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FDA Approves Emergency 'Plasma Treatment' for Coronavirus Patients in US

 The US Food and Drug Administration (FDA) has given emergency authorisation for the use of plasma to treat coronavirus patients on Sunday.

 "Known and potential benefits of the product outweigh the known and potential risks of the product," it said.

The technique uses antibody-rich blood plasma from people who've recovered from the disease, and has already been used on over 70,000 people in the US.

The announcement came a day after President Donald Trump accused the FDA of impeding the rollout of vaccines and therapeutics for political reasons, and on the eve of the Republican National Convention, where Mr Trump will launch his campaign to win a second term in the White House.

"Today I am pleased to make a truly historic announcement in our battle against the China virus that will save countless lives," President Trump said at a White House briefing, referring to the coronavirus that causes Covid-19. "Today's action will dramatically increase access to this treatment."

The FDA says early trials indicate it is safe, although more are needed to prove effectiveness.

"This is what I've been looking forward to doing for a long time," the president told reporters on Sunday.

Mr Trump described the procedure as a powerful therapy, as he appealed for Americans to come forward to donate plasma if they'd recovered from Covid-19.

How Efficient is the Plasma Treatment?

US Health and Human Services Secretary Alex Azar said studies involving 70,000 volunteers justified the EUA.

"The data we gathered suggests that patients who were treated early in their disease course, within three days of being diagnosed, with plasma containing high levels of antibodies, benefited the most from treatment. We saw about a 35% better survival in the patients who benefited most from the treatment," Azar told the White House briefing.

Azar appeared to be referring to a national study of 35,000 patients treated with convalescent plasma. The study, released August 12 in a pre-print, meaning it had not yet been peer-reviewed, showed that 8.7% of patients who were treated within three days of diagnosis died, compared to about 12% of patients who were treated four days or more after their diagnosis. That's about a difference of about 37%.

Those treated with plasma containing the highest levels of antibodies had a 35% lower risk of dying within a week compared to those treated with less-rich plasma.

Convalescent plasma is taken from the blood of people who have recovered from Covid-19. At the end of March, the FDA set up a pathway for scientists to try convalescent plasma with patients and study its impact. It has already been used to treat more than 60,000 Covid-19 patients.

However, like blood, convalescent plasma is in limited supply and must come from donors. And while there are promising signals from some studies, there is not yet randomized clinical trial data on convalescent plasma to treat Covid-19. Some of those trials are underway.

More than 176,000 people have died from coronavirus since the start of the outbreak in the United States, according to a tally by Johns Hopkins University. Nearly 5.7 million cases have also been confirmed nationwide. The country has had more confirmed cases and deaths than anywhere else in the world.

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