The Coronavirus Disease 2019 (COVID-19) vaccines licensed or authorized by the U.S. Food and Drug Administration (FDA) are a critical tool to reduce the spread and severity of COVID-19. FDA initially authorized the vaccines, between December 2020 and February 2021, under Section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), a regulatory pathway that allows certain medical products to be made available in the market prior to full FDA approval under specified circumstances, including during a public health emergency. In August 2021, FDA licensed the first COVID-19 vaccine, Pfizer’s Comirnaty, for the prevention of COVID-19 in individuals 16 years of age and older, after determining that the vaccine, for the licensed use, meets the standards for safety, purity, and potency (i.e., effectiveness) under the Public Health Service Act.
Given the data supporting the safety and efficacy of the licensed and authorized COVID-19 vaccines, many public health experts view promoting high COVID-19 vaccination rates—along with continued engagement in community mitigation activities that prevent transmission, such as mask wearing in certain settings—as key components of the United States’ pandemic response.
One available legal tool for increasing vaccination rates is for governments to require vaccination. In 2021, various state, local, and federal governmental entities instituted COVID-19 vaccination requirements to address the pandemic, particularly as the Delta variant—a highly contagious strain of SARS-CoV-2 (the virus that causes COVID-19)—spread in the United States. 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. That 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 the 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, and modern courts’ analyses of more recent challenges to state vaccination mandates based on the First Amendment’s Free Exercise Clause. The report then analyzes the Supreme Court’s evolving free exercise jurisprudence and the questions it raises regarding whether and when governments must provide for or grant religious exemptions to vaccination requirements. It then looks at how courts have addressed challenges to COVID-19 vaccination requirements imposed by states and state entities.
The second part of the report provides an overview of federal authority to mandate vaccination. It discusses several sources of existing federal statutory authority that could serve, or have been invoked, as the basis for federal COVID-19 vaccination mandates. It then provides an overview of four employment-based civilian mandates issued by the executive branch to date directed at (1) federal executive agency civilian employees; (2) federal contractors for executive departments, agencies, and offices; (3) most Medicare- and Medicaid-certified providers and suppliers; and (4) employers with 100 or more employees. The report then discusses the state of litigation challenging these mandates. This part also reviews the extent of Congress’s constitutional authority under the Constitution’s Spending and Commerce Clauses to mandate vaccination.
The report concludes with a brief discussion of a legal issue specific to COVID-19 vaccination mandates, particularly before FDA’s licensure of Comirnaty. Namely, it reviews how courts have addressed some litigants’ argument that the Emergency Use Authorization status of COVID-19 vaccines preclude entities from mandating COVID-19 vaccination.
“State and Federal Authority to Mandate COVID-19 Vaccination,” CRS Report R46745, January 12, 2022 (11-page PDF
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