The Food and Drug Administration (FDA) announced on Sunday that it had issued an emergency use authorization for a convalescent blood plasma as experimental treatment for COVID-19.
The treatment, which relies on injecting COVID-19 survivors’ antibodies into other patients to increase their body’s defenses against the virus, has been used on at least 97,000 patients. To date, plasma treatment has produced only medium-term data to support its effectiveness.
“This is what I have long sought to do,” President Trump said at a Sunday afternoon news conference, announcing what he called a “very historic breakthrough.”
The announcement came just days after the FDA reportedly withdrew from issuing the same authorization on concerns of Drs. Anthony Fauci and other top executives for health professionals on the effectiveness of treatment.
FDA Commissioner Stephen Hahn said Sunday that the agency had seen “a lot of demand” from doctors asking to use plasma in COVID-19 treatments. And to be sure, four former FDA chiefs have expressed support for the therapy, citing its effectiveness in treating previous epidemics, including SARS, measles, Ebola, and the outbreak of influenza from 1918. But they argued that it must be fully tested before widespread implementation in a clinical setting.
“Let’s do the tests & if the results are life saving, let’s make it the standard of care, and thus benefit hundreds of thousands to millions,” former FDA commissioner Robert Califf wrote in a tweetje. “If not, we can avoid the enormous expense and effort and continue to look for the best treatments.”
A Mayo Clinic analysis of 35,000 plasma recipients found that COVID-19 patients who received the plasma earlier in their treatment had a better chance of surviving than those who received the plasma later. But that work, like other efforts to study the use of convalescent plasma therapy on COVID-19, has not been peer-reviewed, and it does not include a control group – making it unclear how seriously doctors and health officials should take results. .
There have been signs since March that plasma therapy might work. Between late January and late March, a team of physicians at Shenzhen Third People’s Hospital in China administered convalescent plasma from five recovering donors to five critically ill COVID-19 patients.
The results were encouraging. Body temperature quickly returned to normal in four out of five patients. Reduced viral loads. The hospital soon discharged three of the patients. The other two were stable at the time of publication in late March.
But Shenzen’s doctors warned against drawing firm conclusions from an experiment involving only five people. “This was a small case series that contained no controls,” she wrote. “It is unclear if these patients would have improved without transfusion of plasma recovery.”
Convalescent plasma is “not all hype,” Paul Offit, director of the Center for Vaccine Education at the Children’s Hospital of Philadelphia, told The Daily Beast. But it is also “certainly not a game-changer,” he said.
“I would say it’s probably beneficial to issue an emergency authorization, which makes it easier to manage more broadly,” Stephen Jameson, an immunologist at the University of Minnesota, told The Daily Beast. ‘
The announcement came just a day after Trump blew up the FDA, which is led by one of his own proponents. The president accused the agency of deliberately obstructing research into vaccines and therapeutic treatments in order to sabotage his chances of re-election.
“The deep state, or whatever, at the FDA makes it very difficult for drug companies to get people to test the vaccines and therapeutics,” Trump tweeted. “Obviously, they hope to delay the responses until after November 3.”
Trump praised the FDA’s decision on plasma at its press conference Sunday.
“The FDA really stepped up, especially in the last few days,” he said.
For his part, former Obama administration health official Andy Slavitt blew up the FDA authorization before it was official on Sunday, suggesting that the Trump administration was pushing for a political win ahead of proof that the treatment actually works.
“So why the rush?” Slavitt tweeted. “The RNC starts tomorrow. That’s it.”
At his press conference Trump denied just that.
“This has nothing to do with politics,” the president asserted.
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