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FDA to Authorize Convalescent Plasma for Covid-19 Use - The Wall Street Journal

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Convalescent plasma has been seen as a way to help people fight Covid-19 and a bridge while other treatments are under development.

Photo: lindsey wasson/Reuters

The Food and Drug Administration on Sunday is expected to authorize use of convalescent plasma, the antibody-rich blood taken from recovered Covid-19 patients, for the treatment of serious coronavirus cases, a person familiar with the matter said.

President Trump is also expected to discuss the move at a news conference later Sunday, the person said.

The agency’s action, called an emergency-use authorization, would permit use of the treatment on hospitalized Covid-19 patients within three days of diagnosis, the person said. The Wall Street Journal reported last month the move was coming.

For Covid-19 patients and the doctors who treat them, the designation opens up the possibility for faster and easier access to a promising treatment, while studies and clinical trials continue to explore who is helped and how much.

Doctors have been looking for validated coronavirus treatments. The antiviral remdesivir, from Gilead Sciences Inc., has the FDA’s emergency-use authorization.

Convalescent plasma has been seen as a way to help people fight the disease, serving as a bridge while other treatments are under development. The emergency-use authorization doesn’t alleviate the need for a vaccine or for therapies known as monoclonal antibodies that could stave off infection or at least reduce the seriousness of one.

Emergency-use authorization waives some regulatory requirements involved in using products during public-health emergencies that aren’t yet FDA approved.

A growing number of hospitals are investigating antibody testing and blood plasma therapy as a way to combat the new coronavirus in sick patients. WSJ’s Daniela Hernandez explains. Photo illustration: Laura Kammermann

Write to Thomas M. Burton at tom.burton@wsj.com and Amy Dockser Marcus at amy.marcus@wsj.com

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