FDA Curbs Use Of COVID-19 Convalescent Plasma, Citing New Da
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The US Food and Drug Administration (FDA) has revised its emergency use authorization (EUA) for COVID-19 convalescent plasma. The revision states that only high-titer COVID-19 convalescent plasma can be used in hospitalized patients who are early in the disease course and those with impaired humoral immunity who cannot produce an adequate antibody response.

The revisions stem from new clinical trial data analyzed or reported since the original EUA was issued in August 2020. The original EUA did not have these restrictions. "This and other changes to the EUA represent important updates to the use of convalescent plasma for the treatment of COVID-19 patients," Peter Marks, MD, PhD, director, FDA Center for Biologics Evaluation and Research, said in a statement announcing the revisions.

"COVID-19 convalescent plasma used according to the revised EUA may have efficacy, and its known and potential benefits outweigh its potential benefits," FDA says. The agency said it revoked the use of low-titer COVID-19 on the basis of new data from clinical trials.

The FDA’s updated fact sheet for healthcare providers on the use of COVID-19 convalescent plasma also notes that transfusion of COVID-19 convalescent plasma late in the disease course, following respiratory failure requiring intubation and mechanical ventilation, hasn't been found to have clinical benefit.

The revised EUA also includes several additional tests that can be used to manufacture COVID-19 convalescent plasma. "With this update, nine tests are now included in the EUA for testing plasma donations for anti-SARS-CoV-2 antibodies as a manufacturing step to determine suitability before release," the FDA said.

Source:
https://www.fda.gov/media/141478/download
https://www.fda.gov/media/141477/download?source=email
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