State and Federal Authority to Mandate COVID-19 Vaccination

State and Federal Authority to Mandate COVID-19 Vaccination

State and Federal Authority to Mandate
May 17, 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 authorized the first three 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 several employment-based civilian mandates the executive branch has issued,
including those directed at (1) most Medicare- and Medicaid-certified providers and suppliers; (2) employers with 100 or
more employees; (3) federal executive agency civilian employees; (4) federal contractors for executive departments,
agencies, and offices; and (5) staff of the Head Start program. The report then analyzes 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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Contents
State and Local Authority to Mandate Vaccination ......................................................................... 4
Legal Background ..................................................................................................................... 4
State COVID-19 Vaccination Mandates and Related Litigation ............................................... 8
Federal Authority to Mandate Vaccination .................................................................................... 12
Executive Branch Authority to Mandate Vaccination ............................................................. 13
CMS’s Medicare/Medicaid Provider Mandate ................................................................. 15
OSHA’s Large-Employer Vaccination and Testing Mandate ........................................... 19
Federal Employee Mandate .............................................................................................. 26
Federal Contractor Mandate ............................................................................................. 29
Head Start Mandate........................................................................................................... 33
Congress’s Constitutional Authority to Mandate Vaccination ................................................ 39
Emergency Use Authorization and Vaccination Mandates ............................................................ 42
Considerations for Congress.......................................................................................................... 43

Tables
Table 1. Summary of Federal Nonmilitary COVID-19 Vaccination Mandates ............................. 35

Contacts
Author Information ........................................................................................................................ 44

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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. In January 2022, FDA licensed a
second COVID-19 vaccine, Moderna’s Spikevax, for the prevention of COVID-19 in individuals 18 years of age and
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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

older. See Coronavirus (COVID-19) Update: FDA Takes Key Action by Approving Second COVID-19 Vaccine, U.S.
FOOD & DRUG ADMIN. (Jan. 31, 2022), https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-
update-fda-takes-key-action-approving-second-covid-19-vaccine.
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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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
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 several employment-based civilian mandates issued to date by the executive branch
directed at (1) most Medicare- and Medicaid-certified providers and suppliers; (2) employers with
100 or more employees; (3) federal executive agency civilian employees; (4) federal contractors
for executive departments, agencies, and offices; and (5) staff of the Head Start program,21 before
reviewing the extent of Congress’s constitutional authority under the Spending and Commerce
Clauses to potentially mandate vaccination.22

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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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
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

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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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
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

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).
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protection claims against vaccination mandates, giving considerable deference to the states’ use of
their police power to require immunizations to protect public health.41
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

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.
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
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purposes of the Free Exercise Clause,” the Court explained, depends on “the asserted government
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

Court’s non-merits versus merits decisions, see infra note 111.
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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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
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
Two states—California and Louisiana—and the District of Columbia announced in 2021 plans to
add COVID-19 vaccination to their lists of required student vaccinations.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

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 See 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/; Letter from John Bel Edwards, Governor, to Hon. Lawrence A. Bagley,
Chairman of La. House Comm. on Health & Welfare (Dec. 14, 2021), https://gov.louisiana.gov/assets/docs/
househealthletter.pdf; Press Release, Council of the D.C., Student COVID Vaccine Mandate, Ward Redistricting
Receive Final Council Approval (Dec. 22, 2021), https://dccouncil.us/student-covid-vaccine-mandate-ward-
redistricting-receive-final-council-approval/.
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
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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
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

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).
66 See, e.g., Klaassen, 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.
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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
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

74 16 F.4th 20, 28 (2021).
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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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
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

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.
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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
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,
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 rejected applications to stay the Maine and New York emergency rules at
issue in Does and We the Patriots, allowing for their implementation.92 In February 2022, the
Court also denied the Does plaintiffs’ petition for certiorari.93
Federal Authority to Mandate Vaccination
Like state vaccination requirements, federal vaccination requirements are government actions
subject to constitutional constraints.94 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.95 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.96 Depending on the circumstances, the requirements may also be subject to

90 Id. at 289.
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 Does 1–3 v. Mills, 142 S. Ct. 1112 (2022).
94 See, e.g., Pub. Util. Comm’n of D.C. v. Pollak, 343 U.S. 451, 461 (1952).
95 See Nolan & Lewis, supra note 18, at 1.
96 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”).
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statutory requirements under the Administrative Procedure Act (APA), the Religious Freedom
Restoration Act of 1993 (RFRA),97 or other context-specific statutory limits.98
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,99 military,100 and certain federal health care employment contexts.101 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.102 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)103—to make and enforce regulations necessary “to
prevent the introduction, transmission, or spread of communicable diseases from foreign

97 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.
98 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.
99 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.
100 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.
101 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.
102 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”).
103 See Legal Authorities for Isolation and Quarantine, CTRS. FOR DISEASE CONTROL & PREVENTION (Feb. 24, 2020),
https://www.cdc.gov/quarantine/aboutlawsregulationsquarantineisolation.html.
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countries into the States or possessions, or from one State or possession into any other State or
possession.”104 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.”105 Based on this statutory text, some have
argued that a broad construction of CDC’s Section 361(a) authority may permit CDC to issue
regulations requiring vaccination in circumstances that would prevent the foreign or interstate
transmission of COVID-19.106
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.107
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 orders108—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).”109 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.”110
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.111 Characterizing the enumerated measures under
Section 361(a) as measures “directly relate[d] to preventing the interstate spread of disease by

104 42 U.S.C. § 264(a).
105 Id. § 264(a).
106 See Robertson, supra note 102, at 566.
107 85 Fed. Reg. 55,292, 55,296 (Sept. 4, 2020).
108 As discussed infra in note 111 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.
109 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).
110 Tiger Lily, LLC v. U.S. Dep’t of Hous. & Urb. Dev., 992 F.3d 518, 521, 524 (6th Cir. 2021).
111 141 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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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.
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) most Medicare- and Medicaid-
certified providers and suppliers (CMS’s Medicare/Medicaid provider mandate);112 (2) employers
with 100 or more employees (OSHA’s large-employer vaccination and testing mandate);113
(3) federal executive agency civilian employees (federal employee mandate);114 (4) federal
contractors for executive departments, agencies, and offices (federal contractor mandate);115 and
(5) staff of the Head Start program, which provides comprehensive early childhood education and
development services to low-income children (Head Start mandate).116 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.117 (See Table 1 for a summary of these mandates.)
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, 2022.118 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.119 The mandate does not apply to other health care

112 86 Fed. Reg. 61,555 (Nov. 5, 2021).
113 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.
114 Exec. Order No. 14,043 of Sept. 9, 2021, 86 Fed. Reg. 50,989 (Sept. 14, 2021).
115 Exec. Order No. 14,042 of Sept. 9, 2021, 86 Fed. Reg. 50,985 (Sept. 14, 2021).
116 86 Fed. Reg. 68,052 (Nov. 30, 2021).
117 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.
118 86 Fed. Reg. 61,555, 61,563, 61,573 (Nov. 5, 2021).
119 Id. at 61,556.
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entities such as physician offices, organ procurement organizations, and portable X-Ray
suppliers.120
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).121 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.122 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.123
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.124 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).125 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.126
CMS relied on several layers of statutory authorities in issuing the IFR.127 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.128 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.129 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

