With news of at least two vaccines on the near horizon for COVID-19, the U.S. FDA’s “Emergency Use Authorization” (EUA) plays a critical role in timing. But what exactly is an EUA, and how does it differ from normal FDA approvals?
The EUA is a “tool” used to speed up medical product approvals during times of public health emergencies. A major difference between an EUA and typical FDA approval for vaccines is the time required to monitor unexpected side effects in trials. Normally, the FDA requires several months for this stage, but the EUA process requires only two months of data monitoring — a meaningful acceleration. While this may sound concerning, Jess Goodman, M.D., former chief scientist at the FDA, said, “Generally, most safety events occur in the first month or two after vaccination. So, if all the data holds up and is confirmed by the FDA, that'll be good evidence of the safety of the vaccine."