COVID-19 Vaccine: What does an EUA mean for vaccine safety?

I’ve heard that COVID-19 vaccines have been authorized under EUA. What exactly is an EUA?

Whenever new medicines are created, the United States Food and Drug Administration (FDA) is responsible for making sure these drugs are safe and effective for Americans to use. This is a complex and time-consuming process that you can review using this FDA fact sheet.

In emergencies, the experts at the FDA can decide that the benefits of a drug justify a shorter process. If so, the FDA can issue an Emergency Use Authorization (EUA). Under an EUA, the FDA maintains its strict standards but makes decisions more quickly than usual.

This allows for greater flexibility in working to protect and save Americans’ lives.

Since the FDA issued an EUA for COVID-19 vaccines, does that mean that they weren’t studied carefully?

No, the authorized COVID-19 vaccines were still studied thoroughly. Even under the EUA process, the FDA has strict standards to make sure that Americans remain safe. Tens of thousands of people of different ages, genders, and ethnic and racial backgrounds were included in studies.

Results showed that COVID-19 vaccines were consistently safe and effective across all groups. The FDA chose to authorize COVID-19 vaccines under an EUA because the benefits of protecting Americans from COVID-19 outweighed the benefits of the typical review timeline.

The FDA has provided detailed information so that you can learn more about the EUA review process and its requirements.

I saw that use of a vaccine was paused for a few weeks earlier this year. Can I still trust vaccines authorized under an EUA after that?

Yes, you can trust COVID-19 vaccines authorized under an EUA. In April, the United States Centers for Disease Control and Prevention (CDC) and FDA recommended a “pause” in the use of Johnson & Johnson’s Janssen COVID-19 vaccine.

This decision demonstrated their constant efforts to protect Americans by studying COVID-19 vaccines even after they were authorized under an EUA. When experts discovered an incredibly rare side effect that impacted about seven women per one million vaccinated women, use of the J&J/Janssen vaccine was paused for further study.

After reviewing all information, these experts determined that the benefits of the J&J/Janssen vaccine outweighed the risks of that rare side effect and the pause was lifted. This process showed the continued commitment by the CDC and the FDA to keep Americans safe both before and after authorization under an EUA.

Keep an eye out for more answers to your COVID-19 and vaccine questions and remember to follow good health habits in the meantime.

To keep it simple, follow the three W’s when appropriate: wear your masks, wash your hands, and watch your distance from others!

References

• Drug Approval Process | FDA
• Learn More About COVID-19 Vaccines From the FDA | FDA
• Emergency Use Authorization for Vaccines Explained | FDA
• What do I need to know about Johnson & Johnson’s Janssen COVID-19 Vaccine (J&J/Janssen) now? (cdc.gov)
• CDC Recommends Use of Johnson & Johnson’s Janssen COVID-19 Vaccine Resume | CDC