State and Federal Authority to Mandate COVID-19 Vaccination

State and Federal Authority to Mandate
April 2, 2021January 12, 2022
COVID-19 Vaccination
Wen W. Shen
The Coronavirus Disease 2019 (COVID-19) vaccines The Coronavirus Disease 2019 (COVID-19) vaccines recentlylicensed or authorized by the U.S. Food authorized by the U.S. Food and
Legislative Attorney Legislative Attorney
and Drug Administration (FDA) are a critical tool to 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)reduce the spread and severity of COVID- 19. FDA initially authorized the vaccines, between December 2020 and February 2021, under Section 564 of the under Section 564 of the

Federal Food, Drug, and Cosmetic Act (FD&C Act)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, 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 , many public health experts view promoting highexperts believe that promoting COVID-19 vaccination COVID-19 vaccination rates—along with continued engagement in —along with continued engagement in
community mitigation activities that prevent transmission, such as mask wearing community mitigation activities that prevent transmission, such as mask wearing and social distancing—should be ain certain settings—as key components key
component of the United States’ pandemic response. of the United States’ pandemic response.
One available legal tool for increasing vaccination rates is for governments to require vaccination. 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’ Under the United States’
federalist system, states and the federal government share regulatory authority over public health matters, with 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. traditionally exercising the bulk of the authority in this area pursuant to their general police power. ThisThat power authorizes power authorizes
states, within constitutional limits, to enact laws “to provide for the public health, safety, and morals” of the states’ 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 inhabitants. In contrast to this general power, the federal government’s powers are confined to those enumerated in the
Constitution.Constitution.
This report provides an overview of state and federal authority to mandate vaccination. The first part of the report provides 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 background on state and local authority to mandate vaccination under the states’ general police power. It discusses the Supreme 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, Court’s long-standing recognition of state and local authority to mandate vaccination as an exercise of their police power, as
well asand modern courts’ analyses of more recent challenges to state vaccination mandates based on the First Amendment’s modern courts’ analyses of more recent challenges to state vaccination mandates based on the First Amendment’s
Free Exercise Clause. The 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), andreport 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 reviews the extent of
Congress’s constitutional authority under the Constitution’s Spending and Commerce Clauses to Congress’s constitutional authority under the Constitution’s Spending and Commerce Clauses to potentially mandate
vaccination.
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link to page 5 link to page 8 link to page 8 link to page 11 link to page 13 link to page 14mandate 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. Congressional Research Service link to page 7 link to page 7 link to page 11 link to page 15 link to page 16 link to page 18 link to page 19 link to page 22 link to page 25 link to page 32 link to page 35 link to page 36 link to page 30 link to page 36 State and Federal Authority to Mandate COVID-19 Vaccination

Contents
State and Local Authority to Mandate Vaccination ......................................................................... 2
4 Legal Background ..................................................................................................................... 4 State COVID-19 Vaccination Mandates and Related Litigation ............................................... 8 Federal Authority to Mandate Vaccination ...................................................................................... 5 12
Executive Branch Authority to Mandate Vaccination ............................................................... 5
Congress’s 13 Federal Employee Mandate .............................................................................................. 15 Federal Contractor Mandate ............................................................................................. 16 CMS’s Medicare/Medicaid Provider Mandate ................................................................. 19 OSHA’s Large-Employer Vaccination and Testing Mandate ........................................... 22 Congress’s Constitutional Authority to Mandate Vaccination ................................................ 29 Emergency Use Authorization and Vaccination Mandates ............................... 8
Consideration for Congress ............................. 32 Considerations for Congress.......................................................................................................... 33 Tables Table 1. Summary of Federal Nonmilitary COVID-19 Vaccination Mandates ............................. 27 ................... 10

Contacts
Author Information ......................................................................................................................... 11 33

Congressional Research Service Congressional Research Service

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link to page 4 link to page 4 link to page 4 link to page 4
link to page 4 State and Federal Authority to Mandate COVID-19 Vaccination

he Coronavirus Disease 2019 (COVID-19) vaccines he Coronavirus Disease 2019 (COVID-19) vaccines recentlylicensed or authorized by the U.S. authorized by the U.S.
Food and Drug Administration (FDA) are a critical tool to Food and Drug Administration (FDA) are a critical tool to address the pandemic.1 After
determining that these vaccines meet the applicable statutory standards and the Agency’s
specific safety and efficacy standards, FDA issued reduce the spread and severity of COVID-19.1 Until August 2021, all COVID-19 vaccines were authorized under T Section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act),2 a regulatory pathway that allows certain medical products to be made available in the market prior to FDA approval under specified circumstances, including during public health emergencies.3 FDA issued the Emergency Use Authorizations Emergency Use Authorizations
(EUAs) for the vaccines under Section 564 of the Federal Food, Drug, and Cosmetic Act
(FD&C Act).2 In particular(EUAs) under Section 564 after determining that the COVID-19 vaccines met the applicable statutory standards and the Agency’s specific safety and efficacy standards.4 Among other information, data supporting the EUA requests show that the vaccines are effective , data supporting the EUA requests show that the vaccines are effective
at preventing symptomatic COVID-19 in vaccinated individuals.3 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.4
One available legal tool for increasing vaccination rates is for governments to require
vaccination.5 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.6 This power authorizes states, within
constitutional limits, to enact laws “to provide for the public health, safety, and morals” of the
states’ inhabitants.7 In contrast to this general power, the federal government’s powers are
confined to those enumerated in the Constitution.8
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

1 To date, FDA has issued EUAs for three COVID-19 vaccinesat preventing symptomatic COVID-19 in vaccinated individuals.5 Since receiving the EUAs, each COVID-19 vaccine manufacturer, building on the clinical trial safety and effectiveness data previously submitted to FDA in support of their EUA requests, has submitted or is in the process of submitting a biologics license application (BLA) to obtain full approval of the vaccines for specified uses.6 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 (PHSA).7 1 See, e.g., Vaccines Prevented Up to 140,000 COVID-19 Deaths in U.S., NAT’L INST. HEALTH, NIH RESEARCH MATTERS (Aug. 24, 2021), https://www.nih.gov/news-events/nih-research-matters/vaccines-prevented-140000-covid-19-deaths-us; Eric C. Schneider et al., How Many COVID-19 Hospitalizations and Deaths Can Be Averted if States Immediately Accelerate Their Vaccination Efforts?, COMMONWEALTH FUND BLOG (Oct. 5, 2021), https://www.commonwealthfund.org/blog/2021/how-many-covid-19-hospitalizations-deaths-averted-states-accelerate-vaccination. 2 FDA authorized three COVID-19 vaccines under Emergency Use Authorizations between December 2020 and February 2021. . See FDA Takes Key Action in Fight Against COVID-19
by Issuing Emergency Use Authorization for First COVID-19 Vaccine, U.S. FOOD & DRUG ADMIN. (Dec. 11, 2020), , U.S. FOOD & DRUG ADMIN. (Dec. 11, 2020),
https://www.fda.gov/news-events/press-announcements/fda-takes-key-action-fight-against-covid-19-issuing-https://www.fda.gov/news-events/press-announcements/fda-takes-key-action-fight-against-covid-19-issuing-
emergency-use-authorization-first-covid-19; emergency-use-authorization-first-covid-19; FDA Takes Additional Action in Fight Against COVID-19 by Issuing
Emergency Use Authorization for First COVID-19 Vaccine, U.S. FOOD & DRUG ADMIN. (Dec. 18, 2020), , U.S. FOOD & DRUG ADMIN. (Dec. 18, 2020),
https://www.fda.gov/news-events/press-announcements/fda-takes-additional-action-fight-against-covid-19-issuing-https://www.fda.gov/news-events/press-announcements/fda-takes-additional-action-fight-against-covid-19-issuing-
emergency-use-authorization-second-covid; emergency-use-authorization-second-covid; FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine, ,
U.S. FOOD & DRUG ADMIN, (Feb. 27, 2021), https://www.fda.gov/news-events/press-announcements/fda-issues-U.S. FOOD & DRUG ADMIN, (Feb. 27, 2021), https://www.fda.gov/news-events/press-announcements/fda-issues-
emergency-use-authorization-third-covid-19-vaccine [hereinafter, and collectively, FDA EUA Press Releases]. emergency-use-authorization-third-covid-19-vaccine [hereinafter, and collectively, FDA EUA Press Releases].
23 See 21 U.S.C. § 360bbb-3. See also CRS In Focus IF10745, Emergency Use Authorization and FDA’s Related Authorities, by Agata Bodie. 4 FDA EUA Press Releases, FDA EUA Press Releases, supra nonote 12. See also CRS Report R46399, CRS Report R46399, Legal Issues in COVID-19 Vaccine
Development and Deployment, by Kevin J. Hickey, Wen W. Shen, and Erin H. Ward, at 12–14., by Kevin J. Hickey, Wen W. Shen, and Erin H. Ward, at 12–14.
3 5 FDA EUA Press Releases, FDA EUA Press Releases, supra nonote 1. The vaccines authorized to date are at least 672. At the time of the COVID-19 vaccines’ authorization, data supporting their EUA requests showed that the vaccines were between 67%–95% effective at preventing % effective at preventing
symptomatic COVID-19. symptomatic COVID-19. See id. 6 See FDA Approves First COVID-19 Vaccine, U.S. FOOD & DRUG ADMIN. (Aug. 23, 2021), https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine [hereinafter FDA Comirnaty Press Release]; Moderna Completes Submission of Biologics License Application to the U.S. Food and Drug Administration for Its COVID-19 Vaccine, MODERNA (Aug. 25, 2021), https://investors.modernatx.com/news-releases/news-release-details/moderna-completes-submission-biologics-license-application-us; Johnson & Johnson Single-Shot COVID-19 Vaccinations to Resume in the U.S. for All Adults Aged 18 and Older Following CDC and FDA Decision, JOHNSON & JOHNSON (Apr. 23, 2021), https://www.jnj.com/johnson-johnson-single-shot-covid-19-vaccinations-to-resume-in-the-u-s-for-all-adults-aged-18-and-older-following-cdc-and-fda-decision. 7 See FDA Comirnaty Press Release, supra note 6. See also 42 U.S.C. § 262(a)(2)(C). For more information about FDA’s approval of Comirnaty, see CRS Report R46913, FDA Approval of the Pfizer-BioNTech COVID-19 Vaccine: Frequently Asked Questions, by Kevin J. Hickey, Erin H. Ward, and Agata Bodie. Congressional Research Service 1 State and Federal Authority to Mandate COVID-19 Vaccination 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.8 One available legal tool for increasing vaccination rates is for governmental entities to require vaccination.9 During 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 Data relating to the vaccine’s ability to prevent asymptomatic COVID-19—or the
transmission of SAR-CoV-2 (the virus that causes COVID-19)—-CoV-2 (the virus that causes COVID-19)—are not yet available as of the date of this report’s
publication. See id.
4 See, e.g.,spread in the United States.10 For instance, some states imposed COVID-19 vaccination requirements on certain state employees and/or health care workers;11 many state entities, such as public universities, likewise imposed vaccination requirements on their staff and students.12 Several cities issued ordinances or orders that require certain indoor business establishments to verify their patrons’ proof of vaccination before permitting entry.13 The federal government issued several employment- or workforce-based mandates that either directly require certain employees to receive COVID-19 vaccinations or direct certain employers to impose a vaccination or vaccination-and-testing 8 See, e.g., COVID-19: Prevent Getting Sick, CTRS FOR DISEASE CONTROL & PREVENTION (Apr. 27, 2021), https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/index.html; Stacy Wood & Kevin Schulman, Stacy Wood & Kevin Schulman, Beyond Politics—Promoting Covid-19 Vaccination in the United States, ,
NEW ENG. J. MED. (Feb. 18, 2021), https://www.nejm.org/doi/full/10.1056/NEJMms2033790; Mary Van Beusekom, NEW ENG. J. MED. (Feb. 18, 2021), https://www.nejm.org/doi/full/10.1056/NEJMms2033790; Mary Van Beusekom,
Experts Propose Steps to Promote, Distribute COVID Vaccine, CIDRAP NEWS (Dec. 15, 2020), , CIDRAP NEWS (Dec. 15, 2020),
https://www.cidrap.umn.edu/news-perspective/2020/12/experts-propose-steps-promote-distribute-covid-vaccinehttps://www.cidrap.umn.edu/news-perspective/2020/12/experts-propose-steps-promote-distribute-covid-vaccine.
5; Gypsyamber D’Souza & David Dowdy, Rethinking Herd Immunity and the COVID-19 Response End Game, JOHNS HOPKINS (Sept. 13, 2021), https://publichealth.jhu.edu/2021/what-is-herd-immunity-and-how-can-we-achieve-it-with-covid-19. 9 While it is beyond the scope of this report, there are also a range of public policy and other legal tools available (such While it is beyond the scope of this report, there are also a range of public policy and other legal tools available (such
as education, accessibility, and outreach efforts) to increase vaccine uptake short of a mandate. as education, accessibility, and outreach efforts) to increase vaccine uptake short of a mandate. See Kevin G. Volpp et Kevin G. Volpp et
al., al., Behaviorally Informed Strategies for a National COVID-19 Vaccine Promotion Program, JAMA (Dec. 14, 2020), , JAMA (Dec. 14, 2020),
https://jamanetwork.com/journals/jama/fullarticle/2774381; Matt Motta et al., https://jamanetwork.com/journals/jama/fullarticle/2774381; Matt Motta et al., Encouraging COVID-19 Vaccine Uptake
Through Effective Health Communication, FRONTIER IN POL. SCI. (Jan. 28, 2021), https://www.frontiersin.org/articles/, FRONTIER IN POL. SCI. (Jan. 28, 2021), https://www.frontiersin.org/articles/
10.3389/fpos.2021.630133/full. 10.3389/fpos.2021.630133/full. See also Dorit Rubinstein Reiss & Lois A. Weithorn, Dorit Rubinstein Reiss & Lois A. Weithorn, Responding to the Childhood
Vaccination Crisis: Legal Frameworks and Tools in the Context of Parental Vaccine Refusal, 63 BUFF. L. REV. 881, , 63 BUFF. L. REV. 881,
958–79 (2015) (describing a continuum of legal tools to increase vaccination rates). 958–79 (2015) (describing a continuum of legal tools to increase vaccination rates).
6 See Elizabeth Y. McCuskey, Body of Preemption: Health Law Traditions and the Presumption Against Preemption,
89 TEMPLE L. REV. 95, 113–20 (2016).
7 Barnes v. Glen Theatre, Inc., 501 U.S. 560, 569 (1991).
8 See CRS Report R45323, Federalism-Based Limitations on Congressional Power: An Overview, coordinated by
Andrew Nolan and Kevin M. Lewis, at 1.
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10 Delta Variant: What We Know About the Science, CTRS. FOR DISEASE CONTROL & PREVENTION (Aug. 26, 2021), https://www.cdc.gov/coronavirus/2019-ncov/variants/delta-variant.html. As of December 20, 2021, a new variant of SARS-CoV-2 first detected in the United States in late November 2021—the Omicron variant—has overtaken Delta to become the dominant strain for new COVID-19 infections in the United States. See COVID Data Tracker, CTRS. FOR DISEASE CONTROL & PREVENTION, https://covid.cdc.gov/covid-data-tracker/#variant-proportions (last accessed Dec. 21, 2021). 11 See, e.g., N.M. DEP’T OF HEALTH, AMENDED PUBLIC HEALTH EMERGENCY ORDER REQUIRING ALL SCHOOL WORKERS COMPLY WITH CERTAIN HEALTH REQUIREMENTS AND REQUIRING CONGREGATE CARE FACILITY WORKERS, HOSPITAL WORKERS, AND EMPLOYEES OF THE OFFICE OF THE GOVERNOR BE FULLY VACCINATED (Sept. 15, 2021), https://www.nmhealth.org/publication/view/rules/6875/; OFF. OF THE GOVERNOR, COMMONWEALTH OF MASS., IMPLEMENTING A REQUIREMENT FOR COVID-19 VACCINATION FOR THE COMMONWEALTH’S EXECUTIVE DEPARTMENT EMPLOYEES (Aug. 19, 2021), https://www.mass.gov/doc/august-19-2021-executive-department-employee-vaccination-order/download; Code Me. R. tit. 10-144, ch. 264, § 2 (2021) (emergency regulation issued by Maine’s Department of Health and Human Services adding COVID-19 vaccination to the list of required vaccinations for most health care workers); 10 N.Y.C.R.R. § 2.61 (emergency regulation issued by the New York Department of Health requiring COVID-19 vaccination for certain health care workers). 12 See Elissa Nadworny, Full FDA Approval Triggers More Universities to Require the COVID-19 Vaccine, NPR (Sept. 1, 2021), https://www.npr.org/2021/09/01/1031385629/full-fda-approval-triggers-more-universities-to-require-the-covid-19-vaccine. 13 See, e.g., 10 L.A. Municipal Code § 200.122 (2021), https://clkrep.lacity.org/onlinedocs/2021/21-0878_ord_187219_11-08-21.pdf; CITY OF N.Y., EMERGENCY EXECUTIVE ORDER NO. 228, § 4 (Aug. 25, 2021), https://www1.nyc.gov/assets/home/downloads/pdf/executive-orders/2021/eeo-228.pdf. Congressional Research Service 2 link to page 16 link to page 11 link to page 16 link to page 16 link to page 7 link to page 11 link to page 16 link to page 32 State and Federal Authority to Mandate COVID-19 Vaccination requirement on their employees or staff.14 With the exception of a few state health care worker vaccination requirements that provide only for medical exemptions, the governmental vaccination mandates issued to date generally provide exceptions from the vaccination requirements based on a disability, medical condition, or sincerely held religious belief.15 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.16 This power authorizes states, within constitutional limits, to enact laws “to provide for the public health, safety, and morals” of the states’ inhabitants.17 In contrast to this general power, the federal government’s powers are confined to those enumerated in the Constitution.18 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 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 local authority to mandate vaccination as an exercise of their police power, as well asand modern modern
courts’ analyses of more recent challenges to state vaccination mandates based on the First courts’ analyses of more recent challenges to state vaccination mandates based on the First
Amendment’s Free Exercise Clause. Amendment’s Free Exercise Clause. The first part of the report closes withIt then analyzes the Supreme Court’s evolving Free Exercise Clause jurisprudence and the questions it raises regarding whether and when governments must provide for or grant religious exemptions to vaccination requirements.19 It then takes a look at a look at how courts have addressed challenges to COVID-19-vaccination requirements imposed by state and state entities to date.20 The second part of the report provides an overview of federal authority to mandate vaccination. It begins by discussing 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 analyzes the litigation challenging these mandates,21 before reviewinghow 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 the extent of Congress’s constitutional authority under the
Constitution’s Spending and Commerce Clauses to potentially mandate vaccination.Spending and Commerce Clauses to potentially mandate vaccination.
State and Local Authority to Mandate Vaccination
The22 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 looks at how courts have 14 See infra “Executive Branch Authority to Mandate Vaccination.” 15 See infra “State COVID-19 Vaccination Mandates and Related Litigation” and “Executive Branch Authority to Mandate Vaccination.” In addition to governmental entities, private entities—especially private employers—have also opted to institute vaccination requirements in response to the pandemic. For more information about legal constraints on vaccination requirements imposed by private employers, see CRS Legal Sidebar LSB10573, COVID-19 Vaccination Requirements: Potential Constraints on Employer Mandates Under Federal Law, by April J. Anderson and Victoria L. Killion. 16 See Elizabeth Y. McCuskey, Body of Preemption: Health Law Traditions and the Presumption Against Preemption, 89 TEMPLE L. REV. 95, 113–20 (2016). 17 Barnes v. Glen Theatre, Inc., 501 U.S. 560, 569 (1991). 18 See CRS Report R45323, Federalism-Based Limitations on Congressional Power: An Overview, coordinated by Andrew Nolan and Kevin M. Lewis, at 1. 19 See infra “Legal Background.” 20 See infra “State COVID-19 Vaccination Mandates and Related Litigation.” 21 See infra “Executive Branch Authority to Mandate Vaccination.” 22 See infra “Congress’s Constitutional Authority to Mandate Vaccination.” Congressional Research Service 3 link to page 35 link to page 5 State and Federal Authority to Mandate COVID-19 Vaccination addressed some litigants’ argument that the EUA status of COVID-19 vaccines precludes entities from mandating COVID-19 vaccination.23 State and Local Authority to Mandate Vaccination Legal Background State and local vaccination requirements—as government actions—are subject to constitutional constraints, including those that protect individual rights.24 For instance, the government is prohibited by the Bill of Rights from infringing the free exercise of religion or violating due process of law.25 For more than a century, however, the Supreme Court has recognized few rights-based constraints on states’ ability to mandate vaccination, holding instead that the states’ general police power to promote public health and safety encompasses authority to states’ general police power to promote public health and safety encompasses authority to
mandate vaccination.mandate vaccination.9 26 In the early part of the 20th In the early part of the 20th Centurycentury, the Supreme Court twice considered , the Supreme Court twice considered
constitutional challenges to state vaccination mandates.constitutional challenges to state vaccination mandates.1027 Each time, the Court rejected the Each time, the Court rejected the
challengeschallenges to the mandates and recognized such laws as falling squarely within the states’ police power. and recognized such laws as falling squarely within the states’ police power.1128 In 1905, In 1905,
the Supreme Court in the Supreme Court in Jacobson v. Massachusetts upheld a state law that gave municipal boards of upheld a state law that gave municipal boards of
health health the authority to require the vaccination of persons over the age of 21 against smallpox, authority to require the vaccination of persons over the age of 21 against smallpox,
determining the vaccination program had a “real [and] substantial relation to the protection of the determining the vaccination program had a “real [and] substantial relation to the protection of the
public health and safety.”public health and safety.”1229 In doing so, the Court rejected an argument that such a program In doing so, the Court rejected an argument that such a program
violated a liberty interest that, under more modern jurisprudence, the plaintiff might have asserted violated a liberty interest that, under more modern jurisprudence, the plaintiff might have asserted
as a substantive due process right.as a substantive due process right.1330
Less than two decades later, in Less than two decades later, in Zucht v. King, parents of a child who was excluded from school , parents of a child who was excluded from school
due to her unvaccinated status challenged the local ordinance requiring vaccination for due to her unvaccinated status challenged the local ordinance requiring vaccination for
schoolchildren, arguing that the ordinance violated the Fourteenth Amendment’s Equal Protection schoolchildren, arguing that the ordinance violated the Fourteenth Amendment’s Equal Protection
and Due Process Clauses.and Due Process Clauses.1431 Relying on Relying on Jacobson, the Supreme Court rejected the constitutional , the Supreme Court rejected the constitutional
challenges, concludingchallenges, concluding that “it is within the police power of a State to provide for compulsory “it is within the police power of a State to provide for compulsory
vaccination” and that the ordinance vaccination” and that the ordinance did not bestow “arbitrary power, but bestowed “only that broad only that broad
discretion required for the protection of the public health.”discretion required for the protection of the public health.”1532
Based on the Supreme Court’s recognition of this authority, states and localities have enacted Based on the Supreme Court’s recognition of this authority, states and localities have enacted
vaccination mandates for certain populations and circumstances. All vaccination mandates for certain populations and circumstances. All fifty50 states and the District of states and the District of
Columbia, for instance, currently have laws requiring Columbia, for instance, currently have laws requiring students to receive specified vaccines as a
condition of school entry.16 With respect to adults, states—to the extent they have mandated
vaccination—have limited the mandates to health care workers, who are required to be vaccinated

