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?"