BB/TS Guidance Addresses SARS-CoV-2 Vaccines

December 23, 2020

The Blood Banks and Transfusion Services Standards Committee (BB/TS SC) released a 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 the Food and Drug Administration, the Standards Committee deemed it necessary to provide information in a Q&A format on how accredited facilities should manage the deferral of donors who have received a COVID-19 vaccine under emergency use authorization (EUA) or are participating in a COVID-19 vaccine trial.

Per Reference Standard 5.4.1A, medical directors can consider a deferral period of 14 days from inoculation for individuals receiving live attenuated vaccines. No deferral is necessary for blood donors who received non-replicating, inactivated or RNA-based vaccines, such as the Pfizer-BioNTech vaccine or Moderna vaccine. Please note, Reference Standard 5.4.1A requires a 12-month deferral for recipients of unlicensed vaccines, subject to review by the medical director. This review allows a medical director the discretion to define a deferral period less than 12 months, such as those described above, based on information received from FDA.  

The guidance also discusses deferrals related to potential COVID-19 convalescent plasma donors who have received a SARS CoV-2 vaccine under the EUA or as part of a clinical trial. 

The guidance can be found in the Standards Portal and the Standards Library.