Under an Emergency Use Authorization, FDA may permit the use of unapproved medical products or unapproved uses of approved medical products in certain emergencies to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when there are no adequate, approved, and available alternatives. We encourage applicants to submit any questions to CBEREUA@fda.hhs.gov.

COVID-19 Convalescent Plasma

On August 23, 2020 FDA issued an Emergency Use Authorization (EUA) for COVID-19 Convalescent Plasma. A summary of updated evidence to support the emergency use of COVID-19 Convalescent Plasma is available here.

COVID-19 Vaccines

In October 2020, FDA issued guidance on Emergency Use Authorizations for Vaccines to Prevent COVID-19 with recommendations for vaccine sponsors regarding the scientific data and information that would support the issuance of an emergency use authorization (EUA) for an investigational vaccine intended to prevent COVID-19. In addition to outlining our expectations for vaccine sponsors, we also hope the agency’s guidance on COVID-19 vaccines helps the public understand our science-based decision-making process that assures vaccine quality, safety and efficacy for any vaccine that is authorized or approved.

In addition, on October 22, 2020, FDA’s Vaccine and Related Biological Products Advisory Committee met in open session, to discuss, in general, the development, authorization and/or licensure of vaccines to prevent COVID-19. No specific application was discussed at this meeting. FDA intends to convene an open session of the VRBPAC upon submission of an EUA for a COVID-19 vaccine in order to publicly discuss the safety and efficacy of the particular vaccine.

EUA Transparency

We believe that transparency about CBER’s review of the scientific information supporting our recommendations to issue EUAs for COVID-19 therapeutics and vaccines promotes public confidence in FDA’s scientific review process and ultimately in using the authorized products appropriately.

Therefore, our goal is to be as transparent as possible about the scientific basis for recommending that a biological product be authorized for emergency use under section 564 of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 360bbb-3) or be revised or revoked. In addition to convening FDA’s VRBPAC regarding COVID-19 vaccines:

• When a CBER-regulated product is authorized for emergency use, we intend to the extent appropriate and permitted by law to make public the Center’s review of the scientific data and information supporting our recommendation to issue the EUA
• When an EUA is revised, we also intend to make public the Center’s review of the scientific data and information supporting our recommendations to revise the EUA

Our goal is to disclose information from our EUA review documents as appropriate and consistent with our longstanding practice of posting scientific reviews after product approvals. We may redact certain information that is exempt from disclosure under the Freedom of Information Act (FOIA), 5 U.S.C. sec. 552, such as trade secrets or other information identified by the EUA requestors that is exempt under FOIA. The redacted information may vary depending on the type of data contained in the reviews and whether the requestor consents to release of information that is exempt under FOIA.