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FDA Suspends COVID-19 Emergency Approval Treatment

FDA Suspends COVID-19 Emergency Approval Treatment
View of stored plasma donated by patients who recovered from COVID-19 on August 14, 2020 in Bogota, Colombia.(Guillermo Legaria/Getty Images)

By    |   Wednesday, 19 August 2020 05:38 PM

The Food and Drug Administration has placed on hold its emergency authorization for blood plasma to treat COVID-19 so officials can review more data, according to the agency, The New York Times reported.

According to H. Clifford Lane, clinical director at the National Institute of Allergy and Infectious Diseases, the agency may issue another emergency approval down the road if needed.

Plasma with coronavirus antibody has been donated by surviving patients but clinical trials haven't shown it can do much to fight the virus. Last week, Dr. Anthony Fauci and Dr. Francis Collins, director of the National Institutes of Health said the results on the treatment were not robust enough to continue the practice, two senior administration officials told The Times.

Fauci, Lane and Collins instead, told other medical experts to hold off on using coronavirus antibody plasma until the results of a Mayo Clinic study are available.

“The three of us are pretty aligned on the importance of robust data through randomized control trials, and that a pandemic does not change that,” Lane told the Times on Tuesday.

The emergency use was authorized due to its effectiveness in treating other diseases during outbreaks and in animal research.

FDA researchers found the plasma infusion to be safe after treating 20,000 patients with coronavirus, according to a study published in Mayo Clinic Proceedings.

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The Food and Drug Administration has placed on hold its emergency authorization for blood plasma to treat COVID-19 so officials can review more data, according to the agency...
fda, coronavirus, covid, fauci, coronavirus
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2020-38-19
Wednesday, 19 August 2020 05:38 PM
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