FDA restricts use of convalescent plasma to hospitalized COVID-19 patients

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The FDA last week revised and reissued the emergency use authorization for COVID-19 convalescent plasma to limit its use to only hospitalized patients early in the course of the disease and those with a medical condition that impairs their ability to make antibodies, The Wall Street Journal reported. 

The revised authorization also clarifies that patients will only be given plasma that has a high concentration of antibodies. 

"The update is meant so convalescent plasma can best be used on those who will benefit," Peter Marks, MD, PhD, director of the FDA's Center for Biologics Evaluation and Research, told the Journal

Dr. Marks said the FDA made the decision to limit the therapy's authorization after evaluating results from additional clinical trials, some of which showed benefits from convalescent plasma while others showed no benefits. Three trials involving hospitalized patients reported some benefit from the therapy, but only when given soon after the patients were admitted to the hospital, the Journal reported. 

Since the FDA authorized convalescent plasma as a treatment for COVID-19 patients last August, an average of roughly 20,600 units of convalescent plasma have been distributed to hospitals around the country each week, according to data from the American Red Cross cited by the Journal

Read the full article here

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