The U.S. Food and Drug Administration (FDA) has updated the emergency use authorization (EUA) for COVID-19 convalescent plasma.
The update limits the authorization to the use of COVID-19 convalescent plasma with high titers of anti-SARS-CoV-2 antibodies for the treatment of COVID-19 in patients with immunosuppressive disease or who are receiving immunosuppressive treatment.
The FDA said these patients may be treated in outpatient or inpatient settings.
“To help assure the manufacture of high titer COVID-19 convalescent plasma, the revisions to the EUA revise acceptable tests and increase qualifying result cutoffs to be used for manufacturing COVID-19 convalescent plasma with high titers of anti-SARS-CoV-2 antibodies,” the agency said.
COVID-19 convalescent plasma is human plasma collected from individuals whose plasma contains high titers of anti-SARS-CoV-2 antibodies, and who meet all donor eligibility requirements.
For the December 28, 2021, authorization, the FDA said it “reviewed additional studies including several randomized controlled trials and observational studies, which reported on the use of COVID-19 convalescent plasma in both the inpatient and outpatient settings.” Based on assessment of these data, transfusion of COVID-19 convalescent plasma in hospitalized immunocompetent patients is unlikely to be associated with clinical benefit and the known and potential benefits do not outweigh the known and potential risks in this population.”
On the other hand, the agency said, “evidence supports a potential clinical benefit of transfusion of COVID-19 convalescent plasma with high titers of anti-SARS-CoV-2 antibodies to treat COVID-19 in patients with immunosuppressive disease or receiving immunosuppressive treatment.”
