Trump announces emergency clearance for ‘breakthrough’ coronavirus treatment

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President Trump on Sunday granted emergency clearance for the use of convalescent plasma to treat coronavirus patients, calling it a “major breakthrough.”

Speaking to White House reporters on Sunday, Trump said the FDA had “issued an emergency use authorization … for a treatment known as convalescent plasma.”

“This is a potent therapy that transfuses very, very potent antibodies from the blood of recovered patients to help treat patients battling a current infection,” Trump said, adding that the clearance “will expand access to this treatment.” .

President Donald Trump speaks during a press briefing in the James Brady Briefing Room of the White House, Sunday, August 23, 2020, in Washington.
(AP)

“Based on science and data, the FDA has independently determined that the treatment is safe and highly effective,” Trump said, before urging all COVID-19 patients in the United States to do so. a donation of their blood plasma.

White House Press Secretary Kayleigh McEnany announced Trump’s press conference in a Saturday night tweet, writing that it involved “a major therapeutic breakthrough on the Chinese virus.”

Trump’s announcement on Sunday follows White House officials suggesting last week that the Food and Drug Administration politically delayed approval of a vaccine and treatment for the coronavirus.

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Treatment takes convalescent plasma from patients who have recovered from the coronavirus and is rich in antibodies. While it may offer benefits to those fighting the virus, the evidence is inconclusive as to how it works or how best to administer it.

The White House is increasingly agitated by the pace of plasma approval. White House Chief of Staff Mark Meadows did not go into specifics but said: ‘We have looked at a number of people who are not as diligent as they should be to get to the bottom. things “.

Food and Drug Administration Commissioner Dr Stephen Hahn speaks during a press briefing in the James Brady Briefing Room of the White House, Sunday, August 23, 2020, in Washington.

Food and Drug Administration Commissioner Dr Stephen Hahn speaks during a press briefing in the James Brady Briefing Room of the White House, Sunday, August 23, 2020, in Washington.
(AP)

“This president wants to cut red tape,” Meadows said in an ABC interview with “This Week.” “He had to make sure they felt the heat. If they can’t see the light, they need to feel the heat because Americans are suffering. ”

Sunday’s push came a day after Trump tweeted strong criticism of the process for dealing with the virus, which has killed more than 176,000 Americans and jeopardized his chance for re-election.

The White House has invested vast resources in a fast-track vaccine development process, and Trump aides have bet it would be an ‘October surprise’ that could help the president catch up in the polls .

“The deep state, or whoever, at the FDA, makes it very difficult for drug companies to get people to test vaccines and therapies,” Trump tweeted. “Obviously, they’re hoping to delay the response until November 3. You have to focus on speed and save lives! ”

More than 64,000 patients in the United States have received convalescent plasma, a century-old approach to fighting influenza and measles ahead of vaccines. It’s a go-to tactic when new diseases appear, and history suggests that it works against some infections, but not all.

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There is not yet strong evidence that it fights the coronavirus and, if so, how to best use it. The FDA, in announcing the emergency clearance for convalescent plasma, said its benefits “outweigh the known and potential risks of the product and that there are no adequate, approved and alternative treatments. available ”.

Former FDA commissioner Scott Gottlieb on CBS’s “Face the Nation” said on Sunday that convalescent plasma treatment was “probably beneficial,” but rejected Trump’s suggestion of a deliberate slowdown.

“I strongly reject the idea that they would slow down anything or speed up anything on the basis of any political considerations or any considerations other than what is best for public health and a real sense of mission. to patients, ”said Gottlieb.

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Hundreds of drugs are currently in development as possible treatments for coronavirus infection, taking a range of approaches.

The Associated Press contributed to this report.

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