The initial issuance of this EUA for COVID-19 convalescent plasma was based on a review of historical evidence using convalescent plasma in prior outbreaks of respiratory viruses, certain preclinical evidence, results from small clinical trials of convalescent plasma conducted during the current outbreak, and data obtained from the National Convalescent Plasma Expanded Access Protocol (EAP) sponsored by the Mayo Clinic.
Additional studies, including randomized, controlled trials, have provided data to further inform the safety and efficacy of COVID-19 convalescent plasma, and further characterize product attributes and patient populations for its use. Based on an assessment of these data, the potential clinical benefit of transfusion of COVID-19 convalescent plasma in hospitalized patients with COVID-19 is associated with high titer units administered early in the course of the disease. Transfusion of COVID-19 convalescent plasma in hospitalized patients late in the course of illness (e.g., following respiratory failure requiring intubation and mechanical ventilation) has not been associated with clinical benefit. These considerations may be different in patients with suppressed or deficient humoral immunity. The EUA originally issued on August 23, 2020, is being revised to authorize only the use of high titer COVID-19 convalescent plasma for the treatment of hospitalized patients with COVID-19, early in the disease course.
As always, be thankful for the researchers, the scientists, the FDA, the CDC, and everyone else who has our best interests at heart! Stay the course, stay well, mask up, get vaccinated, and stay tuned!