120 Id.
121 Id. at 61,570–61,571.
122 Id. at 61,571.
123 Id. at 61,574.
124 Id. at 61,586.
125 Id.
126 Id. at 61,583–61,584, 61,586.
127 Id. at 61,567.
128 42 U.S.C. § 1302(a).
129 Id. § 1395hh(a).
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finds necessary to protect the health and safety of individuals who receive services from the
relevant entities.130
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.131 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.132 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.133
Later in the same month, however, two district courts—in Missouri v. Biden and Louisiana v.
Becerra—granted the plaintiffs’ motions for preliminary injunctions in each respective case.134
The Missouri court enjoined the IFR in 10 plaintiff states, while the Louisiana court enjoined the
rule in the remaining states.135 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;136 the agency likely lacked “good
cause” to waive notice-and-comment rulemaking procedures;137 and the plaintiffs sufficiently
demonstrated they would suffer irreparable harm—including in the form of significant staffing
shortages—if the IFR was not enjoined.138 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 the injunction to the 14 plaintiff states.139 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.140 As of December 31,
2021, CMS was 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

130 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).
131 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).
132 Florida, 2021 WL 5416122, at *1.
133 Id. at *3–4.
134 Missouri, 2021 WL 5564501, at *15; Louisiana, 2021 WL 5609846, at *17.
135 Missouri, 2021 WL 5564501, at *15; Louisiana, 2021 WL 5609846, at *17.
136 See Missouri, 2021 WL 5564501, at *3; Louisiana, 2021 WL 5609846, at *10-11.
137 See Missouri, 2021 WL 5564501, at *5–6; Louisiana, 2021 WL 5609846, at *8–9.
138 See Missouri, 2021 WL 5564501, at *12–13; Louisiana, 2021 WL 5609846, at *16.
139 Louisiana v. Becerra, 2021 WL 5913302, at *2–3 (5th Cir. Dec. 15, 2021).
140 Texas v. Becerra, 2021 WL 5964687, at *16.
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preliminary injunction in the 14 plaintiff states—concluded the government had not sufficiently
demonstrated that the rule fell within the agency’s statutory authority.141
On this issue, a divided panel of the U.S. Court of Appeals for the Eleventh Circuit (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.142 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.143 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.”144 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.”145 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.”146 The dissent’s analysis, on the other hand, largely echoes that of
the district courts in Missouri and Louisiana.147
On December 30, 2021, CMS announced that the IFR would be implemented and enforced, on a
modified timeline, in the jurisdictions not subject to the preliminary injunctions in Missouri,
Louisiana, and Texas.148 The deadline to receive the first dose of a vaccine was extended to
January 27, 2022, and the deadline to complete the vaccination series was extended to February
28, 2022.149
The government filed an application with the Supreme Court seeking to stay the preliminary
injunctions in both Louisiana and Missouri. On January 13, 2022, the Supreme Court granted the
application.150 Among other determinations, the Court concluded that the IFR “fits neatly” within
the Secretary’s statutory authority to impose necessary conditions to protect the “health and
safety” of patients served by the relevant providers and suppliers, as well as the Secretary’s
general authority to issue necessary regulations to support the “efficient administration” of
Medicare and Medicaid.151

141 See Louisiana, 2021 WL 5913302, at *1.
142 Florida v. Dep’t of Health & Human Servs., 2021 WL 5768796, at *12.
143 Id.
144 Id.
145 Id.
146 Id.
147 Id. at 24.
148 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).
149 Id.
150 Biden v. Missouri, 142 S. Ct. 647 (2022) (per curiam).
151 Id. at 652. The Court acknowledged that not all statutory provisions invoked by CMS contain the “health and
safety” statutory language. See id. at n.*. It explained, however, that facilities not subject to the statutory language
represent less than 3% of the workers covered by the rule, and that the pertinent statutory language “may be read as
incorporating the ‘health and safety’ authorities applicable to the other 97%.” Id. The Court thus saw no reason to let
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In so concluding, the Court rejected the dissent’s view that the Secretary’s authority under these
provisions is limited to issuing “bureaucratic rules regarding the technical administration of
Medicare and Medicaid”; it also rejected the dissent’s view that the catchall authority to issue
necessary “health and safety” regulations is limited to measures similar to the enumerated
“administrative requirements”—such as maintaining clinical records on all patients or providing
24-hour nursing service—that precede the catchall provision.152 In the Court’s view, such a
limited construction is inconsistent with the Secretary’s historical and ongoing use of this
authority to impose “a host of conditions” that address the safe and effective provision of health
care, as well as the qualifications and duties of health care workers themselves.153 This
“longstanding litany” of health-related participation conditions, the Court concluded, amply
illustrates the Secretary’s authority to address infection problems in Medicare and Medicaid
facilities.154 Given that vaccination requirements for health care workers are “a common feature
of the provision of healthcare in America” and a well-recognized means of infection control in the
health care setting, a vaccination mandate—even though it “goes further than what the Secretary
has done in the past to implement infection control”—nevertheless falls within the Secretary’s
statutory authority, particularly given the COVID-19 pandemic’s unprecedented scale and
scope.155
As of January 19, 2022, the IFR was in effect nationwide. Following the Court’s decision, CMS
issued an updated guidance on the IFR for the 24 states previously subject to the preliminary
injunctions in Missouri and Louisiana.156 In these states, covered staff must receive the first dose
of a vaccine by February 14, 2022, and complete the vaccination series by March 15, 2022.157 On
January 20, 2022, CMS issued an updated guidance on the IFR for Texas, after the district court
granted the state’s request to voluntarily dismiss Texas. In Texas, covered staff must receive the
first dose of a vaccine by February 22, 2022, and complete the vaccine series by March 21,
2022.158
Since the Supreme Court’s order issued, both Missouri and Louisiana have been remanded to the
district courts where the government has sought, or is expected to seek, dismissal of the cases.
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

the 3% “wag the . . . dog.” Id.
152 See id. at 652, 657.
153 Id. at 652–53.
154 Id. at 653.
155 Id.
156 CTRS. FOR MEDICARE & MEDICAID SERVS., CTRS. FOR CLINICAL STANDARDS AND QUALITY/QUALITY, SAFETY &
OVERSIGHT GRP., GUIDANCE FOR THE INTERIM FINAL RULE – MEDICARE AND MEDICAID PROGRAMS; OMNIBUS COVID-
19 HEALTH CARE STAFF VACCINATION (Jan. 14, 2022), https://www.cms.gov/files/document/qso-22-09-all-injunction-
lifted.pdf.
157 Id. at 3.
158 CTRS. FOR MEDICARE & MEDICAID SERVS., CTRS. FOR CLINICAL STANDARDS AND QUALITY/QUALITY, SAFETY &
OVERSIGHT GRP., GUIDANCE FOR THE INTERIM FINAL RULE – MEDICARE AND MEDICAID PROGRAMS; OMNIBUS COVID-
19 HEALTH CARE STAFF VACCINATION 3 (Jan. 20, 2022), https://www.cms.gov/files/document/qso-22-11-all-injunction-
lifted.pdf. Pursuant to the guidance, the deadline to receive the first dose is adjusted to next business day because the
end of the applicable 30-day period, February 19, 2022, falls on a federal holiday weekend. See id. at 3 n.2.
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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.159 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.160 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)161 or that compliance with the other mandate is deemed
sufficient to meet the employers’ obligations under the ETS (in the case of executive agencies).162
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.163 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.164 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.165 Covered employers
can, but are not required to, pay for any costs associated with testing,166 but they must provide
employees with paid leave to receive and recover from the vaccination.167 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, 2022.168 After that, all covered employers must ensure that employees who are not
fully vaccinated are subject to regular COVID-19 testing.169 Noncompliant covered employers
could face OSHA citations and civil monetary penalties.170

