Abstract
Emergency use authorizations (EUAs) are a mechanism to allow for the availability and use of medical products during a public health emergency. During the COVID-19 pandemic, hundreds of products have been authorized for use under an EUA. This has led to legal issues—most prominently, the legality of vaccine mandates. Language within the statute that created the EUA pathway has been subject to varying interpretations that could refuse or allow the implementation of EUA vaccine mandates and suits have been filed against organizations that have established vaccine mandates as a term of continued employment.
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References
1.U.S. Food and Drug Administration . Emergency use authorization for vaccines explained . November 20 , 2020 . Accessed September 8, 2022 . https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained
2.
Iwry
J.
From 9/11 to COVID-19: a brief history of FDA Emergency Use Authorization . January 28 , 2021 . Accessed September 8, 2022 . https://blog.petrieflom.law.harvard.edu/2021/01/28/fda-emergency-use-authorization-history/
3.U.S. Department of Health and Human Services . Emergency use authorization of medical products and related authorities. Guidance for industry and other stakeholders . January 2017 . Accessed September 8, 2022 . https://www.fda.gov/media/97321/download
4.U.S. Food and Drug Administration . Emergency use authorization . September 7 , 2022 . Accessed September 8, 2022 . https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#coviddrugs
5.
Parasidis
E
Kesselheim
AS
. Assessing the legality of mandates for vaccines authorized via an emergency use authorization . February 16 , 2021 . Accessed September 8, 2022 . https://www.healthaffairs.org/do/10.1377/forefront.20210212.410237/full/
6.National Public Radio . A judge has thrown out a lawsuit brought by hospital workers over a vaccine mandate . June 13 , 2021 . Accessed September 8, 2022 . https://www.npr.org/2021/06/13/1006065385/a-judge-has-thrown-out-a-lawsuit-brought-by-hospital-workers-over-a-vaccine-mand
7.
Jennifer Bridges
, et al . versus Houston Methodist Hospital, et al . Civil action H-21-1774. Order of dismissal . June 12 , 2021 . Accessed September 8, 2022 . https://www.documentcloud.org/documents/20860669-houston-methodist-lawsuit-order-of-dismissal
8.
Gooch
K.
Former Houston Methodist employees lose appeal in vaccination mandate case . June 15 , 2022 . Accessed September 8, 2022 . https://www.beckershospitalreview.com/legal-regulatory-issues/former-houston-methodist-employees-lose-appeal-of-vaccination-mandate-case.html
