The Food and Drug Administration has issued an emergency authorization for convalescent plasma as a ‘promising’ coronavirus treatment in the US, concluding that the known and potential benefits of the therapy “outweigh the risks.”
“The FDA has made the independent determination that the treatment is safe and very effective,” US President Donald Trump said at a press conference on Sunday, amid criticism that his administration ‘forced’ the approval of ‘untested’ treatment.
The plasma transfusion therapy has been around for decades and involves treating sufferers with a liquid made from the blood of people who have recovered from an illness and have antibodies. Amid the Covid-19 pandemic the therapy has already been given to tens of thousands of patients across the globe.
The EUA authorizes the distribution of #COVID19 convalescent plasma in the U.S. and its administration by health care providers, as appropriate, to treat suspected or laboratory-confirmed COVID-19 in hospitalized COVID-19 patients.
Trump, however, touted convalescent plasma as a major breakthrough made possible by the so-called operation Warp Speed, his administration’s multi-agency initiative dedicated to creating Covid-19 vaccines and treatments.
Urging recovered patients to donate blood, the US president said it “will save countless lives,” until first vaccines are available and approved – which Trump hinted might also come sooner than expected.
TRUMP: “We have a truly historic announcement in our battle against the China Virus that will save countless lives. The FDA has issued an emergency use authorization… for convalescent plasma” pic.twitter.com/2xIxZdIxVQ
Many medical experts have said the treatment could be helpful to treat the Covid-19 virus, but some say it may not be the breakthrough needed to deal with the pandemic.
On Saturday, Trump accused FDA Commissioner Stephen Hahn and the “deep state” of delaying approval on Covid-19 treatments until after the election. He had earlier said the agency was making a “political decision” in delaying it to hurt his election chances.
READ MORE: ‘No evidence of benefit’: FDA says hydroxychloroquine no longer approved for Covid-19 emergency use
Former FDA commissioner Scott Gottlieb said on CBS News’ Face The Nation on Sunday that there were “perceived delays” in authorizing it.
Gottlieb said that while the plasma treatment could be beneficial, “there’s reasons people have questions about it” and that the trial based on 70,000 patients “wasn’t a very rigorously done trial.”
He rejected the idea that the FDA was making political decisions, saying it is a “foundational truth that what guides that agency is science.”
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