What is FDA approval, and how does something get approved?

FDA approval requires a rigorous and structured review process, and it means that a vaccine or drug has cleared every level of review. Compared to emergency use authorization, FDA approval of vaccines requires even more data on safety, manufacturing, and effectiveness over longer periods of time and includes real-world data. The FDA conducts its own analyses of the information included in an application for approval to make sure the vaccine is safe and effective and meets the FDA’s standards for approval.

Added August 23, 2021