Frequently Asked Questions: EAP to EUA Transition - Convalescent Plasma COVID-19 (Coronavirus) Treatment

Frequently Asked Questions: EAP to EUA Transition

Last updated: March 10, 2021

On August 23, 2020, the US Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for COVID-19 convalescent plasma for the treatment of hospitalized patients with COVID-19.

When can the EAP program be closed out at our site, and our IRB Authorization Agreement terminated?

Site IRB Authorization Agreements (IAAs) with Mayo Clinic as the IRB of Record for the Expanded Access Program (EAP) need to remain in place until inquiries from the EAP to study sites are complete. While enrollment and treatment under the EAP were discontinued on 31 August 2020, Mayo Clinic continues to issue inquiries to sites that are needed for site reimbursement, and clarification of physician registration data needed for regulatory review. These inquiries may involve access to patient identifying information, which is the reason for IAAs remaining in place. Another update on the EAP website will provide notification of when the IAA with the EAP can be terminated at all sites. Thank you for your participation in the EAP and for its success in providing life-saving convalescent plasma.

Has a continuing review been submitted to the Mayo IRB?

The current IRB approval is valid through March 31, 2021. A continuing review has been submitted to the Mayo Clinic IRB, for which approval is anticipated in late March.

Is the discontinuation of the EAP effective immediately?

Yes, enrollment has ended, but physicians who have patients already enrolled in the EAP should continue to update and submit forms.

Can I still enroll patients in the Mayo Clinic Expanded Access Program (EAP)?

The Emergency Use Authorization (EUA) issued by the US FDA is currently active and going forward and should be the preferred means of administering COVID-19 convalescent plasma. New patient enrollment in the Mayo Clinic EAP is no longer authorized.

Can I still transfuse patients with convalescent plasma under the Mayo Clinic Expanded Access Program?

The Emergency Use Authorization (EUA) issued by the US FDA is active and represents the preferred means of administering convalescent plasma. Placing an order for COVID-19 convalescent plasma under the Mayo Clinic EAP is no longer authorized after 11:59 p.m. on August 31, 2020.

What are the differences between the Expanded Access Program (EAP) and Emergency Use Authorization (EUA)?

Reference the EAP vs. EUA comparison information and the FDA Fact Sheet to learn more about the EUA.

How do I treat hospitalized patients with COVID-19 under the Emergency Use Authorization (EUA)?

Refer to the US FDA Fact sheet for health care providers for information on treating patients under the EUA.

Am I required to complete forms for patients enrolled on or before August 28, 2020?

Yes. It is a requirement of the EAP to complete the following forms for each patient enrolled in the EAP:

  • Medical History Form
  • Transfusion Forms
  • Serious Adverse Event (SAE) Reports
  • SAE Resolution Forms
  • Weekly Patient Update/End of Study Forms

Where can I get more information and any fact sheets associated with the EUA?