REGULATORY UPDATE: FDA Confirms Safety of Blood Components From Vaccinated Donors

AABB contacted the Food and Drug Administration to confirm the agency’s position on the safety of blood donated by individuals who received a COVID-19 vaccine. This communication with FDA was intended to support the important work of blood donor centers and hospital transfusion services that receive questions regarding the safety of donations following COVID-19 vaccination.

FDA continues to monitor blood transfusion safety for this and many issues. Key communications are listed in AABB’s summary of donor safety and eligibility requirements during the pandemic, including the Jan. 19 Safety and Availability Communication, Information for Blood Establishments Regarding the COVID-19 Pandemic and Blood Donation, which specifically addresses the safety requirements for blood donation during the pandemic. The agency has consistently confirmed that COVID-19-vaccinated individuals are acceptable blood donors.

In response to AABB’s June 30 inquiry, FDA provided a prompt response to again confirm that “at this time there is no evidence to suggest that transfusion of blood from those having received COVID-19 vaccination is associated with an increased risk of adverse events in recipients.”