Updated Guidance for COVID-19 Convalescent Plasma Use from the FDA and AABB

With a lack of effective treatments for COVID-19, the U.S. FDA issued Emergency Use Authorization to use convalescent plasma to treat COVID-19 in August 2020 based on the safety and early evidence from patients enrolled in the Expanded Access Program.   To date, over 500,000 patients have been infused with COVID-19 convalescent plasma (CCP), and limited randomized trial data are now available.  Based on these data, both the AABB and the FDA have updated guidance for CCP use.  Both urge the use of high titer CCP for treating hospitalized patients early in the disease course.  In addition, the transfusion of CCP late in the course of the disease or once significant respiratory distress occurs has not shown to be beneficial.  The AABB further recommends that clinicians should consider the risks of CCP to be comparable to standard plasma transfusions.  In addition, the AABB suggests the transfusion of group A or O CCP with low anti-A/B titers may be acceptable for some patients when group B or group AB CCP is  not available. Both the AABB and the FDA urge clinicians to continue to enroll patients in randomized controlled trials to more fully understand the efficacy of CCP, specifically for subpopulations of patients.  Recommendations and guidance will be updated as more data become available.

References:

1. Cohn CS, Estcourt L, Grossman BJ, Pagano M, et al.  COVID-19 convalescent plasma:  interim recommendations from the AABB.  Transfusion 2021
2. FDA in Brief: FDA updates Emergency Use Authorization for COVID-19 convalescent plasma to reflect new data.  FDA News Events
3. FDA Investigational COVID-19 Convalescent Plasma. Guidance for Industry.   Issued February 11, 2021