The U.S. Food and Drug Administration (FDA) stated it is issuing this guidance to provide sponsors of requests for Emergency Use Authorization (EUA) for COVID-19 vaccines with recommendations regarding the data and information needed to support the issuance of an EUA under section 564 of the FD&C Act (21 U.S.C. 360bbb-3) for an investigational vaccine to prevent COVID-19 for the duration of the COVID-19 public health emergency.
This guidance describes FDA’s current recommendations regarding the data and information needed to support the issuance of an Emergency Use Authorization (EUA) under section 564 of the FD&C Act (21 U.S.C. 360bbb-3) for an investigational vaccine to prevent COVID-19, including chemistry, manufacturing, and controls information (CMC); nonclinical data and information; and clinical data and information, as well as administrative and regulatory information. In addition, the guidance provides recommendations regarding key information and data that should be submitted to a relevant investigational new drug application (IND) or cross-referenced master file (MF) prior to submission of an EUA request in order to facilitate FDA’s complete and timely review of such a submission, including convening the Vaccines and Related Biological Products Advisory Committee (VRBPAC).
This guidance also discusses FDA’s current thinking regarding the circumstances under which the issuance of an EUA for a COVID-19 vaccine would be appropriate, providing additional context to the discussion regarding EUAs in the guidance for industry entitled “Development and Licensure of Vaccines to Prevent COVID-19.” These recommendations are specific to COVID-19 vaccines, which are complex biological products that are intended to be administered to millions of individuals, including healthy people, to prevent disease. These vaccines have the potential for broad use under an EUA.
The recommendations in this guidance are not necessarily applicable to drugs and biological products intended for treatment of COVID-19, for which there may be significantly different considerations under the standard set forth in section 564 of the FD&C Act (21 U.S.C. 360bbb-3), reflecting the products’ characteristics and anticipated clinical uses.
Sponsors engaged in the development of vaccines to prevent COVID-19 should refer to the guidance for industry entitled “Development and Licensure of Vaccines to Prevent COVID-19” the Secretary of Health and Human Services Alex M. Azar, Determination that a Public Health Emergency Exists. (Jan. 31, 2020, renewed Apr. 21, 2020, and July 23, 2020), is available at https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx.
Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19) Outbreak (Mar. 13, 2020), is available at https://www.whitehouse.gov/presidential-actions/proclamation-declaring-nationalemergency-concerning-novel-coronavirus-disease-covid-19-outbreak/.
Contains Nonbinding Recommendations guidance for industry and investigators entitled “COVID-19 Public Health Emergency: General Considerations for Pre-IND Meeting Requests for COVID-19 Related Drugs and Biological Products”, and the guidance for industry and other stakeholders entitled “Emergency Use Authorization of Medical Products and Related Authorities.”
Based on this declaration and determination, FDA may issue an EUA after FDA has determined that the following statutory requirements are met (section 564 of the FD&C Act (21 U.S.C. 360bbb-3)):
• The chemical, biological, radiological, or nuclear (CBRN) agent referred to in the March 27, 2020 EUA declaration by the Secretary of HHS (SARS-CoV-2) can cause a serious or life-threatening disease or condition.
• Based on the totality of scientific evidence available, including data from adequate and well-controlled trials, if available, it is reasonable to believe that the product may be effective to prevent, diagnose, or treat such serious or life-threatening disease or condition that can be caused by SARS-CoV-2.
• The known and potential benefits of the product, when used to diagnose, prevent, or treat the identified serious or life-threatening disease or condition, outweigh the known and potential risks of the product.
• There is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating the disease or condition. In the case of investigational vaccines being developed for the prevention of COVID-19, any assessment regarding an EUA will be made on a case by case basis considering the target population, the characteristics of the product, the preclinical and human clinical study data on the product, and the totality of the available scientific evidence relevant to the product.
