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What to know about convalescent
plasma
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The US
Food and Drug Administration issued an
emergency use authorization on Sunday for convalescent plasma to
treat Covid-19, saying the "known and potential benefits of the product
outweigh the known and potential risks of the product."
The FDA said more than 70,000 patients had been treated with convalescent plasma, which is made using the blood of people who have recovered from coronavirus infections. There has been a lot of interest in the possibility of convalescent plasma, but questions linger about whether enough research has been done. Earlier this year, the FDA set up a pathway for scientists to try convalescent plasma in patients and study its impact. Thousands of Covid-19 patients have already been treated with plasma. However, as with 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 coronavirus. The gold standard in research is a randomized, placebo-controlled clinical trial, which means doctors randomly choose who gets the treatment and who doesn't, so they can truly tell whether it's the treatment affecting survival and not something else. That, so far, has not been completed. Dr. Francis Collins, head of the National Institutes of Health; Dr. Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases and Dr. H. Clifford Lane, who works at NIAID, were among government health officials who had been skeptical there was enough data to justify emergency authorization of plasma for Covid-19, according to a knowledgeable source.
An EUA
can open the treatment to more patients. But it could also limit enrollment
in clinical trials that determine whether it's effective.
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