State and Federal Authority to Mandate COVID-19 Vaccination

Changes from January 12, 2022 to January 18, 2022

This page shows textual changes in the document between the two versions indicated in the dates above. Textual matter removed in the later version is indicated with ~~red strikethrough~~ and textual matter added in the later version is indicated with blue.

State and Federal Authority to Mandate
January January 1218, 2022 , 2022
COVID-19 Vaccination
Wen W. Shen
The Coronavirus Disease 2019 (COVID-19) vaccines licensed or authorized by the U.S. Food The Coronavirus Disease 2019 (COVID-19) vaccines licensed or authorized by the U.S. Food
Legislative Attorney Legislative Attorney
and Drug Administration (FDA) are a critical tool to reduce the spread and severity of COVID- and Drug Administration (FDA) are a critical tool to reduce the spread and severity of COVID-

19. FDA initially authorized the vaccines, between December 2020 and February 2021, under 19. FDA initially authorized the vaccines, between December 2020 and February 2021, under
Section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), a regulatory pathway that 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 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-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 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 that the vaccine, for the licensed use, meets the standards for safety, purity, and potency (i.e., effectiveness) under the Public
Health Service Act. Health Service Act.
Given the data supporting the safety and efficacy of the licensed and authorized COVID-19 vaccines, many public health 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 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’ activities that prevent transmission, such as mask wearing in certain settings—as key components of the United States’
pandemic response. pandemic response.
One available legal tool for increasing vaccination rates is for governments to require vaccination. In 2021, various state, 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 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 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 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. 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” 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 of the states’ inhabitants. In contrast to this general power, the federal government’s powers are confined to those enumerated
in the Constitution. in the Constitution.
This report provides an overview of state and federal authority to mandate vaccination. The first part of the report provides This report provides an overview of state and federal authority to mandate vaccination. The first part of the report provides
background on state and local authority to mandate vaccination under the states’ general police power. It discusses the 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 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 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 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. 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 It then looks at how courts have addressed challenges to COVID-19 vaccination requirements imposed by states and state
entities. entities.
The second part of the report provides an overview of federal authority to mandate vaccination. It discusses several sources 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 of existing federal statutory authority that could serve, or have been invoked, as the basis for federal COVID-19 vaccination
mandates. It then provides an overview of four employment-based civilian mandates issued by the executive branch to date mandates. It then provides an overview of four employment-based civilian mandates issued by the executive branch to date
directed at (1) federal executive agency civilian employees; (2) federal contractors for executive departments, agencies, and directed at (1) federal executive agency civilian employees; (2) federal contractors for executive departments, agencies, and
offices; (3) most Medicare- and Medicaid-certified providers and suppliers; and (4) employers with 100 or more employees. offices; (3) most Medicare- and Medicaid-certified providers and suppliers; and (4) employers with 100 or more employees.
The report then discusses the state of litigation challenging these mandates. This part also reviews the extent of Congress’s The report then discusses the state of litigation challenging these mandates. This part also reviews the extent of Congress’s
constitutional authority under the Constitution’s Spending and Commerce Clauses to mandate vaccination. 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 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 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. Use Authorization status of COVID-19 vaccines preclude entities from mandating COVID-19 vaccination.
Congressional Research Service Congressional Research Service

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

he Coronavirus Disease 2019 (COVID-19) vaccines licensed or authorized by the U.S. 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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, 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 purity, and potency (i.e., effectiveness) under the Public Health Service Act (PHSA).7

1 1 See, e.g., , Vaccines Prevented Up to 140,000 COVID-19 Deaths in U.S., NAT’L INST. HEALTH, NIH RESEARCH , NAT’L INST. HEALTH, NIH RESEARCH
MATTERS (Aug. 24, 2021), https://www.nih.gov/news-events/nih-research-matters/vaccines-prevented-140000-covid-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., 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), , COMMONWEALTH FUND BLOG (Oct. 5, 2021),
https://www.commonwealthfund.org/blog/2021/how-many-covid-19-hospitalizations-deaths-averted-states-accelerate-https://www.commonwealthfund.org/blog/2021/how-many-covid-19-hospitalizations-deaths-averted-states-accelerate-
vaccination. vaccination.
2 FDA authorized three COVID-19 vaccines under Emergency Use Authorizations between December 2020 and 2 FDA authorized three COVID-19 vaccines under Emergency Use Authorizations between December 2020 and
February 2021. 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-, 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; 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-, 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; 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), , U.S. FOOD & DRUG ADMIN, (Feb. 27, 2021),
https://www.fda.gov/news-events/press-announcements/fda-issues-emergency-use-authorization-third-covid-19-https://www.fda.gov/news-events/press-announcements/fda-issues-emergency-use-authorization-third-covid-19-
vaccine [hereinafter, and collectively, FDA EUA Press Releases]. vaccine [hereinafter, and collectively, FDA EUA Press Releases].
3 3 See 21 U.S.C. § 360bbb-3. 21 U.S.C. § 360bbb-3. See also CRS In Focus IF10745, CRS In Focus IF10745, Emergency Use Authorization and FDA’s Related
Authorities, by Agata Bodie. , by Agata Bodie.
4 FDA EUA Press Releases, 4 FDA EUA Press Releases, supra nonote 2. See also CRS Report R46399, CRS Report R46399, Legal Issues in COVID-19 Vaccine
Development and Deployment, by Kevin J. Hickey, Wen W. Shen, and Erin H. Ward, at 12–14. , by Kevin J. Hickey, Wen W. Shen, and Erin H. Ward, at 12–14.
5 FDA EUA Press Releases, 5 FDA EUA Press Releases, supra nonote 2. At the time of the COVID-19 vaccines’ authorization, data supporting their 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. EUA requests showed that the vaccines were between 67%–95% effective at preventing symptomatic COVID-19. See
id.
6 6 See FDA Approves First COVID-19 Vaccine, U.S. FOOD & DRUG ADMIN. (Aug. 23, 2021), https://www.fda.gov/news-, 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]; 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-, 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 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 & 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-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. s-for-all-adults-aged-18-and-older-following-cdc-and-fda-decision.
7 7 See FDA Comirnaty Press Release, FDA Comirnaty Press Release, supra nonote 6. See also 42 U.S.C. § 262(a)(2)(C). For more information about 42 U.S.C. § 262(a)(2)(C). For more information about
FDA’s approval of Comirnaty, see CRS Report R46913, 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. , by Kevin J. Hickey, Erin H. Ward, and Agata Bodie.
Congressional Research Service Congressional Research Service

1 1

State and Federal Authority to Mandate COVID-19 Vaccination

Given the data supporting the safety and efficacy of the licensed and authorized COVID-19 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 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 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 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 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 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 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 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 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 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 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 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 vaccination before permitting entry.13 The federal government issued several employment- or
workforce-based mandates that either directly require certain employees to receive COVID-19 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 vaccinations or direct certain employers to impose a vaccination or vaccination-and-testing

8 8 See, e.g., , COVID-19: Prevent Getting Sick, CTRS FOR DISEASE CONTROL & PREVENTION (Apr. 27, 2021), , CTRS FOR DISEASE CONTROL & PREVENTION (Apr. 27, 2021),
https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/index.html; Stacy Wood & Kevin Schulman, 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), , NEW ENG. J. MED. (Feb. 18, 2021),
https://www.nejm.org/doi/full/10.1056/NEJMms2033790; Mary Van Beusekom, 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/, 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, 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), , JOHNS HOPKINS (Sept. 13, 2021),
https://publichealth.jhu.edu/2021/what-is-herd-immunity-and-how-can-we-achieve-it-with-covid-19. 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 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. as education, accessibility, and outreach efforts) to increase vaccine uptake short of a mandate. See Kevin G. Volpp et Kevin G. Volpp et
al., al., Behaviorally Informed Strategies for a National COVID-19 Vaccine Promotion Program, JAMA (Dec. 14, 2020), , JAMA (Dec. 14, 2020),
https://jamanetwork.com/journals/jama/fullarticle/2774381; Matt Motta et al., https://jamanetwork.com/journals/jama/fullarticle/2774381; Matt Motta et al., Encouraging COVID-19 Vaccine Uptake
Through Effective Health Communication, FRONTIER IN POL. SCI. (Jan. 28, 2021), https://www.frontiersin.org/articles/, FRONTIER IN POL. SCI. (Jan. 28, 2021), https://www.frontiersin.org/articles/
10.3389/fpos.2021.630133/full. 10.3389/fpos.2021.630133/full. See also Dorit Rubinstein Reiss & Lois A. Weithorn, Dorit Rubinstein Reiss & Lois A. Weithorn, Responding to the Childhood
Vaccination Crisis: Legal Frameworks and Tools in the Context of Parental Vaccine Refusal, 63 BUFF. L. REV. 881, , 63 BUFF. L. REV. 881,
958–79 (2015) (describing a continuum of legal tools to increase vaccination rates). 958–79 (2015) (describing a continuum of legal tools to increase vaccination rates).
10 10 Delta Variant: What We Know About the Science, CTRS. FOR DISEASE CONTROL & PREVENTION (Aug. 26, 2021), , 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 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 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. become the dominant strain for new COVID-19 infections in the United States. See COVID Data Tracker, CTRS. FOR , CTRS. FOR
DISEASE CONTROL & PREVENTION, https://covid.cdc.gov/covid-data-tracker/#variant-proportions (last accessed Dec. 21, DISEASE CONTROL & PREVENTION, https://covid.cdc.gov/covid-data-tracker/#variant-proportions (last accessed Dec. 21,
2021). 2021).
11 11 See, e.g., N.M. DEP’T OF HEALTH, AMENDED PUBLIC HEALTH EMERGENCY ORDER REQUIRING ALL SCHOOL WORKERS , 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 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), 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., 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 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-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 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 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 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). COVID-19 vaccination for certain health care workers).
12 12 See Elissa Nadworny, Elissa Nadworny, Full FDA Approval Triggers More Universities to Require the COVID-19 Vaccine, NPR , NPR
(Sept. 1, 2021),(Sept. 1, 2021), https://www.npr.org/2021/09/01/1031385629/full-fda-approval-triggers-more-universities-to-require-https://www.npr.org/2021/09/01/1031385629/full-fda-approval-triggers-more-universities-to-require-
the-covid-19-vaccine. the-covid-19-vaccine.
13 13 See, e.g., 10 L.A. Municipal Code § 200.122 (2021), https://clkrep.lacity.org/onlinedocs/2021/21-0878_ord_187219_, 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/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. assets/home/downloads/pdf/executive-orders/2021/eeo-228.pdf.
Congressional Research Service Congressional Research Service