9all students enrolled in both public and 23 See infra “Emergency Use Authorization and Vaccination Mandates.” 24 See U.S. CONST. art. XIV, cl. 1, § 1; Edmonson v. Leesville Concrete Co., 500 U.S. 614, 619 (1991) (“The Constitution’s protections of individual liberty and equal protection apply in general only to action by the government.”). 25 See U.S. CONST. amends. I & XIV. 26 See Jacobson v. Massachusetts, 197 U.S. 11, 39 (1905). Jacobson v. Massachusetts, 197 U.S. 11, 39 (1905).
1027 Id.; Zucht v. King, 260 U.S. 174 (1922). ; Zucht v. King, 260 U.S. 174 (1922).
1128 Jacobson, 197 U.S. at 39; , 197 U.S. at 39; Zucht, 260 U.S. at 175–77. , 260 U.S. at 175–77.
1229 Jacobson, 197 U.S. at 31. , 197 U.S. at 31.
1330 See Reiss & Weithorn, Reiss & Weithorn, supra notnote 59, at 897–98. 31 Zucht, 260 U.S. at 175–77. 32 Id. at 176–77. Congressional Research Service 4 link to page 8 link to page 8 link to page 8 link to page 8 link to page 5 State and Federal Authority to Mandate COVID-19 Vaccination private schools to receive specified vaccines as a condition of school entry.33 With respect to adults, states—to the extent they have mandated vaccination—have typically limited the mandates to health care workers, who are required to be vaccinated , at 897–98. Since Jacobson, for instance, the Supreme Court has recognized that
“a competent person has a constitutionally protected liberty interest in refusing unwanted medical treatment” under the
Fourteenth Amendment. Cruzan v. Dir., Mo. Dep’t of Health, 497 U.S. 261, 278 (1990).
14 Zucht, 260 U.S. at 175–77.
15 Id. at 176–77.
16 States with Religious and Philosophical Exemptions From School Immunization Requirements, NAT’L CONF. OF
STATE LEGISLATURES (NCSL) (June 26, 2020), https://www.ncsl.org/research/health/school-immunization-exemption-
state-laws.aspx.
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against certain vaccine-preventable diseases as a condition of their employment.against certain vaccine-preventable diseases as a condition of their employment.1734 These These
vaccination requirements are generally subject to certain exemptions, which vary from state to vaccination requirements are generally subject to certain exemptions, which vary from state to
state.state.1835 While most vaccination mandates generally provide for some degree of medical While most vaccination mandates generally provide for some degree of medical
exemption (e.g., if one is allergic to vaccines or is immunocompromised), some exemption (i.e., when individuals have a contraindication to a vaccine that makes receipt of the vaccine harmful or unsafe),36 many mandates also mandates also
include include religious exemptions for those whose exemptions for those whose religious beliefs counsel against immunization.beliefs counsel against immunization.1937 In the case In the case
of student vaccination mandates, several states also provide a broader philosophical exemption of student vaccination mandates, several states also provide a broader philosophical exemption
for those who object to immunizations because of personal, moral, or other beliefs.for those who object to immunizations because of personal, moral, or other beliefs.20
State38 These state and local vaccination mandates and local vaccination mandates—including ones that do not provide a religious
exemption— have withstood more recent legal challenges.have withstood more recent legal challenges.2139 While the Supreme Court’s While the Supreme Court’s
constitutional jurisprudence has evolved substantially since constitutional jurisprudence has evolved substantially since Jacobson and and Zucht,,2240 modern courts modern courts
have continued to rely on these cases to reject due process and equal protection claims against have continued to rely on these cases to reject due process and equal protection claims against
vaccination mandates, giving considerable deference to the states’ use of their police power to vaccination mandates, giving considerable deference to the states’ use of their police power to
require immunizations to protect public health.23 In cases that also challenge a mandate’s lack of
religious exemption, plaintiffs have typically asserted a claim under the First Amendment’s Free
Exercise Clause.24 Courts have generally rejected this claim—which was not available to the
plaintiffs in Jacobson or Zucht because the Supreme Court had not yet held that the First
Amendment applied to the states25—and concluded that a state is not constitutionally required to
provide a religious exemption.26 The courts reasoned that under Employment Division,

17require immunizations to protect public health.41 33 States with Religious and Philosophical Exemptions From School Immunization Requirements, NAT’L CONF. OF STATE LEGISLATURES (NCSL) (Nov. 22, 2021), https://www.ncsl.org/research/health/school-immunization-exemption-state-laws.aspx. 34 See Brian Dean Abramson, Brian Dean Abramson, Vaccine Law in the Health Care Workplace, 12 J. HEALTH & LIFE SCI. L. 22, 24–27 , 12 J. HEALTH & LIFE SCI. L. 22, 24–27
(2019) (describing different approaches states have taken to impose vaccination requirements on health care workers: (2019) (describing different approaches states have taken to impose vaccination requirements on health care workers:
some states require health care workers to receive annual flu vaccines; several others require hospitals or other health some states require health care workers to receive annual flu vaccines; several others require hospitals or other health
care facilities to ensure their employees have been vaccinated against certain vaccine-preventable diseases, including care facilities to ensure their employees have been vaccinated against certain vaccine-preventable diseases, including
hepatitis B, rubella, and mumps; and still others require hospital employees to provide proof of immunization against hepatitis B, rubella, and mumps; and still others require hospital employees to provide proof of immunization against
certain vaccine-preventable diseases). certain vaccine-preventable diseases).
1835 See id. at 28–31 (describing scope of medical and religious exemptions for vaccination mandates for health care at 28–31 (describing scope of medical and religious exemptions for vaccination mandates for health care
workers); NCSL, workers); NCSL, supra no note 1633 (describing exemptions for student vaccination mandates). (describing exemptions for student vaccination mandates).
19 Abramson, supra note 17, at 28–31; NCSL, supra note 16.
20 NCSL, supra note 16.
2136 See, e.g., N.Y. Pub. Health Law § 2164(8) (providing a medical exemption from school vaccination requirements if a licensed physician “certifies that such immunization may be detrimental to a child’s health”). 37 Abramson, supra note 34, at 28–31; NCSL, supra note 33. 38 NCSL, supra note 33. 39 See, e.g., Phillips v. City of New York, 775 F.3d 538, 542–44 (2d Cir. 2015); Workman v. Mingo Cty. Bd. of Edu. , Phillips v. City of New York, 775 F.3d 538, 542–44 (2d Cir. 2015); Workman v. Mingo Cty. Bd. of Edu.
419 F. App’x 348 (4th Cir. 2011); Whitlow v. California, 203 F. Supp. 3d 1079, 1085–89 (S.D. Cal. 2016); Boone v. 419 F. App’x 348 (4th Cir. 2011); Whitlow v. California, 203 F. Supp. 3d 1079, 1085–89 (S.D. Cal. 2016); Boone v.
Boozman, 217 F. Supp. 2d 938, 952–57 (E.D. Ark. 2002). Boozman, 217 F. Supp. 2d 938, 952–57 (E.D. Ark. 2002). ChallengesPrior to the COVID-19 pandemic, challenges against state vaccination mandates have against state vaccination mandates have
primarily occurred in the context of student vaccination requirements. However, in 2009, following the emergence of a primarily occurred in the context of student vaccination requirements. However, in 2009, following the emergence of a
new strain of type A influenza (H1N1), New York State issued a regulation that made vaccination against seasonal and new strain of type A influenza (H1N1), New York State issued a regulation that made vaccination against seasonal and
H1N1 influenza a condition of employment for health care workers who have direct contact with patientsH1N1 influenza a condition of employment for health care workers who have direct contact with patients, or who may or who may
expose patients to disease. This directive drew several legal challenges from local health care workersexpose patients to disease. This directive drew several legal challenges from local health care workers, who argued that who argued that
the regulation violated the Fourteenth Amendment’s Due Process Clause, the First Amendment’s Free Exercise Clause, the regulation violated the Fourteenth Amendment’s Due Process Clause, the First Amendment’s Free Exercise Clause,
and the right to “freedom of contract” guaranteed by the Fifth and Fourteenth Amendments. and the right to “freedom of contract” guaranteed by the Fifth and Fourteenth Amendments. See Alexander M. Stewart, Alexander M. Stewart,
Mandatory Vaccination of Health Care Workers, NEW ENG. J. OF MED. (Nov. 19, 2009), https://www.nejm.org/doi/full/, NEW ENG. J. OF MED. (Nov. 19, 2009), https://www.nejm.org/doi/full/
10.1056/nejmp0910151. The litigation, however, was mooted in its early stages after the governor suspended the 10.1056/nejmp0910151. The litigation, however, was mooted in its early stages after the governor suspended the
regulation due to a vaccine shortage. regulation due to a vaccine shortage. See Joe Nocera, Joe Nocera, When New York Mandated Vaccinations, Nurses Sued, ,
BLOOMBERG BUSINESSWEEK (Mar. 23, 2020), https://www.bloomberg.com/news/articles/2020-03-23/can-states-BLOOMBERG BUSINESSWEEK (Mar. 23, 2020), https://www.bloomberg.com/news/articles/2020-03-23/can-states-
mandate-vaccinations-for-health-care-workers. mandate-vaccinations-for-health-care-workers.
2240 Commentators have observed, for instance, that the Supreme Court decided Commentators have observed, for instance, that the Supreme Court decided Jacobson and and Zucht before the advent of before the advent of
tiered scrutiny, which tiered scrutiny, which subjectsmay subject regulations that infringe upon certain fundamental liberty interests to heightened regulations that infringe upon certain fundamental liberty interests to heightened
scrutiny. Reiss & Weithorn, scrutiny. Reiss & Weithorn, supra no note 59, at 896–97. A regulation survives at 896–97. A regulation survives this heightenedthe most heightened level of scrutiny only if it is scrutiny only if it is
narrowly tailored to serve a compelling government interest. narrowly tailored to serve a compelling government interest. See Reno v. Flores, 507 U.S. 292, 301–02 (1993). Reno v. Flores, 507 U.S. 292, 301–02 (1993).
2341 See, e.g., , Phillips, 775 F.3d at 543; , 775 F.3d at 543; Workman, 419 F. App’x at 352–54; , 419 F. App’x at 352–54; Whitlow, 203 F. Supp. 3d at 1085–87. , 203 F. Supp. 3d at 1085–87.
24 See, e.g., Phillips, 775 F.3d at 543; Workman, 419 F. App’x at 352–54; Whitlow, 203 F. Supp. 3d at 1085–87; Boone,
217 F. Supp. 2d at 952–55.
25 See Phillips, 775 F.3d at 543.
26 See, e.g., id. at 543; Workman, 419 F. App’x at 352–54; Whitlow, 203 F. Supp. 3d at 1085–87; Boone, 217 F. Supp.
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Department of Human Resources of Oregon v. Smith and its progeny, a vaccination mandate is a
neutral, generally applicable law (i.e., one that does not target specific religious groups) that is
not subject to heightened scrutiny.27 Under the lenient rational basis review, Congressional Research Service 5 link to page 8 link to page 17 State and Federal Authority to Mandate COVID-19 Vaccination Prior to the COVID-19 pandemic, courts have also generally upheld state vaccination requirements that do not provide for a religious exemption. While most states’ school vaccination requirements provide for religious exemptions, several states—some in response to concerns over outbreaks of vaccine-preventable diseases and/or declining vaccination rates—have eliminated those exemptions to permit only medical exemptions.42 In the modern era, these mandates without religious exemptions have been subject to several legal challenges, in which plaintiffs have argued the applicable mandate violated their rights under the First Amendment’s Free Exercise Clause.43 Courts generally rejected these claims and concluded that a state is not constitutionally required to provide for a religious exemption.44 The courts reasoned that, under Employment Division v. Smith and its progeny, the vaccination mandates at issue were neutral, generally applicable laws—i.e., laws that do not single out religion or selectively burden religiously motivated conduct.45 As such, the vaccination mandates, in these courts’ view, were not subject to heightened scrutiny under Smith.46 Applying rational-basis review, a lenient standard under which courts generally uphold laws that reasonably further legitimate government interests, courts have held that courts have held that
“the right to free exercise of religion . . . [is] subordinated to society’s interest in protecting “the right to free exercise of religion . . . [is] subordinated to society’s interest in protecting
against the spread of disease.”against the spread of disease.”28
The vaccines that are currently subject to governmental mandates were licensed under a
biological license application (BLA), the standard regulatory framework under which vaccines
are typically introduced into interstate commerce.29 By contrast, FDA has not yet licensed the
COVID-19 vaccines under BLAs. Instead (as discussed in detail in other CRS products), the
COVID-19 vaccines are authorized for emergency use under the FD&C Act’s EUA provision,
which allows the HHS Secretary to permit patient access to an unlicensed vaccine for emergency
use under specified conditions.30
Some commentators have argued that Section 564(e)(1) of the EUA provision precludes states
and private employers from mandating the COVID-19 vaccines.31 Section 564(e)(1) directs the
HHS Secretary, when issuing an EUA for a medical product, to impose such necessary conditions
to protect the public health, including appropriate conditions designed to inform individuals “of
the option to accept or refuse administration of the product, of the consequences, if any, of
refusing administration of the product, and of the alternatives to the product that are available and
of their benefits and risks.”32 Because each individual must be provided with “the option to accept
or refuse,” some commentators assert that this provision “suggests that mandates are categorically
prohibited.”33
While no court has interpreted this provision, making it difficult to predict how one might
consider this argument, Section 564(e)(1) might not address the permissibility of a vaccination
mandate. As these commentators acknowledge, the provision essentially directs the HHS
Secretary to require health care professionals administering an EUA product to provide informed

