What does emergency use authorization by the Food and Drug Administration (FDA) mean?

June 7, 2021 (updated August 23, 2021)

Emergency use authorization (EUA) facilitates the use of medical countermeasures — including vaccines — during public health emergencies, such as the COVID-19 pandemic. An EUA requires a finding that it’s “reasonable to believe” that the vaccine “may be effective” to prevent serious or life-threatening diseases, or to mitigate a disease or condition.

In the case of the COVID-19 vaccines under EUA, both the safety and efficacy have now been demonstrated well beyond the initial clinical trial data; millions of shots have been administered; and only one vaccine — Johnson & Johnson — has been linked to any serious issue following its EUA approval. That review led to the requirement that a warning be added to the Johnson & Johnson label regarding a very rare side effect, and the vaccine remains in use in the U.S.

On Aug. 23, 2021, the FDA gave full authorization for the Pfizer-BioNTech vaccine for those 16 years old and older. The Pfizer vaccine continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.