The U.S. Food and Drug Administration (FDA) recently announced that the convalescent plasma guidance has been updated. The guidance titled “Investigational COVID-19 Convalescent Plasma (CCP)” was updated on October 13th. In August 2020, FDA issued an Emergency Use Authorization (EUA) for CCP for the treatment of hospitalized patients with COVID-19. FDA subsequently reissued the EUA with revisions. Most recently, FDA revised the EUA to limit authorization to the use of 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.
The recommendations in the updated guidance are unchanged from the January 2022 guidance. However, FDA has removed the language limiting the duration of the policy in the guidance to the public health emergency. The policy in the guidance will now remain in effect for the duration of the declaration under section 564 of the Federal Food, Drug, and Cosmetic Act by the Secretary of Health and Human Services on March 27, 2020 declaring that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic, or until the time that FDA determines it is appropriate to revoke the EUA for CCP because the circumstances that justify its issuance no longer exist. In preparation for when the EUA is no longer in effect, blood establishments interested in submitting an investigational new drug (IND) application or biologics license application (BLA) for CCP may contact the Center for Biologics Evaluation and Research’s (CBER) Office of Blood Research and Review (OBRR).
America’s Blood Centers (ABC)continues to support ongoing research into the potential benefits of convalescent plasma to treat COVID-19. ABC members played a vital role in COVID-19 pandemic response efforts.