Likening it to the national push to build the atomic bomb during World War II, President Trump on Friday announced Operation Warp Speed, a government coordinating effort aimed at securing a coronavirus vaccine by the end of the year.
“Operation Warp Speed, that means big and it means fast,” Trump said from the White House Rose Garden. “A massive scientific and industrial, logistic endeavor unlike anything our country has seen since the Manhattan Project.”
Its objective is to finish developing and then manufacture and distribute a proven coronavirus vaccine as fast as possible.
“We’d love to see if we can do it prior to the end of the year,” Trump said. “I think we’re going to have some very good results coming out very quickly.”
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The presentation was short on details but noted the initiative is evaluating roughly 100 vaccine candidates from all over the world and has identified more than 14 believed to be the most promising. Officials are working to narrow the list still further.
“We have some really interesting choices to be made,” Trump said.
The government is providing support and resources to safely expedite trials on those vaccine candidates, “moving on at record, record, record speed,” the President said.
Trump confirmed the United States will invest in manufacturing all of the top vaccine candidates before they’re approved. Known as “at risk” production, the government will take on the financial costs, legal liability and clinical trial costs, with no guarantee of getting a usablevaccine.
“That means they better come up with a good vaccine,” Trump said.
Such extraordinary steps will allow the United States to have vaccine ready as soon as a specific candidate is signed off on as safe and effective by regulatory authorities. The military will be used to help distribute doses.
‘We’re getting ready so that when we get the good word that we have the vaccine, we have the formula, we have what we need, we’re ready to go, as opposed to taking years,” Trump said.
Trump acknowledged the risk and expense but said, “we’ll be saving years if we do this properly.”
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The initiative brings together expertise from the National Institutes for Health, the Centers for Disease Control and Prevention, the Food and Drug Administration and other agencies.The partnership also joins the resources of the Department of Health and Human Services together with the Department of Defense.
At the news conference, Trump brought to the podium venture capitalist and former pharmaceutical head Moncef Slaoui. It was announced Wednesday he would lead the partnership.
Slaoui was chair of the vaccines division at pharmaceutical GlaxoSmithKline, a British multinational pharmaceutical company headquartered in London. He is now a partner at Medicxi Capital, a Philadelphia-area venture capital firm.
In addition, four-star Army Gen. Gustave Perna will serve as the chief operating officer overseeing logistics. Perna is the commanding general at U.S. Army Materiel Command in Huntsville, Alabama.
The national project will bring together the best of American industry and innovation, the full resources of the United States government and the excellence and precision of the United States military, Trump said.
The U.S. is working with its allies and other countries on the effort. Specifically, Trump said, the U.S. would work with China, despite previous reports that a vaccine from the country where the pandemic began would not be considered for use in the United States.
“We have no ego, whoever gets it, we’re going to work with them, they’re going to work with us,” Trump said, adding the U.S. is viewed as the vaccine effort’s global leader. “Whoever gets it is going to be very proud to give it.”
In order to make a vaccine available to the entire American population by January, the Food and Drug Administration mayissue an emergency use authorization. Such orders allow unapproved medical products to be used during a public health crisis, without the benefit of the validated testing that would normally take place.
“We’re working for a fully approved vaccine but we’ll also use … all of our regulatory tools appropriate to bring vaccine available for the entire American population by January,” Secretary of Health and Human Services Alex Azar said at the news conference.
In the past, drugs authorized for emergency use have mostly been given to people with terminal illnesses with little to lose.
“There’s never been an emergency use authorization for a vaccine before because it’s by and large a technology that is given to healthy people,” said Thomas Bollyky, who directs the global health program at the Council on Foreign Relations.
Big ideas are certainly needed, said Lois Privor-Dumm, policy director at the International Vaccine Access Center at Johns Hopkins Bloomberg School of Public Health.
But, she cautioned: “We just need to ensure that decisions are made thoughtfully and in an apolitical manner as to not undermine the existing structures and expertise in place to keep vaccines safe and ensure impact. Any misstep risks eroding confidence in vaccines that could have lasting implications.”
Trump said even if a vaccine is not discovered, the United States would prevail. He asserted the coronavirus could disappear on its own without an immunization, though having one would put America ahead.
“It’ll go away at some point, it’ll go away,” he said. “Vaccine or no vaccine, we’re back.”
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Source Article from https://www.usatoday.com/story/news/health/2020/05/15/coronavirus-operation-warp-speed-could-deliver-vaccine-years-end-trump/5199969002/
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