FDA issues guidance on EUA for COVID-19 vaccines

Editor's Note

The Food and Drug Administration (FDA) on October 6 released guidance on the data and information needed to support the issuance of emergency use authorization (EUA) for COVID-19 vaccines.

The recommended data and information include:

• chemistry, manufacturing, and controls information
• clinical and nonclinical data and information
• administration and regulatory information.

The guidance is being implemented immediately, but it remains subject to comments, which may be submitted at any time for FDA consideration.

The guidance will remain in effect for the duration of the public health emergency related to COVID-19.