REGULATORY UPDATE: Evaluating Donor Risk and Deferrals Following Vaccination

November 20, 2020

The potential for a growing number of donor deferrals for investigational COVID-19 vaccines could pose another challenge to the blood supply during this pandemic. As blood center medical directors evaluate current vaccine deferral policies, AABB has additional information to consider. Regulatory Affairs developed a proposed approach and an example flowchart found on pages 18-19 of the Toolkit for COVID-19 Convalescent Plasma under Emergency Use Authorization for donor eligibility based on this new information.

FDA does not require donor deferral from routine blood donations based on receipt of a vaccine, including the investigational COVID-19 vaccines. In response to AABB’s August request for assistance with an evidence-based approach to help ensure safety while preventing unnecessary deferrals, FDA stated the following, which includes the Moderna vaccine, as an example:

“…the responsible physician may wish to consider the potential infectious risk associated with the vaccines, and the use of short deferral periods (e.g., 14 days) for live attenuated vaccines and no deferral for non-replicating, inactivated or RNA-based vaccines.” 

“We agree that no deferral is necessary for routine blood donors who might have received the mRNA-1273, Moderna vaccine.”

However, FDA updated deferral recommendations for CCP donors in the November 2020 CCP guidance. FDA’s new recommendations confirm that blood centers “should not collect CCP from individuals who have received an investigational COVID-19 vaccine because of the uncertainty regarding the quality of the immune response produced by such investigational vaccines.” 

For more information, contact regulatory@aabb.org.