BB/TS SC Updates Guidance That Addresses SARS-CoV-2 Vaccines

February 01, 2021

The Blood Banks and Transfusion Services Standards Committee (BB/TS SC) has updated the guidance crafted to focus on Reference Standard 5.4.1A, Requirements for Allogeneic Donor Qualification, concerning the receipt of vaccines, including COVID-19 (SARS CoV-2) vaccines. The Committee updated the guidance based on the Food and Drug Administration’s Updated Information for Blood Establishments Regarding the COVID-19 Pandemic and Blood Donation, posted Jan. 19, 2021, which refers to deferrals of donors who have received a COVID-19 vaccine. The question-and-answer format describes how accredited facilities should manage the deferral of donors who have received a COVID-19 vaccine.

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 for a COVID-19 vaccine, based on information received from FDA. Individuals who have been vaccinated but are not sure which vaccine was administered should refrain from donating for at least 14 days (the required deferral period for individuals that received a live-attenuated vaccine).

The BB/TS guidance also discusses deferrals related to potential COVID-19 convalescent plasma (CCP) donors who have received an investigational COVID-19 vaccine. FDA’s guidance, Investigational COVID-19 Convalescent Plasma, updated Jan. 15, describes that an individual can donate CCP after receipt of an investigational, authorized or licensed COVID-19 vaccine if they meet the specified eligibility requirements of the guidance. 

To ensure that COVID-19 convalescent plasma collected from donors contains sufficient antibodies directly related to their immune response to COVID-19 infection, they must have received a COVID-19 vaccine after diagnosis of COVID-19, had symptoms of COVID-19 and a positive test result from a diagnostic test approved, cleared or authorized by FDA, and are donating within 6 months after complete resolution of COVID-19 symptoms. If one of the criteria are not met, a potential CCP donor would not be allowed to donate.

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