Trump to announce emergency authorization of convalescent plasma as ‘breakthrough’ coronavirus treatment

On the eve of the Republican National Convention where President Trump hopes to revive his flagging political fortunes, he will announce the emergency authorization of convalescent plasma for covid-19, a treatment that already has been given to more than 70,000 patients, according to officials familiar with the decision.

In a tweet late Saturday night, White House press secretary Kayleigh McEnany said the announcement at 5:30 p.m. Sunday involved “a major therapeutic breakthrough on the China virus.” Officials confirmed on Sunday the treatment is convalescent plasma; they spoke on the condition of anonymity because they weren’t authorized to discuss the issue. The White House declined to comment.

Many scientists and physicians believe that convalescent plasma might provide some benefit but is far from a breakthrough. It is rich in antibodies that could be helpful in fighting the coronavirus, but the evidence so far has not been conclusive about whether it works, when to administer it and what dose is needed. On CBS’s “Face the Nation” on Sunday, former FDA commissioner Scott Gottlieb said the blood product — derived from patients who have survived covid-19 — is “probably beneficial” for covid-19 patients. The issuance of an emergency authorization would make it easier to get in some settings. But he also said it already is widely available, so the change would be “incremental.”

The announcement comes as Trump has put extraordinary pressure on federal agencies to test and approve treatments and, especially, a vaccine against the novel coronavirus which has already killed more than 170,000 Americans. The president’s political advisers believe that having a vaccine by Election Day is key to his prospects for winning.

It also lands a day after the president without evidence accused the FDA of impeding enrollment in clinical trials for coronavirus vaccines and therapeutics for political reasons. McEnany said in her tweet that FDA Commissioner Stephen Hahn and Health and Human Services Secretary Alex Azar would appear at the news conference.

“The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics,” Trump said on Twitter on Saturday. “Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives!” He tagged Hahn in the tweet.

On Sunday, White House chief of staff Mark Meadows defended Trump’s tweet.

“I can tell you that the announcement that’s coming today should have been made several weeks ago,” Meadows said on “Fox News Sunday,” previewing the administration’s plans. “It was a fumble by a number of people in the federal government that should have done it differently . . . and having been personally involved with it. Sometimes you have to make them feel the heat if they don’t see the light.”

Convalescent plasma has long has been used for other infectious diseases, including Ebola. The treatment’s effectiveness for covid-19 has appeared promising but has remained unsettled because scientists don’t yet have results from rigorous clinical trials. The tens of thousands of patients already treated have been enrolled in an expanded access program sponsored by the FDA and run by the Mayo Clinic.

Carlos del Rio, executive associate dean of the Emory School of Medicine, said that it was an exaggeration to call plasma a “breakthrough.” He called plasma an “interesting strategy” and said the data so far was a “nice hint” that it could be helpful, but stressed that it was “not going to win the game.”

“The problem is, the President, in my mind, has lost total credibility because of what he’s done with hydroxychloroquine. He’s touted so many things that don’t work,” del Rio said. “The reality is what we have today to treat covid is extremely limited.”

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Source: MSN