The Food and Drug Administration revised the emergency use authorization (EUA) for COVID-19 convalescent plasma (CCP) on Dec. 28 to permit the use of high-titer CCP for treatment of COVID-19 in patients with immunosuppressive disease or receiving immunosuppressive treatment, in either the outpatient or inpatient setting. The Dec. 28 EUA also revises the list of acceptable tests in Appendix A, increases qualifying result cutoffs to be used for the manufacture of high-titer CCP, and makes corresponding changes to the authorized fact sheets for health care providers and for patients and caregivers. AABB has posted a table to clearly track these changes in the EUA.
FDA previously authorized CCP for emergency use in patients hospitalized with COVID-19 in March 2021. Following a review of several randomized controlled trials and observational studies that examined CCP use in both the inpatient and outpatient settings, the agency determined that the evidence supports a potential clinical benefit among COVID-19 patients with immunosuppressive disease or who are receiving immunosuppressive treatment. In addition, FDA noted that there is no adequate, approved available alternative to the emergency use of high-titer CCP for this patient population.
As described in the FDA’s Dec 27 Clinical Memorandum, the agency also determined that CCP transfusion 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.”