2 2

link to page 16 link to page 11 link to page 16 link to page 16 link to page 7 link to page 11 link to page 16 link to page 32 link to page 16 link to page 11 link to page 16 link to page 16 link to page 7 link to page 11 link to page 16 link to page 32 State and Federal Authority to Mandate COVID-19 Vaccination

requirement on their employees or staff.14 With the exception of a few state health care worker 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 vaccination requirements that provide only for medical exemptions, the governmental vaccination
mandates issued to date generally provide exceptions from the vaccination requirements based on mandates issued to date generally provide exceptions from the vaccination requirements based on
a disability, medical condition, or sincerely held religious belief.15 a disability, medical condition, or sincerely held religious belief.15
Under the United States’ federalist system, states and the federal government share regulatory 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 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 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 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 states’ inhabitants.17 In contrast to this general power, the federal government’s powers are
confined to those enumerated in the Constitution.18 confined to those enumerated in the Constitution.18
This report provides an overview of state and federal authority to mandate vaccination. The first 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 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 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 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 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 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 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 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 how courts have addressed challenges to COVID-19-vaccination requirements imposed by state
and state entities to date.20 and state entities to date.20
The second part of the report provides an overview of federal authority to mandate vaccination. It 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 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 have been invoked, as the basis for federal COVID-19 vaccination mandates. It then provides an
overview of four employment-based civilian mandates issued by the executive branch to date overview of four employment-based civilian mandates issued by the executive branch to date
directed at (1) federal executive agency civilian employees; (2) federal contractors for executive directed at (1) federal executive agency civilian employees; (2) federal contractors for executive
departments, agencies, and offices; (3) most Medicare- and Medicaid-certified providers and departments, agencies, and offices; (3) most Medicare- and Medicaid-certified providers and
suppliers; and (4) employers with 100 or more employees. The report then analyzes the litigation suppliers; and (4) employers with 100 or more employees. The report then analyzes the litigation
challenging these mandates,21 before reviewing the extent of Congress’s constitutional authority challenging these mandates,21 before reviewing the extent of Congress’s constitutional authority
under the Spending and Commerce Clauses to potentially mandate vaccination.22 under the Spending and Commerce Clauses to potentially mandate vaccination.22
The report concludes with a brief discussion of a legal issue specific to COVID-19 vaccination 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 mandates, particularly before FDA’s licensure of Comirnaty. Namely, it looks at how courts have

14 14 See infra “Executive Branch Authority to Mandate Vaccination.” ”
15 15 See infra “State COVID-19 Vaccination Mandates and Related Litigation” and and “Executive Branch Authority to
Mandate Vaccination.” In addition to governmental entities, private entities—especially private employers—have also 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 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, 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. , by April J. Anderson and Victoria L.
Killion. Killion.
16 16 See Elizabeth Y. McCuskey, Elizabeth Y. McCuskey, Body of Preemption: Health Law Traditions and the Presumption Against Preemption, ,
89 TEMPLE L. REV. 95, 113–20 (2016). 89 TEMPLE L. REV. 95, 113–20 (2016).
17 Barnes v. Glen Theatre, Inc., 501 U.S. 560, 569 (1991). 17 Barnes v. Glen Theatre, Inc., 501 U.S. 560, 569 (1991).
18 18 See CRS Report R45323, CRS Report R45323, Federalism-Based Limitations on Congressional Power: An Overview, coordinated by , coordinated by
Andrew Nolan and Kevin M. Lewis, at 1. Andrew Nolan and Kevin M. Lewis, at 1.
19 19 See infra “Legal Background.”
20 20 See infra “State COVID-19 Vaccination Mandates and Related Litigation.” ”
21 21 See infra “Executive Branch Authority to Mandate Vaccination.” ”
22 22 See infra “Congress’s Constitutional Authority to Mandate Vaccination.” ”
Congressional Research Service Congressional Research Service

3 3

link to page 35 link to page 5 link to page 35 link to page 5 State and Federal Authority to Mandate COVID-19 Vaccination

addressed some litigants’ argument that the EUA status of COVID-19 vaccines precludes entities addressed some litigants’ argument that the EUA status of COVID-19 vaccines precludes entities
from mandating COVID-19 vaccination.23 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 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 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 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-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 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 police power to promote public health and safety encompasses authority to mandate
vaccination.26 vaccination.26
In the early part of the 20th century, the Supreme Court twice considered constitutional 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 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, mandates and recognized such laws as falling squarely within the states’ police power.28 In 1905,
the Supreme Court in the Supreme Court in Jacobson v. Massachusetts upheld a state law that gave municipal boards of upheld a state law that gave municipal boards of
health the authority to require the vaccination of persons over the age of 21 against smallpox, 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 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 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 violated a liberty interest that, under more modern jurisprudence, the plaintiff might have asserted
as a substantive due process right.30 as a substantive due process right.30
Less than two decades later, in Less than two decades later, in Zucht v. King, parents of a child who was excluded from school , parents of a child who was excluded from school
due to her unvaccinated status challenged the local ordinance requiring vaccination for due to her unvaccinated status challenged the local ordinance requiring vaccination for
schoolchildren, arguing that the ordinance violated the Fourteenth Amendment’s Equal Protection schoolchildren, arguing that the ordinance violated the Fourteenth Amendment’s Equal Protection
and Due Process Clauses.31 Relying on and Due Process Clauses.31 Relying on Jacobson, the Supreme Court rejected the constitutional , the Supreme Court rejected the constitutional
challenges, concluding “it is within the police power of a State to provide for compulsory 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 vaccination” and that the ordinance bestowed “only that broad discretion required for the
protection of the public health.”32 protection of the public health.”32
Based on the Supreme Court’s recognition of this authority, states and localities have enacted Based on the Supreme Court’s recognition of this authority, states and localities have enacted
vaccination mandates for certain populations and circumstances. All 50 states and the District of 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 Columbia, for instance, currently have laws requiring all students enrolled in both public and

23 23 See infra “Emergency Use Authorization and Vaccination Mandates.”
24 24 See U.S. CONST. art. XIV, cl. 1, § 1; Edmonson v. Leesville Concrete Co., 500 U.S. 614, 619 (1991) (“The 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 Constitution’s protections of individual liberty and equal protection apply in general only to action by the
government.”). government.”).
25 25 See U.S. CONST. amends. I & XIV. U.S. CONST. amends. I & XIV.
26 26 See Jacobson v. Massachusetts, 197 U.S. 11, 39 (1905). Jacobson v. Massachusetts, 197 U.S. 11, 39 (1905).
27 27 Id.; Zucht v. King, 260 U.S. 174 (1922). ; Zucht v. King, 260 U.S. 174 (1922).
28 28 Jacobson, 197 U.S. at 39; , 197 U.S. at 39; Zucht, 260 U.S. at 175–77. , 260 U.S. at 175–77.
29 29 Jacobson, 197 U.S. at 31. , 197 U.S. at 31.
30 30 See Reiss & Weithorn, Reiss & Weithorn, supra notnote 9, at 897–98. at 897–98.
31 31 Zucht, 260 U.S. at 175–77. , 260 U.S. at 175–77.
32 32 Id. at 176–77. at 176–77.
Congressional Research Service Congressional Research Service

4 4

link to page 8 link to page 8 link to page 8 link to page 8 link to page 5 link to page 8 link to page 8 link to page 8 link to page 8 link to page 5 State and Federal Authority to Mandate COVID-19 Vaccination

private schools to receive specified vaccines as a condition of school entry.33 With respect to 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 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-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 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 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 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 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 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 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 philosophical exemption for those who object to immunizations because of personal, moral, or
other beliefs.38 other beliefs.38
These state and local vaccination mandates have withstood more recent legal challenges.39 While These state and local vaccination mandates have withstood more recent legal challenges.39 While
the Supreme Court’s constitutional jurisprudence has evolved substantially since the Supreme Court’s constitutional jurisprudence has evolved substantially since Jacobson and and
Zucht,40 modern courts have continued to rely on these cases to reject due process and equal ,40 modern courts have continued to rely on these cases to reject due process and equal
protection claims against vaccination mandates, giving considerable deference to the states’ use of protection claims against vaccination mandates, giving considerable deference to the states’ use of
their police power to require immunizations to protect public health.41 their police power to require immunizations to protect public health.41

33 33 States with Religious and Philosophical Exemptions From School Immunization Requirements, NAT’L CONF. OF , NAT’L CONF. OF
STATE LEGISLATURES (NCSL) (Nov. 22, 2021), https://www.ncsl.org/research/health/school-immunization-exemption-STATE LEGISLATURES (NCSL) (Nov. 22, 2021), https://www.ncsl.org/research/health/school-immunization-exemption-
state-laws.aspx. state-laws.aspx.
34 34 See Brian Dean Abramson, Brian Dean Abramson, Vaccine Law in the Health Care Workplace, 12 J. HEALTH & LIFE SCI. L. 22, 24–27 , 12 J. HEALTH & LIFE SCI. L. 22, 24–27
(2019) (describing different approaches states have taken to impose vaccination requirements on health care workers: (2019) (describing different approaches states have taken to impose vaccination requirements on health care workers:
some states require health care workers to receive annual flu vaccines; several others require hospitals or other health some states require health care workers to receive annual flu vaccines; several others require hospitals or other health
care facilities to ensure their employees have been vaccinated against certain vaccine-preventable diseases, including care facilities to ensure their employees have been vaccinated against certain vaccine-preventable diseases, including
hepatitis B, rubella, and mumps; and still others require hospital employees to provide proof of immunization against hepatitis B, rubella, and mumps; and still others require hospital employees to provide proof of immunization against
certain vaccine-preventable diseases). certain vaccine-preventable diseases).
35 35 See id. at 28–31 (describing scope of medical and religious exemptions for vaccination mandates for health care at 28–31 (describing scope of medical and religious exemptions for vaccination mandates for health care
workers); NCSL, workers); NCSL, supra no note 33 (describing exemptions for student vaccination mandates). (describing exemptions for student vaccination mandates).
36 36 See, e.g., N.Y. Pub. Health Law § 2164(8) (providing a medical exemption from school vaccination requirements if a , 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”). licensed physician “certifies that such immunization may be detrimental to a child’s health”).
37 Abramson, 37 Abramson, supra nonote 34, at 28–31; NCSL, at 28–31; NCSL, supra no note 33.
38 NCSL, 38 NCSL, supra no note 33.
39 39 See, e.g., Phillips v. City of New York, 775 F.3d 538, 542–44 (2d Cir. 2015); Workman v. Mingo Cty. Bd. of Edu. , Phillips v. City of New York, 775 F.3d 538, 542–44 (2d Cir. 2015); Workman v. Mingo Cty. Bd. of Edu.
419 F. App’x 348 (4th Cir. 2011); Whitlow v. California, 203 F. Supp. 3d 1079, 1085–89 (S.D. Cal. 2016); Boone v. 419 F. App’x 348 (4th Cir. 2011); Whitlow v. California, 203 F. Supp. 3d 1079, 1085–89 (S.D. Cal. 2016); Boone v.
Boozman, 217 F. Supp. 2d 938, 952–57 (E.D. Ark. 2002). Prior to the COVID-19 pandemic, challenges against state 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, 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 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 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 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 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 Amendment’s Free Exercise Clause, and the right to “freedom of contract” guaranteed by the Fifth and Fourteenth
Amendments. Amendments. See Alexander M. Stewart, Alexander M. Stewart, Mandatory Vaccination of Health Care Workers, NEW ENG. J. OF MED. (Nov. , 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 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. stages after the governor suspended the regulation due to a vaccine shortage. See Joe Nocera, Joe Nocera, When New York
Mandated Vaccinations, Nurses Sued, BLOOMBERG BUSINESSWEEK (Mar. 23, 2020), https://www.bloomberg.com/news/, BLOOMBERG BUSINESSWEEK (Mar. 23, 2020), https://www.bloomberg.com/news/
articles/2020-03-23/can-states-mandate-vaccinations-for-health-care-workers. articles/2020-03-23/can-states-mandate-vaccinations-for-health-care-workers.
40 Commentators have observed, for instance, that the Supreme Court decided 40 Commentators have observed, for instance, that the Supreme Court decided Jacobson and and Zucht before the advent of before the advent of
tiered scrutiny, which may subject regulations that infringe upon certain fundamental liberty interests to heightened tiered scrutiny, which may subject regulations that infringe upon certain fundamental liberty interests to heightened
scrutiny. Reiss & Weithorn, scrutiny. Reiss & Weithorn, supra no note 9, at 896–97. A regulation survives the most heightened level of scrutiny only if at 896–97. A regulation survives the most heightened level of scrutiny only if
it is narrowly tailored to serve a compelling government interest. it is narrowly tailored to serve a compelling government interest. See Reno v. Flores, 507 U.S. 292, 301–02 (1993). Reno v. Flores, 507 U.S. 292, 301–02 (1993).
41 41 See, e.g., , Phillips, 775 F.3d at 543; , 775 F.3d at 543; Workman, 419 F. App’x at 352–54; , 419 F. App’x at 352–54; Whitlow, 203 F. Supp. 3d at 1085–87. , 203 F. Supp. 3d at 1085–87.
Congressional Research Service Congressional Research Service