2d at 952–55.
2747 In 2021, however, the Supreme Court issued two decisions that potentially weaken these precedents involving free exercise challenges to vaccination mandates. In Tandon v. Newsom, the Court ruled that a law is not neutral and generally applicable if it treats “any comparable secular activity more favorably than religious exercise.”48 “[W]hether two activities are comparable for purposes of the Free Exercise Clause,” the Court explained, depends on “the asserted government 42 See James Colgrove & Abigail Lowin, A Tale of Two States: Mississippi, West Virginia, And Exemptions to Compulsory School Vaccination Laws, HEALTH AFFS. (Feb. 2016), https://www.healthaffairs.org/doi/10.1377/hlthaff.2015.1172. From 1979 to 2016, Mississippi and West Virginia were the only two states that did not offer nonmedical exemptions. Since 2016, four additional states—California, New York, Maine, and Connecticut—have eliminated nonmedical exemptions. See NCSL, supra note 33. 43 See, e.g., Phillips, 775 F.3d at 543; Workman, 419 F. App’x at 352–54; Whitlow, 203 F. Supp. 3d at 1085–87; Boone, 217 F. Supp. 2d at 952–55. 44 See, e.g., Phillips, 775 F.3d at 543; Workman, 419 F. App’x at 352–54; Whitlow, 203 F. Supp. 3d at 1085–87; Boone, 217 F. Supp. 2d at 952–55. The alleged violation of the Free Exercise Clause was not a claim available to the plaintiffs in Jacobson or Zucht because at that time, the Supreme Court had not yet held that the First Amendment applied to the states. See Phillips, 775 F.3d at 543. 45 See, e.g., , Phillips, 775 F.3d at 543; , 775 F.3d at 543; Workman, 419 F. App’x at 352–54; , 419 F. App’x at 352–54; Whitlow, 203 F. Supp. 3d at 1085–87; , 203 F. Supp. 3d at 1085–87; Boone, ,
217 F. Supp. 2d at 952–55.217 F. Supp. 2d at 952–55. The Supreme Court heard oral arguments on November 4, 2020 in Fulton v. City of
Philadelphia, a case in which the petitioners have asked the Court to, among other things, revisit Smith. See Pet. for a
Writ of Cert. 31, Fulton v. City of Philadelphia, No. 19-123 (2020).
28 46 See, e.g., Phillips, 775 F.3d at 543; Workman, 419 F. App’x at 352–54; Whitlow, 203 F. Supp. 3d at 1085–87; Boone, 217 F. Supp. 2d at 952–55. 47 Boone, 217 F. Supp. 2d at 954; , 217 F. Supp. 2d at 954; see also Phillips, 775 F.3d at 543; , 775 F.3d at 543; Workman, 419 F. App’x at 352–54; , 419 F. App’x at 352–54; Whitlow, 203 , 203
F. Supp. 3d at 1085–87. In cases where a vaccination mandate includes a religious exemption, plaintiffs have also filed F. Supp. 3d at 1085–87. In cases where a vaccination mandate includes a religious exemption, plaintiffs have also filed
suit to challenge their unsuccessful invocation of the exemption. In these cases, courts, applying the relevant state law, suit to challenge their unsuccessful invocation of the exemption. In these cases, courts, applying the relevant state law,
typically considered whether the plaintiffs’ objections to vaccination are based on a typically considered whether the plaintiffs’ objections to vaccination are based on a sinceresincerely held religious belief. religious belief. See, e.g., ,
N.M. v. Hebrew Acad. Long Beach, 155 F. Supp. 3d 247, 257–58 (E.D.N.Y. 2016) (finding that plaintiff failed to N.M. v. Hebrew Acad. Long Beach, 155 F. Supp. 3d 247, 257–58 (E.D.N.Y. 2016) (finding that plaintiff failed to
establish her objections to vaccination were religious in nature); establish her objections to vaccination were religious in nature); In re Christine M., 157 Misc. 2d 4, 21 (N.Y. 1992) Christine M., 157 Misc. 2d 4, 21 (N.Y. 1992)
(finding that plaintiff’s objections to vaccination were based on plaintiff’s personal and medical, rather than religious, (finding that plaintiff’s objections to vaccination were based on plaintiff’s personal and medical, rather than religious,
beliefs); Lewis v. Sobol, 710 F. Supp. 506, 516 (S.D.N.Y. 1989) (finding that plaintiffs’ objections to vaccination beliefs); Lewis v. Sobol, 710 F. Supp. 506, 516 (S.D.N.Y. 1989) (finding that plaintiffs’ objections to vaccination
stemmed from their religious beliefs, which entailed “views of spiritual perfection” that they apply in their dietary and stemmed from their religious beliefs, which entailed “views of spiritual perfection” that they apply in their dietary and
medical practices). medical practices).
29 See, e.g., CRS Report R46593, Vaccine Safety in the United States: Overview and Considerations for COVID-19
Vaccines, by Kavya Sekar and Agata Bodie, at 15, 34–35.
30 See id.; see also Hickey et al., supra note 2, at 12–14.
31 See Efthimios Parasidis & Aaron S. Kesselheim, Assessing the Legality of Mandates for Vaccines Authorized Via an
Emergency Use Authorization, HEALTH AFFAIRS (Feb. 16, 2021), https://www.healthaffairs.org/do/10.1377/
hblog20210212.410237/full/.
32 21 U.S.C. § 360bbb-3(e)(1)(A)(ii)(III).
33 Parasidis & Kesselheim, supra note 31.
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consent as part of the medical procedure, and to provide an “option to refuse” in that context.34 As
discussed above, existing vaccination mandates—as they are typically structured—generally do
not interfere with the medical informed consent process and an individual’s right to refuse in that
context.35 Rather, they impose secondary consequences—often in the form of exclusion from
certain desirable activities, such as schools or employment—in the event of refusal.36 Put another
way, mandates generally do not require involuntary vaccination, but instead impose consequences
on individuals who refuse to get vaccinated.37 Thus, to the extent a state vaccination mandate for
an EUA-authorized vaccine is so structured, Section 564(e)(1) may not address the mandate’s
permissibility.38
If a state mandates COVID-19 vaccination in a neutral, generally applicable manner while the
vaccines are still authorized under an EUA,39 courts are likely to factor the vaccines’ EUA status
into their rational-basis review.40 In particular, courts will likely consider whether requiring
vaccines subject to an EUA—including the specific steps taken by FDA in issuing the EUA41—
under the specified conditions of the mandate is reasonably related to a legitimate government
interest given the nature of the pandemic.42
Federal Authority to Mandate Vaccination
Executive Branch Authority to Mandate Vaccination
Except in certain limited circumstances, including in the immigration43 and military44 contexts, no
existing federal law expressly imposes vaccination requirements on the general population.

34 See id.
35 See supra notes 16–17 and accompanying text.
36 See id.
37 Cf. Zucht v. King, 260 U.S. 174, 175–77 (1922).
38 Section 564(e)(1) may more directly limit mandates that require involuntary vaccination without consent. Cf. Doe v.
Rumsfeld, 341 F. Supp. 2d 1 (D.D.C. 2004) (enjoining Department of Defense’s anthrax vaccination program under 10
U.S.C. § 1107—which permits the Secretary of Defense to require service members to receive an investigatory new
drug or drug unapproved for its intended use without their informed consent only upon a waiver from the President—
after concluding that FDA improperly licensed the vaccine for inhalation anthrax and no presidential waiver had been
sought).
39 FDA’s guidance states that sponsors of the EUA-authorized vaccines are expected to continue to collect data to
support eventual submission of a BLA to obtain full licensure. U.S. FOOD & DRUG ADMIN., EMERGENCY USE
AUTHORIZATION FOR VACCINES TO PREVENT COVID-19: GUIDANCE FOR INDUSTRY 11 (Feb. 2021),
https://www.fda.gov/media/142749/download.
40 See, e.g., Whitlow v. California, 203 F. Supp. 3d 1079, 1086 n.4 (S.D. Cal. 2016).
41 Sekar & Bodie, supra note 29, at 34 (noting that FDA officials have stated that the amount of safety and
effectiveness data needed to support EUA-authorized vaccines is similar to the data that is appropriate for a BLA).
42 See Roman Catholic Diocese of Brooklyn v. Cuomo, 141 S. Ct. 63 (2020) (Gorsuch, J., concurring) (stating that the
Court in Jacobson “essentially applied rational basis review” to the vaccination mandate in question, determining that
the law was “reasonable” in light of an ongoing smallpox pandemic).
43 Under 8 U.S.C. § 1182(a)(1)(A), for instance, immigrants seeking permanent residence in the United States must
present documentation showing they have been vaccinated against certain specified vaccine-preventable diseases.
44 The Department of Defense’s Immunization Program, for instance, requires all health care personnel working in the
Department’s medical treatment facilities, as well as all active duty and selected reserve personnel, to receive annual
seasonal influenza vaccines or to obtain a medical or administrative exemption. DEP’T OF DEFENSE INSTRUCTION
6205.02 § 1.2b (July 23, 2019), https://www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodi/620502p.pdf?ver=
2019-07-23-085404-617.
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State and Federal Authority to Mandate COVID-19 Vaccination

Certain existing authorities, however, could potentially form the basis of executive action in the
context of the COVID-19 pandemic. One such law could be Section 361 of the PHSA.45
Subsection (a) of this provision, which one court has characterized as “broad [and] flexible,”46
grants the Secretary of HHS the authority—delegated in part to the Centers for Disease Control
and Prevention (CDC)47—to make and enforce regulations necessary “to prevent the introduction,
transmission, or spread of communicable diseases from foreign countries into the States or
possessions, or from one State or possession into any other State or possession.”48 A broad
construction of this authority may permit CDC to issue regulations requiring vaccination in
circumstances that would prevent the foreign or interstate transmission of COVID-19.49 The
Constitution and other generally applicable statutory requirements, such as the Administrative
Procedure Act50 and the Religious Freedom Restoration Act of 1993 (RFRA),51 would
nevertheless constrain CDC’s exercise of this authority. RFRA, for example, requires courts to
recognize certain religious exemptions from a generally applicable rule that imposes a substantial
burden on a regulated person’s religious exercise.52
On the other hand, Section 361’s statutory text and context may be ambiguous as to the scope of
CDC’s subsection (a) authority to issue “necessary” regulations, possibly suggesting a narrower
construction. Following the broad statement of authority identified above, Section 361(a)
provides: “For purposes of carrying and enforcing such regulations,” the Agency “may provide
for such inspection, fumigation, disinfection, sanitation, pest extermination, destruction of
animals or articles found to be so infected or contaminated as to be sources of dangerous infection
to human beings, and other measures, as in [its] judgment may be necessary.”53 The remaining
subsections of Section 361 primarily set forth CDC’s foreign and interstate quarantine and
isolation authority, including the authority to apprehend, examine, and detain any individual
reasonably believed to be infected with certain communicable diseases.54 The text of these
subsections frame this quarantine authority as another example of possible regulations issued
under “this section,”55 while imposing certain additional safeguards to which these regulations are
subject, such as limiting the exercise of this authority to certain specified communicable
diseases.56

45 42 U.S.C. § 264.
46 Louisiana v. Matthews, 427 F. Supp. 174, 176 (E.D. La. 1977).
47 See Legal Authorities for Isolation and Quarantine, CTRS. FOR DISEASE CONTROL & PREVENTION (Feb. 24, 2020),
https://www.cdc.gov/quarantine/aboutlawsregulationsquarantineisolation.html.
48 42 U.S.C. § 264(a).
49 See Christopher T. Robertson, Vaccines and Airline Travel: A Federal Role to Protect the Public Health, 42 AM. J.L.
& MED. 543, 566 (2016) (suggesting CDC has authority under Section 361 “to require vaccinations as a condition of
airline travel”); cf. CRS Legal Sidebar LSB10572, Mask Mandate: Does the Federal Aviation Administration Have
Authority to Require Masks on Flights?, by Bryan L. Adkins.
50 See, e.g., CRS Legal Sidebar LSB10523, Administrative Law Reform Legislation in the 116th Congress, by Daniel J.
Sheffner.
51 See, e.g., CRS In Focus IF11490, The Religious Freedom Restoration Act: A Primer, by Whitney K. Novak.
52 42 U.S.C. § 2000bb-1.
53 Id. § 264(a).
54 Id. § 264(b)–(d).
55 Id.
56 See id. § 264(b) (limiting the use of foreign and interstate quarantine and isolation authority only to prevent the
spread of communicable diseases designated by an executive order); § 264(d) (limiting the application of interstate
quarantine and isolation authority only to individuals “reasonably believed to be infected with a communicable disease
in a qualifying stage”).
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In the context of Section 361’s focus on quarantine authority and its parameters, the enumerated
list under subsection (a) could potentially be understood as a list of measures that facilitate or
supplement quarantine efforts.57 These considerations could suggest a narrower reading of
Section 361(a) that limits the authority to issue “necessary” regulations to measures related to
quarantine or other similar public health measures. The larger context of the related PHSA
provisions may also highlight the ambiguity in Section 361’s scope.58
To the extent Section 361’s text is ambiguous as to the scope of delegated authority, certain
canons of construction may apply to support a narrower construction.59 On several occasions
when assessing an agency’s statutory authority, for instance, the Supreme Court has cautioned
that courts must “be guided to a degree by common sense as to the manner in which Congress is
likely to delegate a policy decision of [significant] economic and political magnitude to an
administrative agency.”60 Thus, to the extent a federal vaccination mandate involves significant
economic and political considerations, there may be an interpretative question as to whether
Congress intended to empower the CDC with such authority through Section 361(a).61
In addition, a practical consideration in the federal government’s use of Section 361 authority is
the applicable enforcement scheme. Under Section 368 of the PHSA, violators of regulations
issued under Section 361 are subject to statutory penalties of up to one year in jail or a fine of
$1,000, or both.62 Generally applicable criminal statutes on sentencing, however, authorize higher

57 See id. §§ 264–272 (codified under the subheading “Part G – Quarantine and Inspection”); id. § 268(b) (directing
U.S. Customs officers and Coast Guard officers to aid only “in the enforcement of quarantine rules and regulations”).
But see id. § 264 (codified under the section heading “control of communicable disease” and not limited to quarantine
and related measures).
58 See Hearing before a Subcomm. on Interstate and Foreign Commerce on H.R. 3379: A Bill to Codify the Laws
Relating to the Public Health Service, and for Other Purposes, 78th Cong. 64 (1944) (noting that the second sentence of
Section 361(a) “would expressly authorize the Public Health Service to make inspections and take other steps necessary
in the enforcement of quarantine”). But see id. at 140 (also noting that the Section 361 provisions were “written in
broader terms in order to make it possible to cope with emergency situations which we cannot now foresee”).
59 See United States v. Turkette, 452 U.S. 576, 581 (1981) (explaining that canons of statutory construction “come[ ]
into play only when there is some uncertainty as to the meaning of a particular clause in a statute”).
60 FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 133 (2000). More recently, Justice Neil Gorsuch has
characterized this doctrine as a canon of statutory construction that presumes Congress, absent express and specific
delegation, does not intend to grant agencies the power to fill in statutory gaps concerning “a question of deep
economic and political significance that is central to [a] statutory scheme.” Gundy v. United States, 139 S. Ct. 2116,
2141–42 (2019) (Gorsuch, J., dissenting); see also Paul v. United States, 140 S. Ct. 342 (2019) (statement of
Kavanaugh, J.) (noting the Court has applied a “statutory interpretation doctrine” related to “major questions” that
requires Congress to either “(i) expressly and specifically decide the major policy question itself and delegate to the
agency the authority to regulate and enforce; or (ii) expressly and specifically delegate to the agency the authority both
to decide the major policy question and to regulate and enforce”).
61 For instance, large-scale vaccination campaigns can implicate costly and complex issues of supply and distribution
that have required congressional action. See, e.g., Nat’l Swine Flu Immunization Program of 1976, Pub. L. No. 94-380,
90 Stat. 1113 (1976) (authorizing the Secretary to conduct necessary activities to carry out a national swine flu
immunization program); Consolidated Appropriations Act, 2021, Pub. L. No. 116-260, div. M, tit. III (2020)
(authorizing appropriations for activities “to plan, prepare for, promote, distribute, administer, monitor, and track
coronavirus vaccines to ensure broad-based distribution, access, and vaccine coverage”). They can also implicate issues
of vaccine hesitancy stemming in part from prior governmental vaccine campaigns. See discussion supra note 21;
Wendy E. Parmet, Pandemics, Populism and the Role of Law in the H1N1 Vaccine Campaign, 4 ST. LOUIS UNIV. L.J.
113, 115–24 (2010) (describing the history of pandemic influenza responses in the United States and issues related to
the 2009 H1N1 vaccine campaign); Kat Eschner, The Long Shadow of the 1976 Swine Flu Vaccine ‘Fiasco’,
SMITHSONIAN MAG. (Feb. 6, 2017), https://www.smithsonianmag.com/smart-news/long-shadow-1976-swine-flu-
vaccine-fiasco-180961994/.
62 42 U.S.C. § 271(a).
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fines.63 CDC has incorporated the higher fines into applicable regulations, which subject violating
individuals to a fine up to $100,000 if the violation does not result in death, or a fine of up to
$250,000 if the violation results in a death.64 Violations by organizations are subject to a fine of
up to $200,000 per event if the violation does not result in a death, or $500,000 per event if the
violation results in a death.65 Given the significant potential penalties, any mandate issued under
the provision—assuming that it falls within the Agency’s delegated authority—may be more
appropriately structured as requirements on entities in interstate commerce, such as a requirement
on entities to verify vaccination status.66
Congress’s Authority to Mandate Vaccination
Although states have traditionally exercised the bulk of authority over public health matters,
including vaccination, Congress shares certain concurrent authority in this area emanating from
its enumerated powers in the Constitution.67 This authority derives from, among other sources,
the Constitution’s Spending and Commerce Clauses.68
The Spending Clause empowers Congress to tax and spend for the general welfare.69 Under this
authority, which is subject to several limitations, Congress may offer federal funds to nonfederal
entities and prescribe the terms and conditions under which the funds are accepted and used by
recipients.70 Over the past century, Congress has frequently invoked this authority in the public
health context, including for purposes of controlling specified diseases, establishing
neighborhood or community health centers, and creating federal health insurance programs,
including Medicare and Medicaid.71
Applying its authority in the context of a vaccination mandate, Congress could encourage states
to enact a vaccination mandate meeting certain federal requirements by imposing it as a condition
of receiving certain federal funds.72 This use of the Spending Clause authority, assuming it falls
within the broad parameters of being for the “general welfare,” would be permissible so long as
(1) Congress provides clear notice of the vaccination mandate that states must enact; (2) the
mandate is related to the purpose of the federal funds; (3) this conditional grant of funds is not

