November 20, 2020
The Blood Banks and Transfusion Services Standards Committee (BB/TS SC) recently released guidance to Reference Standard 5.4.1A, Requirements for Allogeneic Donor Qualification, concerning the receipt of vaccines, including unlicensed SARS CoV-2 vaccines. Based on communications from FDA, the Standards Committee felt it was necessary to provide information in a Q&A format on how accredited facilities should manage the deferral of donors participating in vaccine trials.
Reference Standard 5.4.1A requires a 12-month deferral for recipients of unlicensed vaccines, subject to review by the medical director. Medical directors can consider a shorter deferral period (as short as 14 days from inoculation) for those receiving live attenuated vaccines. No deferral is necessary for blood donors who received non-replicating, inactivated or RNA-based vaccines such as the mRNA-1273 Moderna vaccine.
The guidance also discusses deferrals related to potential CCP donors who have received the SARS CoV-2 vaccine.