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
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FDA Guidance on EUA for Vaccines to Prevent COVID-19 |
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