Returning to the White House after being hospitalized for three days for covid-19, President Donald Trump said in a video that the coronavirus vaccine “comes in a moment”, a statement as reckless as that you should not have him fear of the virus that has killed more than 205,000 people in the United States.
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For a COVID-19 vaccine to be available in the United States, it must first gather enough data from phase 3 clinical trials to demonstrate to the Food and Drug Administration (FDA) that it is safe. effective and providing immunity to the virus.
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Five candidate vaccines are being tested in phase 3 trials. Each of them involves at least 30,000 people, of whom half will receive the active vaccine and the other half a placebo.
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FDA chief Dr. Stephen Hahn has said repeatedly that these trials must be completed and the data consolidated; your agency will not approve a vaccine until it is shown to be safe and effective.
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The White House has blocked new rules to approve the vaccine issued by the FDA, in an attempt to speed up its production so that President Trump can announce it shortly before the election.
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Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told CNN that the FDA plans to make sure any vaccine is safe.
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“They have career scientists who could develop these kinds of models of what needs to be done to ensure safety and efficacy,” Fauci added.
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“And right now, this is what they said and we’ll see what happens,” he added.
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Paul Pottinger, a professor of infectious diseases at the University of Washington School of Medicine, is hopeful that positive trial results will soon be achieved, but warns that a “robust supply” of a safe vaccine will not be available until within of “many, many months.”
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Dr. Mark McClellan, Director of the Duke-Margolis Center for Health Policy at Duke University and former FDA Commissioner quoted in USA Today, agrees that scientific times are imposed on political urgencies. “This is not an easy process to interrupt just because someone says something about it,” he said at the time. “However, it does undermine confidence.”
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