63 See 18 U.S.C. §§ 3559, 3571(b)(5), 3571(c)(5).
64 See 42 C.F.R. § 70.18(a).
65 See id. § 70.18(b).
66 For instance, CDC’s public transit mask mandate was issued under Section 361 and includes an obligation on
conveyance operators to require passengers to wear masks while also contemplating “widespread voluntary
compliance” and enforcement support from other federal agencies with access to civil enforcement schemes. See 86
Fed. Reg. 8025, 8026, 8030 n.33 (Feb. 3, 2021). See also Abramson, supra note 17, at 24–27 (noting that some state
vaccination mandates for health care workers are structured as a requirement on hospitals and health care facilities to
ensure that their employees are vaccinated against specified vaccine-preventable diseases).
67 McCuskey, supra note 6, at 113–20.
68 See id. at 116–19.
69 U.S. CONST. art. I, § 8, cl. 1.
70 See Nolan & Lewis, supra note 8, at 29–31 (discussing South Dakota v. Dole, 483 U.S. 203, 207–08 (1987)).
71 See James G. Hodge, Jr., The Role of New Federalism and Public Health Law, 12 J.L. & HEALTH 309, 335–37
(1998); McCuskey, supra note 6, at 118–19.
72 See Dole, 483 U.S. at 211–12 (holding that 23 U.S.C. § 158, which conditioned the provision of certain federal
highway funds upon a state’s enactment of a minimum drinking age of twenty-one, was a valid exercise of Congress’s
spending clause authority).
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otherwise barred by the 48 141 S. Ct. 1294, 1296 (2021) (per curiam) (alteration in original). The Supreme Court’s Tandon ruling was issued on the Court’s non-merits docket. For more information about the potential differences in the precedential value of the Court’s non-merits versus merits decisions, see infra note 110. Congressional Research Service 6 State and Federal Authority to Mandate COVID-19 Vaccination interest that justifies the regulation at issue.”49 Applying this standard, the Court concluded that the state regulations at issue in Tandon, which limited religious gatherings in response to the COVID-19 pandemic, treated some comparable secular activities—such as getting haircuts and retail shopping—more favorably without showing that these secular activities posed a lower risk of transmission of COVID-19.50 Thus, the Court applied heightened scrutiny and granted a preliminary injunction, staying enforcement of the state regulations during pendency of the litigation.51 A few months after the Tandon ruling, the Supreme Court, in Fulton v. City of Philadelphia, considered whether a city’s contract provision prohibiting sexual orientation discrimination by contractors violated a religious foster care agency’s free exercise rights.52 The contract provision at issue generally prohibited providers from rejecting a child or family for services based on their sexual orientation unless a specified city official, at his “sole discretion,” granted an exception.53 Even though the City had never granted an exception under the provision, the Court held that this exemption system meant that the nondiscrimination policy was not generally applicable under Smith.54 This system, in the Court’s view, “incorporate[d] a system of individual exemptions” that invited the government “to decide which reasons for not complying with the policy are worthy of solicitude.”55 Because a law lacks general applicability “if it prohibits religious conduct while permitting secular conduct that undermines the government’s asserted interest in a similar way,” the Court held that the City “may not refuse to extend that exemption system to cases of religious hardship without compelling reason.”56 The Court concluded that the City failed to offer any compelling reason for “why it has a particular interest in denying an exception to [the plaintiff foster care agency] while making them available to others.”57 Together, Fulton and Tandon could suggest that where a governmental requirement provides a secular exemption from the requirement (but no religious exemption), and the exemption system is to some extent discretionary, the requirement may not be neutral and generally applicable for purposes of the Free Exercise Clause.58 This interpretation would mean that a governmental requirement with only a secular exemption—assuming that the secular exemption is comparable to a hypothetical religious exemption as measured against the asserted government interest underlying the requirement—may be subject to heightened scrutiny.59 For state vaccination requirements—which typically provide, at a minimum, medical exemptions to those with contraindications—Fulton and Tandon thus raise a number of questions that potentially unsettle the law concerning vaccination requirements and religious freedom. These questions include whether a vaccination requirement that provides only for a medical exemption—a secular exemption—is not neutral and generally applicable; whether that analysis depends on the extent to which the medical exemption process is discretionary; and whether 49 Tandon, 141 S. Ct. at 1296. 50 Id. at 1297. 51 Id. at 1297–98. 52 141 S. Ct. 1868 53 Id. at 1878. 54 Id. 55 Id. at 1879. 56 Id. at 1877–78 (internal alterations and quotations omitted) (quoting Emp. Div., Dep’t of Hum. Res. of Or. v. Smith, 494 U.S. 872, 884 (1990)). 57 Id. 58 See id. at 1878–79; Tandon v. Newsom, 141 S. Ct. 1294, 1297–98 (2021) (per curiam). 59 See Fulton, 141 S. Ct. at 1878–79; Tandon, 141 S. Ct. at 1297–98. Congressional Research Service 7 link to page 5 link to page 5 link to page 5 link to page 9 State and Federal Authority to Mandate COVID-19 Vaccination medical and religious exemptions—as measured against the relevant underlying government interest for vaccination requirements—are comparable exemptions in the context of this analysis. To the extent a vaccination requirement that provides only a medical exemption would be subject to heightened scrutiny, Fulton and Tandon also leave unanswered whether there are certain circumstances under which the requirement would survive such scrutiny. While courts have historically upheld state vaccination requirements generally, more recent developments in the Supreme Court’s free exercise jurisprudence raise questions regarding whether, when, and under what circumstances states must provide or grant religious exemptions to a vaccination requirement. State COVID-19 Vaccination Mandates and Related Litigation In 2021, various state and local entities instituted COVID-19 vaccination requirements to address the pandemic, particularly as the Delta variant began to cause surges in COVID-19 cases across the country. Many public universities, for instance, imposed vaccination requirements on their students and staff as a condition of in-person attendance and employment.60 A few cities required certain indoor business establishments in their jurisdictions to verify their patrons’ proof of vaccination before permitting their entry.61 To date, only a few states have imposed statewide vaccination requirements, and these requirements are generally limited to health care workers.62 At least one state—California—announced in 2021 plans to add COVID-19 vaccination to the list of required student vaccinations. The requirement is expected to be phased-in by grade span in 2022, applying to grades 7 through 12 starting on July 1, 2022.63 With the exception of several state health care worker mandates (as well as California’s expected student vaccination requirements) that provide only for a medical exemption,64 most of these state and local vaccination requirements provide for both medical and religious exemptions. Many of these state COVID-19 vaccination requirements have drawn legal challenges. To date, consistent with the discussion in the preceding section, courts have generally upheld these requirements, particularly if the requirements provide for both medical and religious exemptions.65 Some of the common claims raised in these challenges include, for instance, an alleged violation of the plaintiffs’ substantive due process rights to bodily integrity or right to refuse unwanted medical treatment, or an alleged violation of their equal protection rights. Courts 60 See supra note 12 and accompanying text. 61 See supra note 13 and accompanying text. 62 See supra note 11 and accompanying text. 63 California Becomes First State in Nation to Announce COVID-19 Vaccine Requirements for Schools, OFF. OF GOVERNOR (Oct. 1, 2021), https://www.gov.ca.gov/2021/10/01/california-becomes-first-state-in-nation-to-announce-covid-19-vaccine-requirements-for-schools/. 64 As noted supra in note 42, California eliminated, in 2016, nonmedical exemptions for its student vaccination requirements generally. 65 See, e.g., Klaassen v. Trustees of Ind. Univ., 7 F.4th 592 (7th Cir. 2021) (affirming district court’s denial of a motion to enjoin a state university’s policy requiring COVID-19 vaccination as a condition of in-person attendance); Norris v. Stanley, No. 1:21-CV-756, 2021 WL 4738827, at *4 (W.D. Mich. Oct. 8, 2021) (denying plaintiff’s motion to enjoin a state university policy requiring employees to receive COVID-19 vaccination); Kheriaty v. Regents of the Univ. of Cal., No. 8:21-cv-01367, 2021 WL 4714664 (C.D. Cal. Sept. 29, 2021) (similar); Dixon v. De Blasio, No. 21-cv-5090, 2021 WL 5740187, at *14 (E.D.N.Y. Oct. 12, 2021) (denying plaintiffs’ motion to enjoin several mayoral executive orders that require certain business entities to prevent individuals who have not received a COVID-19 vaccine from remaining in certain indoor facilities); Valdez v. Grisham, No. 21-cv-783, 2021 WL 4145746, at *4–5 (D.N.M. Sept. 13, 2021) (denying plaintiffs’ motion to enjoin state public health orders that require all hospital workers and state fair exhibitors to be vaccinated against COVID-19). Congressional Research Service 8 link to page 35 State and Federal Authority to Mandate COVID-19 Vaccination have generally rejected these claims, relying on Jacobson to conclude that a fundamental right or a suspect class is not implicated by the vaccination mandates, which reasonably further a legitimate government interest under rational-basis review.66 The principal area of legal uncertainty as to state vaccination requirements, as explained in the preceding section, is whether and when state vaccination requirements must provide for religious exemptions, and the circumstances under which such exemptions may be granted or denied. On this issue, the federal courts of appeals have reached arguably conflicting results. In Dahl v. Board of Trustees of Western Michigan University, the district court preliminarily enjoined (i.e., temporarily suspended) a state university’s policy requiring student-athletes to be vaccinated in order to participate in team activities.67 The university’s policy—which applied only to student-athletes and not the student body at large—provided that “[m]edical or religious exemptions and accommodations will be considered on an individual basis.”68 Several student-athletes who were denied religious exemptions and barred from participation sued to challenge the policy, alleging, among other claims, that the policy violated their free exercise rights.69 In considering the university’s motion to lift the preliminary injunction, the U.S. Court of Appeals for the Sixth Circuit (Sixth Circuit) concluded that the university’s discretionary exemption process provided a “mechanism for individualized exemptions” under Fulton that rendered the policy not generally applicable, subjecting it to heightened scrutiny.70 Applying heightened scrutiny, the Sixth Circuit concluded that the student-athletes were likely to succeed on their free exercise claim because while the university had a compelling interest “in fighting COVID-19,” the policy was not narrowly tailored to achieve that.71 The court reasoned that nonathlete students were not required to be vaccinated, undermining the university’s stated interest in prohibiting conduct that created health risks.72 The court also drew comparisons to other university policies that allowed exemptions, suggesting the university’s vaccination policy might have been unnecessarily “severe.”73 In Does v. Mills, the U.S. Court of Appeals for the First Circuit (First Circuit) considered Maine’s August 2021 emergency regulation that added COVID-19 vaccination to the list of required vaccinations that employees of licensed health care facilities must receive.74 The state legislature in 2019 eliminated all nonmedical exemptions to the state’s health care worker and student vaccination requirements, citing declining vaccination rates and the need to protect those who are 66 See, e.g., Klaasen, 7 F.4th at 592–94; Norris, 2021 WL 4738827, at *2-4; Dixon, 2021 WL 5740187, at *4–6, *8–9; Valdez, 2021 WL 4145746, at *5–9. In addition to these claims, another common claim raised by plaintiffs challenging COVID-19 vaccination requirements—particularly before FDA fully approved a COVID-19 vaccine—is a claim asserting that the vaccination requirements in question violate the EUA provision of the FD&C Act. See infra “Emergency Use Authorization and Vaccination Mandates” for additional discussion. 67 2021 WL 3891620, at *3 (W.D. Mich. Aug. 31, 2021). 68 Dahl v. Bd. of Tr. of W. Mich. Univ., 15 F.4th 728, 730 (6th Cir. 2021) (per curiam). 69 See id. 70 Id. at 733–34. 71 Id. at 734–35. 72 Id. 73 Id. On November 18, 2021, the parties in Dahl voluntarily dismissed the appeal after entering into a consent decree, wherein the university agreed not to prevent plaintiffs from participating in team activities because of their unvaccinated status. Under the consent decree, the university may require unvaccinated plaintiffs to submit to COVID-19 testing weekly or more frequently, and may also require them to wear face coverings during team activities. See Dahl v. Bd. of Tr. of W. Mich. Univ., Consent Decree ¶ 2, ECF No. 46, Nov. 16, 2021 (M.D. Mich.). Accordingly, no final decision on the merits is expected in this case. 74 16 F.4th 20, 28 (2021). Congressional Research Service 9 State and Federal Authority to Mandate COVID-19 Vaccination immunocompromised and reliant on others’ vaccinations for protection.75 In issuing the August 2021 regulation, the Maine Department of Health and Human Services and Maine’s Center for Disease Control determined that the rule was necessary because the highly contagious Delta variant had caused a 300% increase in COVID-19 cases between June and July 2021; health care facilities are uniquely susceptible to outbreaks of infectious diseases like COVID-19; such outbreaks hamper the state’s ability to care for its residents suffering from both COVID-19 and other conditions; the size of Maine’s health care workforce is limited; alternatives to vaccination (such as regular testing or reliance on personal protective equipment) would not be as effective; and no health care facility types at the time—despite the states’ various efforts at promoting voluntary vaccination—had achieved vaccination rates above 90%, which the state public health agency determined was the minimum rate required to prevent community transmission of the Delta variant.76 Several then-unvaccinated health care workers sued to challenge the regulation, alleging, among other claims, that the COVID-19 vaccination requirement violates their free exercise rights because it lacks a religious exemption.77 In affirming the district court’s denial of a preliminary injunction, the First Circuit concluded that the plaintiffs were not likely to succeed on their free exercise claim. In the court’s view, Maine’s vaccination requirement was a neutral and generally applicable law that (1) did not “single[] out religious objections . . . because of their religious nature” and (2) “applie[d] equally across the board” without requiring the state government “to exercise discretion in evaluating individual requests for exemptions.”78 According to the First Circuit, the availability of a general medical exemption to employees who provide a written statement from specified licensed medical professionals that the vaccination is medically inadvisable did not render the vaccination requirement not generally applicable. Unlike the exemption system at issue in Fulton, the medical exemption, in the court’s view, was “a single objective exemption” that did not call for discretionary evaluation, nor did it permit “secular conduct that undermines the government’s asserted interests in a similar way” as would a religious exemption.79 Instead, according to the court, exempting only those whose health would be endangered by vaccination reinforced the state’s underlying interests in protecting the health and safety of its residents, including that of the health care workforce and those who are most vulnerable because they cannot be vaccinated for medical reasons.80 Because the medical exemption is meaningfully different from a religious exemption—the availability of which would undermine the relevant state interests—the court concluded that Maine’s vaccination requirement was generally applicable and subject to rational-basis review, which it “easily satisfie[d].”81 Even though the court did not need to reach this issue, the First Circuit further concluded that even if heightened scrutiny applied, the vaccination requirement would likely survive such scrutiny. According to the court, the state has a compelling interest in both stemming the spread of COVID-19 and in denying an exception to plaintiffs, who provide health care services, because exemptions from the requirement for non-health-related reasons threaten “the most vulnerable 75 Id. at 24–25. The amended exemptions became effective in 2020. See id. 76 See id. at 27–28. 77 Id. at 28. 78 Id. at 30. 79 Id. at 30–31. 80 Id. 81 Id. at 31–32. Congressional Research Service 10 State and Federal Authority to Mandate COVID-19 Vaccination Mainers.”82 The vaccination requirement, according to the court, was also sufficiently narrowly tailored to achieve those interests, given that (1) Maine considered alternatives such as testing, masking, and social distancing, but found them to be inadequate in meeting the state’s goals particularly in the face of the spread of the Delta variant; (2) Maine “demonstrated that it ha[d] tried many alternatives to get its healthcare workers vaccinated short of a mandate” but such efforts failed to achieve the at least 90% vaccination rate necessary to halt community transmission; and (3) the requirement was not underinclusive—in that it applies to all except those who have a medical contraindication—or overinclusive—in that it was limited to “the narrow sphere of healthcare workers . . . who regularly enter healthcare facilities.”83 In We the Patriots USA, Inc. v. Hochul, the U.S. Court of Appeals for the Second Circuit (Second Circuit) considered an emergency rule adopted by the New York Department of Health, 10 N.Y.C.R.R. § 2.61, that directed specified health care facilities in the state to require certain employees to receive COVID-19 vaccines.84 Like the Maine emergency regulation, New York’s vaccination requirement provided only a medical exemption, which applied “only until such immunization is found no longer to be detrimental to [the employees’] health and must be supported by a certification from a licensed physician or nurse practitioner issued in accordance with generally accepted medical standards, including recommendations of the Advisory Committee on Immunization Practices.”85 Several health care workers sued to challenge New York’s rule, asserting, among other claims, that it violated the Free Exercise Clause.86 The Second Circuit concluded that the plaintiffs did not demonstrate a likelihood of success on their free exercise claim at the preliminary injunction phase.87 Like the First Circuit, the Second Circuit concluded that the plaintiffs did not meet their burden to show that New York’s rule—by providing a medical but not a religious exemption—was not a neutral, generally applicable law under Smith, or that the rule did not satisfy rational-basis review.88 Similar to the First Circuit, the Second Circuit found that the medical and religious exemptions were not “comparable” exemptions relative to the asserted government interests—which included protecting the health of health care employees to reduce staffing shortages that can compromise patient safety—because a medical exemption furthered those interests while a religious exemption would undermine them.89 Also similar to the First Circuit, the Second Circuit found that § 2.61’s medical exemption did not create a system of individualized exemptions under Fulton because the rule “provide[d] for an objectively defined category of people to whom the vaccine requirement does not apply”—i.e., those who present the appropriate certification from a specified medical professional in accordance with generally accepted medical standards.90 Because the plaintiffs, in the court’s view, did not demonstrate that § 2.61 is not neutral or generally applicable, the court applied rational-basis review. An emergency rule that requires health care employees to be vaccinated in the face of an especially contagious variant of the virus that has claimed the lives of more than 82 Id. at 32. 83 Id. at 32–33. 84 17 F.4th 266, 274 (2d Cir. 2021) (per curiam). 85 Id. at 275. 86 Id. at 273. 87 Id. 88 Id. 89 Id. at 285. 90 Id. at 289. Congressional Research Service 11 link to page 6 State and Federal Authority to Mandate COVID-19 Vaccination 750,000 in the United States and some 55,000 in New York, the court reasoned, “easily m[et] that standard.”91 In sum, Dahl on one hand, and Does and We the Patriots on the other hand, highlight some of the unsettled questions raised by Fulton and Tandon as they apply to vaccination requirements and the circumstances under which states may be constitutionally required to provide for or grant religious exemptions. Whereas Dahl suggests that the availability of a medical exemption may render a vaccination requirement not generally applicable and thus subject to heightened scrutiny, for instance, Does and We the Patriots indicate that, at least in the health care employment context, a vaccination requirement providing for only a medical exemption is a generally applicable requirement subject to rational-basis review. The Supreme Court has so far rejected applications to stay the Maine and New York emergency rules at issue in Does and We the Patriots, allowing for their implementation.92 The plaintiffs in Does filed a petition for certiorari, and the Court, if it grants the petition, may provide further clarification on these open questions. Federal Authority to Mandate Vaccination Like state vaccination requirements, federal vaccination requirements are government actions subject to constitutional constraints.93 In addition to constitutional constraints based on individual rights—which apply in broadly similar ways to both state and federal vaccination mandates—federal vaccination requirements must fall within the powers granted to the federal government in the Constitution.94 Federal requirements imposed by the executive branch are also subject to statutory constraints. Such requirements generally must rely on the federal government’s existing statutory authorities.95 Depending on the circumstances, the requirements may also be subject to statutory requirements under the Administrative Procedure Act (APA), the Religious Freedom Restoration Act of 1993 (RFRA),96 or other context-specific statutory limits.97 91 Id. at 290. 92 See Dr. A v. Hochul, 142 S. Ct. 552 (2021); Does v. Mills, 142 S. Ct. 17 (2021). Justices Neil Gorsuch, Clarence Thomas, and Samuel Alito dissented from the application denial in both cases. Among other determinations, the dissent concluded that the vaccination requirements at issue were not generally applicable, including because the medical exemption process was “individualized” and because both medical and religious exemptions are comparable exemptions as measured against the states’ asserted interest in infectious disease control and protecting the states’ health care infrastructure. See Does, 142 S. Ct. at 19–20; Dr. A, 142 S. Ct. at 556–57. 93 See, e.g., Pub. Util. Comm’n of D.C. v. Pollak, 343 U.S. 451, 461 (1952). 94 See Nolan & Lewis, supra note 18, at 1. 95 See, e.g., City of Arlington v. Fed. Commc’ns Comm’n, 569 U.S. 290, (2013) (stating that agencies’ “power to act and how they are to act is authoritatively prescribed by Congress” and thus a question concerning agencies’ statutory authority “is always whether the agency has gone beyond what Congress has permitted it to do”). 96 The APA generally establishes the procedures that federal agencies use for rulemaking and adjudication, and the procedures for how courts may review those agency actions. RFRA generally imposes a heightened standard of review for federal government actions that substantially burden a person’s religious exercise and creates a private right of action to those so burdened to assert that violation as a claim or defense and obtain appropriate relief against the government. For more information about the APA, see CRS In Focus IF10003, An Overview of Federal Regulations and the Rulemaking Process, by Maeve P. Carey; and CRS Legal Sidebar LSB10558, Judicial Review Under the Administrative Procedure Act (APA), by Jonathan M. Gaffney. For more information about RFRA, see CRS In Focus IF11490, The Religious Freedom Restoration Act: A Primer, by Whitney K. Novak. 97 In the military context, for instance, additional waiver requirements under 10 U.S.C. § 1107a may apply to the administration of medical products subject to EUAs to servicemembers. Congressional Research Service 12 State and Federal Authority to Mandate COVID-19 Vaccination This part begins by discussing the executive branch’s authority to mandate vaccination, including the asserted statutory authority for the non-military federal COVID-19 vaccination mandates issued to date, and the state of the litigation challenging these mandates. This part then reviews the extent of Congress’s constitutional authority under the Constitution’s Spending and Commerce Clauses to mandate vaccination. Executive Branch Authority to Mandate Vaccination Prior to the COVID-19 pandemic, federal vaccination requirements were primarily limited to the immigration,98 military,99 and certain federal health care employment contexts.100 Certain existing statutory authorities, however, could potentially encompass the authority to mandate vaccination in specified contexts. Earlier in the COVID-19 pandemic, and even before the pandemic, some commentators believed that one likely source of authority for federal public health orders—including those related to vaccination requirements—may be Section 361(a) of the PHSA.101 This provision, codified at 42 U.S.C. § 264(a), grants the Secretary of HHS the authority—delegated in part to the Centers for Disease Control and Prevention (CDC)102—to make and enforce regulations necessary “to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the States or possessions, or from one State or possession into any other State or possession.”103 Following this text, Section 361(a) states that “[f]or purposes of carrying and enforcing such regulations,” the Agency “may provide for such inspection, fumigation, disinfection, sanitation, pest extermination, destruction of animals or articles found to be so infected or contaminated as to be sources of dangerous infection to human beings, and other measures, as in [its] judgment may be necessary.”104 Based on this statutory text, some have argued that a broad construction of CDC’s Section 361(a) authority may permit CDC to issue 98 Under 8 U.S.C. § 1182(a)(1)(A), for instance, immigrants seeking permanent residence in the United States must present documentation showing they have been vaccinated against certain specified vaccine-preventable diseases. 99 The Department of Defense’s Immunization Program, for instance, requires all health care personnel working in the Department’s medical treatment facilities, as well as all active duty and selected reserve personnel, to receive annual seasonal influenza vaccines or to obtain a medical or administrative exemption. DEP’T OF DEFENSE INSTRUCTION 6205.02 § 1.2b (July 23, 2019), https://www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodi/620502p.pdf?ver=2019-07-23-085404-617. For more information about the military’s vaccination requirements, see CRS In Focus IF11816, Defense Health Primer: Military Vaccinations, by Bryce H. P. Mendez. 100 The Indian Health Service, for instance, has required proof of immunization for measles and rubella as a condition of employment for all health care personnel since 1991. The agency added seasonal influenza vaccine as a mandatory vaccination for all health care personnel in 2015. See SGM 21-04, Memorandum from Elizabeth A. Fowler, Acting Director of Indian Health Serv. to all agency employees, available at https://www.ihs.gov/sites/ihm/themes/responsive2017/display_objects/documents/sgm/2021/covid-19-immunizations-requirement.pdf. 101 See, e.g., Lindsay F. Wiley, CDC’s Boundary-Pushing Eviction Freeze, AM. CONST. SOC’Y (Sept. 3, 2020), https://www.acslaw.org/expertforum/cdcs-boundary-pushing-eviction-freeze/ (prior to the availability of COVID-19 vaccines, noting that “[t]he most likely source of authority for federal executive action to mandate and support social distancing and face covering is Section 361(a) of the Public Health Service Act”); Christopher T. Robertson, Vaccines and Airline Travel: A Federal Role to Protect the Public Health, 42 AM. J.L. & MED. 543, 566 (2016) (suggesting CDC has authority under Section 361 “to require vaccinations as a condition of airline travel”). 102 See Legal Authorities for Isolation and Quarantine, CTRS. FOR DISEASE CONTROL & PREVENTION (Feb. 24, 2020), https://www.cdc.gov/quarantine/aboutlawsregulationsquarantineisolation.html. 103 42 U.S.C. § 264(a). 104 Id. § 264(a). Congressional Research Service 13 link to page 16 link to page 17 State and Federal Authority to Mandate COVID-19 Vaccination regulations requiring vaccination in circumstances that would prevent the foreign or interstate transmission of COVID-19.105 Before the COVID-19 vaccines became available under EUAs during the Trump Administration, the CDC invoked PHSA Section 361 to issue a nationwide eviction moratorium in September 2020. CDC based the moratorium on its findings that evictions threatened to increase the spread of COVID-19 as they would force people to live in new shared housing or congregate settings.106 Numerous legal challenges to the eviction moratorium followed. By June 2021, the U.S. Court of Appeals for the District of Columbia Circuit (D.C. Circuit) and the Sixth Circuit—in the context of reviewing procedural motions to stay or lift the stay of the district courts’ preliminary injunction orders107—had reached different conclusions as to the CDC’s statutory authority to issue the order. The D.C. Circuit, adopting a broad construction of Section 361, concluded that “the CDC’s eviction moratorium f[ell] within the plain text of 42 U.S.C. § 264(a).”108 The Sixth Circuit, in contrast, characterized the enumerated measures under Section 361(a) as “property interest restrictions” and concluded that the eviction moratorium was “radically unlike” such restrictions and thus “f[ell] outside the scope of the statute.”109 The eviction moratorium litigation introduced much legal uncertainty over the scope of CDC’s authority under PHSA Section 361(a), including the agency’s authority to issue regulations relating to public health measures, such as vaccination, that arguably bear more directly on infectious disease control than eviction moratoria. Uncertainty as to the reach of Section 361(a) deepened after August 2021, when the Supreme Court—in the context of granting a procedural motion to lift a stay of the eviction moratorium in Alabama Ass’n of Realtors v. Department of Health and Human Services—concluded that the plaintiffs challenging the eviction moratorium were likely to succeed on their statutory claim.110 Characterizing the enumerated measures under Section 361(a) as measures “directly relate[d] to preventing the interstate spread of disease by identifying, isolating, and destroying the disease itself,” the Court concluded that the eviction moratorium “relate[d] to interstate infection far more indirectly” and the sheer scope of CDC’s claimed authority counseled against the government’s interpretation. The government has since voluntarily dismissed its appeal, and a final decision on the merits is not expected in the case. In short, while the eviction moratorium litigation indicates that the CDC’s authority under Section 361(a) does not extend to issuing eviction moratoriums, it leaves unresolved the precise scope of the agency authority under the provision to take other measures to prevent the spread of communicable diseases. 105 See Robertson, supra note 101, at 566. 106 85 Fed. Reg. 55,292, 55,296 (Sept. 4, 2020). 107 As discussed infra in note 110 in more detail, these orders were issued on the courts’ non-merits dockets without full briefing or oral argument from the parties; thus, their precedential value beyond the cases in which they were issued is uncertain. 108 Ala. Ass’n of Realtors v. U.S. Dep’t of Health & Human Servs., No. 21-5093, 2021 WL 2221646, at *1 (D.C. Cir. June 2, 2021). 109 Tiger Lily, LLC v. U.S. Dep’t of Hous. & Urb. Dev., 992 F.3d 518, 521, 524 (6th Cir. 2021). 110 141 S. Ct. 2485, 2488–89 (2021) (per curiam). This order was issued on the Supreme Court’s non-merits or motions docket—sometimes informally called the Court’s “shadow docket”—without full briefing and oral argument. Unlike the Court’s majority merits decisions, which are generally issued after considering both briefs and oral arguments from the parties as well as input from non-parties known as amici curiae, the precedential value of a non-merits orders beyond the case in which it was issued is more uncertain, and lower courts have not traditionally treated such orders as binding. For more discussion about the Supreme Court’s non-merits orders, see CRS Legal Sidebar LSB10637, The “Shadow Docket”: The Supreme Court’s Non-Merits Orders, by Joanna R. Lampe. Congressional Research Service 14 link to page 30 link to page 6 State and Federal Authority to Mandate COVID-19 Vaccination To address the spread of the Delta variant in 2021, the President and several executive agencies—including the Centers for Medicare and Medicaid Services (CMS) and the Occupational Safety and Health Administration (OSHA)—ultimately invoked several other statutory authorities to issue several employment- or workforce-based COVID-19 vaccination mandates for civilians. These vaccination requirements include those that apply to (1) federal executive agency civilian employees (federal employee mandate);111 (2) federal contractors for executive departments, agencies, and offices (federal contractor mandate);112 (3) most Medicare- and Medicaid-certified providers and suppliers (CMS’s Medicare/Medicaid provider mandate);113 and (4) employers with 100 or more employees (OSHA’s large-employer vaccination and testing mandate).114 Subject to accommodations required by federal law for medical disabilities and religious beliefs, these employment-based mandates either directly require certain employees to receive COVID-19 vaccinations or direct certain employers to impose a vaccination or vaccination-and-testing requirement on their employees or staff.115 (See Table 1 for a summary of these mandates.) Federal Employee Mandate Executive Order 14,043, issued on September 9, 2021, instructs each executive agency to implement a program to require COVID-19 vaccination for all federal employees, subject to exceptions required by law, including those based on a disability, medical condition, or a sincerely held religious belief.116 The federal employee mandate directs the Safer Federal Workforce Task Force (Task Force) to issue guidance on this requirement’s implementation.117 The mandate is based on the President’s statutory authority under 5 U.S.C. §§ 3301, 3302, and 7301.118 These provisions grant the President general authority to prescribe rules and/or regulations for executive branch employees.119 Under the Task Force’s guidance, federal employees must have been fully vaccinated (i.e., two weeks after completing either a one-dose vaccine or a two-dose vaccine series) or have obtained an exception by November 22, 2021.120 The vaccination requirement applies to employees who are under maximum telework or remote-work arrangements.121 Employees who refuse to be 111 Exec. Order No. 14,043 of Sept. 9, 2021, 86 Fed. Reg. 50,989 (Sept. 14, 2021). 112 Exec. Order No. 14,042 of Sept. 9, 2021, 86 Fed. Reg. 50,985 (Sept. 14, 2021). 113 86 Fed. Reg. 61,555 (Nov. 5, 2021). 114 86 Fed. Reg. 61,402 (Nov. 5, 2021). In addition to these mandates, the Secretary of Defense mandated COVID-19 vaccination for servicemembers. For more information about the military’s COVID-19 vaccination mandate, see CRS Insight IN11764, The Military’s COVID-19 Vaccination Mandate, by Bryce H. P. Mendez. 115 For more information about reasonable accommodations employers may need to provide—including providing exceptions from the vaccination requirement to employees who do not get vaccinated because of a disability or a sincerely held religious belief—see Anderson & Killion, supra note 15. 116 86 Fed. Reg. 50,989, 50,990 (Sept. 14, 2021). 117 Id. 118 Id. at 50,989. 119 See 5 U.S.C. §§ 3301 (authorizing the President to “prescribe such regulations for the admission of individuals into the civil service in the executive branch as will best promote the efficiency of that service” and to “ascertain the fitness of applicants as to . . . health”), 3302 (authorizing the President to “prescribe rules governing the competitive service”), 7301 (authorizing the President to “prescribe regulations for the conduct of employees in the executive branch”). 120 See FAQs – Vaccinations: Vaccination Requirement for Federal Employees, SAFER FEDERAL WORKFORCE TASK FORCE, https://www.saferfederalworkforce.gov/faq/vaccinations/ (last accessed Dec. 7, 2021). 121 See id. (“Employees who are on maximum telework or working remotely are not excused from this requirement, including because employees working offsite may interact with the public as part of their duties and agencies may need to recall employees who are on maximum telework or working remotely”). Congressional Research Service 15 link to page 19 link to page 12 State and Federal Authority to Mandate COVID-19 Vaccination vaccinated or provide proof of vaccination, and have neither an exception nor an exception request under consideration, are subject to disciplinary measures, up to and including removal or termination.122 Under the guidance, any removal or termination would be preceded by a brief period of education and counseling and a suspension period of generally up to 14 days.123 Several federal employees and at least one employee union have sued to challenge the federal employee mandate.124 These suits raise a variety of claims, including some claims common to challenges to state vaccination requirements.125 As discussed above, courts have generally rejected these claims.126 Plaintiffs have also asserted several claims specific to the federal employee mandate, based on certain generally applicable statutory requirements under the RFRA and APA. One set of claims, for instance, challenged the agencies’ alleged denial of religious exemption requests as violating RFRA and the First Amendment’s Free Exercise Clause.127 In a November 2021 decision, however, the district court considering these claims rejected them as unripe—or too early—for review, given that each plaintiff had a pending request for exemption and had not suffered any adverse employment consequence.128 Another claim, raised by an employee union, challenges the manner by which the mandate was implemented. According to the plaintiffs, the vaccination requirement was implemented without undergoing the notice-and-comment rulemaking procedures required by the APA.129 The district court in December 2021 dismissed the case for lack of standing, concluding, among other determinations, that the plaintiff failed to allege that any of its members had suffered an injury-in-fact because it was “speculative as to whether [they] would be disciplined for failure to become vaccinated because, for example, they may choose to become vaccinated or receive an exemption.”130 Federal Contractor Mandate Executive Order 14,042, also issued on September 9, 2021, directs federal executive departments and agencies to include in certain contracts a clause requiring compliance with the Task Force’s workplace safety guidance.131 The Task Force guidance, issued on September 24, 2021, requires federal contractors and subcontractors with a covered contract to conform to several workplace safety protocols, including COVID-19 vaccination of covered contractor-employees, subject to 122 See FAQs – Vaccinations: Enforcement of Vaccination Requirement for Employees, SAFER FEDERAL WORKFORCE TASK FORCE, https://www.saferfederalworkforce.gov/faq/vaccinations/ (last accessed Dec. 7, 2021). 123 See id. 124 See, e.g., Brnovich v. Biden, No. 2:21-cv-01568, Second Amended Complaint, ECF No. 70 (D. Ariz. filed Nov. 19, 2021) [hereinafter Brnovich Second Amended Complaint]; Church v. Biden, No. 1:21-cv02815, Complaint, ECF No. 1 (D.D.C. filed Oct. 24, 2021); Am. Fed. of Gov’t Emp. v. Biden, No. 1:21-cv-23828, Complaint, ECF No. 1 (D. Fla. filed Oct. 30, 2021). 125 See, e.g., Brnovich Second Amended Complaint, supra note 124, ¶¶ 47, 55–57. 126 See supra note 66 and accompanying text. 127 See Order Denying Emergency Application for Temporary Restraining Order and Mot. for Preliminary Injunction, ECF No. 17, Church v. Biden, No. 1:21-cv02815 (D.D.C. Nov. 8, 2021). 128 See id. at 1. 129 See Mot. for Preliminary Injunction at 9–10, ECF No. 19, Am. Fed. of Gov’t Emp. v. Biden, No. 1:21-cv-23828 (S.D. Fla. filed Nov. 12, 2021). 130 See Order Dismissing Case for Lack of Subject Matter Jurisdiction, ECF No. 33, Am. Fed. of Gov’t Emp. v. Biden, No. 1:21-cv-23828 (S.D. Fla. Dec. 22, 2021). 131 Exec. Order No. 14,042 of Sept. 9, 2021, 86 Fed. Reg. 50,985, 50,985 (Sept. 14, 2021). Congressional Research Service 16 link to page 20 State and Federal Authority to Mandate COVID-19 Vaccination exceptions required by law.132 Covered contractor-employees include those working on or in connection with a covered contract or working at a covered contractor workplace.133 Covered contractor-employees working remotely are subject to the vaccination requirements.134 Consistent with the executive order, the federal contractor mandate sets forth a phase-in period for the new clause to be added to federal contracts.135 Generally, new contracts awarded on or after November 14, 2021, must include the new clause, while contracts awarded prior to October 15, 2021, would incorporate the new clause only at the point at which the government renews the contract or exercises an option.136 By January 18, 2022, covered contractors must ensure that their covered employees are fully vaccinated by the first day of performance of a new contract or when there is a renewal, extension, or exercised option on an existing contract.137 The Task Force guidance instructs that “significant actions, such as termination of the contract,” should be taken if a contractor does not take steps to comply with the requirements.138 The Federal Contractor executive order is based on the President’s authorities under 3 U.S.C. § 301 and the Federal Property and Administrative Services Act (Procurement Act), including 40 U.S.C. § 121.139 The Procurement Act empowers the President to “prescribe policies and directives that the President considers necessary to carry out” the Act if they are consistent with the Act,140 the purpose of which is to provide “an economical and efficient system” for, among other objectives, federal procurement.141 The Federal Contractor executive order states that it was issued to promote this purpose “by ensuring that the parties that contract with the Federal Government provide adequate COVID-19 safeguards to their workers” performing on or in connection with a covered contract.142 The President determined that the safeguards would “decrease worker absence, reduce labor costs, and improve the efficiency of contractors and subcontractors at sites where they are performing work for the Federal Government.”143 The executive order, pursuant to 3 U.S.C. § 301, tasked the Director of the Office of Management and Budget (OMB) with determining whether the Task Force’s guidance “will promote economy 132 SAFER FEDERAL WORKFORCE TASK FORCE, COVID-19 WORKPLACE SAFETY: GUIDANCE FOR FEDERAL CONTRACTORS AND SUBCONTRACTORS (updated Nov. 10, 2021), https://www.saferfederalworkforce.gov/downloads/Guidance%20for%20Federal%20Contractors_Safer%20Federal%20Workforce%20Task%20Force_20211110.pdf [hereinafter TASK FORCE FEDERAL CONTRACTOR GUIDANCE]. 133 Id. at 3. 134 See FAQs – Federal Contractors: Workplaces, SAFER FEDERAL WORKFORCE TASK FORCE, https://www.saferfederalworkforce.gov/faq/contractors/ (last accessed Dec. 7, 2021). 135 See FAQs – Federal Contractors: Scope and Applicability of Task Force Guidance for Federal Contractors, SAFER FEDERAL WORKFORCE TASK FORCE, https://www.saferfederalworkforce.gov/faq/contractors/ (last accessed Dec. 7, 2021). 136 See id. 137 TASK FORCE FEDERAL CONTRACTOR GUIDANCE, supra note 132, at 5. 138 See FAQs – Federal Contractors: Compliance, SAFER FEDERAL WORKFORCE TASK FORCE, https://www.saferfederalworkforce.gov/faq/contractors/ (last accessed Dec. 7, 2021). For more information about the Federal Contractor EO’s requirements, see CRS Insight IN11803, Executive Order 14042 Requirements for COVID-19 Vaccination of Federal Contractors, coordinated by Heidi M. Peters. 139 See 86 Fed. Reg. 50,985, 50,985 (Sept. 14, 2021). 140 40 U.S.C. § 121(a). 141 Id. § 101. 142 86 Fed. Reg. 50,985, 50,985 (Sept. 14, 2021). 