What is an emergency use authorization (EUA) and how is it used to respond to COVID-19?
In certain types of emergencies, the FDA can issue an EUA to provide more timely access to critical medical products that may help during the emergency when there are no adequate, approved, and available alternative options. The EUA process is different from full FDA approval, clearance or licensing because the EUA standard requires significantly less data than otherwise would be required for approval, clearance or licensing by the FDA. This enables the FDA to authorize the emergency use of medical products that meet the criteria for issuance within weeks rather than months to years. It must be determined that the vaccines are safe and effective in diminishing the severity of COVID-19 symptoms to gain an FDA emergency use authorization or full licensing.