What Are Emergency Use Authorizations, and Do They Guarantee That a Vaccine or Drug Is Safe?
December 3, 2020
(The Conversation) – In coming days, the Food and Drug Administration is likely to authorize new COVID-19 vaccines based on applications submitted by two companies. These authorizations have happened very fast in a process called “emergency use authorizations,” or EUAs. Does this swift action mean that products are proven safe and effective? Not exactly. But it suggests that they may present a reasonable balance of risks and benefits. We are a physician and a lawyer, and we also study drug development from the perspectives of history and philosophy. The longer view is helpful to understand the differences between full FDA approval and EUAs.