5 5

link to page 8 link to page 17 link to page 8 link to page 17 State and Federal Authority to Mandate COVID-19 Vaccination

Prior to the COVID-19 pandemic, courts have also generally upheld state vaccination 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 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 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 outbreaks of vaccine-preventable diseases and/or declining vaccination rates—have eliminated
those exemptions to permit only medical exemptions.42 those exemptions to permit only medical exemptions.42
In the modern era, these mandates without religious exemptions have been subject to several legal 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 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 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 that a state is not constitutionally required to provide for a religious exemption.44 The courts
reasoned that, under reasoned that, under Employment Division v. Smith and its progeny, the vaccination mandates at and its progeny, the vaccination mandates at
issue were neutral, generally applicable laws—i.e., laws that do not single out religion or 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 selectively burden religiously motivated conduct.45 As such, the vaccination mandates, in these
courts’ view, were not subject to heightened scrutiny under courts’ view, were not subject to heightened scrutiny under Smith.46 Applying rational-basis .46 Applying rational-basis
review, a lenient standard under which courts generally uphold laws that reasonably further 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 . . . 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 [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 In 2021, however, the Supreme Court issued two decisions that potentially weaken these
precedents involving free exercise challenges to vaccination mandates. In precedents involving free exercise challenges to vaccination mandates. In Tandon v. Newsom, the , the
Court ruled that a law is not neutral and generally applicable if it treats “Court ruled that a law is not neutral and generally applicable if it treats “any comparable secular comparable secular
activity more favorably than religious exercise.”48 “[W]hether two activities are comparable for activity more favorably than religious exercise.”48 “[W]hether two activities are comparable for
purposes of the Free Exercise Clause,” the Court explained, depends on “the asserted government purposes of the Free Exercise Clause,” the Court explained, depends on “the asserted government

42 42 See James Colgrove & Abigail Lowin, 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/, 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 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 nonmedical exemptions. Since 2016, four additional states—California, New York, Maine, and Connecticut—have
eliminated nonmedical exemptions. eliminated nonmedical exemptions. See NCSL, NCSL, supra ~~not~~enote 33.
43 43 See, e.g., , Phillips, 775 F.3d at 543; , 775 F.3d at 543; Workman, 419 F. App’x at 352–54; , 419 F. App’x at 352–54; Whitlow, 203 F. Supp. 3d at 1085–87; , 203 F. Supp. 3d at 1085–87; Boone, ,
217 F. Supp. 2d at 952–55. 217 F. Supp. 2d at 952–55.
44 44 See, e.g., , Phillips, 775 F.3d at 543; , 775 F.3d at 543; Workman, 419 F. App’x at 352–54; , 419 F. App’x at 352–54; Whitlow, 203 F. Supp. 3d at 1085–87; , 203 F. Supp. 3d at 1085–87; Boone, ,
217 F. Supp. 2d at 952–55. The alleged violation of the Free Exercise Clause was not a claim available to the plaintiffs 217 F. Supp. 2d at 952–55. The alleged violation of the Free Exercise Clause was not a claim available to the plaintiffs
in in Jacobson or or Zucht because at that time, the Supreme Court had not yet held that the First Amendment applied to the because at that time, the Supreme Court had not yet held that the First Amendment applied to the
states. states. See Phillips, 775 F.3d at 543., 775 F.3d at 543.
45 45 See, e.g., , Phillips, 775 F.3d at 543; , 775 F.3d at 543; Workman, 419 F. App’x at 352–54; , 419 F. App’x at 352–54; Whitlow, 203 F. Supp. 3d at 1085–87; , 203 F. Supp. 3d at 1085–87; Boone, ,
217 F. Supp. 2d at 952–55. 217 F. Supp. 2d at 952–55.
46 46 See, e.g., , Phillips, 775 F.3d at 543; , 775 F.3d at 543; Workman, 419 F. App’x at 352–54; , 419 F. App’x at 352–54; Whitlow, 203 F. Supp. 3d at 1085–87; , 203 F. Supp. 3d at 1085–87; Boone, ,
217 F. Supp. 2d at 952–55. 217 F. Supp. 2d at 952–55.
47 47 Boone, 217 F. Supp. 2d at 954; , 217 F. Supp. 2d at 954; see also Phillips, 775 F.3d at 543; , 775 F.3d at 543; Workman, 419 F. App’x at 352–54; , 419 F. App’x at 352–54; Whitlow, 203 , 203
F. Supp. 3d at 1085–87. In cases where a vaccination mandate includes a religious exemption, plaintiffs have also filed F. Supp. 3d at 1085–87. In cases where a vaccination mandate includes a religious exemption, plaintiffs have also filed
suit to challenge their unsuccessful invocation of the exemption. In these cases, courts, applying the relevant state law, suit to challenge their unsuccessful invocation of the exemption. In these cases, courts, applying the relevant state law,
typically considered whether the plaintiffs’ objections to vaccination are based on a sincerely held religious belief. 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 , N.M. v. Hebrew Acad. Long Beach, 155 F. Supp. 3d 247, 257–58 (E.D.N.Y. 2016) (finding that plaintiff failed to
establish her objections to vaccination were religious in nature); establish her objections to vaccination were religious in nature); In re Christine M., 157 Misc. 2d 4, 21 (N.Y. 1992) Christine M., 157 Misc. 2d 4, 21 (N.Y. 1992)
(finding that plaintiff’s objections to vaccination were based on plaintiff’s personal and medical, rather than religious, (finding that plaintiff’s objections to vaccination were based on plaintiff’s personal and medical, rather than religious,
beliefs); Lewis v. Sobol, 710 F. Supp. 506, 516 (S.D.N.Y. 1989) (finding that plaintiffs’ objections to vaccination beliefs); Lewis v. Sobol, 710 F. Supp. 506, 516 (S.D.N.Y. 1989) (finding that plaintiffs’ objections to vaccination
stemmed from their religious beliefs, which entailed “views of spiritual perfection” that they apply in their dietary and stemmed from their religious beliefs, which entailed “views of spiritual perfection” that they apply in their dietary and
medical practices). medical practices).
48 141 S. Ct. 1294, 1296 (2021) (per curiam) (alteration in original). The Supreme Court’s 48 141 S. Ct. 1294, 1296 (2021) (per curiam) (alteration in original). The Supreme Court’s Tandon ruling was issued on ruling was issued on
the Court’s non-merits docket. For more information about the potential differences in the precedential value of the the Court’s non-merits docket. For more information about the potential differences in the precedential value of the
Court’s non-merits versus merits decisions, see Court’s non-merits versus merits decisions, see infra nonote 110.
Congressional Research Service Congressional Research Service

6 6

State and Federal Authority to Mandate COVID-19 Vaccination

interest that justifies the regulation at issue.”49 Applying this standard, the Court concluded that interest that justifies the regulation at issue.”49 Applying this standard, the Court concluded that
the state regulations at issue in the state regulations at issue in Tandon, which limited religious gatherings in response to the , which limited religious gatherings in response to the
COVID-19 pandemic, treated some comparable secular activities—such as getting haircuts and 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 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 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 preliminary injunction, staying enforcement of the state regulations during pendency of the
litigation.51 litigation.51
A few months after the A few months after the Tandon ruling, the Supreme Court, in ruling, the Supreme Court, in Fulton v. City of Philadelphia, ,
considered whether a city’s contract provision prohibiting sexual orientation discrimination by 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 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 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 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 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 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 .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 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 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,” 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 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 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 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 foster care agency] while making them available to others.”57
Together, Together, Fulton and and Tandon could suggest that where a governmental requirement provides a could suggest that where a governmental requirement provides a
secular exemption from the requirement (but no religious exemption), and the exemption system 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 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 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 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 to a hypothetical religious exemption as measured against the asserted government interest
underlying the requirement—may be subject to heightened scrutiny.59 underlying the requirement—may be subject to heightened scrutiny.59
For state vaccination requirements—which typically provide, at a minimum, medical exemptions For state vaccination requirements—which typically provide, at a minimum, medical exemptions
to those with contraindications—to those with contraindications—Fulton and and Tandon thus raise a number of questions that thus raise a number of questions that
potentially unsettle the law concerning vaccination requirements and religious freedom. These potentially unsettle the law concerning vaccination requirements and religious freedom. These
questions include whether a vaccination requirement that provides only for a medical questions include whether a vaccination requirement that provides only for a medical
exemption—a secular exemption—is not neutral and generally applicable; whether that analysis 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 depends on the extent to which the medical exemption process is discretionary; and whether

