The pressure to create a coronavirus vaccine is increasing by day, but for a safe vaccine to enter the market, it takes time.
The United States announced on Friday that it will pay French pharmaceutical company Sanofi and Britain’s 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 early-stage clinical trials to ensure it is safe and effective. The rest will pay for the first 100 million doses, with an option over another 500 million.
The majority of the $ 2.1 billion will go to Sanofi, which made the candidate for the vaccine. GlaxoSmithKline has made a booster that improves how 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’s initiative has now spent more than $ 8 billion on experimental vaccines that may or may not make it across the finish line.
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They’re being manufactured “at risk” – before they are licensed. If any of the vaccines is not approved, the stored doses are destroyed.
The companies are collaborating with the U.S. Department of Health and Human Services and the Department of Defense to expand their manufacturing capabilities in the United States.
Sanofi’s experimental vaccine uses DNA and an experimental vaccine that has never been released against the SARS virus. The Phase 1 and Phase 2 clinical trials of the candidate vaccine will begin in September, said Thomas Triomphe, global head of Sanofi Pasteur, Sanofi’s wing vaccine.
The potential vaccine could start Phase 3 studies, the final phase before licensing, by the end of 2020. If proven safe and effective, companies anticipate seeking regulatory approval in the first half of 2021.
This is the fourth agreement in which the federal government has committed to purchasing doses if companies develop successful coronavirus vaccines.
On Tuesday Anthony Fauci said the development of a coronavirus vaccine was progressing rapidly. Fauci spoke as President Donald Trump issued a tough defense on Tuesday over the untapped use of malaria medicine as a cure.e coronavirus. (28 July)
According to a deal reached in May, British-Swedish firm AstraZeneca will receive $ 1.2 billion for 300 million doses. In July, a $ 1.95 billion deal was announced with the U.S.-based Pfizer for 100 million doses. And Maryland-based Newvax announced in July that it will 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 assembled for Operation Warp Speed increases the likelihood that we will get at least one safe and effective vaccine by the end of this year,” said the Secretary of Health and Human Services Alex Azar in a written statement.
He said “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 manufacturing capacities to produce up to 1 billion doses a year.
The candidate for the DNA-based vaccine is one of two companies working on them. The other is an RNA vaccine for the messenger, the same type being developed by Modern.
For the second one, they anticipate the Phase 1 test starting 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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