143 Id. Congressional Research Service 17 State and Federal Authority to Mandate COVID-19 Vaccination and efficiency in Federal contracting.”144 In accordance with this delegation, the OMB Director made an affirmative determination in a Federal Register notice published on the same date of the Task Force guidance’s release.145 The executive order also directs the Federal Acquisition Regulatory Council to make corresponding amendments to the Federal Acquisition Regulation, and to issue guidance to federal agencies on how to comply with the federal contractor mandate in the interim.146 The Council issued the guidance on September 30, 2021.147 More than 20 states, on behalf of their state agencies and political subdivisions that may have a covered contract subject to the federal contractor mandate, have filed at least four separate suits in different district courts to challenge the mandate.148 Plaintiffs in each case filed a motion for preliminary injunction seeking to enjoin the mandate while the litigation is pending. In November 2021, one district court—in Kentucky v. Biden, a challenge filed by Kentucky, Ohio, and Tennessee—granted the states’ motion and enjoined the mandate in those three states while the litigation is pending.149 In December 2021, another district court—in Georgia v. Biden, a challenge filed by Georgia and six other states—granted the states’ motion and issued a nationwide injunction.150 Among other determinations, both district courts concluded that the President likely exceeded his statutory authority under the Procurement Act in imposing the vaccination requirement.151 The government has appealed the district courts’ orders in both cases. On January 5, 2022, the Sixth Circuit denied the government’s application to stay the injunction in Kentucky.152 Among other determinations, the Sixth Circuit agreed with the district court that the federal contractor mandate likely exceeded the President’s statutory authority.153 In the Sixth Circuit’s view, the relevant Procurement Act provisions authorize the President “to implement an ‘economical and efficient’ method of contracting . . . to obtain nonpersonal services,” and this authority does not permit the President to “impose whatever medical procedure deemed ‘necessary’ on the relevant services personnel” after those services have been acquired.154 The government’s appeal in Georgia is pending before the U.S. Court of Appeals for the Eleventh Circuit (Eleventh Circuit).155 144 Id. at 50,985–50,986. 145 See 86 Fed. Reg. 53,691 (Sept. 24, 2021). 146 86 Fed. Reg. 50,985, 50,986 (Sept. 14, 2021). 147 Memorandum from the Fed. Acquisition Regul. Council to Chief Acquisition Officers, Senior Procurement Executives, Defense Acquisition Regulations Council, Civilian Agency Acquisition Council (Sept. 30, 2021), https://www.whitehouse.gov/wp-content/uploads/2021/09/FAR-Council-Guidance-on-Agency-Issuance-of-Deviations-to-Implement-EO-14042.pdf. 148 See, e.g., Florida v. Nelson, No. 8:21-cv-2524 (M.D. Fla. filed Oct. 28, 2021); Kentucky v. Biden, No. 3:21-cv-00055, 2021 WL 5587446 (E.D. Ky. Nov. 30, 2021); Georgia v. Biden, No. 1:21-cv-00163 2021 WL 5779939 (S.D. Ga. Dec. 7, 2021). 149 Kentucky, 2021 WL5587446, at *13–14. 150 Georgia, 2021 WL 5779939, at *12. 151 Kentucky, 2021 WL5587446, at *6–7; Georgia, 2021 WL 5779939, at *10. 152 Kentucky v. Biden, No. 21-6147, 2022 WL 43178, at *1 (6th Cir. Jan. 5, 2022). 153 Id. at *11–16. 154 Id. at *12. 155 See Georgia v. Biden, No. 21-14269 (11th Cir. filed Dec. 10, 2021). Congressional Research Service 18 State and Federal Authority to Mandate COVID-19 Vaccination CMS’s Medicare/Medicaid Provider Mandate On November 4, 2021, CMS released an Interim Final Rule (IFR), effective November 5, 2021, that requires specified Medicare- and Medicaid-certified providers and suppliers to establish a policy that requires all eligible staff (subject to legally required exceptions) to receive the first dose of a two-dose COVID-19 vaccine or a one-dose COVID-19 vaccine by December 6, 2021, and to complete their vaccination series by January 4, 2022.156 This mandate applies to 15 provider and supplier types that participate in Medicare and Medicaid, including hospitals, long-term-care facilities, and rural health clinics.157 The mandate does not apply to other health care entities such as physician offices, organ procurement organizations, and portable X-Ray suppliers.158 For providers and suppliers subject to the IFR, their vaccination policy must apply to all staff who directly provide any care, treatment, or other services for the facility and/or its patients, including (1) employees (including administrative staff as well as facility leadership); (2) licensed practitioners; (3) students, trainees, and volunteers; and (4) individuals who provide care, treatment, or other services for the facility and/or its patients under contract or other arrangements (including housekeeping and food services).159 Individuals who provide services 100% remotely from sites of patient care and away from staff who work at sites of care—such as fully remote telehealth or payroll services—are not subject to the vaccination requirements.160 CMS states that noncompliant providers and suppliers will be subject to enforcement remedies based on the level of noncompliance and available remedies, which may include civil monetary penalties, denial of payment for new admissions, and termination of the Medicare/Medicaid provider agreement.161 According to CMS, the Medicare/Medicaid provider mandate is based on its determination that a vaccination mandate for health care workers is an essential component of the nation’s COVID-19 pandemic response, particularly in light of several factors, including (1) the failure to achieve sufficiently high levels of vaccination based on voluntary efforts and patchwork requirements; (2) potential harm to patients from unvaccinated health care workers; (3) continuing strain on the health care system; and (4) known efficacy and safety of available vaccines.162 The agency found “good cause” to waive the notice-and-comment rulemaking procedures under the APA and Section 1871(b) of the Social Security Act (SSA).163 The agency based that determination on several considerations, including (1) that Delta-variant outbreaks showed that current levels of COVID-19 vaccination coverage have been inadequate to protect health care consumers and staff; (2) the pandemic’s strain on the health care system; (3) that respiratory infections typically circulate more frequently during the winter months; and (4) the onset of the 2021-2022 influenza season.164 156 86 Fed. Reg. 61,555, 61,563, 61,573 (Nov. 5, 2021). 157 Id. at 61,556. 158 Id. 159 Id. at 61,570–61,571. 160 Id. at 61,571. 161 Id. at 61,574. 162 Id. at 61,586. 163 Id. 164 Id. at 61,583–61,584, 61,586. Congressional Research Service 19 State and Federal Authority to Mandate COVID-19 Vaccination CMS relied on several layers of statutory authorities in issuing the IFR.165 Across all providers and suppliers, CMS invokes SSA Section 1102, a provision that grants the Secretary of HHS general authority to issue rules “as may be necessary to the efficient administration of the functions” with which the Secretary is charged under the SSA.166 For Medicare providers and suppliers, CMS additionally relies on SSA Section 1871, which authorizes the Secretary to prescribe regulations “as may be necessary to carry out the administration” of the Medicare programs.167 Finally, for each provider and supplier, CMS also relies on certain provider- and supplier-specific provisions, many of which authorize the Secretary to impose requirements he finds necessary to protect the health and safety of individuals who receive services from the relevant entities.168 At least 25 states, on behalf of certain state-run health care facilities that may be subject to the vaccination requirements, filed four separate suits to challenge the IFR shortly after its issuance.169 Plaintiffs in each case filed a motion for preliminary injunction seeking to enjoin the IFR while the litigation proceeds. In November 2021, one district court, in Florida v. Department of Health & Human Services, declined to enjoin the IFR, concluding the state had not shown “irreparable harm” to justify an injunction.170 In the court’s view, the state had not provided sufficient factual evidence to demonstrate that the vaccination requirements’ alleged likely adverse impact, such as potential staffing shortages, would result if the requirements were not halted.171 Later in the same month, however, two district courts—in Missouri v. Biden and Louisiana v. Becerra—granted the plaintiffs’ motions in each respective case.172 The Missouri court enjoined the IFR in 10 plaintiff states, while the Louisiana court enjoined the rule in the remaining states.173 Among other determinations, both courts concluded that CMS likely exceeded its statutory authority in issuing the IFR because the applicable provisions do not specifically authorize the agency to mandate vaccination;174 the agency likely lacked “good cause” to waive notice-and-comment rulemaking procedures;175 and the plaintiffs sufficiently demonstrated they would suffer irreparable harm—including in the form of significant staffing shortages—if the IFR was not enjoined.176 The U.S. Court of Appeals for the Fifth Circuit (Fifth Circuit), in considering the government’s motion to stay the preliminary injunction in Louisiana, narrowed the scope of 165 Id. at 61,567. 166 42 U.S.C. § 1302(a). 167 Id. § 1395hh(a). 168 See, e.g., 42 U.S.C. §§ 1395x(e)(9) (authorizing the Secretary to impose requirements on hospitals that he “finds necessary in the interest of the health and safety of individuals” who receive service from the hospitals), 1395x(dd) (similar for hospices), 1395x(aa) (rural health clinics), 1395i-3(d)(4)(B) (long-term care facilities). 169 See Florida v. Dep’t of Health & Human Servs., No. 3:21-cv-2722, 2021 WL 5416122 (N.D. Fla. Nov. 20, 2021); Missouri v. Biden, No. 4:21-cv-1329, 2021 WL 5564501 (E.D. Mo. Nov. 29, 2021); Louisiana v. Becerra, No. 3:32-cv-3970, 2021 WL 5609846 (W.D. La. Nov. 30, 2021); Texas v. Becerra, No. 2:21-cv-229, 2021 WL 5964687 (N.D. Tex. filed Nov. 15, 2021). 170 Florida, 2021 WL 5416122, at *1. 171 Id. at *3–4. 172 Missouri, 2021 WL 5564501, at *15; Louisiana, 2021 WL 5609846, at *17. 173 Missouri, 2021 WL 5564501, at *15; Louisiana, 2021 WL 5609846, at *17. 174 See Missouri, 2021 WL 5564501, at *3; Louisiana, 2021 WL 5609846, at *10-11. 175 See Missouri, 2021 WL 5564501, at *5–6; Louisiana, 2021 WL 5609846, at *8–9. 176 See Missouri, 2021 WL 5564501, at *12–13; Louisiana, 2021 WL 5609846, at *16. Congressional Research Service 20 State and Federal Authority to Mandate COVID-19 Vaccination the injunction to the 14 plaintiff states.177 Since the Fifth Circuit’s order, the U.S. District Court for the Northern District of Texas, in Texas v. Becerra, issued a preliminary injunction order enjoining the IFR’s enforcement in that state.178 As of December 31, 2021, CMS is enjoined from enforcing the IFR in the 25 states that are plaintiffs in Missouri, Louisiana, or Texas. As noted by the Fifth Circuit in Louisiana, one key legal question on the merits concerning the Medicare/Medicaid provider mandate litigation is whether the rule exceeds the agency’s statutory authority because the relevant provisions do not explicitly authorize the agency to mandate vaccination. Characterizing this issue as a “close call,” the Fifth Circuit—in upholding the preliminary injunction in the 14 plaintiff states—concluded that the government had not sufficiently demonstrated that the rule fell within the agency’s statutory authority.179 On this issue, a divided panel of the Eleventh Circuit, in considering Florida’s motion for an injunction pending its appeal of the district court’s order in Florida, concluded that the relevant Medicare and Medicaid provisions “plainly encompass[]” the IFR’s vaccination requirement.180 In the Eleventh Circuit’s view, the relevant Medicare and Medicaid statutes expressly “authorized the Secretary to set standards to protect the health and safety of patients” served by Medicare and Medicaid facilities.181 The IFR’s vaccination requirements, according to the Eleventh Circuit, fell squarely within this grant of authority, given that COVID-19 is a deadly, highly transmissible disease, health care workers have long been required to obtain inoculations for infectious diseases, and required vaccination is “a common-sense measure designed to prevent healthcare workers . . . from making [patients] sicker.”182 Thus, in the Eleventh Circuit’s view, “when it comes to vaccination mandates, there was no reason for Congress to be more specific than authorizing the Secretary to make regulations for the ‘health and safety’ of Medicare and Medicaid recipients.”183 To suggest otherwise, the court continued, “would mean that Congress had to have anticipated both the unprecedented COVID-19 pandemic and the unprecedented politicization of the disease to regulate vaccination against it.”184 The dissent’s analysis, on the other hand, largely echoes that of the district courts in Missouri and Louisiana.185 On December 30, 2021, CMS announced that the IFR will be implemented and enforced, on a modified timeline, in the jurisdictions not subject to the preliminary injunctions in Missouri, Louisiana, and Texas.186 The deadline to receive the first dose of a vaccine is extended to January 27, 2022, and the deadline to complete the vaccination series is extended to February 28, 2022.187 The government has filed an application with the Supreme Court seeking to stay the preliminary injunctions in both Louisiana and Missouri. The Court held an oral argument regarding the 177 Louisiana v. Becerra, 2021 WL 5913302, at *2–3 (5th Cir. Dec. 15, 2021). 178 Texas v. Becerra, 2021 WL 5964687, at *16. 179 See Louisiana, 2021 WL 5913302, at *1. 180 Florida v. Dep’t of Health & Human Servs., 2021 WL 5768796, at *12. 181 Id. 182 Id. 183 Id. 184 Id. 185 Id. at 24. 186 See Current Emergencies, CTRS. FOR MEDICARE & MEDICAID SERVS., https://www.cms.gov/About-CMS/Agency-Information/Emergency/EPRO/Current-Emergencies/Current-Emergencies-page (last accessed Dec. 30, 2021). 187 Id. Congressional Research Service 21 State and Federal Authority to Mandate COVID-19 Vaccination application on January 7, 2022, and, in issuing a decision on the application, may opt to clarify the scope of CMS’s statutory authority with respect to the IFR.188 OSHA’s Large-Employer Vaccination and Testing Mandate On November 4, 2021, OSHA released an emergency temporary standard (ETS) that generally requires private employers with 100 or more employees to establish and enforce a policy that either (1) requires all employees to receive a COVID-19 vaccination, subject to legally required exceptions; or (2) requires employees to receive either a COVID-19 vaccination or provide proof of regular COVID-19 testing and wear a face covering when indoors or occupying a vehicle with another person.189 For the 26 states, Puerto Rico, and the U.S. Virgin Islands that have opted to adopt their own OSHA-approved state plans, the ETS also applies to state agency and local government employers.190 To the extent a workplace is subject to both the ETS and one of the preceding mandates, the non-OSHA-ETS mandate generally applies. For those workplaces, OSHA specifically states either that the ETS does not apply (in the case of federal contractors or health care providers and suppliers)191 or that compliance with the other mandate is deemed sufficient to meet the employers’ obligations under the ETS (in the case of executive agencies).192 Under the large-employer vaccination and testing mandate, employees who are not fully vaccinated—including those who have been granted exceptions—generally must be tested at least once every seven days if they report at least once every seven days to a work site where others are present.193 Employees who do not report to such a workplace during a period of seven or more days must be tested within seven days prior to returning to the workplace.194 Employees exempt from the ETS’s requirements include (1) employees who work remotely or at a site where other people are not present; and (2) employees who work exclusively outside.195 Covered employers can, but are not required to, pay for any costs associated with testing,196 but they must provide employees with paid leave to receive and recover from the vaccination.197 Covered employers must establish and begin to implement the relevant vaccination policy by December 6, 2021, and ensure their employees have completed a one-dose vaccine or a two-dose vaccine series by January 4, 2022.198 After that, all covered employers must ensure that employees who are not 188 See U.S. SUPREME COURT, Docket, Becerra v. Louisiana, No. 21A241, https://www.supremecourt.gov/search.aspx?filename=/docket/docketfiles/html/public/21a241.html (last accessed Jan. 10, 2022). 189 86 Fed. Reg. 61,402, 61,552 (Nov. 5, 2021) (adding 29 C.F.R. § 1910.501(d)). 190 Section 18 of the Occupational Safety and Health Act of 1970 (29 U.S.C. § 667) authorizes states, subject to OSHA’s approval, to develop and enforce their own state plans of occupational safety and health standards that are “at least as effective” as OSHA’s federal standards and enforcement. Whereas OSHA’s jurisdiction does not extend to state agency and local government as employers, see 29 U.S.C. § 652(5), OSHA-approved state plans must provide coverage for state agencies and local government entities as employers, see 29 U.S.C. § 667. For more information about OSHA’s jurisdiction and coverage of OSHA-approved state plans, see CRS In Focus IF11619, OSHA Jurisdiction Over Public Schools and Other State and Local Government Entities: COVID-19 Issues, by Scott D. Szymendera. 191 See 86 Fed. Reg. 61,402, 61,447 (Nov. 5, 2021). 192 See id. at 61,402. 193 See id. at 61,553 (adding 29 C.F.R. § 1910.501(g)). 194 See id. at 61,553 (adding 29 C.F.R. § 1910.501(g)(ii)). 195 See id. at 61,419. 196 See id. at 61,553 (Note 1 to paragraph (g)(1)). 197 See id. at 61,553 (adding § 1910.501(f)). 198 See id. at 61,554 (adding § 1910.501(m)(2)). Congressional Research Service 22 State and Federal Authority to Mandate COVID-19 Vaccination fully vaccinated are subject to regular COVID-19 testing.199 Noncompliant covered employers could face OSHA citations and civil monetary penalties.200 The large-employer vaccination and testing mandate is based on OSHA’s authority under Section 6(c) of the Occupational Safety and Health Act of 1970 (29 U.S.C. § 655(c)).201 The provision authorizes the agency to issue an ETS that takes effect immediately upon publication in the Federal Register, without undergoing the APA’s rulemaking proceedings, if it determines “(A) that employees are exposed to grave danger from exposure to substances or agents determined to be toxic or physically harmful or from new hazards, and (B) that such emergency standard is necessary to protect employees from such danger.”202 OSHA issued the ETS upon its determination that unvaccinated workers face a grave danger from exposure to SARS-CoV-2 in the workplace, given that COVID-19 has killed more than 725,000 people in the United States in fewer than two years; that unvaccinated individuals remain at much higher risk of severe health outcomes; and that evidence demonstrates the virus’s transmissibility in the workplace and the prevalence of infections in employee populations.203 OSHA further determined that the ETS is necessary to protect unvaccinated workers from the risk of contracting COVID-19 given the potential severe health consequences from occupational exposure to COVID-19 and the fact that vaccination provides the most effective and efficient control available, with the use of other mitigation measures further protecting workers who remain unvaccinated.204 On the same day the ETS was issued, numerous petitioners—including covered employers, states, and religious groups—moved to stay and permanently enjoin the mandate in several federal courts of appeals.205 In response to a petition and motion to stay filed by several covered employers and four states, the Fifth Circuit stayed the enforcement of the ETS the day after it was issued.206 On November 12, 2021, the Fifth Circuit affirmed the stay, largely based on its conclusion that the ETS “grossly exceeds OSHA’s statutory authority.”207 In the Fifth Circuit’s view, an airborne virus like SARS-CoV-2 likely falls outside the scope of a “new hazard” within the meaning of Section 6(c) under a canon of statutory construction known as noscitur a sociis, which counsels that the more precise meaning of a word should be determined by the neighboring words with which it is associated.208 Because “new hazard” is neighbored by “substances or agents” and “toxic or physically harmful”—phrases that, in the court’s view, connote toxicity and poisonousness—the term likely does not encompass an airborne virus that is both widely present 199 See id. 200 See id. at 61,443; see also OSHA Penalties, OCCUPATIONAL SAFETY & HEALTH ADMIN., https://www.osha.gov/penalties (last accessed Dec. 13, 2021). For more information about the ETS’s requirements, see CRS Report R46288, Occupational Safety and Health Administration (OSHA): COVID-19 Emergency Temporary Standards (ETS) on Health Care Employment and Vaccinations and Testing for Large Employers, by Scott D. Szymendera; and CRS Legal Sidebar LSB10658, Fifth Circuit Stays OSHA Vaccination and Testing Standard, by Jon O. Shimabukuro. 201 86 Fed. Reg. 61,402, 61,402 (Nov. 5, 2021). 202 29 U.S.C. § 655(c)(1). 203 See 86 Fed. Reg. 61,402, 61,402–61,403 (Nov. 5, 2021). 204 See id. at 61,403. Under 29 U.S.C. § 655(f), any person adversely affected by an ETS may file a petition to challenge the validity of the standard in the federal court of appeals in which the person resides. 205 See BST Holdings, LLC v. Occupational Safety & Health Admin., 17 F. 4th 604, 610 (5th Cir. 2021). 206 See id. 207 Id. at 612. 208 Id. at 613. Congressional Research Service 23 link to page 28 State and Federal Authority to Mandate COVID-19 Vaccination in society and “non-life-threatening to a vast majority of employees.”209 Moreover, the court concluded that COVID-19 does not pose the required “grave danger” for purposes of Section 6(c), given that the agency cannot demonstrate that all covered workplaces are in fact exposed to COVID-19, the effects of COVID-19 could be mild, and the status of the virus’s spread has changed over time.210 The ETS, in the court’s view, was also not “necessary” to protect unvaccinated workers given its “staggering[] overb[readth],” such that it was both overinclusive—applying to employers and employees in virtually all industries and workplaces in America without an attempt to account for differences in COVID-19 exposure—and underinclusive—disregarding workplaces with 99 or fewer employees.211 Pursuant to 28 U.S.C. § 2112, which specifies the procedures for review when an agency order is challenged in more than one federal appellate court, the Judicial Panel on Multistate Litigation, on November 16, 2021, randomly selected the Sixth Circuit as the court in which all of the pending petitions will be consolidated for review. Under § 2112(a)(4), the Sixth Circuit may modify, revoke, or extend the Fifth Circuit’s stay.212 On December 17, 2021, a divided panel of the Sixth Circuit, in In re: MCP No. 165, Occupational Safety and Health Administration, Interim Final Rule: COVID-19 Vaccination and Testing, granted the government’s motion to dissolve the stay issued by the Fifth Circuit.213 In the Sixth Circuit’s view, based on the OSH Act’s language, structure, and direct instances of congressional approval following the law’s enactment, OSHA has a “clear and exercised authority to regulate viruses” and wide discretion under this authority “to form and implement the best possible solution to ensure the health and safety of all workers” under the OSH Act.214 According to the Sixth Circuit, the text of Section 6(c) expressly encompasses the authority to regulate viruses because a virus is an “agent” (i.e., a biologically active principle) that is physically harmful (i.e., causes bodily harm) within the meaning of the provision.215 This authority to regulate viruses and infectious diseases, the court continued, is reinforced by other provisions of the OSH Act that reference “illnesses arising out of work situations” and “health hazards,” as well as a provision that contemplates “medical examination, immunization, or treatment” as possible measures the agency may employ.216 This interpretation, in the court’s view, is further consistent with several instances of Congress’s approval of OSHA’s authority to regulate bloodborne pathogens and viruses such as HIV, hepatitis B, and hepatitis C.217 According to the Sixth Circuit, this clear authority to regulate viruses necessarily encompasses “the authority to regulate infectious diseases that are not unique to the workplace.”218 Because “no virus—HIV, [hepatitis B], COVID-19—is unique to the workplace and affects only workers,” the court 209 Id. 210 Id. at 613–14. 211 Id. at 611, 615. In addition to its statutory analysis, the court commented that the ETS likely exceeds the federal government’s authority under the Constitution’s Commerce Clause. Id. Characterizing the relevant regulated activity as compulsory vaccination, the Fifth Circuit expressed the view that the ETS impermissibly “regulates noneconomic inactivity that falls squarely within the States’ police power.” Id. As discussed infra in note 225, the Sixth Circuit disagreed with this conclusion. 212 28 U.S.C. § 2112(a)(4). 213 2021 WL 5989357, at *1 (6th Cir. Dec. 17, 2021). 214 Id. at *5–6. 215 Id. at *4. 216 Id. (citing, for instance, 29 U.S.C. §§ 651(a), 651(b)(1), 669(a)(5)). 217 Id. at *5. 218 Id. at *6. Congressional Research Service 24 State and Federal Authority to Mandate COVID-19 Vaccination reasoned, OSHA’s authority to regulate hazards extends to those that “co-exist in the workplace and in society but are at heightened risk in the workplace.”219 In the court’s view, OSHA’s issuance of the ETS “[was] not a novel expansion of OSHA’s power; it [was] an existing application of authority to a novel and dangerous worldwide pandemic.”220 After concluding that OSHA did not exceed its statutory authority, the Sixth Circuit further concluded that the agency’s determination that the ETS was warranted was supported by substantial evidence, including the agency’s determination that employees were exposed to “grave danger” from COVID-19 and that the ETS was “necessary to protect employees from such danger.”221 Under Section 6(f) of the OSH Act, the Secretary’s determinations are “conclusive if supported by substantial evidence in the record considered as a whole.”222 As to the existence of “grave danger,” the Sixth Circuit found, for instance, that OSHA has demonstrated “the pervasive danger that COVID-19 poses to workers—unvaccinated workers in particular—in their workplaces,” explaining why traditional indoor workplaces place workers at heightened risk of contracting COVID-19; evidence of the severity of the harm from COVID-19; the likelihood that the ETS would save over 6,500 worker lives and prevent more than 250,000 hospitalizations over the next six months; and that voluntary guidance on vaccination proved inadequate, particularly in the face of the Delta variant.223 As to the necessity of the ETS, the court found, for instance, that OSHA sufficiently demonstrated that the evolving course of the pandemic—and in particular, the emergence of the Delta variant—necessitated an ETS at this time and that extensive evidence cited by the agency showed that vaccination reduces the presence and severity of COVID-19 cases in the workplace.224 The choice to limit the ETS to employers with 100 or more employees, in the court’s view, did not undermine the standard’s necessity because the agency demonstrated the relationship between this chosen threshold and the underlying regulatory problem, given that “larger employers are better able to implement the policies, are at heightened risk, and regulating them will be a significant step in protecting the entire workforce from COVID-19 transmission.”225 In the dissent’s view, OSHA lacked statutory authority to issue the ETS because the agency did not appropriately establish the standard’s “necessity” or the existence of a “grave danger” in the workplace. According to the dissent, an ETS is “necessary” within the meaning of Section 6(c) only if it is an “indispensable” means of addressing COVID-19 in the workplace.226 Because OSHA “failed to explore whether other feasible alternatives would have allowed [it] to tackle the problem,” the dissent reasoned that the agency cannot show the ETS was “necessary” for 219 Id. 220 Id. at *7. 221 Id. at *8, 10–16. 222 29 U.S.C. § 655(f). 223 In re MCP No. 165, 2021 WL 5989357, at *10–13. 224 Id. at *14. 225 Id. at *15. The Sixth Circuit also found that OSHA sufficiently determined that the ETS is economically feasible, including considering the Standard’s costs in relation to the financial health of the affected industries and its impact on consumer prices. Id. at *15–16. The Sixth Circuit also disagreed with the Fifth Circuit’s view that the ETS likely exceeded the federal government’s Commerce Clause authority because it regulates noneconomic inactivity. Id. at *16. In the Sixth Circuit’s view, the ETS regulates employers that are “indisputabl[y] . . . engag[ing] in commercial activity that Congress has the power to regulate.” To hold otherwise, according to the Sixth Circuit, “would upend nearly a century of precedent upholding laws that regulate employers to effectuate a myriad of employee workplace policies.” Id. 226 See id. at 22. Congressional Research Service 25 State and Federal Authority to Mandate COVID-19 Vaccination purposes of Section 6(c).227 Additionally, the dissent found that OSHA had not provided substantial evidence that all covered employees faced a “grave danger” from COVID-19 because not all employees have a high risk both of contracting COVID-19 and suffering severe consequences from it.228 Finally, in the dissent’s view, OSHA’s authority under the OSH Act is limited to “the workplace walls,” and thus, such authority does not extend to the regulation of a virus that is not uniquely a workplace condition, particularly when the agency “cannot state with precision the total number of workers in our nation who have contracted COVID-19 at work.”229 The authority to protect “employees” from a “grave danger” under Section 6(c), in the dissent’s view, is limited to regulating “workplace hazards with workplace solutions.”230 Thus, the dissent reasoned, this authority does not encompass the authority to mandate safety measures beyond the workplace boundary, “even if taking such precautions would save many ‘employee’ lives.”231 Following the Sixth Circuit’s dissolution of the stay, OSHA announced that it is resuming implementation of the ETS and exercising its enforcement discretion with respect to the compliance dates of the ETS.232 To give employers sufficient time to comply with the standard, OSHA will not issue citations for noncompliance with any requirements of the ETS before January 10 and will not issue citations for noncompliance with the standard’s testing requirements before February 9, so long as an employer is exercising reasonable, good faith efforts to comply with the standard.233 Several petitioners have filed an application with the Supreme Court seeking to stay the ETS. The Court held an oral argument regarding the application on January 7, 2022, and, in issuing a decision on the application, may opt to clarify the scope of OSHA’s statutory authority with respect to the ETS.234 227 Id. at *23–24. 228 Id. at *25. 229 Id. at *26 (quoting 86 Fed. Reg. at 61,424). 230 Id. at *27. 231 Id. 232 See Emergency Temporary Standard: COVID-19 Vaccination and Testing ETS, OCCUPATIONAL SAFETY & HEALTH ADMIN., https://www.osha.gov/coronavirus/ets2 (last accessed Dec. 20, 2021). 233 Id. 234 See U.S. SUPREME COURT, Docket, Ohio v. Dep’t of Labor, No. 21A247, https://www.supremecourt.gov/search.aspx?filename=/docket/docketfiles/html/public/21a247.html (last accessed Jan. 10, 2022). Congressional Research Service 26 link to page 32 State and Federal Authority to Mandate COVID-19 Vaccination Table 1. Summary of Federal Nonmilitary COVID-19 Vaccination Mandates As of January 12, 2022 Covered Federal Statutory Individuals/ Vaccination Compliance Mandate Authority Entities Requirement Deadline(s) Status Federal 5 U.S.C. Federal Employees must be Receive a one- In effect Employee §§ 3301, executive branch ful y vaccinated,a dose vaccine or Mandate 3302, 7301 employees unless granted a two-dose (Executive legally required vaccine series Order exception based on a by November 8, 14,043) disability/medical 2021. condition or a Be ful y sincerely held vaccinated by religious belief. November 22, Remote-working 2021. employees are subject to requirement. Federal 40 U.S.C. Federal Covered contractors As of January Enjoined by Contractor § 101 et contractors/ must ensure covered 18, 2022, courts: (Executive seq.; subcontractors contractor- covered Kentucky v. Order 3 U.S.C. that have a employees are ful y contractor- Biden, No. 21- 14,042) § 301 covered vaccinated, except in employees must 6147), 2022 WL contract with circumstances where be ful y 43178 (6th Cir. executive an employee is legally vaccinated on Jan. 5, 2022) departments and entitled to an the first day of (declining to agencies exemption based on a performance on stay the district disability/medical a new contract court’s condition or a or the renewal, preliminary sincerely held extension, or injunction in KY, religious belief. exercised OH, and TN); Remote-working option of an covered contractor- existing employees are contract. Georgia v. subject to Biden, No. 1:21- requirement. cv-00163 2021 WL 5779939 (S.D. Ga. Dec. 7, 2021) (enjoined the vaccination requirement nationwide). Congressional Research Service 27 State and Federal Authority to Mandate COVID-19 Vaccination Covered Federal Statutory Individuals/ Vaccination Compliance Mandate Authority Entities Requirement Deadline(s) Status CMS’s 42 U.S.C. Specified Covered providers By January 27, Enjoined by Medicare/ §§ 1302, provider and and suppliers must 2022, courts in 25 Medicaid 1395hh, and supplier types ensure covered staff (1) covered states: Provider other that participate who directly provide providers and Missouri v. Mandate provider- in Medicare and care or other suppliers must Biden, No. 4:21- (CMS IFR) or supplier- Medicaid services for their establish and cv-1329, 2021 specific facilities and/or begin to WL 5564501 provisions patients are ful y implement the (E.D. Mo. Nov. vaccinated, except in vaccination 29, 2021) circumstances where policies and (enjoining the a staff member is (2) covered staff IFR in AK, AR, legally entitled to an must receive IA, KS, MO, NE, exemption based on a first dose of a NH, ND, SD, disability/medical two-dose and WY); condition or a vaccine or a sincerely held one-dose Louisiana v. religious belief. vaccine. Becerra, No. 21-30734, 2021 WL Staff who work 100% Covered staff 5913302, at *2-3 remotely from sites must complete (5th Cir. Dec. of patient care or two-dose 15, 2021) away from onsite staff vaccine series (enjoining the are not subject to the by February 28, IFR in AL, AZ, requirement. 2022. GA, ID, IN, KY, LA, MS, MT, OH, OK, SC, UT, and WV); Texas v. Becerra, No. 2:21-cv-229, 2021 WL 5964687 (N.D. Tex. Dec. 15, 2021) (enjoining the IFR in TX). Supreme Court heard oral argument on the government’s application to stay injunctions on January 7, 2022. Congressional Research Service 28 link to page 6 State and Federal Authority to Mandate COVID-19 Vaccination Covered Federal Statutory Individuals/ Vaccination Compliance Mandate Authority Entities Requirement Deadline(s) Status OSHA’s 29 U.S.C. In all A covered employer Covered In effect. Large- § 655(c) jurisdictions, must establish and employers must (See In re MCP Employer private enforce a policy that establish and No. 165, Vaccination employers with either (1) ensures begin to Occupational and Testing 100 or more employees are ful y implement the Safety and Mandate employees. vaccinated, except in vaccination Health Admin., (OSHA ETS) In 26 states, circumstances where policies by Interim Final Puerto Rico, and an employee is legally January 10, Rule: COVID-19 the U.S. Virgin entitled to an 2022. Vaccination and Islands with exemption based on a Covered Testing, 2021 OSHA-approved disability/medical employees must WL 5989357 state plans, state condition or sincerely receive either a (6th Cir. Dec. and local held religious belief; one-dose 17, 2021) government or (2) requires vaccine or a (dissolving a employers with employees to be ful y two-dose prior stay of the 100 or more vaccinated or provide vaccine series, ETS by the U.S. employees. proof of regular or begin regular Court of COVID-19 testing testing by Appeals of the and wear a face February 9, Fifth Circuit)) covering when 2022. indoors. Employees who work Supreme Court remotely, at a site heard oral where other people argument on are not present, or petitioners’ exclusively outside application to are not subject to the stay the ETS on requirements. January 7, 2022. Source: CRS analysis of the relevant Executive Orders, CMS IFR, and OSHA ETS, as well as related litigation. a. For purposes of the relevant Executive Orders, CMS IFR, and OSHA ETS, individuals are considered “ful y vaccinated” for COVID-19 two weeks after they have received either a one-dose vaccine or a two-dose vaccine series. Congress’s Constitutional Authority to Mandate Vaccination Although states have traditionally exercised the bulk of authority over public health matters, including vaccination, Congress shares certain concurrent authority in this area emanating from its enumerated powers in the Constitution.235 This authority derives from, among other sources, the Constitution’s Spending and Commerce Clauses, which may be used by Congress to clarify existing statutory authorities as they relate to vaccination requirements, or create additional sources of authority for or limitations on such requirements.236 235 McCuskey, supra note 16, at 113–20. For instance, while the Supreme Court has long recognized the states’ central role in regulating public health, the Court has also recognized, for equally as long albeit in dicta, Congress’s power over infectious disease control under its Commerce Clause authority. Commenting in 1913 on quarantine laws used to prevent the introduction or spread of disease, for example, the Supreme Court stated that “[s]uch laws undoubtedly operate upon interstate and foreign commerce” and “could not be effective otherwise.” Minnesota Rate Cases, 230 U.S. 352, 406 (1913). 236 See id. at 116–19. Congressional Research Service 29 link to page 6 link to page 6 link to page 6 link to page 33 link to page 6 State and Federal Authority to Mandate COVID-19 Vaccination The Spending Clause empowers Congress to tax and spend money for the general welfare.237 Under this authority, which is subject to several limitations, Congress may offer federal funds to nonfederal entities and prescribe the terms and conditions under which the funds are accepted and used by recipients.238 Over the past century, Congress has frequently invoked this authority in the public health context, including for purposes of controlling specified diseases, establishing neighborhood or community health centers, and creating federal health insurance programs, including Medicare and Medicaid.239 Applying its spending authority in the context of a vaccination mandate, Congress could, for instance, encourage states to enact a vaccination mandate meeting certain federal requirements by imposing it as a condition of receiving certain federal funds.240 This use of Spending Clause authority, assuming it falls within the broad parameters of being for the “general welfare,” would be permissible so long as (1) Congress provides clear notice of the vaccination mandate that states (or other funding recipients) must enact or implement; (2) the mandate is related to the purpose of the federal funds; (3) this conditional grant of funds is not otherwise barred by the Constitution; and (4) the amount of federal funds offered is not “so Constitution; and (4) the amount of federal funds offered is not “so
coercive as to pass the point at which pressure turns into compulsion.”coercive as to pass the point at which pressure turns into compulsion.”73241
In addition, the Commerce Clause grants Congress the power “[t]o regulate Commerce with In addition, the Commerce Clause grants Congress the power “[t]o regulate Commerce with
foreign Nations, and among the several States, and with the Indian Tribes.”foreign Nations, and among the several States, and with the Indian Tribes.”74242 This authority This authority
empowers Congress to regulate “three broad categories of activities”: (1) “channels of interstate empowers Congress to regulate “three broad categories of activities”: (1) “channels of interstate
commerce,” like roads and canals; (2) instrumentalities of, or persons or things in, interstate commerce,” like roads and canals; (2) instrumentalities of, or persons or things in, interstate
commerce; and (3) activities that substantially affect interstate commerce.commerce; and (3) activities that substantially affect interstate commerce.75243 Congress relied on Congress relied on
the Commerce Clause to enact some of the earliest federal health laws aimed at protecting the the Commerce Clause to enact some of the earliest federal health laws aimed at protecting the
public from contagion and products posing health concerns.public from contagion and products posing health concerns.76244 As the federal government As the federal government
increased its role in public health, Congress relied on the Commerce Clause to pass more increased its role in public health, Congress relied on the Commerce Clause to pass more
comprehensive national health regulations, beginning with the Food and Drug Act of 1906.comprehensive national health regulations, beginning with the Food and Drug Act of 1906.77245
While Congress’s authority under the Commerce Clause is expansive, a majority of the Supreme While Congress’s authority under the Commerce Clause is expansive, a majority of the Supreme
Court in Court in National Federation of Independent Business (NFIB) v. Sebelius agreed that there is a agreed that there is a
discrete limit to this authority—it cannot discrete limit to this authority—it cannot compel individuals to engage in commercial activity. individuals to engage in commercial activity.78246 According to Chief Justice John Roberts, in a portion of the opinion not joined by other Justices 237 U.S. CONST. art. I, § 8, cl. 1. 238 See Nolan & Lewis, supra note 18, at 29–31 (discussing South Dakota v. Dole, 483 U.S. 203, 207–08 (1987)). 239 See James G. Hodge, Jr., The Role of New Federalism and Public Health Law, 12 J.L. & HEALTH 309, 335–37 (1998); McCuskey, supra note 16, at 118–19. 240 See Dole, 483 U.S. at 211–12 (holding that 23 U.S.C. § 158, which conditioned the provision of certain federal highway funds upon a state’s enactment of a minimum drinking age of 21, was a valid exercise of Congress’s spending clause authority). 241 See id. at 207–08, 211 (internal quotations omitted). 242 U.S. CONST. art. I, § 8, cl. 3. 243 United States v. Lopez, 514 U.S. 549, 558–59 (1995). 244 McCuskey, supra note 16, at 116–19 (noting that the Commerce Clause enabled several early federal health laws, including a law that authorized the quarantine of diseased livestock and people, and a law that regulated certain drugs and food products posing health concerns). 245 See id.; see also Medtronic, Inc. v. Lohr, 518 U.S. 470, 475 (1996); Hodge, supra note 239, at 335–36 (noting that “[f]ederal regulation now reaches broad aspects of public health such as air and water quality, food and drug safety, tobacco advertising, pesticide production and sales, consumer product safety, occupational health and safety, and medical care”). 246 See Nolan & Lewis, supra note 18, at 10. Congressional Research Service 30 link to page 6 link to page 8 link to page 9 link to page 11 State and Federal Authority to Mandate COVID-19 Vaccination
According to Chief Justice John Roberts, in a portion of the opinion not joined by other Justices
but largely echoed in the view of the four dissenting Justices, the Commerce Clause did not but largely echoed in the view of the four dissenting Justices, the Commerce Clause did not
empower Congress “to regulate individuals precisely because they are doing nothing.”empower Congress “to regulate individuals precisely because they are doing nothing.”79247 While it While it
is uncertain whether this conclusion constitutes binding precedent,is uncertain whether this conclusion constitutes binding precedent,80248 it suggests that a direct it suggests that a direct
federal mandate on individuals to receive a vaccine may be susceptible to challenge because such federal mandate on individuals to receive a vaccine may be susceptible to challenge because such
mandates could be construed as compelling individuals who are “doing nothing” to engage in the mandates could be construed as compelling individuals who are “doing nothing” to engage in the
commercial activity of receiving a specified health care service.commercial activity of receiving a specified health care service.81249 On the other hand, a federal On the other hand, a federal
mandate that requires vaccination as a condition to engage in existing economic activities, such as mandate that requires vaccination as a condition to engage in existing economic activities, such as
employment or interstate travel, may raise fewer constitutional concerns.employment or interstate travel, may raise fewer constitutional concerns.82250
Even if a vaccine mandate falls within Congress’s enumerated powers, other constitutional Even if a vaccine mandate falls within Congress’s enumerated powers, other constitutional
provisions may constrain provisions may constrain governmentalthe government’s action. action.83251 In the context of public health regulations, the In the context of public health regulations, the
key constraints are those grounded in federalism and the protection of individual rights.key constraints are those grounded in federalism and the protection of individual rights.84252 For For
example, the Supreme Court has interpreted the Tenth Amendment to prevent the federal example, the Supreme Court has interpreted the Tenth Amendment to prevent the federal
government from commandeering or requiring states or localities to adopt or enforce federal government from commandeering or requiring states or localities to adopt or enforce federal