159 86 Fed. Reg. 61,402, 61,552 (Nov. 5, 2021) (adding 29 C.F.R. § 1910.501(d)).
160 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.
161 See 86 Fed. Reg. 61,402, 61,447 (Nov. 5, 2021).
162 See id. at 61,402.
163 See id. at 61,553 (adding 29 C.F.R. § 1910.501(g)).
164 See id. at 61,553 (adding 29 C.F.R. § 1910.501(g)(ii)).
165 See id. at 61,419.
166 See id. at 61,553 (Note 1 to paragraph (g)(1)).
167 See id. at 61,553 (adding § 1910.501(f)).
168 See id. at 61,554 (adding § 1910.501(m)(2)).
169 See id.
170 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.
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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)).171 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.”172 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.173 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.174
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.175 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.176
On November 12, 2021, the Fifth Circuit affirmed the stay, largely based on its conclusion that
the ETS “grossly exceeds OSHA’s statutory authority.”177 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.178 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
in society and “non-life-threatening to a vast majority of employees.”179 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.180 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

171 86 Fed. Reg. 61,402, 61,402 (Nov. 5, 2021).
172 29 U.S.C. § 655(c)(1).
173 See 86 Fed. Reg. 61,402, 61,402–61,403 (Nov. 5, 2021).
174 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.
175 See BST Holdings, LLC v. Occupational Safety & Health Admin., 17 F. 4th 604, 610 (5th Cir. 2021).
176 See id.
177 Id. at 612.
178 Id. at 613.
179 Id.
180 Id. at 613–14.
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America without an attempt to account for differences in COVID-19 exposure—and
underinclusive—disregarding workplaces with 99 or fewer employees.181
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.182
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.183 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.184
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.185 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.186 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.187 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.”188 Because “no virus—HIV,
[hepatitis B], COVID-19—is unique to the workplace and affects only workers,” the court
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.”189 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.”190
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

181 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 195, the Sixth Circuit
disagreed with this conclusion.
182 28 U.S.C. § 2112(a)(4).
183 2021 WL 5989357, at *1 (6th Cir. Dec. 17, 2021).
184 Id. at *5–6.
185 Id. at *4.
186 Id. (citing, for instance, 29 U.S.C. §§ 651(a), 651(b)(1), 669(a)(5)).
187 Id. at *5.
188 Id. at *6.
189 Id.
190 Id. at *7.
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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.”191 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.”192
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.193 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.194 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.”195
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.196 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
purposes of Section 6(c).197 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.198 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

191 Id. at *8, 10–16.
192 29 U.S.C. § 655(f).
193 In re MCP No. 165, Occupational Safety & Health Admin., Interim Final Rule: COVID-19 Vaccination and
Testing, 2021 WL 5989357, at *10–13 (6th Cir. 2021).
194 Id. at *14.
195 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.
196 See id. at 22.
197 Id. at *23–24.
198 Id. at *25.
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precision the total number of workers in our nation who have contracted COVID-19 at work.”199
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.”200 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.”201
Following the Sixth Circuit’s dissolution of the stay, several petitioners filed an application with
the Supreme Court seeking to stay the ETS. On January 13, 2022, the Supreme Court, in National
Federation of Independent Business (NFIB) v. Department of Labor, granted the application and
stayed enforcement of the ETS once again.202 The Court concluded a stay was warranted because
the applicants were likely to succeed on the merits of their claim that the ETS exceeded OSHA’s
statutory authority.203 According to the Court, because the ETS applies to roughly 84 million
workers across industries, it undoubtedly qualifies as an exercise of authority “of vast economic
and political significance.”204 Such a use of authority would only be permissible, the Court found,
if “plainly authorize[d]” by the OSH Act.205 In the Court’s view, however, the OSH Act
authorizes the agency “to set workplace safety standards, not broad public health measures.”206
Because the ETS does not distinguish between (1) workplaces that pose a heightened risk of
COVID-19 exposure based on a job’s particular features or the nature of the workplace and
(2) workplaces that pose a generalized exposure risk that is not different in kind from the risk
presented by other nonwork settings in which people gather, the Court concluded it was an
impermissible general public health measure, rather than a permissible occupational safety or
health standard.207 Allowing OSHA to regulate the hazards of daily life untethered to occupation-
specific risks, in the Court’s view, would significantly expand OSHA’s authority without “clear
congressional authorization.”208 This conclusion was bolstered by the fact that OSHA never
before adopted a regulation that was similarly untethered causally from the workplace.209
The Court clarified, however, that OSHA may exercise more targeted authority to address
workplaces that face a heightened risk of contracting COVID-19 beyond the everyday risk that all
workplaces face.210 As examples, the Court stated that “OSHA could regulate researchers who
work with the COVID-19 virus” or “regulate risks associated with working in particularly
crowded or cramped environments.”211
On January 25, 2022, OSHA announced that the agency was withdrawing the ETS as an
enforceable emergency temporary standard.212 The agency, however, further noted it was not

199 Id. at *26 (quoting 86 Fed. Reg. at 61,424).
200 Id. at *27.
201 Id.
202 142 S. Ct. 661, 662 (2022) (per curiam).
203 Id. at 664–65.
204 Id. at 662, 665.
205 Id. at 665.
206 Id.
207 Id.
208 Id.
209 Id.
210 Id. at 665–66.
211 Id.
212 See COVID-19 Vaccinationa nd Testing ETS, OCCUPATIONAL SAFETY & HEALTH ADMIN., https://www.osha.gov/
coronavirus/ets2 (last accessed Feb. 4, 2022).
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withdrawing the ETS as a proposed rule, but was prioritizing its resources to focus on finalizing a
permanent COVID-19 Healthcare Standard.213 On February 18, 2022, the Sixth Circuit granted
the government’s motion to dismiss the consolidated proceedings as moot in light of OSHA’s
withdrawal of the ETS.214
The different results reached by the Supreme Court in NFIB, as to the OSHA ETS, and in
Missouri, as to the CMS IFR, highlight the contextual nature of statutory interpretation. Although
the statutory provisions at issue in both cases, at a high level of generality, authorize both
agencies to issue certain health and safety regulations governing regulated entities, the different
language, context, and scope of the two statutory schemes—as well as the scope of the rules at
issue—appear to have contributed to the different case outcomes. In Missouri, the Court approved
the vaccination requirement as fitting neatly within a general statutory authority to issue “health
and safety” regulations—or perhaps even a broader authority to “administer” Medicare and
Medicaid—when the requirement is imposed on a single, heavily regulated industry that faces a
recognized, heightened risk of exposure to COVID-19 and in which vaccination requirements—
even though never federally required before—are generally a common requirement in the
industry.215 In concluding that relevant statutory authorities plainly authorized the vaccination
requirement, the Court gave significant weight to the numerous, detailed, health and safety-
related federal requirements, including those related to infectious disease control, that the
Secretary of HHS already imposes on these regulated entities.216
By contrast, in NFIB, the Court invalidated the vaccination-and-testing requirement as not
“plainly” authorized by a general statutory authority to protect “employees” exposed to grave
danger from a physically harmful agent when the requirement—though less stringent than the
CMS vaccination requirement—is imposed across all industries by an agency that historically has
not issued a regulation of this scale before. According to the Court, this “lack of historical
precedent, coupled with the breadth of authority that the Secretary [of Labor] now claims, is a
telling indication that the mandate extends beyond the agency’s legitimate reach.”217
These cases tend to suggest that in considering whether an applicable statutory provision
“clearly” authorizes the agency to impose an unprecedented requirement (e.g., vaccination) on
regulated entities to address an unprecedented circumstance (e.g., the pandemic), some of the
factors that may inform this determination include the scope of the rule, whether it targets specific
sectors or entities, the extent to which the targeted entities have been subject to other health-
related regulations by the applicable agency, and whether vaccination requirements are a common
requirement within the relevant sectors.218 As litigation concerning other federal vaccination
mandates continue, courts may provide further insight or clarification on the relevant statutory
analysis.

