they are licensed. If any of the vaccines are not approved, the reserved doses will be destroyed.

The companies are collaborating with the U.S. Department of Health and Human Services and the Department of Defense to enhance their manufacturing capabilities in the United States.

The Sanofi experimental vaccine uses DNA and an experimental vaccine that is never released against the SARS virus. Phase 1 and Phase 2 clinical trials of the candidate vaccine will begin in September, said Thomas Triomphe, global head of Sanofi Pasteur, Sanofi vaccine arm.

The potential vaccine could begin Phase 3 studies, the final stage before licensing, by the end of 2020. If proven to be safe and effective, companies anticipate seeking regulatory approval in the first half of 2021.

This is the fourth deal in which the federal government has pledged to buy doses if companies develop successful coronavirus vaccines.

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Dr Anthony Fauci said on Tuesday the development of a coronavirus vaccine was moving at a rapid pace. Fauci spoke as President Donald Trump on Tuesday issued a stern defense to a negligible use of a malaria drug as a coronavirus treatment.e. (July 28)

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Under an agreement reached 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 US-based Pfizer for 100 million doses. And the Maryland-based Novavax announced in July that it would receive $ 1.6 billion from the government to fund the development, testing and 100 million doses of its vaccine candidate.

“The portfolio of vaccines being collected for Operation Warp Speed ​​increases the chances that we will have at least one safe, effective vaccine as soon as possible by 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 production capacity to produce up to 1 billion doses a year.

The candidate for DNA-based vaccines is one of two companies working. Next is a messenger RNA vaccine, the same type being developed by Moderna.

For the second, they anticipate the start of 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.

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