REGULATORY UPDATE: FDA Withdraws EUA for COVID-19 Convalescent Plasma

The Food and Drug Administration provided an update this week to ensure the AABB community is aware that the agency revoked emergency use authorization (EUA) for COVID-19 convalescent plasma (CCP), effective Aug. 27.

Revocation notices for COVID-19 drug and biological product EUAs are available on FDA's Emergency Use Authorization - Archived Information web page. Concomitantly, FDA has withdrawn its associated October 2023 guidance document titled, “Investigational COVID-19 Convalescent Plasma.”

FDA’s July 2024 guidance document, “Recommendations for Investigational and Licensed COVID-19 Convalescent Plasma,” provides the current recommendations for blood establishments submitting a biologics license application (BLA) to manufacture CCP. The guidance also provides FDA’s recommendations for investigational new drug applications (INDs) for investigational CCP for transfusion.

In addition, FDA provided the following information:

• FDA revoked the EUA for CCP because a variety of circumstances have changed, including that FDA has received supplemental BLAs to manufacture licensed CCP for the treatment of COVID-19 patients with immunosuppressive disease or receiving immunosuppressive treatments.
• Licensed CCP is available. The distribution of CCP that is not covered in an approved BLA must be under an applicable IND (21 CFR 312).
• FDA does not intend to object to the use of any remaining CCP inventory distributed before the EUA revocation, as outlined in Section IV of the July 2024 guidance document. 

FDA encourages blood establishments interested in manufacturing licensed or investigational CCP to refer to the July 2024 guidance document.

The agency directed blood establishments with questions about their regulatory submissions to contact OBRR directly through the regulatory project managers. For general questions blood establishments may send questions to FDA’s OBRR/Blood and Plasma Branch mailbox. 

AABB’s Plasma Antibody Network (PLAN) is working to support licensed CCP for the approximately 7 million immunosuppressed people who rely on CCP. For questions about PLAN activities, please contact standards@aabb.org.