213 See id.
214 In re MCP No. 165, Occupational Safety & Health Admin., Interim Final Rule: COVID-19 Vaccination and
Testing, Order, ECF. No. 153, No. 21-4027 (6th Cir. Feb. 18, 2022).
215 Biden v. Missouri, 142 S. Ct. 661, 652–53 (2022) (per curiam).
216 Id. (citing “a host of [regulatory] conditions that address the safe and effective provision of healthcare” and
“longstanding litany of health-related participation conditions”).
217 Nat’l Fed. of Ind. Bus. (NFIB) v. Dep’t of Labor, 142 S. Ct. 661, 666 (2022) (per curiam) (quoting Free Enterp.
Fund v. Pub. Co. Acct. Oversight Bd., 561 U.S. 477, 505 (2010)) (internal quotation marks omitted).
218 See Missouri, 142 S. Ct. at 652–53; NFIB, 142 S. Ct. at 662–66.
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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.219 The federal employee mandate directs the Safer Federal
Workforce Task Force (Task Force) to issue guidance on this requirement’s implementation.220
The mandate is based on the President’s statutory authority under 5 U.S.C. §§ 3301, 3302, and
7301.221 These provisions grant the President general authority to prescribe rules and/or
regulations for executive branch employees.222
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, 2021.223 The vaccination requirement applies to employees who
are under maximum telework or remote-work arrangements.224 Employees who refuse to be
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.225 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.226
Several federal employees and at least one employee union have sued to challenge the federal
employee mandate.227 These suits raise a variety of claims, including some claims common to
challenges to state vaccination requirements.228 As discussed above, courts have generally
rejected these claims.229
In several cases filed before the compliance deadline, plaintiffs also asserted several claims
specific to the federal employee mandate. 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.230 In a November 2021 decision, however, the district court

219 86 Fed. Reg. 50,989, 50,990 (Sept. 14, 2021).
220 Id.
221 Id. at 50,989.
222 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”).
223 See FAQs – Vaccinations: Vaccination Requirement for Federal Employees, SAFER FEDERAL WORKFORCE TASK
FORCE, https://www.saferfederalworkforce.gov/faq/vaccinations/ (last accessed Dec. 7, 2021).
224 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”).
225 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).
226 See id.
227 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).
228 See, e.g., Brnovich Second Amended Complaint, supra note 227, ¶¶ 47, 55–57.
229 See supra note 66 and accompanying text.
230 See Order Denying Emergency Application for Temporary Restraining Order and Mot. for Preliminary Injunction,
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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.231 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.232 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.”233
Following the expiration of the compliance deadline, the White House stated that as of December
8, 2021, the federal government achieved 97.2% compliance with the mandate, with 92.5% of
employees having received at least one COVID-19 vaccination dose. For employees who had not
yet complied, agencies were undertaking the first step in the enforcement process with education
and counseling.234 On December 21, 2021, before agencies began to implement additional
enforcement actions, a nonprofit federal employee organization, a federal employee union, and
several individual federal employees filed suit to challenge the mandate on various grounds,
including that the mandate exceeds the President’s statutory authority.
On January 21, 2022—the earliest date on which the government informed the court that
noncompliant employees would face disciplinary actions—the district court, in Feds for Medical
Freedom v. Biden, granted the plaintiffs’ request for preliminary injunction and suspended
enforcement of the federal employee vaccination mandate nationwide.235 Among other
determinations, the court concluded the mandate likely exceeded the President’s statutory
authorities under 5 U.S.C. §§ 3301, 3302, and 7301, as well as his constitutional authority over
the executive branch under Article II of the Constitution.236 Specifically, according to the court,
§ 3301, by its own terms, applies only to civil service “applicants” and could not be invoked to
impose requirements on current federal employees; the rules the President may prescribe
governing the competitive service under § 3302 are limited to providing necessary exceptions to
certain Title 5 requirements, such as certain reporting, examination, and antidiscrimination
requirements.237
Relying on the Supreme Court’s OSHA ETS decision in NFIB, the district court further
concluded that the President’s authority under § 7301 to “prescribe regulations for the conduct of
employees in the executive branch” is limited to regulating “workplace conduct.”238 Because, in
the court’s view, COVID-19 presents a “universal risk” and not a workplace risk under NFIB, the

ECF No. 17, Church v. Biden, No. 1:21-cv02815 (D.D.C. Nov. 8, 2021).
231 See id. at 1.
232 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).
233 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).
234 See Update on Implementation of COVID-19 Vaccination Requirement for Federal Employees, WHITE HOUSE (Dec.
9, 2021), https://www.whitehouse.gov/omb/briefing-room/2021/12/09/update-on-implementation-of-covid-
%E2%81%A019-vaccination-requirement-for-federal-employees/.
235 No. 3:21-cv-356, 2022 WL 188329, *7 (S.D. Tx. Jan. 21, 2022).
236 Id. at *5–6.
237 Id. at *5.
238 Id. (alteration in original).
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mandate falls outside of the President’s § 7301 authority.239 Applying similar reasoning, the court
further concluded that the mandate exceeds the President’s constitutional authority over federal
officials under Article II because to conclude otherwise would grant the President unlimited
power over federal employees “in [and] out of the workplace.”240
It is unclear whether other courts would agree that the Supreme Court’s reasoning in NFIB
applies directly to the federal employee mandate. Unlike the OSHA ETS, which implicates a
workplace safety statutory scheme that authorizes an agency to regulate third-party employers,
the federal employee mandate concerns the federal government’s authority, as an employer itself,
to set the conditions of employment for its workforce. In general, employers—unless specifically
prohibited by applicable state law—may impose vaccination requirements as a condition of
employment, subject to constraints under federal antidiscrimination laws.241
During the pandemic, many workplaces—including both private and public state employers—
have in fact imposed such requirements,242 which have withstood legal challenges.243 Through
this lens, the scope of the federal employee mandate could be characterized as a work rule or
condition of employment implemented by a single employer. Given this limited scope, and absent
clearer statutory language stating otherwise, some courts may consider it more reasonable to
construe the relevant general grant of authority—including the authority to regulate “the conduct
of employees” under 5 U.S.C. § 7301—as encompassing no less authority than other employers
enjoy in imposing work rules or conditions during the pandemic,244 particularly given the
Supreme Court’s prior acknowledgment that the federal government “has a much freer hand in
dealing with citizen employees than it does when it brings its sovereign power to bear on citizens
at large.”245 At least one judge expressed the view that the federal employee mandate also falls
within the President’s Article II duty to “take Care that the Laws be faithfully executed.”246 In his
view, discharging such duties as “CEO of the federal workforce,” the President issued the
mandate to ensure, for instance, the continued provision of vital governmental services by
agencies such as the Transportation Security Administration.247
On April 7, 2022, a divided panel of the Fifth Circuit vacated the district court’s preliminary
injunction without reaching the question on the merits concerning the President’s authority to
issue the federal employee mandate.248 Instead, the court held, as a threshold matter, the district

