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# FDA Updates Covid Vaccine EUA Guidance
- URL: https://www.fdaweb.com/fda-updates-covid-vaccine-eua-guidance/
- Published: 2022-03-31T12:00:00.000Z
- Updated: 2026-09-14T17:38:55.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5151498

FDA has issued an immediately effective update to its 5/2021 guidance *Emergency Use Authorization for Vaccines to Prevent Covid-19*. The [document](https://www.fda.gov/media/142749/download?ref=fdaweb.com) provides the agency’s current thinking on the data and information needed to support the issuance of an emergency use authorization for an investigational vaccine to prevent Covid-19.

Included are recommendations on chemistry, manufacturing, and controls; nonclinical data and information; and clinical data and information, as well as administrative and regulatory information. The guidance also has recommendations regarding key information and data that should be submitted to a relevant IND or cross-referenced master file before submission of an EUA request to facilitate FDA’s complete and timely review of such a submission, including convening the Vaccines and Related Biological Products Advisory Committee.

The guidance also discusses FDA’s current thinking about the circumstances under which the issuance of an EUA for a Covid-19 vaccine would be appropriate.