> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Revised Guide on Covid-19 Vaccines
- URL: https://www.fdaweb.com/revised-guide-on-covid-19-vaccines/
- Published: 2023-10-19T12:00:00.000Z
- Updated: 2026-09-14T14:13:48.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5155609

FDA has published a [revised guidance](https://www.fda.gov/media/139638/download?ref=fdaweb.com) entitled “Development and Licensure of Vaccines to Prevent Covid-19.” It updates the guidance under the same name that was released 8/2020\. The document is intended to assist the agency and sponsors in the clinical development and licensure of vaccines for preventing Covid. Additionally, it provides an overview of key considerations to satisfy regulatory requirements articulated in the IND regulations and in the licensing regulations for chemistry, manufacturing and controls, and nonclinical and clinical data through development and licensure, and for post-licensure safety evaluation of Covid-19 preventive vaccines.