State and Federal Authority to Mandate
January 12, 2022
COVID-19 Vaccination
Wen W. Shen
The Coronavirus Disease 2019 (COVID-19) vaccines licensed or authorized by the U.S. Food
Legislative Attorney
and Drug Administration (FDA) are a critical tool to reduce the spread and severity of COVID-

19. FDA initially authorized the vaccines, between December 2020 and February 2021, under
Section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), a regulatory pathway that

allows certain medical products to be made available in the market prior to full FDA approval
under specified circumstances, including during a public health emergency. In August 2021, FDA licensed the first COVID-
19 vaccine, Pfizer’s Comirnaty, for the prevention of COVID-19 in individuals 16 years of age and older, after determining
that the vaccine, for the licensed use, meets the standards for safety, purity, and potency (i.e., effectiveness) under the Public
Health Service Act.
Given the data supporting the safety and efficacy of the licensed and authorized COVID-19 vaccines, many public health
experts view promoting high COVID-19 vaccination rates—along with continued engagement in community mitigation
activities that prevent transmission, such as mask wearing in certain settings—as key components of the United States’
pandemic response.
One available legal tool for increasing vaccination rates is for governments to require vaccination. In 2021, various state,
local, and federal governmental entities instituted COVID-19 vaccination requirements to address the pandemic, particularly
as the Delta variant—a highly contagious strain of SARS-CoV-2 (the virus that causes COVID-19)—spread in the United
States. Under the United States’ federalist system, states and the federal government share regulatory authority over public
health matters, with states traditionally exercising the bulk of the authority in this area pursuant to their general police power.
That power authorizes states, within constitutional limits, to enact laws “to provide for the public health, safety, and morals”
of the states’ inhabitants. In contrast to this general power, the federal government’s powers are confined to those enumerated
in the Constitution.
This report provides an overview of state and federal authority to mandate vaccination. The first part of the report provides
background on state and local authority to mandate vaccination under the states’ general police power. It discusses the
Supreme Court’s long-standing recognition of state and local authority to mandate vaccination as an exercise of their police
power, and modern courts’ analyses of more recent challenges to state vaccination mandates based on the First Amendment’s
Free Exercise Clause. The report then analyzes the Supreme Court’s evolving free exercise jurisprudence and the questions it
raises regarding whether and when governments must provide for or grant religious exemptions to vaccination requirements.
It then looks at how courts have addressed challenges to COVID-19 vaccination requirements imposed by states and state
entities.
The second part of the report provides an overview of federal authority to mandate vaccination. It discusses several sources
of existing federal statutory authority that could serve, or have been invoked, as the basis for federal COVID-19 vaccination
mandates. It then provides an overview of four employment-based civilian mandates issued by the executive branch to date
directed at (1) federal executive agency civilian employees; (2) federal contractors for executive departments, agencies, and
offices; (3) most Medicare- and Medicaid-certified providers and suppliers; and (4) employers with 100 or more employees.
The report then discusses the state of litigation challenging these mandates. This part also reviews the extent of Congress’s
constitutional authority under the Constitution’s Spending and Commerce Clauses to mandate vaccination.
The report concludes with a brief discussion of a legal issue specific to COVID-19 vaccination mandates, particularly before
FDA’s licensure of Comirnaty. Namely, it reviews how courts have addressed some litigants’ argument that the Emergency
Use Authorization status of COVID-19 vaccines preclude entities from mandating COVID-19 vaccination.
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he Coronavirus Disease 2019 (COVID-19) vaccines licensed or authorized by the U.S.
Food and Drug Administration (FDA) are a critical tool to reduce the spread and severity
of COVID-19.1 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 (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 at 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), https://www.fda.gov/news-events/press-
announcements/fda-takes-key-action-fight-against-covid-19-issuing-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), https://www.fda.gov/news-events/press-announcements/fda-
takes-additional-action-fight-against-covid-19-issuing-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-emergency-use-authorization-third-covid-19-
vaccine [hereinafter, and collectively, FDA EUA Press Releases].
3 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, supra note 2. See also 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.
5 FDA EUA Press Releases, supra note 2. 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 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.
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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-CoV-2 (the virus that causes COVID-19)—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, 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, Experts Propose Steps to Promote,
Distribute COVID Vaccine, CIDRAP NEWS (Dec. 15, 2020), https://www.cidrap.umn.edu/news-perspective/2020/12/
experts-propose-steps-promote-distribute-covid-vaccine; 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
as education, accessibility, and outreach efforts) to increase vaccine uptake short of a mandate. See Kevin G. Volpp et
al., Behaviorally Informed Strategies for a National COVID-19 Vaccine Promotion Program, JAMA (Dec. 14, 2020),
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/
10.3389/fpos.2021.630133/full. See also 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,
958–79 (2015) (describing a continuum of legal tools to increase vaccination rates).
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.
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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 and local authority to mandate vaccination as an exercise of their police power, and modern
courts’ analyses of more recent challenges to state vaccination mandates based on the First
Amendment’s Free Exercise Clause. It 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
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 reviewing the extent of Congress’s constitutional authority
under the Spending and Commerce Clauses to potentially mandate vaccination.22
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.”
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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 mandate
vaccination.26
In the early part of the 20th century, the Supreme Court twice considered constitutional
challenges to state vaccination mandates.27 Each time, the Court rejected the challenges to the
mandates and recognized such laws as falling squarely within the states’ police power.28 In 1905,
the Supreme Court in Jacobson v. Massachusetts upheld a state law that gave municipal boards of
health the 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
public health and safety.”29 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
as a substantive due process right.30
Less than two decades later, in Zucht v. King, parents of a child who was excluded from school
due to her unvaccinated status challenged the local ordinance requiring vaccination for
schoolchildren, arguing that the ordinance violated the Fourteenth Amendment’s Equal Protection
and Due Process Clauses.31 Relying on Jacobson, the Supreme Court rejected the constitutional
challenges, concluding “it is within the police power of a State to provide for compulsory
vaccination” and that the ordinance bestowed “only that broad discretion required for the
protection of the public health.”32
Based on the Supreme Court’s recognition of this authority, states and localities have enacted
vaccination mandates for certain populations and circumstances. All 50 states and the District of
Columbia, for instance, currently have laws requiring all 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).
27 Id.; Zucht v. King, 260 U.S. 174 (1922).
28 Jacobson, 197 U.S. at 39; Zucht, 260 U.S. at 175–77.
29 Jacobson, 197 U.S. at 31.
30 See Reiss & Weithorn, supra note 9, at 897–98.
31 Zucht, 260 U.S. at 175–77.
32 Id. at 176–77.
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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 against certain vaccine-
