The Food, Drug, and Cosmetic Act’s Emergency
Use Authorization: A Pandemic Vaccine Godsend
with Devils in the Details

John A. Casciotti*

ABSTRACT

The COVID-19 pandemic presented a decisive test of the Emergency Use Authorization (EUA) mechanism, which Congress created in 2003, to utilize the best
available medical countermeasure in a public health emergency when there is no FDAapproved product. For nine months, three COVID-19 vaccines under FDA-issued EUAs were the nation’s primary weapon to fight the historic pandemic. The results demonstrated two things: first, the EUA mechanism worked remarkably well in reducing morbidity and mortality; and second, in an effort to improve preparedness for a future potential pandemic, there are significant lessons to be learned from FDA actions on implementation details.

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