239 Id.
240 Id. at *6.
241 See Anderson & Killion, supra note 15.
242 See, e.g., Chris Isidore, Most Major Employers Are Keeping Vaccine Mandate for Workers, Despite Supreme Court
Ruling, CNN (Jan. 26, 2022), https://www.cnn.com/2022/01/26/business/employer-vaccine-mandates/index.html;
Haley Messenger, From McDonald’s to Goldman Sachs, Here are the Companies Mandating Vaccines for All or Some
Employees, NBCNEWS (Nov. 16, 2021), https://www.nbcnews.com/business/business-news/here-are-companies-
mandating-vaccines-all-or-some-employees-n1275808.
243 See, e.g., supra “State COVID-19 Vaccination Mandates and Related Litigation.”
244 See Feds for Med. Freedom v. Biden, 25 F. 4th 354, 358 (5th Cir. 2022) (Higginson, J., dissenting); cf. Nat’l Fed. of
Ind. Bus. v. Dep’t of Labor, 142 S. Ct. 661, 665 (2022) (per curiam) (declining to construe OSHA’s authority in a
manner that would significantly expand the agency’s authority “without clear congressional authority”); Biden v.
Becerra, 142 S. Ct. 647, 653 (2022) (per curiam) (affirming the Secretary of HHS’s statutory authority to impose
CMS’s Medicare/Medicaid provider mandate, in part because “[v]accination requirements are a common feature of the
provision of healthcare in America”).
245 See Nat’l Aeronautics & Space Admin. v. Nelson, 562 U.S. 134, 148 (2011).
246 Feds for Med. Freedom, 25 F. 4th at 358.
247 See id.
248 Feds for Med. Freedom v. Biden, 30 F. 4th 503, 504 (5th Cir. 2022).
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court lacked subject matter jurisdiction under the Civil Service Reform Act of 1978 (CSRA) to
consider the case.249 The CSRA, according to the court, established “the comprehensive and
exclusive procedures for settling work-related controversies between federal civil-service
employees and the federal government,” including an “elaborate” remedial scheme that specified
the manner by which federal employees may obtain administrative and judicial review of
specified adverse employment actions.250 In light of this remedial scheme, the Fifth Circuit
rejected plaintiffs’ argument that the CSRA does not apply until the plaintiffs suffer an adverse
employment action, agreeing with the government that such an interpretation “would allow
federal employees to circumvent the CSRA by filing suit before their employer disciplines or
discharges them, thereby ‘gutting the statutory scheme.’”251 Accordingly, the court concluded that
the CSRA provided the exclusive avenue for judicial review of the federal employee mandate:
once an employing agency finalizes an adverse action, the aggrieved employee may appeal to the
Merit Systems Protection Board (MSPB), and an employee who is dissatisfied with the MSPB’s
decision is entitled to judicial review in the U.S. Court of Appeals for the Federal Circuit, which
has exclusive jurisdiction over such appeals and is “fully capable of providing meaningful
review.”252 For these reasons, the Fifth Circuit concluded that the district court lacked subject
matter jurisdiction over the plaintiffs’ action and directed the district court to dismiss the case.253
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.254 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
exceptions required by law.255 Covered contractor-employees include those working on or in
connection with a covered contract or working at a covered contractor workplace.256 Covered
contractor-employees working remotely are subject to the vaccination requirements.257
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.258 Generally, new contracts awarded on or

249 Id.
250 Id. at 506–07 (citing Rollins v. Marsh, 937 F.2d 135, 139 (5th Cir. 1991)).
251 Id. at 508 (internal alterations omitted) (quoting Elgin v. Dep’t of Treasury, 567 U.S. 1, 11 (2012)).
252 Id. at 508–11.
253 Id. at 504. As of the publication date of this updated report, the district court has not issued an order implementing
the Fifth Circuit’s opinion because the appellate court has not yet issued the mandate terminating its jurisdiction.
Consistent with the applicable procedural rules under FED. R. APP. P. 40(a) and 41(b), the Fifth Circuit stated that it will
issue the mandate on May 31, 2022.
254 Exec. Order No. 14,042 of Sept. 9, 2021, 86 Fed. Reg. 50,985, 50,985 (Sept. 14, 2021).
255 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].
256 Id. at 3.
257 See FAQs – Federal Contractors: Workplaces, SAFER FEDERAL WORKFORCE TASK FORCE, https://www.
saferfederalworkforce.gov/faq/contractors/ (last accessed Dec. 7, 2021).
258 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).
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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.259 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.260 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.261
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. § 121.262 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,263 the purpose of which is to provide “an economical and efficient system” for, among
other objectives, federal procurement.264 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.265 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.”266
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
and efficiency in Federal contracting.”267 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.268 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.269 The Council issued the guidance on September 30, 2021.270
More than 20 states, on behalf of their state agencies and political subdivisions that may have a
contract subject to the federal contractor mandate, have filed at least four separate suits in

259 See id.
260 TASK FORCE FEDERAL CONTRACTOR GUIDANCE, supra note 255, at 5.
261 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.
262 See 86 Fed. Reg. 50,985, 50,985 (Sept. 14, 2021).
263 40 U.S.C. § 121(a).
264 Id. § 101.
265 86 Fed. Reg. 50,985, 50,985 (Sept. 14, 2021).
266 Id.
267 Id. at 50,985–50,986.
268 See 86 Fed. Reg. 53,691 (Sept. 24, 2021).
269 86 Fed. Reg. 50,985, 50,986 (Sept. 14, 2021).
270 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.
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different district courts to challenge the mandate.271 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
litigation is pending.272 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.273 Among other determinations, both district courts concluded that the
President likely exceeded his statutory authority under the Procurement Act in imposing the
vaccination requirement, including because the relevant Procurement Act provisions do not
empower the President to require a public health measure such as a vaccination.274 Since the
nationwide injunction went into effect, several other district courts, including the Western District
of Louisiana, Eastern District of Missouri, the Middle District of Florida, and the District of
Arizona, have further enjoined the mandate in certain states.275
The government 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.276 Among other
determinations, the Sixth Circuit agreed with the district court that the federal contractor mandate
likely exceeded the President’s statutory authority.277 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.278
In contrast to the Sixth Circuit’s arguably narrow construction, which appears to preclude the
President from regulating any post-contract conduct by federal contractors, other courts that have
assessed the validity of federal contractor requirements under the Procurement Act have arguably
interpreted the President’s Procurement Act authorities more broadly. Applying a lenient,
rational-basis-like standard, those courts have upheld the validity of executive orders that have “a
‘sufficiently close nexus’ to the values of providing the government an ‘economical and efficient’
system for . . . procurement and supply.”279 Past court decisions, for example, have upheld the
President’s use of Procurement Act authority to prohibit federal contractors from discriminating
against any employees or applicants for employment because of race, creed, color, or national
origin;280 require contractors to adopt certain wage and price standards;281 require contractors to
adopt an electronic employment verification system to confirm the eligibility of employees to