49 49 Tandon, 141 S. Ct. at 1296. , 141 S. Ct. at 1296.
50 50 Id. at 1297. at 1297.
51 51 Id. at 1297–98. at 1297–98.
52 141 S. Ct. 186852 141 S. Ct. 1868
53 53 Id. at 1878. at 1878.
54 54 Id.
55 55 Id. at 1879. at 1879.
56 56 Id. at 1877–78 (internal alterations and quotations omitted) (quoting Emp. Div., Dep’t of Hum. Res. of Or. v. Smith, 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)). 494 U.S. 872, 884 (1990)).
57 57 Id.
58 58 See id. at 1878–79; Tandon v. Newsom, 141 S. Ct. 1294, 1297–98 (2021) (per curiam). at 1878–79; Tandon v. Newsom, 141 S. Ct. 1294, 1297–98 (2021) (per curiam).
59 59 See Fulton, 141 S. Ct. at 1878–79; , 141 S. Ct. at 1878–79; Tandon, 141 S. Ct. at 1297–98. , 141 S. Ct. at 1297–98.
Congressional Research Service Congressional Research Service

7 7

link to page 5 link to page 5 link to page 5 link to page 9 link to page 5 link to page 5 link to page 5 link to page 9 State and Federal Authority to Mandate COVID-19 Vaccination

medical and religious exemptions—as measured against the relevant underlying government medical and religious exemptions—as measured against the relevant underlying government
interest for vaccination requirements—are comparable exemptions in the context of this analysis. 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 the extent a vaccination requirement that provides only a medical exemption would be subject
to heightened scrutiny, to heightened scrutiny, Fulton and and Tandon also leave unanswered whether there are certain also leave unanswered whether there are certain
circumstances under which the requirement would survive such scrutiny. circumstances under which the requirement would survive such scrutiny.
While courts have historically upheld state vaccination requirements generally, more recent While courts have historically upheld state vaccination requirements generally, more recent
developments in the Supreme Court’s free exercise jurisprudence raise questions regarding 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 whether, when, and under what circumstances states must provide or grant religious exemptions
to a vaccination requirement. 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 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 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 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 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 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 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 vaccination requirements, and these requirements are generally limited to health care workers.62
At least one state—California—announced in 2021 plans to add COVID-19 vaccination to the list At least one state—California—announced in 2021 plans to add COVID-19 vaccination to the list
of required student vaccinations. The requirement is expected to be phased-in by grade span in of required student vaccinations. The requirement is expected to be phased-in by grade span in
2022, applying to grades 7 through 12 starting on July 1, 2022.63 With the exception of several 2022, applying to grades 7 through 12 starting on July 1, 2022.63 With the exception of several
state health care worker mandates (as well as California’s expected student vaccination 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 requirements) that provide only for a medical exemption,64 most of these state and local
vaccination requirements provide for both medical and religious exemptions. vaccination requirements provide for both medical and religious exemptions.
Many of these state COVID-19 vaccination requirements have drawn legal challenges. To date, 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 consistent with the discussion in the preceding section, courts have generally upheld these
requirements, particularly if the requirements provide for both medical and religious 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 exemptions.65 Some of the common claims raised in these challenges include, for instance, an
alleged violation of the plaintiffs’ substantive due process rights to bodily integrity or right to 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 refuse unwanted medical treatment, or an alleged violation of their equal protection rights. Courts

60 60 See supra nonote 12 and accompanying text. and accompanying text.
61 61 See supra nonote 13 and accompanying text. and accompanying text.
62 62 See supra nonote 11 and accompanying text. and accompanying text.
63 63 California Becomes First State in Nation to Announce COVID-19 Vaccine Requirements for Schools, OFF. OF , OFF. OF
GOVERNOR (Oct. 1, 2021), https://www.gov.ca.gov/2021/10/01/california-becomes-first-state-in-nation-to-announce-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/. covid-19-vaccine-requirements-for-schools/.
64 As noted 64 As noted supra in noin note 42, California eliminated, in 2016, nonmedical exemptions for its student vaccination California eliminated, in 2016, nonmedical exemptions for its student vaccination
requirements generally. requirements generally.
65 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 , 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. 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 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 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, 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 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 orders that require certain business entities to prevent individuals who have not received a COVID-19 vaccine from
remaining in certain indoor facilities); Valdez v. Grisham, No. 21-cv-783, 2021 WL 4145746, at *4–5 (D.N.M. Sept. 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 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). exhibitors to be vaccinated against COVID-19).
Congressional Research Service Congressional Research Service

8 8

link to page 35 link to page 35 State and Federal Authority to Mandate COVID-19 Vaccination

have generally rejected these claims, relying on have generally rejected these claims, relying on Jacobson to conclude that a fundamental right or to conclude that a fundamental right or
a suspect class is not implicated by the vaccination mandates, which reasonably further a a suspect class is not implicated by the vaccination mandates, which reasonably further a
legitimate government interest under rational-basis review.66 legitimate government interest under rational-basis review.66
The principal area of legal uncertainty as to state vaccination requirements, as explained in the 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 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 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. this issue, the federal courts of appeals have reached arguably conflicting results.
In In Dahl v. Board of Trustees of Western Michigan University, the district court preliminarily , the district court preliminarily
enjoined (i.e., temporarily suspended) a state university’s policy requiring student-athletes to be 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 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 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-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 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 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 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 for the Sixth Circuit (Sixth Circuit) concluded that the university’s discretionary exemption
process provided a “mechanism for individualized exemptions” under process provided a “mechanism for individualized exemptions” under Fulton that rendered the that rendered the
policy policy not generally applicable, subjecting it to heightened scrutiny.70 Applying heightened 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 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,” 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 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 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 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 that allowed exemptions, suggesting the university’s vaccination policy might have been
unnecessarily “severe.”73 unnecessarily “severe.”73
In In Does v. Mills, the U.S. Court of Appeals for the First Circuit (First Circuit) considered Maine’s , 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 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 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 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 vaccination requirements, citing declining vaccination rates and the need to protect those who are

66 66 See, e.g., , Klaasen, 7 F.4th at 592–94; , 7 F.4th at 592–94; Norris, 2021 WL 4738827, at *2-4;, 2021 WL 4738827, at *2-4; Dixon, 2021 WL 5740187, at *4–6, *8–9; , 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 , 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 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. 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. for additional discussion.
67 2021 WL 3891620, at *3 (W.D. Mich. Aug. 31, 2021). 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). 68 Dahl v. Bd. of Tr. of W. Mich. Univ., 15 F.4th 728, 730 (6th Cir. 2021) (per curiam).
69 69 See id.
70 70 Id. at 733–34. at 733–34.
71 71 Id. at 734–35. at 734–35.
72 72 Id.
73 73 Id. On November 18, 2021, the parties in On November 18, 2021, the parties in Dahl voluntarily dismissed the appeal after entering into a consent decree, 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 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-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. 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 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. final decision on the merits is expected in this case.
74 16 F.4th 20, 28 (2021). 74 16 F.4th 20, 28 (2021).
Congressional Research Service Congressional Research Service

9 9

State and Federal Authority to Mandate COVID-19 Vaccination

immunocompromised and reliant on others’ vaccinations for protection.75 In issuing the August 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 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 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 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 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 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 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; (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 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 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 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, 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 alleging, among other claims, that the COVID-19 vaccination requirement violates their free
exercise rights because it lacks a religious exemption.77 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 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 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 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 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 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 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 exemption to employees who provide a written statement from specified licensed medical
professionals that the vaccination is medically inadvisable did not render the vaccination professionals that the vaccination is medically inadvisable did not render the vaccination
requirement not generally applicable. Unlike the exemption system at issue in requirement not generally applicable. Unlike the exemption system at issue in Fulton, the medical , the medical
exemption, in the court’s view, was “a single objective exemption” that did not call for 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 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 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 court, exempting only those whose health would be endangered by vaccination reinforced the the
state’s underlying interests in protecting the health and safety of its residents, including that of 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 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 medical reasons.80 Because the medical exemption is meaningfully different from a religious
exemption—the availability of which would exemption—the availability of which would undermine the relevant state interests—the court the relevant state interests—the court
concluded that Maine’s vaccination requirement was generally applicable and subject to rational-concluded that Maine’s vaccination requirement was generally applicable and subject to rational-
basis review, which it “easily satisfie[d].”81 basis review, which it “easily satisfie[d].”81
Even though the court did not need to reach this issue, the First Circuit further concluded that Even 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 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 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 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 exemptions from the requirement for non-health-related reasons threaten “the most vulnerable

75 75 Id. at 24–25. The amended exemptions became effective in 2020. at 24–25. The amended exemptions became effective in 2020. See id.
76 76 See id. at 27–28. at 27–28.
77 77 Id. at 28. at 28.
78 78 Id. at 30. at 30.
79 79 Id. at 30–31. at 30–31.
80 80 Id.
81 81 Id. at 31–32. at 31–32.
Congressional Research Service Congressional Research Service

10 10

State and Federal Authority to Mandate COVID-19 Vaccination

Mainers.”82 The vaccination requirement, according to the court, was also sufficiently narrowly 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, 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 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] 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 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 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 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 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 narrow sphere of healthcare workers . . . who regularly enter healthcare facilities.”83
In In We the Patriots USA, Inc. v. Hochul, the U.S. Court of Appeals for the Second Circuit (Second , 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 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 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 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 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 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 supported by a certification from a licensed physician or nurse practitioner issued in accordance
with generally accepted medical standards, including recommendations of the Advisory with generally accepted medical standards, including recommendations of the Advisory
Committee on Immunization Practices.”85 Several health care workers sued to challenge New 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 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 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 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 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 providing a medical but not a religious exemption—was not a neutral, generally applicable law
under under Smith, or that the rule did not satisfy rational-basis review.88 Similar to the First Circuit, the , 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” 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 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 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 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 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 did not create a system of individualized exemptions under Fulton because the rule “provide[d] because the rule “provide[d]
for an objectively defined category of people to whom the vaccine requirement does not apply”—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 i.e., those who present the appropriate certification from a specified medical professional in
accordance with generally accepted medical standards.90 Because the plaintiffs, in the court’s 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 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 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 the face of an especially contagious variant of the virus that has claimed the lives of more than

82 82 Id. at 32. at 32.
83 83 Id. at 32–33. at 32–33.
84 17 F.4th 266, 274 (2d Cir. 2021) (per curiam). 84 17 F.4th 266, 274 (2d Cir. 2021) (per curiam).
85 85 Id. at 275. at 275.
86 86 Id. at 273. at 273.
87 87 Id.
88 88 Id.
89 89 Id. at 285. at 285.
90 90 Id. at 289. at 289.
Congressional Research Service Congressional Research Service

11 11

link to page 6 link to page 6 State and Federal Authority to Mandate COVID-19 Vaccination

