FDA Issues Guidance on COVID-19 Vaccine Emergency Use Authorization

The U.S. Food and Drug Administration (FDA) has “issued guidance 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.”  The recommendations describe EUA issuance supporting information and data, “including chemistry, manufacturing and controls information, nonclinical and clinical data, and regulatory and administrative information.”  FDA’s EUA authority allows the use of unapproved medical products, or unapproved uses of approved medical products, if a domestic emergency has been determined by the Secretary of Homeland Security, a military emergency has been determined by the Secretary of Defense, or a public health emergency has been determined by the Secretary of Health and Human Services. [see 21 U.S.C § 360bbb-3]  For additional information, see the FDA in Brief: FDA Issues Guidance on Emergency Use Authorization for COVID-19 Vaccines.