271 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).
272 Kentucky, 2021 WL5587446, at *13–14.
273 Georgia, 2021 WL 5779939, at *12.
274 Kentucky, 2021 WL5587446, at *6–7; Georgia, 2021 WL 5779939, at *10.
275 See Louisiana v. Biden, 2021 WL 5986815 (W.D. La. Dec. 16, 2021); Missouri v. Biden, 2021 WL 5998204 (E.D.
Mo. Dec. 20, 2021); State v. Nelson, 2021 WL 6108948 (M.D. Fla. Dec. 22, 2021); Brnovich v. Biden, 2022 WL
252396 (D. Ariz. Jan. 27, 2022).
276 Kentucky v. Biden, No. 21-6147, 2022 WL 43178, at *1 (6th Cir. Jan. 5, 2022).
277 Id. at *11–16.
278 Id. at *12.
279 UAW-Labor Emp. & Training Corp. v. Chao, 325 F.3d 360, 366 (D.C. Cir. 2003).
280 See Farkas v. Tex. Instrument, Inc., 375 F.2d 629, 632 n.1 (5th Cir. 1967).
281 See Am. Fed. of Labor & Cong. of Indus. Orgs. v. Kahn, 618 F.2d 784, 792–94 (D.C. Cir. 1979).
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work in the United States;282 and require contractors to post certain public notices informing
employees that they could not be forced to join a union.283
Under the more lenient standard, courts at times upheld requirements despite an arguably
“attenuated” link between such a requirement and economy and efficiency in federal
procurement, deferring instead to the President’s judgment.284 In the case involving the public
notice requirement, for instance, the D.C. Circuit accepted the President’s rationale that the
requirement would promote economy and efficiency in federal procurement because “[w]hen
workers are better informed of their rights . . . their productivity is enhanced[,] [and] [t]he
availability of such a workforce from which the United States may draw facilitates the efficient
and economical completion of its procurement contracts.”285 Acknowledging that the link “may
seem attenuated,” particularly because unions already had a duty to inform employees of these
rights, the court nevertheless upheld the requirement under the more lenient standard.286 In
contrast to the public notice requirement in that case, there is arguably a stronger link between the
vaccination requirement—a regulation of the contractors’ employment practices—and economy
and efficiency in federal procurement, given the pandemic’s significant impact on workplace
operations and absenteeism.287
The government’s appeal in Georgia is pending before the Eleventh Circuit.288 Among other
issues, the parties’ briefs addressed not only pre-pandemic case law on the Procurement Act, but
also the application of the Supreme Court’s decisions in NFIB and Missouri to the federal
contractor mandate. According to the government, like the CMS mandate, which was an
implementation of the HHS Secretary’s “longstanding practice” of imposing federal health-
related requirements under the Medicare and Medicaid statutes, the federal contractor mandate
reflected a “longstanding practice” by Presidents to use their Procurement Act authority to issue
executive orders directed at improving the economy and efficiency of contractors’ operations.289
As examples of prior, similar uses of the Presidents’ Procurement Act authority, the government
pointed to the antidiscrimination requirements for contractors, the required use of an electronic
employment verification system, as well as a requirement on contractors to provide employees
with paid sick leave.290 Thus, according to the government, under Missouri and prior cases in
which courts of appeals have applied the lenient standard to afford Presidents “necessary
flexibility and broad-ranging authority” in setting procurement policies, the federal contractor
mandate reflects the required nexus to the statutory objective of “an economical and efficient
system” for contracting and procurement, given the mandate would, as the President determined,
reduce absenteeism and improve efficiency of contractors at sites where they are performing work
for the federal government.291

282 Chamber of Commerce v. Napolitano, 648 F. Supp. 2d 726, 736–38 (D. Md. 2009).
283 UAW-Labor Emp., 325 F.3d at 366–67.
284 See id.
285 See id.
286 See id.
287 See id.
288 See Georgia v. Biden, No. 21-14269 (11th Cir. filed Dec. 10, 2021).
289 See Brief for Appellants at 15–16, Georgia v. Biden, No. 21-14269 (11th Cir. Jan. 18, 2022).
290 See id.
291 See id. at 20.
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The state plaintiffs, in contrast, argued that the President’s Procurement Act authority, consistent
with the Sixth Circuit’s interpretation, is limited to prescribing the federal government’s own
internal procurement policies and does not extend to regulations that would improve the
efficiency of federal contractor operations.292 Moreover, the state plaintiffs argued that the federal
contractor mandate, like the OSHA ETS, was “a significant encroachment in the lives—and
health of a vast number of employees” that “involves billions of dollars of economic activity.”293
Thus, in the state plaintiffs’ view, the Procurement Act, like the OSHA Act, does not provide a
clear grant of authority to impose a vaccination requirement.294
The Eleventh Circuit heard oral argument on the government’s appeal on April 8, 2022. The
government’s appeals of other preliminary injunctions are pending in the Fifth, Eighth, Eleventh,
and Ninth Circuits.
Head Start Mandate
On November 30, 2021, the Office of Head Start within HHS’s Administration for Children and
Families issued an IFR that imposed both vaccination and masking requirements for grantees of
the Head Start program.295 Established in 1965, the Head Start program awards funds directly to
public and private non-profits and for-profits, governmental agencies, and schools to promote
school readiness for infants, toddlers, and preschool-aged children from low-income families,
subject to certain federal performance standards.296 The IFR adds to the federal performance
standards to require all Head Start employees, as well as contractors and volunteers who have
contact with or provide direct services to children (collectively, Head Start staff), to receive a one-
dose COVID-19 vaccine or a two-dose vaccine series by January 31, 2022, subject to legally
required exceptions based on a disability, medical condition, or sincerely held religious belief.297
Those who are granted exceptions are required to undergo weekly COVID-19 testing.298
Additionally, the IFR requires universal masking, with some exceptions, for all individuals two
years of age and older when indoors. For those who are not fully vaccinated, the IFR also requires
masking outdoors if the setting is crowded or involves close contact with others.299
According to the Office of Head Start, the Head Start mandate is based on the Secretary of HHS’s
determination, after consulting with child health experts and CDC and FDA recommendations,
that additional health and safety standards are necessary and appropriate to ensure the reduction
in SARS-CoV-2 transmission; avoid severe illness, hospitalization, and death among program
participants; and reduce program closures, which impose multiple hardships on Head Start
children and families that rely on the program to meet their health, nutrition, and early learning
needs.300 Given the Secretary’s determination that COVID-19 vaccines are the safest and most
effective way to protect individuals and the people with whom they live and work from infection
and severe illness and hospitalization, and the fact that most program participants are too young