750,000 in the United States and some 55,000 in New York, the court reasoned, “easily m[et] that 750,000 in the United States and some 55,000 in New York, the court reasoned, “easily m[et] that
standard.”91 standard.”91
In sum, In sum, Dahl on one hand, and on one hand, and Does and and We the Patriots on the other hand, highlight some of the on the other hand, highlight some of the
unsettled questions raised by unsettled questions raised by Fulton and and Tandon as they apply to vaccination requirements and as they apply to vaccination requirements and
the circumstances under which states may be constitutionally required to provide for or grant the circumstances under which states may be constitutionally required to provide for or grant
religious exemptions. Whereas religious exemptions. Whereas Dahl suggests that the availability of a medical exemption may suggests that the availability of a medical exemption may
render a vaccination requirement not generally applicable and thus subject to heightened scrutiny, render a vaccination requirement not generally applicable and thus subject to heightened scrutiny,
for instance, for instance, Does and and We the Patriots indicate that, at least in the health care employment indicate that, at least in the health care employment
context, a vaccination requirement providing for only a medical exemption is a generally context, a vaccination requirement providing for only a medical exemption is a generally
applicable requirement subject to rational-basis review. applicable requirement subject to rational-basis review.
The Supreme Court has so far rejected applications to stay the Maine and New York emergency The Supreme Court has so far rejected applications to stay the Maine and New York emergency
rules at issue in rules at issue in Does and and We the Patriots, allowing for their implementation.92 The plaintiffs in , allowing for their implementation.92 The plaintiffs in
Does filed a petition for certiorari, and the Court, if it grants the petition, may provide further filed a petition for certiorari, and the Court, if it grants the petition, may provide further
clarification on these open questions. clarification on these open questions.
Federal Authority to Mandate Vaccination
Like state vaccination requirements, federal vaccination requirements are government actions Like state vaccination requirements, federal vaccination requirements are government actions
subject to constitutional constraints.93 In addition to constitutional constraints based on individual subject to constitutional constraints.93 In addition to constitutional constraints based on individual
rights—which apply in broadly similar ways to both state and federal vaccination mandates—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 federal vaccination requirements must fall within the powers granted to the federal government in
the Constitution.94 Federal requirements imposed by the executive branch are also subject to the Constitution.94 Federal requirements imposed by the executive branch are also subject to
statutory constraints. Such requirements generally must rely on the federal government’s existing statutory constraints. Such requirements generally must rely on the federal government’s existing
statutory authorities.95 Depending on the circumstances, the requirements may also be subject to statutory authorities.95 Depending on the circumstances, the requirements may also be subject to
statutory requirements under the Administrative Procedure Act (APA), the Religious Freedom statutory requirements under the Administrative Procedure Act (APA), the Religious Freedom
Restoration Act of 1993 (RFRA),96 or other context-specific statutory limits.97 Restoration Act of 1993 (RFRA),96 or other context-specific statutory limits.97

91 91 Id. at 290. at 290.
92 92 See Dr. A v. Hochul, 142 S. Ct. 552 (2021); DoesDr. A v. Hochul, 142 S. Ct. 552 (2021); Does v. Mills, 142 S. Ct. 17 (2021). Justices Neil Gorsuch, Clarence 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 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 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 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’ exemptions as measured against the states’ asserted interest in infectious disease control and protecting the states’
health care infrastructure. health care infrastructure. See Does, 142 S. Ct. at 19–20; , 142 S. Ct. at 19–20; Dr. A, 142 S. Ct. at 556–57. , 142 S. Ct. at 556–57.
93 93 See, e.g., Pub. Util. Comm’n of D.C. v. Pollak, 343 U.S. 451, 461 (1952). , Pub. Util. Comm’n of D.C. v. Pollak, 343 U.S. 451, 461 (1952).
94 94 See Nolan & Lewis, Nolan & Lewis, supra nonote 18, at 1. at 1.
95 95 See, e.g., City of Arlington v. Fed. Commc’ns Comm’n, 569 U.S. 290, (2013) (stating that agencies’ “power to act , 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 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”). authority “is always whether the agency has gone beyond what Congress has permitted it to do”).
96 The APA generally establishes the procedures that federal agencies use for rulemaking and adjudication, and the 96 The APA generally establishes the procedures that federal agencies use for rulemaking and adjudication, and the
procedures for how courts may review those agency actions. RFRA generally imposes a heightened standard of review 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 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 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, 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, , 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 , by Jonathan M. Gaffney. For more information about RFRA, see CRS In Focus
IF11490, IF11490, The Religious Freedom Restoration Act: A Primer, by Whitney K. Novak. , by Whitney K. Novak.
97 In the military context, for instance, additional waiver requirements under 10 U.S.C. § 1107a may apply to the 97 In the military context, for instance, additional waiver requirements under 10 U.S.C. § 1107a may apply to the
administration of medical products subject to EUAs to servicemembers. administration of medical products subject to EUAs to servicemembers.
Congressional Research Service Congressional Research Service

12 12

State and Federal Authority to Mandate COVID-19 Vaccination

This part begins by discussing the executive branch’s authority to mandate vaccination, including 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 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 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 the extent of Congress’s constitutional authority under the Constitution’s Spending and
Commerce Clauses to mandate vaccination. 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 Prior to the COVID-19 pandemic, federal vaccination requirements were primarily limited to the
immigration,98 military,99 and certain federal health care employment contexts.100 Certain existing immigration,98 military,99 and certain federal health care employment contexts.100 Certain existing
statutory authorities, however, could potentially encompass the authority to mandate vaccination statutory authorities, however, could potentially encompass the authority to mandate vaccination
in specified contexts. in specified contexts.
Earlier in the COVID-19 pandemic, and even before the pandemic, some commentators believed 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 that one likely source of authority for federal public health orders—including those related to
vaccination requirements—may be Section 361(a) of the PHSA.101 This provision, codified at 42 vaccination requirements—may be Section 361(a) of the PHSA.101 This provision, codified at 42
U.S.C. § 264(a), grants the Secretary of HHS the authority—delegated in part to the Centers for U.S.C. § 264(a), grants the Secretary of HHS the authority—delegated in part to the Centers for
Disease Control and Prevention (CDC)102—to make and enforce regulations necessary “to Disease Control and Prevention (CDC)102—to make and enforce regulations necessary “to
prevent the introduction, transmission, or spread of communicable diseases from foreign prevent the introduction, transmission, or spread of communicable diseases from foreign
countries into the States or possessions, or from one State or possession into any other State or countries into the States or possessions, or from one State or possession into any other State or
possession.”103 Following this text, Section 361(a) states that “[f]or purposes of carrying and possession.”103 Following this text, Section 361(a) states that “[f]or purposes of carrying and
enforcing such regulations,” the Agency “may provide for such inspection, fumigation, enforcing such regulations,” the Agency “may provide for such inspection, fumigation,
disinfection, sanitation, pest extermination, destruction of animals or articles found to be so 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 infected or contaminated as to be sources of dangerous infection to human beings, and other
measures, as in [its] judgment may be necessary.”104 Based on this statutory text, some have measures, as in [its] judgment may be necessary.”104 Based on this statutory text, some have
argued that a broad construction of CDC’s Section 361(a) authority may permit CDC to issue argued that a broad construction of CDC’s Section 361(a) authority may permit CDC to issue

98 Under 8 U.S.C. § 1182(a)(1)(A), for instance, immigrants seeking permanent residence in the United States must 98 Under 8 U.S.C. § 1182(a)(1)(A), for instance, immigrants seeking permanent residence in the United States must
present documentation showing they have been vaccinated against certain specified vaccine-preventable diseases. present documentation showing they have been vaccinated against certain specified vaccine-preventable diseases.
99 The Department of Defense’s Immunization Program, for instance, requires all health care personnel working in the 99 The Department of Defense’s Immunization Program, for instance, requires all health care personnel working in the
Department’s medical treatment facilities, as well as all active duty and selected reserve personnel, to receive annual 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 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=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 2019-07-23-085404-617. For more information about the military’s vaccination requirements, see CRS In Focus
IF11816, IF11816, Defense Health Primer: Military Vaccinations, by Bryce H. P. Mendez. , by Bryce H. P. Mendez.
100 The Indian Health Service, for instance, has required proof of immunization for measles and rubella as a condition 100 The Indian Health Service, for instance, has required proof of immunization for measles and rubella as a condition
of employment for all health care personnel since 1991. The agency added seasonal influenza vaccine as a mandatory 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. vaccination for all health care personnel in 2015. See SGM 21-04, Memorandum from Elizabeth A. Fowler, Acting SGM 21-04, Memorandum from Elizabeth A. Fowler, Acting
Director of Indian Health Serv. to all agency employees, Director of Indian Health Serv. to all agency employees, available at https://www.ihs.gov/sites/ihm/themes/https://www.ihs.gov/sites/ihm/themes/
responsive2017/display_objects/documents/sgm/2021/covid-19-immunizations-requirement.pdf. responsive2017/display_objects/documents/sgm/2021/covid-19-immunizations-requirement.pdf.
101 101 See, e.g., Lindsay F. Wiley, , Lindsay F. Wiley, CDC’s Boundary-Pushing Eviction Freeze, AM. CONST. SOC’Y (Sept. 3, 2020), , AM. CONST. SOC’Y (Sept. 3, 2020),
https://www.acslaw.org/expertforum/cdcs-boundary-pushing-eviction-freeze/ (prior to the availability of COVID-19 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 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, 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 , 42 AM. J.L. & MED. 543, 566 (2016) (suggesting CDC
has authority under Section 361 “to require vaccinations as a condition of airline travel”). has authority under Section 361 “to require vaccinations as a condition of airline travel”).
102 102 See Legal Authorities for Isolation and Quarantine, CTRS. FOR DISEASE CONTROL & PREVENTION (Feb. 24, 2020), , CTRS. FOR DISEASE CONTROL & PREVENTION (Feb. 24, 2020),
https://www.cdc.gov/quarantine/aboutlawsregulationsquarantineisolation.html. https://www.cdc.gov/quarantine/aboutlawsregulationsquarantineisolation.html.
103 42 U.S.C. § 264(a). 103 42 U.S.C. § 264(a).
104 104 Id. § 264(a). § 264(a).
Congressional Research Service Congressional Research Service

13 13

link to page 16 link to page 17 link to page 16 link to page 17 State and Federal Authority to Mandate COVID-19 Vaccination

regulations requiring vaccination in circumstances that would prevent the foreign or interstate regulations requiring vaccination in circumstances that would prevent the foreign or interstate
transmission of COVID-19.105 transmission of COVID-19.105
Before the COVID-19 vaccines became available under EUAs during the Trump Administration, 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 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 2020. CDC based the moratorium on its findings that evictions threatened to increase the spread
of COVID-19 as they would force people to live in new shared housing or congregate settings.106 of COVID-19 as they would force people to live in new shared housing or congregate settings.106
Numerous legal challenges to the eviction moratorium followed. By June 2021, the U.S. Court of 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 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 of reviewing procedural motions to stay or lift the stay of the district courts’ preliminary
injunction orders107—had reached different conclusions as to the CDC’s statutory authority to injunction orders107—had reached different conclusions as to the CDC’s statutory authority to
issue the order. The D.C. Circuit, adopting a broad construction of Section 361, concluded that issue the order. The D.C. Circuit, adopting a broad construction of Section 361, concluded that
“the CDC’s eviction moratorium f[ell] within the plain text of 42 U.S.C. § 264(a).”108 The Sixth “the CDC’s eviction moratorium f[ell] within the plain text of 42 U.S.C. § 264(a).”108 The Sixth
Circuit, in contrast, characterized the enumerated measures under Section 361(a) as “property 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 interest restrictions” and concluded that the eviction moratorium was “radically unlike” such
restrictions and thus “f[ell] outside the scope of the statute.”109 restrictions and thus “f[ell] outside the scope of the statute.”109
The eviction moratorium litigation introduced much legal uncertainty over the scope of CDC’s 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 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 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) 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 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 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 —concluded that the plaintiffs challenging the eviction moratorium
were likely to succeed on their statutory claim.110 Characterizing the enumerated measures under were likely to succeed on their statutory claim.110 Characterizing the enumerated measures under
Section 361(a) as measures “directly relate[d] to preventing the interstate spread of disease by Section 361(a) as measures “directly relate[d] to preventing the interstate spread of disease by
identifying, isolating, and destroying the disease itself,” the Court concluded that the eviction 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 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 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 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 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 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 the agency authority under the provision to take other measures to prevent the spread of
communicable diseases. communicable diseases.

