OneBlood Becomes First Blood Center to Provide FDA-Licensed High-Titer COVID-19 Convalescent Plasma

January 15, 2025

OneBlood, an AABB institutional member serving the Southeastern United States, recently became the country’s first blood center to receive Food and Drug Administration approval to provide licensed high-titer COVID-19 convalescent plasma (CCP) to treat individuals who are immunocompromised and unable to make their own antibodies to the virus. Licensed high-titer CCP is not approved for other patient populations at this time.

Approximately 3% of the U.S. population is immunocompromised, accounting for 20% of COVID-19-related hospitalizations. According to OneBlood, the licensure of high-titer CCP provides physicians with a safe and effective resource to treat severe complications from COVID-19 in these patients by supplying antibodies that the immune system cannot produce or produce quickly enough.

“A new era of treatment to protect the population who are immunocompromised has arrived,” said George “Bud” Scholl, president and chief executive officer at OneBlood. “OneBlood is proud to be part of this significant accomplishment.”

To earn FDA licensure, OneBlood, Johns Hopkins Medicine, the Johns Hopkins Bloomberg School of Public Health, the Mayo Clinic, AABB, the COVID-19 Convalescent Plasma Project and the COVID-19 Serologic Studies Consortium collaborated to provide the necessary data to demonstrate CCP’s safety and effectiveness for immunocompromised patients. The agency approved OneBlood’s application in December.

“The OneBlood team has been relentlessly refining processes and protocols to ensure the highest quality CCP that meets all FDA guidelines is available for patients in need,” said Rita Reik, MD, chief medical officer at OneBlood.