292 See Response Brief of State Plaintiffs at 25–26, Georgia v. Biden, No. 21-14269 (11th Cir. Feb. 8, 2022).
293 See id. at 33–34.
294 See id.
295 86 Fed. Reg. 68,052 (Nov. 30, 2021).
296 For more information about the Head Start program, see CRS In Focus IF11008, Head Start: Overview and Current
Issues, by Karen E. Lynch.
297 86 Fed. Reg. 68,502, 68,503 (Nov. 30, 2021).
298 Id.
299 Id.
300 Id. at 68,053–55, 68,056–58.
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to be vaccinated at this time, the Secretary concluded that additional health and safety
standards—in the form of required masking and vaccination among everyone who is eligible—
are the best defenses against COVID-19, especially in light of the spread of the Delta and other
variants.301
The Head Start mandate is based on the Secretary’s authority under Section 641A of the Head
Start Act to “modify, as necessary, program performance standards by regulation applicable to
Head Start agencies and programs,” including “administrative and financial management
standards”; “standards relating to the condition and location of facilities (including indoor air
quality assessment standards, where appropriate) for such agencies, and programs”; and “such
other standards as the Secretary finds to be appropriate.”302 Prior to the IFR, the Secretary has
used this authority to impose standards related to staff health and wellness, including a
requirement that grantees ensure their staff undergo an initial health examination and periodic
reexamination as recommended by their health care provider in accordance with state, local, and
tribal law.303
Following the issuance of the IFR, 25 states, in two separate lawsuits, sued to challenge the Head
Start mandate. In each case, plaintiff states filed a motion for preliminary injunction to block the
mandate while litigation is pending. On December 31, 2021, the district court, in Texas v.
Becerra, granted the motion and enjoined the mandate in Texas.304 The next day, the district court,
in Louisiana v. Becerra, also granted the motion and enjoined the mandate in the 24 plaintiff
states.305 Among other determinations, both courts concluded that the plaintiff states are likely to
succeed on their claim that the mandate exceeds the Secretary’s statutory authority.306
According to the Texas court, the mandate cannot be an “administrative standard” under Section
641A(a)(1)(C) because such standards are limited to those related to executive duties and
management; nor can it be a standard “related to the condition . . . of facilities” because such
standards must relate to physical conditions of buildings and equipment.307 The court further
reasoned that the mandate cannot fall within the Secretary’s catchall authority under Section
641A(a)(1)(E) to modify “such other standards as the Secretary finds to be appropriate” because
such standards refer to “performance standards” that are limited to those that “measure the quality
of Head Start programs” in achieving the program’s purpose to promote school readiness of low-
income children.308 According to the court, because the vaccine and masking mandate does not
measure staff’s ability to enhance children’s development, the mandate cannot be a performance
standard that the Secretary has authority to modify under Section 641A.309 The Louisiana court,
on the other hand, more broadly concluded that the Secretary lacks statutory authority to issue a
vaccination and masking mandate because Section 641A does not specifically authorize him to do
so.310

301 See id.
302 42 U.S.C. § 9836a(a)(1)(C), (D), (E).
303 See 45 C.F.R. § 1302.93(a) (2016); see also 81 Fed. Reg. 61,294, 61,433 (Sept. 6, 2016). Prior iterations of this
requirement were imposed as early as 1996. See 61 Fed. Reg. 57, 186, 57,223 (Nov. 5, 1996).
304 No. 5:21-cv-300, 2021 WL 6198109 (N.D. Tex. Dec. 31, 2021).
305 No. 3:21-cv-4370, 2022 WL 16571 (W.D. La. Jan. 1, 2022).
306 See Texas, 2021 WL 6198109, at *4–8; Louisiana, 2022 WL 16571, *8.
307 Texas, 2021 WL 6198109, at *7.
308 See id.
309 See id.
310 See Louisiana, 2022 WL 16571, at *8–11.
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A few days before the Head Start mandate’s January 31 compliance deadline, four Michigan
school districts filed suit to challenge the mandate in Livingston Educational Service Agency v.
Becerra.311 In contrast to the Texas and Louisiana courts, the district court presiding over
Livingston denied the plaintiffs’ motion for preliminary injunction. The court held that the
mandate “plainly falls within the Secretary’s [Section 641A] authority,” including the authority to
issue necessary administrative standards to safely carry out day-to-day Head Start program
operations; the authority to regulate “the condition and location of facilities” given that COVID-
19 spreads through the air via respiratory droplets; and “the broad grant of authority” given to the
Secretary to issue appropriate standards to promote school readiness in a learning environment.312
This conclusion, according to the district court, is supported by the Supreme Court’s decisions in
NFIB and Missouri. The district court reasoned that the Head Start mandate is more like the CMS
mandate affirmed in Missouri because both mandates “are tailored to protect those who work in
places with or provide services to at-risk individuals—Medicare and Medicaid patients [in the
case of the CMS mandate] and children, often from minority and low income backgrounds, who
are too young to be vaccinated.”313 Like the relevant Medicare and Medicaid statutory authorities
with respect to the CMS mandate that the Secretary had long used to implement federal health-
related regulations for providers and suppliers, the district court noted that the authority under
Section 641A has long been used by the Secretary to implement past health and safety standards
related to the Head Start program. These include standards requiring staff to be screened for
communicable diseases, providing for appropriate treatment of children with HIV, requiring
minimal spacing between infant cribs, and requiring exclusion of children with certain contagious
illnesses.314 Plaintiffs have appealed the district court’s order to the Sixth Circuit.

Table 1. Summary of Federal Nonmilitary COVID-19 Vaccination Mandates
As of February 7, 2022
Covered
Federal
Statutory
Individuals/
Vaccination
Compliance
Mandate
Authority
Entities
Requirement
Deadline(s)
Status
Federal
5 U.S.C. §§ 3301, Federal
Employees must be Receive a one-dose
Enjoined by
Employee
3302, 7301
executive
ful y vaccinated,a
vaccine or two-dose
court.b
Mandate
branch
unless granted a
vaccine series by
(Executive
employees
legally required
November 8, 2021.
Order
exception based
Be ful y vaccinated by
14,043)
on a disability/
November 22, 2021.
medical condition
or a sincerely held
religious belief.
Remote-working
employees are
subject to
requirement.

311 Livingston Educ. Serv. Agency v. Becerra, 2022 WL 660793 (E.D. Mich. Mar. 4, 2022).
312 Id. at *4–5.
313 Id. *6.
314 Id. at *2, *7.
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Covered
Federal
Statutory
Individuals/
Vaccination
Compliance
Mandate
Authority
Entities
Requirement
Deadline(s)
Status
Federal
40 U.S.C. §§ 101
Federal
Covered
As of January 18,
Enjoined by
Contractor
et seq.; 3 U.S.C.
contractors/
contractors must
2022, covered
courts:
(Executive
§ 301
subcontractors
ensure covered
contractor-
Kentucky v.
Order
that have a
contractor-
employees must be
Biden, No. 21-
14,042)
covered
employees are ful y ful y vaccinated on
6147), 2022 WL
contract with
vaccinated, except
the first day of
43178 (6th Cir.
executive
in circumstances
performance on a
Jan. 5, 2022)
departments and where an
new contract or the
(declining to stay
agencies
employee is legally
renewal, extension,
the district
entitled to an
or exercised option
court’s
exemption based
of an existing
preliminary
on a
contract.
injunction in KY,
disability/medical
OH, and TN);
condition or a
sincerely held

religious belief.
Georgia v. Biden,
Remote-working
No. 1:21-cv-
covered
00163 2021 WL
contractor-
5779939 (S.D.
employees are
Ga. Dec. 7, 2021)
subject to
(enjoined the
requirement.
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
Phase 1: (1) covered
In effect.
Medicare/
§§ 1302, 1395hh, provider and
and suppliers must
providers and
Medicaid
and other
supplier types
ensure covered
suppliers must
Provider
provider- or
that participate
staff who directly
establish and begin to
Mandate
supplier-specific
in Medicare and
provide care or
implement the
(CMS IFR)
provisions
Medicaid
other services for
vaccination policies
their facilities
and (2) covered staff
and/or patients are
must receive first
ful y vaccinated,
dose of a two-dose
except in
vaccine or a one-
circumstances
dose vaccine.
where a staff

January 27, 2022
member is legally
(in all other
entitled to an
jurisdictions not
exemption based
listed in bul ets
on a disability/
below)
medical condition
or a sincerely held

February 14,
religious belief.
2022 (in AL, AK,
AZ, AR, GA, ID,
Staff who work
IN, IA, KS, KY,
100% remotely
LA, MS, MO,
from sites of
MT, NE, NH,
patient care or
ND, OH, OK,
away from onsite
SC, SD, UT,
staff are not subject
WV, WY)
to the
requirement.

