Know the Facts: Understanding Emergency Use Authorization for the COVID-19 Vaccines

This week, the FDA granted full approval to the Pfizer-BioNTech COVID-19 vaccine. It's great news and once again shows that the vaccine is both safe and effective. But what about the two other COVID-19 vaccines available in the United States (Moderna and Janssen/Johnson & Johnson)?

Those vaccines are approved for use by the FDA under an Emergency Use Authorization (EUA). An EUA is one of several tools the FDA is using to help make certain medical products available quickly during the COVID-19 pandemic. In certain emergencies, the FDA can issue an EUA to provide access to medical products that may be used to help treat new illness/conditions to save or improve lives.

But what does that mean for these COVID-19 vaccines? If a vaccine is approved under an EUA, does that mean it wasn’t fully tested for safety?

No. COVID-19 vaccines were evaluated in tens of thousands of participants in clinical trials. The vaccines met the FDA’s rigorous scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization.

Nearly 350 million doses of COVID-19 vaccines have been given in the United States since they were authorized for emergency use by the FDA and severe side effects are extremely rare. These vaccines have undergone and will continue to undergo the most intensive safety monitoring in U.S. history.

Understanding the facts from trusted sources is so important. Talk to your doctor about vaccine safety if you still have concerns. Additional information on the safety of the COVID-19 vaccines is available here: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety.html