About this program
Earlier this year, the U.S. Government provided support for a national Expanded Access Program to provide access to convalescent plasma to patients in need across the country. This program provided a pathway for patients with serious or life-threatening COVID-19 access to investigational convalescent plasma outside of clinical trials because no satisfactory alternative therapy options were available.
After evaluating safety and efficacy data for patients transfused in the Mayo Clinic-led EAP program and other existing data, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) to further expand access to convalescent plasma for the treatment of COVID-19 in hospitalized patients.
This EUA allows the use of COVID-19 convalescent plasma to be distributed and used by licensed health care providers to treat adult patients hospitalized with COVID-19.
For more information, refer to the FDA's Fact Sheet for Health Care Providers, which details the process and treatment with convalescent plasma.
What does an EUA provide?
In certain types of emergencies, the FDA can issue an emergency use authorization (EUA) as a temporary measure to provide more timely access to critical medical products that may help during an emergency when there are no adequate, approved and available alternative options.
Treating patients with convalescent plasma under the EUA is easier than the EAP because the physician can simply order the plasma as they would normally even though it has not yet been approved by the FDA as long as the temporary emergency situation as long as the declaration of the public health emergency exists. The EUA is not a clinical trial.
The efficacy of convalescent plasma for the treatment of COVID-19 is still being evaluated.
For more information, refer to the FDA's Fact Sheet for Health Care Providers, which outlines their process for treating patients with COVID-19 convalescent plasma in the EUA.
Who can I contact for more information?
For more information about Expanded Access to Convalescent Plasma for the Treatment of Patients with COVID-19 protocol, please contact:
Michael Joyner, M.D.
200 First St. SW
Rochester, MN 55905