How an Emergency Use Authorization (EUA) and Licensure Work

An EUA and licensure of COVID-19 vaccines have similarities. Both:

  • Require FDA’s rigorous evaluation of safety and efficacy data
  • Examine data from clinical trials involving tens of thousands of study participants
  • Can only be issued if benefits of the vaccine outweigh known and potential risks


FDA Information on EUAs

FDA Guidance on EUA for Vaccines to Prevent COVID-19

FDA Video, "What is an EUA?"



Page last reviewed: October 27, 2021