73 See id. at 207–08, 211 (internal quotations omitted).
74 U.S. CONST. art. I, § 8, cl. 3.
75 United States v. Lopez, 514 U.S. 549, 558–59 (1995).
76 McCuskey, supra note 6, at 116–19 (noting that the Commerce Clause enabled several early federal health laws,
including a law that authorized the quarantine of diseased livestock and people, and a law that regulated certain drugs
and food products posing health concerns).
77 See id.; see also Medtronic, Inc. v. Lohr, 518 U.S. 470, 475 (1996); Hodge, supra note 71, at 335–36 (noting that
“[f]ederal regulation now reaches broad aspects of public health such as air and water quality, food and drug safety,
tobacco advertising, pesticide production and sales, consumer product safety, occupational health and safety, and
medical care”).
78 See Nolan & Lewis, supra note 8, at 10.
79 See id. at 10–11 (quoting NFIB v. Sebelius, 567 U.S. 519, 551 (2012) (opinion of Roberts, C.J.)).
80 See id. at 11.
81 See NFIB, 567 U.S. at 551.
82 See policies.253 In the context of vaccination, this principle prevents Congress from directly requiring states or localities to pass mandatory vaccination laws or implement federal vaccination laws.254 It does not, however, impede Congress from using its Spending Clause authority to incentivize states to do so, as long as the amount offered is not so significant as to effectively coerce, or functionally commandeer, states into enacting the mandate.255 As to protection of individual rights, courts have recognized few rights-based constraints on the ability to impose mandatory vaccination requirements.256 As explained above, courts have largely rejected due process and equal protection challenges to compulsory vaccination under Jacobson and Zucht. As with state vaccination requirements, the principal area of legal uncertainty as to rights-based constraints on federal requirements is whether and under what circumstances states must provide religious exemptions to a vaccination requirement.257 247 See id. at 10–11 (quoting NFIB v. Sebelius, 567 U.S. 519, 551 (2012) (opinion of Roberts, C.J.)). 248 See id. at 11. 249 See NFIB, 567 U.S. at 551. 250 See In re MCP No. 165, Occupational Safety & Health Admin., Interim Final Rule: COVID-19 Vaccination and Testing, 2021 WL 5989357, at *16 (6th Cir. 2021) (commenting that OSHA’s large-employer vaccination and testing mandate regulates employers that are “indisputabl[y] . . . engag[ing] in commercial activity that Congress has the power to regulate,” and stating that holding otherwise “would upend nearly a century of precedent upholding laws that regulate employers to effectuate a myriad of employee workplace policies”); see also Liberty Univ., Inc. v. Lew, 773 F.3d 72, 93 (4th Cir. 2013) (rejecting a Commerce Clause challenge to an Liberty Univ., Inc. v. Lew, 773 F.3d 72, 93 (4th Cir. 2013) (rejecting a Commerce Clause challenge to an
Affordable Care Act requirement that certain employers offer a minimum level of health insurance coverage to their Affordable Care Act requirement that certain employers offer a minimum level of health insurance coverage to their
employees and dependents on the grounds that the requirement merely regulates an existing commercial activity). employees and dependents on the grounds that the requirement merely regulates an existing commercial activity).
83 See Nolan & Lewis, supra note 8, at 24–25.
84 See id. at 19, 24–25.
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link to page 6 link to page 7 link to page 7 link to page 8 State and Federal Authority to Mandate COVID-19 Vaccination