105 105 See Robertson, Robertson, supra nonote 101, at 566. at 566.
106 85 Fed. Reg. 55,292, 55,296 (Sept. 4, 2020). 106 85 Fed. Reg. 55,292, 55,296 (Sept. 4, 2020).
107 As discussed 107 As discussed infra in noin note 110 in more detail, these orders were issued on the courts’ non-merits dockets without 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 full briefing or oral argument from the parties; thus, their precedential value beyond the cases in which they were
issued is uncertain. issued is uncertain.
108 Ala. Ass’n of Realtors v. U.S. Dep’t of Health & Human Servs., No. 21-5093, 2021 WL 2221646, at *1 (D.C. Cir. 108 Ala. Ass’n of Realtors v. U.S. Dep’t of Health & Human Servs., No. 21-5093, 2021 WL 2221646, at *1 (D.C. Cir.
June 2, 2021). June 2, 2021).
109 Tiger Lily, LLC v. U.S. Dep’t of Hous. & Urb. Dev., 992 F.3d 518, 521, 524 (6th Cir. 2021). 109 Tiger Lily, LLC v. U.S. Dep’t of Hous. & Urb. Dev., 992 F.3d 518, 521, 524 (6th Cir. 2021).
110 141 S. Ct. 2485, 2488–89 (2021) (per curiam). This order was issued on the Supreme Court’s non-merits or motions 110 141 S. Ct. 2485, 2488–89 (2021) (per curiam). This order was issued on the Supreme Court’s non-merits or motions
docket—sometimes informally called the Court’s “shadow docket”—without full briefing and oral argument. Unlike 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 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 the parties as well as input from non-parties known as amici curiae, the precedential value of a non-merits orders , 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 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, 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. , by Joanna R. Lampe.
Congressional Research Service Congressional Research Service

14 14

link to page 30 link to page 6 link to page 30 link to page 6 State and Federal Authority to Mandate COVID-19 Vaccination

To address the spread of the Delta variant in 2021, the President and several executive agencies— 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 including the Centers for Medicare and Medicaid Services (CMS) and the Occupational Safety
and Health Administration (OSHA)—ultimately invoked several other statutory authorities to and Health Administration (OSHA)—ultimately invoked several other statutory authorities to
issue several employment- or workforce-based COVID-19 vaccination mandates for civilians. issue several employment- or workforce-based COVID-19 vaccination mandates for civilians.
These vaccination requirements include those that apply to (1) federal executive agency civilian These vaccination requirements include those that apply to (1) federal executive agency civilian
employees (federal employee mandate);111 (2) federal contractors for executive departments, employees (federal employee mandate);111 (2) federal contractors for executive departments,
agencies, and offices (federal contractor mandate);112 (3) most Medicare- and Medicaid-certified agencies, and offices (federal contractor mandate);112 (3) most Medicare- and Medicaid-certified
providers and suppliers (CMS’s Medicare/Medicaid provider mandate);113 and (4) employers with providers and suppliers (CMS’s Medicare/Medicaid provider mandate);113 and (4) employers with
100 or more employees (OSHA’s large-employer vaccination and testing mandate).114 Subject to 100 or more employees (OSHA’s large-employer vaccination and testing mandate).114 Subject to
accommodations required by federal law for medical disabilities and religious beliefs, these accommodations required by federal law for medical disabilities and religious beliefs, these
employment-based mandates either directly require certain employees to receive COVID-19 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 vaccinations or direct certain employers to impose a vaccination or vaccination-and-testing
requirement on their employees or staff.115 (requirement on their employees or staff.115 (See Table 1 for a summary of these mandates.) for a summary of these mandates.)
Federal Employee Mandate
Executive Order 14,043, issued on September 9, 2021, instructs each executive agency to 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 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 exceptions required by law, including those based on a disability, medical condition, or a
sincerely held religious belief.116 The federal employee mandate directs the Safer Federal sincerely held religious belief.116 The federal employee mandate directs the Safer Federal
Workforce Task Force (Task Force) to issue guidance on this requirement’s implementation.117 Workforce Task Force (Task Force) to issue guidance on this requirement’s implementation.117
The mandate is based on the President’s statutory authority under 5 U.S.C. §§ 3301, 3302, and The mandate is based on the President’s statutory authority under 5 U.S.C. §§ 3301, 3302, and
7301.118 These provisions grant the President general authority to prescribe rules and/or 7301.118 These provisions grant the President general authority to prescribe rules and/or
regulations for executive branch employees.119 regulations for executive branch employees.119
Under the Task Force’s guidance, federal employees must have been fully vaccinated (i.e., two 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 weeks after completing either a one-dose vaccine or a two-dose vaccine series) or have obtained
an exception by November 22, 2021.120 The vaccination requirement applies to employees who an exception by November 22, 2021.120 The vaccination requirement applies to employees who
are under maximum telework or remote-work arrangements.121 Employees who refuse to be are under maximum telework or remote-work arrangements.121 Employees who refuse to be

111 Exec. Order No. 14,043 of Sept. 9, 2021, 86 Fed. Reg. 50,989 (Sept. 14, 2021). 111 Exec. Order No. 14,043 of Sept. 9, 2021, 86 Fed. Reg. 50,989 (Sept. 14, 2021).
112 Exec. Order No. 14,042 of Sept. 9, 2021, 86 Fed. Reg. 50,985 (Sept. 14, 2021). 112 Exec. Order No. 14,042 of Sept. 9, 2021, 86 Fed. Reg. 50,985 (Sept. 14, 2021).
113 86 Fed. Reg. 61,555 (Nov. 5, 2021). 113 86 Fed. Reg. 61,555 (Nov. 5, 2021).
114 86 Fed. Reg. 61,402 (Nov. 5, 2021). In addition to these mandates, the Secretary of Defense mandated COVID-19 114 86 Fed. Reg. 61,402 (Nov. 5, 2021). In addition to these mandates, the Secretary of Defense mandated COVID-19
vaccination for servicemembers. For more information about the military’s COVID-19 vaccination mandate, see CRS vaccination for servicemembers. For more information about the military’s COVID-19 vaccination mandate, see CRS
Insight IN11764, Insight IN11764, The Military’s COVID-19 Vaccination Mandate, by Bryce H. P. Mendez. , by Bryce H. P. Mendez.
115 For more information about reasonable accommodations employers may need to provide—including providing 115 For more information about reasonable accommodations employers may need to provide—including providing
exceptions from the vaccination requirement to employees who do not get vaccinated because of a disability or a 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, sincerely held religious belief—see Anderson & Killion, supra notenote 15.
116 86 Fed. Reg. 50,989, 50,990 (Sept. 14, 2021). 116 86 Fed. Reg. 50,989, 50,990 (Sept. 14, 2021).
117 117 Id.
118 118 Id. at 50,989. at 50,989.
119 119 See 5 U.S.C. §§ 3301 (authorizing the President to “prescribe such regulations for the admission of individuals into 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 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”), 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”). 7301 (authorizing the President to “prescribe regulations for the conduct of employees in the executive branch”).
120 120 See FAQs – Vaccinations: Vaccination Requirement for Federal Employees, SAFER FEDERAL WORKFORCE TASK , SAFER FEDERAL WORKFORCE TASK
FORCE, https://www.saferfederalworkforce.gov/faq/vaccinations/ (last accessed Dec. 7, 2021). FORCE, https://www.saferfederalworkforce.gov/faq/vaccinations/ (last accessed Dec. 7, 2021).
121 121 See id. (“Employees who are on maximum telework or working remotely are not excused from this requirement, (“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 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”). to recall employees who are on maximum telework or working remotely”).
Congressional Research Service Congressional Research Service

15 15

link to page 19 link to page 12 link to page 19 link to page 12 State and Federal Authority to Mandate COVID-19 Vaccination

vaccinated or provide proof of vaccination, and have neither an exception nor an exception 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 request under consideration, are subject to disciplinary measures, up to and including removal or
termination.122 Under the guidance, any removal or termination would be preceded by a brief termination.122 Under the guidance, any removal or termination would be preceded by a brief
period of education and counseling and a suspension period of generally up to 14 days.123 period of education and counseling and a suspension period of generally up to 14 days.123
Several federal employees and at least one employee union have sued to challenge the federal Several federal employees and at least one employee union have sued to challenge the federal
employee mandate.124 These suits raise a variety of claims, including some claims common to employee mandate.124 These suits raise a variety of claims, including some claims common to
challenges to state vaccination requirements.125 As discussed above, courts have generally challenges to state vaccination requirements.125 As discussed above, courts have generally
rejected these claims.126 rejected these claims.126
Plaintiffs have also asserted several claims specific to the federal employee mandate, based on Plaintiffs have also asserted several claims specific to the federal employee mandate, based on
certain generally applicable statutory requirements under the RFRA and APA. One set of claims, certain generally applicable statutory requirements under the RFRA and APA. One set of claims,
for instance, challenged the agencies’ alleged denial of religious exemption requests as violating for instance, challenged the agencies’ alleged denial of religious exemption requests as violating
RFRA and the First Amendment’s Free Exercise Clause.127 In a November 2021 decision, RFRA and the First Amendment’s Free Exercise Clause.127 In a November 2021 decision,
however, the district court considering these claims rejected them as unripe—or too early—for however, the district court considering these claims rejected them as unripe—or too early—for
review, given that each plaintiff had a pending request for exemption and had not suffered any review, given that each plaintiff had a pending request for exemption and had not suffered any
adverse employment consequence.128 Another claim, raised by an employee union, challenges the adverse employment consequence.128 Another claim, raised by an employee union, challenges the
manner by which the mandate was implemented. According to the plaintiffs, the vaccination manner by which the mandate was implemented. According to the plaintiffs, the vaccination
requirement was implemented without undergoing the notice-and-comment rulemaking requirement was implemented without undergoing the notice-and-comment rulemaking
procedures required by the APA.129 The district court in December 2021 dismissed the case for procedures required by the APA.129 The district court in December 2021 dismissed the case for
lack of standing, concluding, among other determinations, that the plaintiff failed to allege that 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] 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 would be disciplined for failure to become vaccinated because, for example, they may choose to
become vaccinated or receive an exemption.”130 become vaccinated or receive an exemption.”130
Federal Contractor Mandate
Executive Order 14,042, also issued on September 9, 2021, directs federal executive departments 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 and agencies to include in certain contracts a clause requiring compliance with the Task Force’s
workplace safety guidance.131 The Task Force guidance, issued on September 24, 2021, requires workplace safety guidance.131 The Task Force guidance, issued on September 24, 2021, requires
federal contractors and subcontractors with a covered contract to conform to several workplace 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 safety protocols, including COVID-19 vaccination of covered contractor-employees, subject to

