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

Sandra Crouse Quinn, PhD; Amelia M. Jamison, MAA, MPH; Vicki Freimuth, PhD

Disclosures

Am J Public Health. 2021;111(3):355-358. 

In This Article

Abstract and Introduction

Introduction

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]

Since March 2020, the FDA has issued EUA for several therapeutics to treat COVID-19: chloroquine phosphate, hydroxychloroquine sulfate, remdesivir, and a monoclonal antibody drug from Eli Lilly to help the immune system fight COVID-19.[3] The FDA later revoked its approval of chloroquine phosphate and hydroxychloroquine sulfate, stating that the drugs did not meet the legal criteria for approval.[4] The FDA also revised its fact sheet for remdesivir to reflect potential drug interactions.[5] Given the rapidity of changing knowledge of COVID-19, it is not surprising that the FDA would revoke or modify EUA approvals. However, its decisions about several EUAs have called into question the extent to which the FDA can withstand political pressure as it faces all decisions.

Daily news coverage tracks progress in the accelerated COVID-19 vaccine development process.[6] On November 13, 2020, Pfizer became the first company to seek approval of its COVID-19 vaccine through the EUA mechanism, making it the first instance of EUA approval for a vaccine.[7] Therefore, it is vital to assess how the public understands the EUA mechanism and how this may influence willingness to accept COVID-19 vaccines.

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