policies.85 In the context of vaccination, this principle prevents Congress from directly requiring
states or localities to pass mandatory vaccination laws or implement federal vaccination laws.86 It
does not, however, impede Congress from using its Spending Clause authority to incentivize
states to do so, as long as the amount offered is not so significant as to effectively coerce, or
functionally commandeer, states into enacting the mandate.87
As to protection of individual rights, courts have recognized few rights-based constraints on the
ability to impose mandatory vaccination requirements.88 As noted above, courts have largely
rejected due process and equal protection challenges to compulsory vaccination under Jacobson
and Zucht, and potential free exercise concerns are limited under Smith and its progeny.89
To date, the federal government has generally limited its role with respect to vaccination to
promoting, facilitating, or monitoring the use and manufacture of vaccines. For instance, federal
laws and agencies require insurance coverage for recommended vaccinations90 and the purchase
of certain vaccines,91 provide clinical guidance on vaccinations,92 and ensure vaccine safety.93
Consideration for Congress
A vaccination mandate is one available legal tool that governments could use to increase COVID-
19 vaccine uptake. As discussed above, whetherBut see BST Holdings, LLC v. Occupational Safety & Health Admin., 17 F. 4th 604, 615 (5th Cir. 2021) (commenting that OSHA’s large-employer vaccination and testing mandate impermissibly “regulates noneconomic inactivity that falls squarely within the States’ police power”). 251 See Nolan & Lewis, supra note 18, at 24–25. 252 See id. at 19, 24–25. 253 Id. at 25. 254 See id. 255 See id. 256 See supra notes 39–47 and accompanying text. 257 See supra “State COVID-19 Vaccination Mandates and Related Litigation.” Congressional Research Service 31 link to page 4 link to page 35 State and Federal Authority to Mandate COVID-19 Vaccination Emergency Use Authorization and Vaccination Mandates Prior to the COVID-19 pandemic, all vaccines subject to governmental mandates were licensed under a biological license application (BLA), the standard regulatory framework under which vaccines are typically introduced into interstate commerce.258 By contrast, as of December 2021, only one COVID-19 vaccine—Pfizer’s Comirnaty—is licensed by FDA under a BLA.259 Several other COVID-19 vaccines are authorized for emergency use under the FD&C Act’s EUA provision, which allows the Secretary of HHS to permit patient access to an unlicensed vaccine for emergency use under specified conditions, including during a public health emergency.260 Before FDA licensed Pfizer’s COVID-19 vaccine, some commentators raised a legal issue unique to COVID-19 vaccination mandates. Specifically, they argued that Section 564(e)(1) of the EUA provision precludes entities—including governmental entities—from mandating the COVID-19 vaccines.261 Section 564(e)(1) directs the Secretary of HHS, when issuing an EUA for a medical product, to impose such necessary conditions to protect the public health, including appropriate conditions designed to inform individuals “of the option to accept or refuse administration of the product, of the consequences, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks.”262 Because each individual must be provided with “the option to accept or refuse,” some commentators asserted that this provision “suggests that mandates are categorically prohibited.”263 After some state and private entities began mandating COVID-19 vaccinations in 2021, some litigants advanced this argument in court, asserting that COVID-19 vaccination requirements violated Section 564(e) of the FD&C Act. Courts have generally rejected this claim, holding that Section 564(e) imposes only an informed consent requirement on medical providers administering the vaccines to inform would-be recipients of the vaccines’ risks and their right to refuse it.264 As a result, courts generally have concluded that the provision does not prohibit entities from requiring individuals, duly informed by their medical providers, to be vaccinated.265 258 See, e.g., CRS Report R46593, Vaccine Safety in the United States: Overview and Considerations for COVID-19 Vaccines, by Kavya Sekar and Agata Bodie, at 15, 34–35. 259 For more information about FDA’s approval of Comirnaty, the Pfizer-BioNTech COVID-19 vaccine, see Hickey, Ward & Bodie, supra note 7. 260 See id.; see also Hickey et al., supra note 2, at 12–14. 261 See Efthimios Parasidis & Aaron S. Kesselheim, Assessing the Legality of Mandates for Vaccines Authorized Via an Emergency Use Authorization, HEALTH AFFAIRS (Feb. 16, 2021), https://www.healthaffairs.org/do/10.1377/hblog20210212.410237/full/. 262 21 U.S.C. § 360bbb-3(e)(1)(A)(ii)(III). 263 Parasidis & Kesselheim, supra note 261. 264 See, e.g., Valdez v. Grisham, No. 21-cv-783, 2021 WL 4145746, at *4–5 (D.N.M. Sept. 13, 2021); Norris v. Stanley, No. 1:21-cv-756, 2021 WL 4738827, at *3 n.2 (W.D. Mich. Oct. 8, 2021) (rejecting plaintiffs’ argument that a university’s vaccination requirement is preempted by Section 564(e) because the policy “does not preclude Plaintiff from receiving informed consent, nor does it prevent her from accepting or refusing administration of the vaccine”); Johnson v. Brown, 3:21-cv-1494, 2021 WL 4846060, at *18 (D. Ore. Oct. 18, 2021) (holding that Section 564(e)’s “conditions of informed consent only relate to . . . the medical providers who administer the vaccine, not those who issue vaccine mandates”). 265 See Valdez, 2021 WL 4145746, at *4–5; Norris, 2021 WL 4738827, at *3 n.2; Johnson, 2021 WL 4846060, at *18; see also Bridges v. Houston Methodist Hosp., No. H-21-1774, 2021 WL 2399994, at *2 (S.D. Tex. Jun 12, 2021) (holding that Section 546(e) “confers certain powers and responsibilities to the Secretary of Health and Human Services in an emergency,” such that “[i]t neither expands nor restricts the responsibilities of private employers”); see Congressional Research Service 32 link to page 16 State and Federal Authority to Mandate COVID-19 Vaccination Now that FDA has fully licensed Comirnaty, a COVID-19 vaccine, legal challenges to COVID-19 vaccination requirements based on the EUA statute are largely moot.266 Considerations for Congress A vaccination mandate is one available legal tool that governments could use to increase COVID-19 vaccine uptake. Whether the federal government has existing statutory the federal government has existing statutory
authority to mandate vaccination in the context of COVID-19 is subject to debate.94 Thus,
inasmuch as Congress determines that a federal vaccination mandate may be necessary to address
the pandemic, legislative action may be required to implement such a mandate. Congress could,
for instance, update Section 361 of the PHSA—which has remained largely unchanged since its
enactment in 1944—to articulate this authority more clearly and provide a more flexible
enforcement mechanism. Congress could also impose a mandate through other legislative actions,
ifauthority to mandate COVID-19 vaccination in certain contexts is an issue in several pending lawsuits.267 Depending on whether Congress determines that the executive branch’s use of these authorities, including provisions of the Procurement Act, the SSA, and the OSH Act, appropriately reflects congressional intent, Congress—subject to constitutional limits—can generally clarify the scope of these statutory provisions as they apply to vaccination requirements. To the extent Congress determines that a federal vaccination mandate may be necessary to address the evolving pandemic, Congress could also impose a mandate through other legislative actions. Any such legislation, however, must be grounded in Congress’s enumerated constitutional authority and structured consistently with grounded in Congress’s enumerated constitutional authority and structured consistently with
constitutional due process and religious constitutional due process and religious freedom guarantees. Author Information Wen W. Shen Legislative Attorney also U.S. DEP’T OF JUSTICE, OFF. OF LEGAL COUNS., WHETHER SECTION 564 OF THE FOOD, DRUG, AND COSMETIC ACT PROHIBITS ENTITIES FROM REQUIRING THE USE OF A VACCINE SUBJECT TO AN EMERGENCY USE AUTHORIZATION, 45 Op. O.L.C. __, 2021 WL 3418599 (July 6, 2021) (concluding that “section 564 specifies only that certain information be provided to potential vaccine recipients and does not prohibit entities from imposing vaccination requirements”). In addition, courts have emphasized that at least one COVID-19 vaccine has received full FDA approval and is therefore no longer being distributed under an EUA, rendering this claim moot as to that vaccine. See, e.g., Valdez, 2021 WL 4145746, at *4. 266 See, e.g., Norris v. Stanley, No. 1:21-CV-756, 2021 WL 3891615, at p. *2 (W.D. Mich. Aug. 31, 2021) (“[S]hould Plaintiff be offered the FDA-approved Pfizer Comirnaty vaccine, her argument under the EUA statute would be moot . . . .”). The legal issue may remain open with respect to vaccine mandates imposed on individuals 12 to 15 years old, however, as no vaccine is licensed under a BLA for use in this age group, as of the time of this writing. 267 See suprafreedom guarantees.

