REGULATORY UPDATE: AABB's Hot Topic Discussion Addresses New Donor Eligibility Challenges, Including COVID-19 Vaccination

January 11, 2021

Individuals who have recovered from SARS-CoV-2 (COVID-19) infection and otherwise qualify to donate COVID-19 convalescent plasma (CCP), under certain circumstances, may continue to be eligible to donate CCP after receiving the COVID-19 vaccine, Peter Marks, MD, PhD, director of FDA’s Center for Biologics Evaluation and Research, clarified during AABB’s Jan. 7  Hot Topic Discussion, “COVID-19 Vaccines, PrEP, MSM – What you Need to Know as We Head Into 2021.” AABB has confirmed that FDA is actively working on this eligibility issue and once clarified, will update the resource AABB Summary: Donation of CCP and Blood Components Following COVID-19 Vaccines or CCP Transfusion following confirmation. 

The program began with a presentation by Jed Gorlin, MD, MBA, chair of AABB’s Transfusion Transmitted Diseases Committee, on considerations and strategies surrounding the impact of COVID-19 vaccines on blood donation, including CCP donations. Gorlin raised concerns regarding donor deferral information associated with the AstraZeneca and Johnson & Johnson investigational vaccines, which are currently in Phase 3 trials. Marks said he did not anticipate blood donor deferrals when these vaccines become available under Emergency Use Authorization.

Brian Custer, PhD, MPH, from Vitalant Research Institute, presented a summary of current data and information on next steps for practices around HIV detection in the ART/PrEP era. Marks then discussed FDA’s deferral policies for men who have sex with men, current studies and next steps. The session concluded with a question-and-answer session with the three speakers. 

The Hot Topic discussion is available on demand and is complimentary for AABB members. AABB’s next educational offering, Immunohematology Boot Camp: Case Studies Involving MNS Genotyping, will be held Wednesday, Feb. 10. For a complete listing of upcoming AABB programs, visit the calendar of events on the AABB website.    

Contact regulatory@aabb.org with questions.