Communicating Effectively About Emergency Use Authorization and Vaccines in the COVID-19 Pandemic.

Abstract

The Emergency Use Authorization (EUA) mechanism is central to the US response to coronavirus disease 2019 (COVID-19). It allows the US Food and Drug Administration (FDA) to respond quickly to novel threats by approving a new drug, device, or diagnostic procedure or expanding off-label use of an existing drug through an accelerated approval process.1 To obtain authorization, evidence must support that a drug or product "'may be effective' to prevent, diagnose, or treat serious or life-threatening diseases or conditions," and the known or potential benefits of the product must outweigh known or potential risks.2(p7) The authorization also stipulates that when feasible, a fact sheet is provided to address risks and benefits and make clear that acceptance is voluntary.2 (Am J Public Health. Published online ahead of print November 25, 2020: e1-e4. https://doi.org/10.2105/AJPH.2020.306036).