85 Id. at 25.
86 See id.
87 See id.
88 See supra notes 21–28 and accompanying text.
89 See id.
90 See 42 U.S.C. § 300gg-13(a) (requiring private health insurance plans to cover certain recommended
immunizations); id. § 1396s(a) (requiring coverage of certain recommended pediatric vaccines under a state Medicaid
plan).
91 See CRS Insight IN11560, Operation Warp Speed Contracts for COVID-19 Vaccines and Ancillary Vaccination
Materials, by Simi V. Siddalingaiah. See also Vaccines for Children Program (VFC), CTRS. FOR DISEASE CONTROL &
PREVENTION (Feb. 18, 2016), https://www.cdc.gov/vaccines/programs/vfc/index.html (describing the Vaccines for
Children program, under which federally purchased childhood vaccines are provided at no cost to certain children).
92 See Advisory Committee on Immunization Practices (ACIP) Charter, CTRS. FOR DISEASE CONTROL & PREVENTION,
https://www.cdc.gov/vaccines/acip/committee/charter.html.
93 See, e.g., Sekar & Bodie, supra note 29, at 4–11.
94 See discussion supra in “Executive Branch Authority to Mandate Vaccination.””
Congressional Research Service Congressional Research Service

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State and Federal Authority to Mandate COVID-19 Vaccination


Author Information

Wen W. Shen

Legislative Attorney



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