February 22,
2022 (in TX)
Phase 2: Covered
staff must complete
two-dose vaccine
series by February
28, 2022.

February 28,
2022 (in all
other
jurisdictions not
listed in bul ets
below)

March 15, 2022
(in AL, AK, AZ,
AR, GA, ID, IN,
IA, KS, KY, LA,
MS, MO, MT,
NE, NH, ND,
OH, OK, SC,
SD, UT, WV,
WY)

March 21, 2022
(in TX)
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State and Federal Authority to Mandate COVID-19 Vaccination

Covered
Federal
Statutory
Individuals/
Vaccination
Compliance
Mandate
Authority
Entities
Requirement
Deadline(s)
Status
OSHA’s
29 U.S.C.
In all
A covered
Covered employers
Withdrawn.
Large-
§ 655(c)
jurisdictions,
employer must
must establish and

Employer
private
establish and
begin to implement
Vaccination
employers with
enforce a policy
the vaccination
and Testing
100 or more
that either
policies by January
Mandate
employees.
(1) ensures
10, 2022.
(OSHA ETS)
In 26 states,
employees are ful y Covered employees
Puerto Rico, and vaccinated, except
must receive either a
the U.S. Virgin
in circumstances
one-dose vaccine or
Islands with
where an
a two-dose vaccine
OSHA-approved employee is legally
series, or begin
state plans, state entitled to an
regular testing by
and local
exemption based
February 9, 2022.
government
on a
employers with
disability/medical
100 or more
condition or
employees.
sincerely held
religious belief; or

(2) requires
employees to be
ful y vaccinated or
provide proof of
regular COVID-19
testing and wear a
face covering when
indoors.
Employees who
work remotely, at
a site where other
people are not
present, or
exclusively outside
are not subject to
the requirements.
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Covered
Federal
Statutory
Individuals/
Vaccination
Compliance
Mandate
Authority
Entities
Requirement
Deadline(s)
Status
Head Start
42 U.S.C.
Head Start staff
Head start staff
Receive a one-dose
Enjoined by
Mandate
§ 9836a(a)(1)(C),
must be ful y
vaccine or two-dose
courts in 25
(D), (E)
vaccinated, unless
vaccine series by
states:
granted a legally
January 31, 2022.
Texas v. Becerra,
required exception
No. 5:21-cv-300,
based on a
2021 WL
disability/medical
6198109 (N.D.
condition or a
Tex. Dec. 31,
sincerely held
2021) (enjoining
religious belief.c
the mandate in
TX);
Louisiana v.
Becerra, No.
3:21-cv-4370,
2022 WL 16571
(W.D. La. Jan. 1,
2022) (enjoining
the mandate in
AL, AK, AZ AR,
FL, GA, IN, IA.
KS, KY, LA, MI,
MO, MT, NE,
ND, OH, OK,
SC, SD, TN, UT,
WV, WY)
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.
b. The Fifth Circuit issued an opinion vacating the district court’s preliminary injunction on April 7, 2022. See
Feds For Med. Freedom v. Biden, 30 F. 4th 503 (5th Cir. 2022). As of the publication date of this updated
report, the Fifth Circuit, consistent with the applicable federal rules of appellate procedure, has not issued
the mandate terminating its jurisdiction. Accordingly, the district court has not yet issued an order
implementing the mandate.
c. The Head Start mandate also includes a masking requirement for individuals two years of age or older when
indoors.
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.315 This authority derives from, among other sources,
the Constitution’s Spending and Commerce Clauses, which may be used by Congress to clarify

315 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).
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existing statutory authorities as they relate to vaccination requirements, or create additional
sources of authority for or limitations on such requirements.316
The Spending Clause empowers Congress to tax and spend money for the general welfare.317
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.318 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.319
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.320 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.”321
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.”322 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.323 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.324 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 1906.325
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

316 See id. at 116–19.
317 U.S. CONST. art. I, § 8, cl. 1.
318 See Nolan & Lewis, supra note 18, at 29–31 (discussing South Dakota v. Dole, 483 U.S. 203, 207–08 (1987)).
319 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.
320 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).
321 See id. at 207–08, 211 (internal quotations omitted).
322 U.S. CONST. art. I, § 8, cl. 3.
323 United States v. Lopez, 514 U.S. 549, 558–59 (1995).
324 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).
325 See id.; see also Medtronic, Inc. v. Lohr, 518 U.S. 470, 475 (1996); Hodge, supra note 319, 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”).
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discrete limit to this authority—it cannot compel individuals to engage in commercial activity.326
According to Chief Justice John Roberts, in a portion of the opinion not joined by other Justices
but largely echoed in the view of the four dissenting Justices, the Commerce Clause did not
empower Congress “to regulate individuals precisely because they are doing nothing.”327 While it
is uncertain whether this conclusion constitutes binding precedent,328 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.329 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.330
Even if a vaccine mandate falls within Congress’s enumerated powers, other constitutional
provisions may constrain the government’s action.331 In the context of public health regulations,
the key constraints are those grounded in federalism and the protection of individual rights.332 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.333 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.334
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.335
As to protection of individual rights, courts have recognized few rights-based constraints on the
ability to impose mandatory vaccination requirements.336 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.337

326 See Nolan & Lewis, supra note 18, at 10.
327 See id. at 10–11 (quoting NFIB v. Sebelius, 567 U.S. 519, 551 (2012) (opinion of Roberts, C.J.)).
328 See id. at 11.
329 See NFIB, 567 U.S. at 551.
330 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”).
331 See Nolan & Lewis, supra note 18, at 24–25.
332 See id. at 19, 24–25.
333 Id. at 25.
334 See id.
335 See id.
336 See supra notes 39–47 and accompanying text.
337 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.338 By contrast, as of December 2021,
only one COVID-19 vaccine—Pfizer’s Comirnaty—is licensed by FDA under a BLA.339 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.340
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.341 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.”342 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.”343

338 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.
339 For more information about FDA’s approval of Comirnaty, the Pfizer-BioNTech COVID-19 vaccine, see Hickey,
Ward & Bodie, supra note 7.
340 See id.; see also Hickey et al., supra note 2, at 12–14.
341 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/.
342 21 U.S.C. § 360bbb-3(e)(1)(A)(ii)(III).
343 Parasidis & Kesselheim, supra note 341.
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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.344 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.345
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.346
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.347 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.

344 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”).
345 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
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.
346 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.
347 See supra “Executive Branch Authority to Mandate Vaccination.”
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State and Federal Authority to Mandate COVID-19 Vaccination

Author Information

Wen W. Shen

Legislative Attorney

Disclaimer
This document was prepared by the Congressional Research Service (CRS). CRS serves as nonpartisan
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under the direction of Congress. Information in a CRS Report should not be relied upon for purposes other
than public understanding of information that has been provided by CRS to Members of Congress in
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Congressional Research Service
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