preventable diseases as a condition of their employment.34 These vaccination requirements are
generally subject to certain exemptions, which vary from state to state.35 While most vaccination
mandates generally provide for some degree of medical exemption (i.e., when individuals have a
contraindication to a vaccine that makes receipt of the vaccine harmful or unsafe),36 many
mandates also include exemptions for those whose religious beliefs counsel against
immunization.37 In the case 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.38
These state and local vaccination mandates have withstood more recent legal challenges.39 While
the Supreme Court’s constitutional jurisprudence has evolved substantially since Jacobson and
Zucht,40 modern courts 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 require 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, Vaccine Law in the Health Care Workplace, 12 J. HEALTH & LIFE SCI. L. 22, 24–27
(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
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
certain vaccine-preventable diseases).
35 See id. at 28–31 (describing scope of medical and religious exemptions for vaccination mandates for health care
workers); NCSL, supra note 33 (describing exemptions for student vaccination mandates).
36 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.
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). Prior to the COVID-19 pandemic, challenges against state
vaccination mandates have 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 H1N1 influenza a condition of employment for health care workers who have direct
contact with patients or who may expose patients to disease. This directive drew several legal challenges from local
health care workers who argued that 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. See Alexander M. Stewart, Mandatory Vaccination of Health Care Workers, 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 regulation due to a vaccine shortage. See 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-mandate-vaccinations-for-health-care-workers.
40 Commentators have observed, for instance, that the Supreme Court decided Jacobson and Zucht before the advent of
tiered scrutiny, which may subject regulations that infringe upon certain fundamental liberty interests to heightened
scrutiny. Reiss & Weithorn, supra note 9, at 896–97. A regulation survives the most heightened level of scrutiny only if
it is narrowly tailored to serve a compelling government interest. See Reno v. Flores, 507 U.S. 292, 301–02 (1993).
41 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.
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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 “the right to free exercise of religion . . .
[is] subordinated to society’s interest in protecting against the spread of disease.”47
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; Workman, 419 F. App’x at 352–54; Whitlow, 203 F. Supp. 3d at 1085–87; Boone,
217 F. Supp. 2d at 952–55.
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; see also Phillips, 775 F.3d at 543; Workman, 419 F. App’x at 352–54; Whitlow, 203
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,
typically considered whether the plaintiffs’ objections to vaccination are based on a sincerely held 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
establish her objections to vaccination were religious in nature); In re 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,
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
medical practices).
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.
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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.
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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).
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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).
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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.
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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.
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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.
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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).
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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.
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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”).
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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).
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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%20
for%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.
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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).
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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.
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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.
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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.
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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)).
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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.
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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.
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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.
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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).
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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).
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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.
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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.
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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 coercive as to pass the point at
which pressure turns into compulsion.”241
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.”242 This authority
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; and (3) activities that substantially affect interstate commerce.243 Congress relied on
the Commerce Clause to enact some of the earliest federal health laws aimed at protecting the
public from contagion and products posing health concerns.244 As the federal government
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 1906.245
While Congress’s authority under the Commerce Clause is expansive, a majority of the Supreme
Court in National Federation of Independent Business (NFIB) v. Sebelius agreed that there is a
discrete limit to this authority—it cannot compel individuals to engage in commercial activity.246
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.
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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.”247 While it
is uncertain whether this conclusion constitutes binding precedent,248 it suggests that a direct
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
commercial activity of receiving a specified health care service.249 On the other hand, a federal
mandate that requires vaccination as a condition to engage in existing economic activities, such as
employment or interstate travel, may raise fewer constitutional concerns.250
Even if a vaccine mandate falls within Congress’s enumerated powers, other constitutional
provisions may constrain the government’s action.251 In the context of public health regulations,
the key constraints are those grounded in federalism and the protection of individual rights.252 For
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
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 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). But 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.”
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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
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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 authority 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 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 supra “Executive Branch Authority to Mandate Vaccination.”
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State and Federal Authority to Mandate COVID-19 Vaccination

Disclaimer
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copy or otherwise use copyrighted material.

Congressional Research Service
R46745 · VERSION 4 · UPDATED
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