122 122 See FAQs – Vaccinations: Enforcement of Vaccination Requirement for Employees, SAFER FEDERAL WORKFORCE , SAFER FEDERAL WORKFORCE
TASK FORCE, https://www.saferfederalworkforce.gov/faq/vaccinations/ (last accessed Dec. 7, 2021). TASK FORCE, https://www.saferfederalworkforce.gov/faq/vaccinations/ (last accessed Dec. 7, 2021).
123 123 See id.
124 124 See, e.g.,, BrnovichBrnovich v. Biden, No. 2:21-cv-01568, Second Amended Complaint, ECF No. 70 (D. Ariz. filed Nov. 19, 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 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. (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). filed Oct. 30, 2021).
125 125 See, e.g., Brnovich Second Amended Complaint, , Brnovich Second Amended Complaint, supra nonote 124, ¶¶ 47, 55–57. ¶¶ 47, 55–57.
126 126 See supra nonote 66 and accompanying text. nd accompanying text.
127 127 See Order Denying Emergency Application for Temporary Restraining Order and Mot. for Preliminary Injunction, Order Denying Emergency Application for Temporary Restraining Order and Mot. for Preliminary Injunction,
ECF No. 17, Church v. Biden, No. 1:21-cv02815 (D.D.C. Nov. 8, 2021). ECF No. 17, Church v. Biden, No. 1:21-cv02815 (D.D.C. Nov. 8, 2021).
128 128 See id. at 1. at 1.
129 129 See Mot. for Preliminary Injunction at 9–10, ECF No. 19, Am. Fed. of Gov’t Emp. v. Biden, No. 1:21-cv-23828 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). (S.D. Fla. filed Nov. 12, 2021).
130 130 See Order Dismissing Case for Lack of Subject Matter Jurisdiction, ECF No. 33, Am. Fed. of Gov’t Emp. v. Biden, 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). No. 1:21-cv-23828 (S.D. Fla. Dec. 22, 2021).
131 Exec. Order No. 14,042 of Sept. 9, 2021, 86 Fed. Reg. 50,985, 50,985 (Sept. 14, 2021). 131 Exec. Order No. 14,042 of Sept. 9, 2021, 86 Fed. Reg. 50,985, 50,985 (Sept. 14, 2021).
Congressional Research Service Congressional Research Service

16 16

link to page 20 link to page 20 State and Federal Authority to Mandate COVID-19 Vaccination

exceptions required by law.132 Covered contractor-employees include those working on or in exceptions required by law.132 Covered contractor-employees include those working on or in
connection with a covered contract or working at a covered contractor workplace.133 Covered connection with a covered contract or working at a covered contractor workplace.133 Covered
contractor-employees working remotely are subject to the vaccination requirements.134 contractor-employees working remotely are subject to the vaccination requirements.134
Consistent with the executive order, the federal contractor mandate sets forth a phase-in period Consistent with the executive order, the federal contractor mandate sets forth a phase-in period
for the new clause to be added to federal contracts.135 Generally, new contracts awarded on or for the new clause to be added to federal contracts.135 Generally, new contracts awarded on or
after November 14, 2021, must include the new clause, while contracts awarded prior to October 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 15, 2021, would incorporate the new clause only at the point at which the government renews the
contract or exercises an option.136 By January 18, 2022, covered contractors must ensure that their contract or exercises an option.136 By January 18, 2022, covered contractors must ensure that their
covered employees are fully vaccinated by the first day of performance of a new contract or when covered employees are fully vaccinated by the first day of performance of a new contract or when
there is a renewal, extension, or exercised option on an existing contract.137 The Task Force there is a renewal, extension, or exercised option on an existing contract.137 The Task Force
guidance instructs that “significant actions, such as termination of the contract,” should be taken guidance instructs that “significant actions, such as termination of the contract,” should be taken
if a contractor does not take steps to comply with the requirements.138 if a contractor does not take steps to comply with the requirements.138
The Federal Contractor executive order is based on the President’s authorities under 3 U.S.C. 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 § 301 and the Federal Property and Administrative Services Act (Procurement Act), including 40
U.S.C. § 121.139 The Procurement Act empowers the President to “prescribe policies and U.S.C. § 121.139 The Procurement Act empowers the President to “prescribe policies and
directives that the President considers necessary to carry out” the Act if they are consistent with directives that the President considers necessary to carry out” the Act if they are consistent with
the Act,140 the purpose of which is to provide “an economical and efficient system” for, among the Act,140 the purpose of which is to provide “an economical and efficient system” for, among
other objectives, federal procurement.141 The Federal Contractor executive order states that it was other objectives, federal procurement.141 The Federal Contractor executive order states that it was
issued to promote this purpose “by ensuring that the parties that contract with the Federal 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 Government provide adequate COVID-19 safeguards to their workers” performing on or in
connection with a covered contract.142 The President determined that the safeguards would connection with a covered contract.142 The President determined that the safeguards would
“decrease worker absence, reduce labor costs, and improve the efficiency of contractors and “decrease worker absence, reduce labor costs, and improve the efficiency of contractors and
subcontractors at sites where they are performing work for the Federal Government.”143 subcontractors at sites where they are performing work for the Federal Government.”143
The executive order, pursuant to 3 U.S.C. § 301, tasked the Director of the Office of Management 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 Budget (OMB) with determining whether the Task Force’s guidance “will promote economy

132 SAFER FEDERAL WORKFORCE TASK FORCE, COVID-19 WORKPLACE SAFETY: GUIDANCE FOR FEDERAL CONTRACTORS 132 SAFER FEDERAL WORKFORCE TASK FORCE, COVID-19 WORKPLACE SAFETY: GUIDANCE FOR FEDERAL CONTRACTORS
AND SUBCONTRACTORS (updated Nov. 10, 2021), https://www.saferfederalworkforce.gov/downloads/Guidance%20AND SUBCONTRACTORS (updated Nov. 10, 2021), https://www.saferfederalworkforce.gov/downloads/Guidance%20
for%20Federal%20Contractors_Safer%20Federal%20Workforce%20Task%20Force_20211110.pdf [hereinafter TASK for%20Federal%20Contractors_Safer%20Federal%20Workforce%20Task%20Force_20211110.pdf [hereinafter TASK
FORCE FEDERAL CONTRACTOR GUIDANCE]. FORCE FEDERAL CONTRACTOR GUIDANCE].
133 133 Id. at 3. at 3.
134 134 See FAQs – Federal Contractors: Workplaces, SAFER FEDERAL WORKFORCE TASK FORCE, https://www., SAFER FEDERAL WORKFORCE TASK FORCE, https://www.
saferfederalworkforce.gov/faq/contractors/ (last accessed Dec. 7, 2021).saferfederalworkforce.gov/faq/contractors/ (last accessed Dec. 7, 2021).
135 135 See FAQs – Federal Contractors: Scope and Applicability of Task Force Guidance for Federal Contractors, SAFER , SAFER
FEDERAL WORKFORCE TASK FORCE, https://www.saferfederalworkforce.gov/faq/contractors/ (last accessed Dec. 7, FEDERAL WORKFORCE TASK FORCE, https://www.saferfederalworkforce.gov/faq/contractors/ (last accessed Dec. 7,
2021). 2021).
136 136 See id.
137 TASK FORCE FEDERAL CONTRACTOR GUIDANCE, 137 TASK FORCE FEDERAL CONTRACTOR GUIDANCE, supra nonote 132, at 5. at 5.
138 138 See FAQs – Federal Contractors: Compliance, SAFER FEDERAL WORKFORCE TASK FORCE, https://www., SAFER FEDERAL WORKFORCE TASK FORCE, https://www.
saferfederalworkforce.gov/faq/contractors/ (last accessed Dec. 7, 2021). For more information about the Federal saferfederalworkforce.gov/faq/contractors/ (last accessed Dec. 7, 2021). For more information about the Federal
Contractor EO’s requirements, see CRS Insight IN11803, Contractor EO’s requirements, see CRS Insight IN11803, Executive Order 14042 Requirements for COVID-19
Vaccination of Federal Contractors, coordinated by Heidi M. Peters. , coordinated by Heidi M. Peters.
139 139 See 86 Fed. Reg. 50,985, 50,985 (Sept. 14, 2021). 86 Fed. Reg. 50,985, 50,985 (Sept. 14, 2021).
140 40 U.S.C. § 121(a). 140 40 U.S.C. § 121(a).
141 141 Id. § 101. § 101.
142 86 Fed. Reg. 50,985, 50,985 (Sept. 14, 2021). 142 86 Fed. Reg. 50,985, 50,985 (Sept. 14, 2021).
143 143 Id.
Congressional Research Service Congressional Research Service

