The Food and Drug Administration (FDA) has revised the letter of Emergency Use Authorization (EUA) for COVID-19 convalescent plasma to limit the authorization to the use of high titer convalescent plasma only for the treatment of hospitalized patients with COVID-19 early in the disease course and to those hospitalized patients who have impaired humoral immunity and cannot produce an adequate antibody response.

The revision was based on new clinical trial data indicating no evidence of benefit with low titer convalescent plasma for patients hospitalized with COVID-19. As such, the use of low titer COVID-19 convalescent plasma is no longer authorized under the EUA. Additionally, the fact sheet has been updated to note that transfusion of convalescent plasma late in the course of disease (ie, following respiratory failure requiring intubation and mechanical ventilation) has not been shown to provide a clinical benefit.

Other updates to the EUA include more tests that can be used in the manufacture of COVID-19 convalescent plasma, bringing the total to 9 tests that can determine the suitability of plasma donations prior to release.

“Issuance of, and updates to, EUAs are based on a thorough evaluation of currently available scientific evidence about medical products. In this case, as additional scientific evidence about COVID-19 convalescent plasma emerged, we revised the EUA to reflect the updated evidence,” said Peter Marks, MD, PhD, Director of FDA’s Center for Biologics Evaluation and Research. “COVID-19 convalescent plasma used according to the revised EUA may have efficacy and its known and potential benefits outweigh its known and potential risks.”


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Reference

FDA in brief: FDA updates Emergency Use Authorization for COVID-19 convalescent plasma to reflect new data. [press release]. Silver Spring, MD; Food and Drug Administration: February 5, 2021.