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Guidance COVID-19Emergency Legal Preparedness and Response

Guidance: COVID-19 Vaccine and Employer Mandates

July 27, 2021

Overview

With COVID-19 vaccinations underway, public and private employers across the U.S. are considering the potential for vaccine requirements for their workforces, especially among health care workers. This guidance addresses the question of whether public and private sector employers can generally mandate employee vaccination, and whether that answer changes based on the fact that current COVID-19 vaccines have received emergency use authorization, but have not been formally authorized by the FDA.

On December 11, 2020, FDA issued an EUA for a COVID-19 vaccine developed by Pfizer and German partner BioNTech, which has demonstrated upwards of 90% efficacy in trials. On December 17, 2020, FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommended issuance of an EUA for Moderna’s COVID-19 vaccine. Additional EUA applications for other vaccine candidates are also anticipated. While vaccines authorized via EUA begin distribution, public and private employers across the U.S. are considering the potential for issuing vaccine mandates applied to their
workforces, especially among health care workers (HCWs). This guidance addresses employer mandated vaccination during the COVID-19 pandemic, providing key legal and factual updates for public
health officials and employers.

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