REGULATORY UPDATE: FDA Officials Provide Insight on High-Titer CCP, Donor Eligibility Following Vaccination
February 09, 2021
Officials from the Food and Drug Administration answered a series of questions from the blood community during Tuesday’s Hot Topic Discussion
on the updated emergency use authorization
(EUA) for COVID-19 convalescent plasma (CCP). In the hour-long event, Peter Marks, MD, PhD, director of the Center for Biologics Evaluation and Research (CBER); and Nicole Verdun, MD, director of the Office of Blood Research and Review, clarified questions on qualification of CCP units, uses for low-titer units and the eligibility of donors following their vaccination for COVID-19.
Marks and Verdun confirmed that there is a modest clinical benefit for patients with COVID-19 who receive high-titer CCP early in the course of their illness; however, current data does not support the administration of low-titer CCP. Marks and Verdun also emphasized that the revised EUA is effective immediately, noting that the enforcement discretion period was to allow for blood centers to prepare. Verdun confirmed that there is no written documentation that permits the administration of low-titer plasma. FDA does not encourage the use of low-titer units to treat CCP, but those units may be used as fresh-frozen plasma (FFP) or plasma frozen within 24 hours (FP24) if they are relabeled as such. High-titer units must still be labeled after the end of the enforcement discretion period.
Marks and Verdun also discussed CCP donor eligibility. Generally speaking, individuals who donated CCP prior to COVID-19 vaccination may donate following vaccination if they meet remaining donor eligibility criteria, while individuals who did not have symptoms and a positive diagnostic test as evidence of infection prior to vaccination are ineligible to donate CCP after COVID-19 vaccination. In addition, Verdun confirmed that, currently, individuals are only eligible to donate for 6 months after resolution of COVID-19 symptoms (regardless of antibody levels at 6 months), and Marks noted that the agency may reevaluate this determination as more data become available.
Those who were unable to attend the live webinar can access this program on demand
. AABB is continuing to collect questions from the blood community related to the revised EUA for CCP. Individuals with questions are encouraged to send them to firstname.lastname@example.org