Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19 in hospitalized patients as part of the agency’s ongoing efforts to fight COVID-19. The FDA concluded that this product may be effective in treating COVID-19 and that the known and potential benefits of the product outweigh the known and potential risks of the product.

The EUA authorizes the distribution of COVID-19 convalescent plasma in the U.S. and its administration by health care providers, as appropriate, to treat suspected or laboratory-confirmed COVID-19 in hospitalized patients with COVID-19.

The use of convalescent blood plasma goes back to the 1800s, according to the National Institutes of Health.  It has been used to try to help patients with diphtheria, measles, chickenpox, the epidemics of MERS and SARS, and the Spanish Influenza Pandemic of 1918-1920, among others.

The Mayo Clinic  has been spearheading a program supported by the Federal Government, and in collaboration with other institutions,  to collect and provide convalescent plasma to patients in need across the country. Blood plasma from recovered COVID-19 patients contains antibodies that may help fight the disease.

The Mayo Clinic program has since April collected plasma from nearly 94,000 patients.  More than 64,000 COVID-19 patients have received the plasma.

The FDA said the EUA is not intended to replace ongoing clinical trials.  It said  COVID-19 convalescent plasma does not yet represent a new standard of care based on the current available evidence, but at this time, there are no adequate, approved, or available  treatments for COVID-19.

The FDA also provided guidelines for health care providers who are considering using convalescent plasma for COVID-19 patients.