USA – FDA Updates Emergency Use Authorization for COVID-19 Convalescent Plasma to Reflect New Data

“The FDA is issuing a revision of the Emergency Use Authorization (EUA) for COVID-19 convalescent plasma as a result of our evaluation of the most recent information available. Based upon data from new clinical trials analyzed or reported since the original EUA was issued in August 2020, we have revised the EUA to limit the authorization to the use of high titer COVID-19 convalescent plasma for the treatment of hospitalized patients early in the disease course. This and other changes to the EUA represent important updates to the use of convalescent plasma for the treatment of COVID-19 patients.

“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. 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.”…