U.S. FDA Updates Guidance on Convalescent Plasma Use

The U.S. FDA updated its guidance on the use of convalescent plasma on September 2, 2020, to provide additional information related to the use in the treatment of severe COVID-19 disease patients. Previously, on August 23rd, the FDA issued an Emergency Use Authorization for convalescent plasma collected from individuals who have recovered from COVID-19, which contains antibodies to SARS-CoV-2.

Convalescent plasma treatments have been studied in outbreaks of other respiratory infections, including the 2003 SARS-CoV-1 epidemic, the 2009 H1N1 influenza virus (Swine Flu) pandemic, and the 2012 MERS-CoV epidemic.

This new FDA guidance provides recommendations to healthcare providers and investigators, also provides recommendations to blood establishments on collection.