REGULATORY UPDATE: FDA Issues Revised CCP Guidance, AABB Updates CCP Toolkit

By Drew Case posted 01-11-2022 11:53 AM


The Food and Drug Administration issued a revised final guidance on Friday that provides updated recommendations on the use of COVID-19 convalescent plasma (CCP) related to the December 2021 emergency use authorization (EUA) for CCP.

FDA revised the guidance to reflect that the EUA authorizes CCP with high titers of anti-SARS-CoV-2 antibodies for the treatment of COVID-19 in patients with immunosuppressive disease or receiving immunosuppressive treatment in either the outpatient or inpatient setting. It also includes updated recommendations pertaining to CCP donors.

AABB detailed the changes to the revised guidance in an updated CCP toolkit to assist member centers with operational considerations. This toolkit, along with other regulatory toolkits for members, is available on the AABB website.

AABB will continue to work with FDA and partner organizations in the blood community to identify and remove unnecessary donor deferral criteria wherever possible. Individuals with questions may contact AABB’s Regulatory Affairs staff for additional information.