The Coronavirus Disease 2019 (COVID-19) vaccines recently authorized by the U.S. Food and Drug Administration (FDA) are a critical tool to address the pandemic. After determining that these vaccines meet the applicable statutory standards and the Agency’s specific safety and efficacy standards, FDA issued Emergency Use Authorizations (EUAs) under Section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). In particular, data supporting the EUA requests show that the vaccines are effective at preventing symptomatic COVID-19 in vaccinated individuals. Given this data, many public health experts believe that promoting COVID-19 vaccination—along with continued engagement in community mitigation activities that prevent transmission, such as mask wearing and social distancing—should be a key component of the United States’ pandemic response.
One available legal tool for increasing vaccination rates is for governments to require vaccination. Under the United States’ federalist system, states and the federal government share regulatory authority over public health matters, with states traditionally exercising the bulk of the authority in this area pursuant to their general police power. This power authorizes states, within constitutional limits, to enact laws “to provide for the public health, safety, and morals” of the states’ inhabitants. In contrast to this general power, the federal government’s powers are confined to those enumerated in the Constitution.
This report provides an overview of state and federal authority to mandate vaccination. The first part of the report provides background on state and local authority to mandate vaccination under states’ general police power. It discusses the Supreme Court’s long-standing recognition of state and local authority to mandate vaccination as an exercise of their police power, as well as modern courts’ analyses of more recent challenges to state vaccination mandates based on the First Amendment’s Free Exercise Clause. The first part of the report closes with a look at how the COVID-19 vaccines’ EUA status may affect a court’s analysis of a potential mandate.
The second part of the report provides an overview of federal authority to mandate vaccination. It discusses one possible source of existing federal authority, Section 361 of the Public Health Service Act (PHSA), and reviews the extent of Congress’s constitutional authority under the Constitution’s Spending and Commerce Clauses to potentially mandate vaccination.
State and Federal Authority to Mandate COVID-19 Vaccination, CRS Report R46745, April 2, 2021 (17-page PDF
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