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US FDA Restricts Use of Convalescent Plasma

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eMediNexus    07 February 2021

The US Food and Drug Administration (FDA) has issued a revision to its emergency use authorization (EUA) for use of convalescent plasma in COVID-19, based on the latest data.

The updated EUA states that only high-titer COVID-19 convalescent plasma can be used and only in hospitalized patients, early during the disease course, and in patients with impaired humoral immunity who cannot produce an adequate antibody response. New clinical trial data have emerged since the original EUA was issued in August 2020, which has prompted the revision in EUA. Use of low-titer COVID-19 convalescent plasma is no longer authorized, basis novel data available from clinical trials which did not show that low-titer convalescent plasma may have efficacy in the treatment of hospitalized COVID-19 patients… (Medscape)

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