17 17

State and Federal Authority to Mandate COVID-19 Vaccination

and efficiency in Federal contracting.”144 In accordance with this delegation, the OMB Director and efficiency in Federal contracting.”144 In accordance with this delegation, the OMB Director
made an affirmative determination in a made an affirmative determination in a Federal Register notice published on the same date of the notice published on the same date of the
Task Force guidance’s release.145 The executive order also directs the Federal Acquisition Task Force guidance’s release.145 The executive order also directs the Federal Acquisition
Regulatory Council to make corresponding amendments to the Federal Acquisition Regulation, 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 and to issue guidance to federal agencies on how to comply with the federal contractor mandate
in the interim.146 The Council issued the guidance on September 30, 2021.147 in the interim.146 The Council issued the guidance on September 30, 2021.147
More than 20 states, on behalf of their state agencies and political subdivisions that may have a More than 20 states, on behalf of their state agencies and political subdivisions that may have a
covered contract subject to the federal contractor mandate, have filed at least four separate suits in covered contract subject to the federal contractor mandate, have filed at least four separate suits in
different district courts to challenge the mandate.148 Plaintiffs in each case filed a motion for different district courts to challenge the mandate.148 Plaintiffs in each case filed a motion for
preliminary injunction seeking to enjoin the mandate while the litigation is pending. In November preliminary injunction seeking to enjoin the mandate while the litigation is pending. In November
2021, one district court—in 2021, one district court—in Kentucky v. Biden, a challenge filed by Kentucky, Ohio, and , a challenge filed by Kentucky, Ohio, and
Tennessee—granted the states’ motion and enjoined the mandate in those three states while the Tennessee—granted the states’ motion and enjoined the mandate in those three states while the
litigation is pending.149 In December 2021, another district court—in litigation is pending.149 In December 2021, another district court—in Georgia v. Biden, a , a
challenge filed by Georgia and six other states—granted the states’ motion and issued a challenge filed by Georgia and six other states—granted the states’ motion and issued a
nationwide injunction.150 Among other determinations, both district courts concluded that the nationwide injunction.150 Among other determinations, both district courts concluded that the
President likely exceeded his statutory authority under the Procurement Act in imposing the President likely exceeded his statutory authority under the Procurement Act in imposing the
vaccination requirement.151 vaccination requirement.151
The government has appealed the district courts’ orders in both cases. On January 5, 2022, the The government has appealed the district courts’ orders in both cases. On January 5, 2022, the
Sixth Circuit denied the government’s application to stay the injunction in Sixth Circuit denied the government’s application to stay the injunction in Kentucky.152 Among .152 Among
other determinations, the Sixth Circuit agreed with the district court that the federal contractor other determinations, the Sixth Circuit agreed with the district court that the federal contractor
mandate likely exceeded the President’s statutory authority.153 In the Sixth Circuit’s view, the mandate likely exceeded the President’s statutory authority.153 In the Sixth Circuit’s view, the
relevant Procurement Act provisions authorize the President “to implement an ‘economical and 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 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 permit the President to “impose whatever medical procedure deemed ‘necessary’ on the relevant
services personnel” services personnel” after those services have been acquired.154 The government’s appeal in those services have been acquired.154 The government’s appeal in
Georgia is pending before the U.S. Court of Appeals for the Eleventh Circuit (Eleventh is pending before the U.S. Court of Appeals for the Eleventh Circuit (Eleventh
Circuit).155Circuit).155

144 144 Id. at 50,985–50,986. at 50,985–50,986.
145 145 See 86 Fed. Reg. 53,691 (Sept. 24, 2021). 86 Fed. Reg. 53,691 (Sept. 24, 2021).
146 86 Fed. Reg. 50,985, 50,986 (Sept. 14, 2021). 146 86 Fed. Reg. 50,985, 50,986 (Sept. 14, 2021).
147 Memorandum from the Fed. Acquisition Regul. Council to Chief Acquisition Officers, Senior Procurement 147 Memorandum from the Fed. Acquisition Regul. Council to Chief Acquisition Officers, Senior Procurement
Executives, Defense Acquisition Regulations Council, Civilian Agency Acquisition Council (Sept. 30, 2021), 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-https://www.whitehouse.gov/wp-content/uploads/2021/09/FAR-Council-Guidance-on-Agency-Issuance-of-Deviations-
to-Implement-EO-14042.pdf. to-Implement-EO-14042.pdf.
148 148 See, e.g., Florida v. Nelson, No. 8:21-cv-2524 (M.D. Fla. filed Oct. 28, 2021); Kentucky v. Biden, No. 3:21-cv-, 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. 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). Ga. Dec. 7, 2021).
149 149 Kentucky, 2021 WL5587446, at *13–14. , 2021 WL5587446, at *13–14.
150 150 Georgia, 2021 WL 5779939, at *12. , 2021 WL 5779939, at *12.
151 151 Kentucky, 2021 WL5587446, at *6–7; , 2021 WL5587446, at *6–7; Georgia, 2021 WL 5779939, at *10. , 2021 WL 5779939, at *10.
152 Kentucky v. Biden, No. 21-6147, 2022 WL 43178, at *1 (6th Cir. Jan. 5, 2022). 152 Kentucky v. Biden, No. 21-6147, 2022 WL 43178, at *1 (6th Cir. Jan. 5, 2022).
153 153 Id. at *11–16. at *11–16.
154 154 Id. at *12. at *12.
155 155 See Georgia v. Biden, No. 21-14269 (11th Cir. filed Dec. 10, 2021). Georgia v. Biden, No. 21-14269 (11th Cir. filed Dec. 10, 2021).
Congressional Research Service Congressional Research Service

18 18

State and Federal Authority to Mandate COVID-19 Vaccination

CMS’s Medicare/Medicaid Provider Mandate
On November 4, 2021, CMS released an Interim Final Rule (IFR), effective November 5, 2021, 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 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 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, dose of a two-dose COVID-19 vaccine or a one-dose COVID-19 vaccine by December 6, 2021,
and to complete their vaccination series by January 4, 2022.156 This mandate applies to 15 and to complete their vaccination series by January 4, 2022.156 This mandate applies to 15
provider and supplier types that participate in Medicare and Medicaid, including hospitals, long-provider and supplier types that participate in Medicare and Medicaid, including hospitals, long-
term-care facilities, and rural health clinics.157 The mandate does not apply to other health care term-care facilities, and rural health clinics.157 The mandate does not apply to other health care
entities such as physician offices, organ procurement organizations, and portable X-Ray entities such as physician offices, organ procurement organizations, and portable X-Ray
suppliers.158 suppliers.158
For providers and suppliers subject to the IFR, their vaccination policy must apply to all staff who 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 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 (1) employees (including administrative staff as well as facility leadership); (2) licensed
practitioners; (3) students, trainees, and volunteers; and (4) individuals who provide care, 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 treatment, or other services for the facility and/or its patients under contract or other arrangements
(including housekeeping and food services).159 Individuals who provide services 100% remotely (including housekeeping and food services).159 Individuals who provide services 100% remotely
from sites of patient care and away from staff who work at sites of care—such as fully remote from sites of patient care and away from staff who work at sites of care—such as fully remote
telehealth or payroll services—are not subject to the vaccination requirements.160 CMS states that telehealth or payroll services—are not subject to the vaccination requirements.160 CMS states that
noncompliant providers and suppliers will be subject to enforcement remedies based on the level 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 of noncompliance and available remedies, which may include civil monetary penalties, denial of
payment for new admissions, and termination of the Medicare/Medicaid provider agreement.161 payment for new admissions, and termination of the Medicare/Medicaid provider agreement.161
According to CMS, the Medicare/Medicaid provider mandate is based on its determination that a 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 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 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) 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 potential harm to patients from unvaccinated health care workers; (3) continuing strain on the
health care system; and (4) known efficacy and safety of available vaccines.162 The agency found health care system; and (4) known efficacy and safety of available vaccines.162 The agency found
“good cause” to waive the notice-and-comment rulemaking procedures under the APA and “good cause” to waive the notice-and-comment rulemaking procedures under the APA and
Section 1871(b) of the Social Security Act (SSA).163 The agency based that determination on Section 1871(b) of the Social Security Act (SSA).163 The agency based that determination on
several considerations, including (1) that Delta-variant outbreaks showed that current levels of 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; 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 (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 circulate more frequently during the winter months; and (4) the onset of the 2021-2022 influenza
season.164 season.164

156 86 Fed. Reg. 61,555, 61,563, 61,573 (Nov. 5, 2021). 156 86 Fed. Reg. 61,555, 61,563, 61,573 (Nov. 5, 2021).
157 157 Id. at 61,556. at 61,556.
158 158 Id.
159 159 Id. at 61,570–61,571. at 61,570–61,571.
160 160 Id. at 61,571. at 61,571.
161 161 Id. at 61,574. at 61,574.
162 162 Id. at 61,586. at 61,586.
163 163 Id.
164 164 Id. at 61,583–61,584, 61,586. at 61,583–61,584, 61,586.
Congressional Research Service Congressional Research Service

19 19

State and Federal Authority to Mandate COVID-19 Vaccination

CMS relied on several layers of statutory authorities in issuing the IFR.165 Across all providers CMS relied on several layers of statutory authorities in issuing the IFR.165 Across all providers
and suppliers, CMS invokes SSA Section 1102, a provision that grants the Secretary of HHS 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 general authority to issue rules “as may be necessary to the efficient administration of the
functions” with which the Secretary is charged under the SSA.166 For Medicare providers and functions” with which the Secretary is charged under the SSA.166 For Medicare providers and
suppliers, CMS additionally relies on SSA Section 1871, which authorizes the Secretary to 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 prescribe regulations “as may be necessary to carry out the administration” of the Medicare
programs.167 Finally, for each provider and supplier, CMS also relies on certain provider- and programs.167 Finally, for each provider and supplier, CMS also relies on certain provider- and
supplier-specific provisions, many of which authorize the Secretary to impose requirements he supplier-specific provisions, many of which authorize the Secretary to impose requirements he
finds necessary to protect the health and safety of individuals who receive services from the finds necessary to protect the health and safety of individuals who receive services from the
relevant entities.168 relevant entities.168
At least 25 states, on behalf of certain state-run health care facilities that may be subject to the 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 vaccination requirements, filed four separate suits to challenge the IFR shortly after its
issuance.169 Plaintiffs in each case filed a motion for preliminary injunction seeking to enjoin the issuance.169 Plaintiffs in each case filed a motion for preliminary injunction seeking to enjoin the
IFR while the litigation proceeds. In November 2021, one district court, in 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 , declined to enjoin the IFR, concluding the state had not shown
“irreparable harm” to justify an injunction.170 In the court’s view, the state had not provided “irreparable harm” to justify an injunction.170 In the court’s view, the state had not provided
sufficient factual evidence to demonstrate that the vaccination requirements’ alleged likely 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 adverse impact, such as potential staffing shortages, would result if the requirements were not
halted.171 halted.171
Later in the same month, however, two district courts—in Later in the same month, however, two district courts—in Missouri v. Biden and and Louisiana v.
Becerra—granted the plaintiffs’ motions in each respective case.172 The —granted the plaintiffs’ motions in each respective case.172 The Missouri court enjoined court enjoined
the IFR in 10 plaintiff states, while the the IFR in 10 plaintiff states, while the Louisiana court enjoined the rule in the remaining court enjoined the rule in the remaining
states.173 Among other determinations, both courts concluded that CMS likely exceeded its states.173 Among other determinations, both courts concluded that CMS likely exceeded its
statutory authority in issuing the IFR because the applicable provisions do not specifically statutory authority in issuing the IFR because the applicable provisions do not specifically
authorize the agency to mandate vaccination;174 the agency likely lacked “good cause” to waive authorize the agency to mandate vaccination;174 the agency likely lacked “good cause” to waive
notice-and-comment rulemaking procedures;175 and the plaintiffs sufficiently demonstrated they notice-and-comment rulemaking procedures;175 and the plaintiffs sufficiently demonstrated they
would suffer irreparable harm—including in the form of significant staffing shortages—if the IFR would suffer irreparable harm—including in the form of significant staffing shortages—if the IFR
was not enjoined.176 The U.S. Court of Appeals for the Fifth Circuit (Fifth Circuit), in considering was not enjoined.176 The U.S. Court of Appeals for the Fifth Circuit (Fifth Circuit), in considering
the government’s motion to stay the preliminary injunction in the government’s motion to stay the preliminary injunction in Louisiana, narrowed the scope of , narrowed the scope of

165 165 Id. at 61,567. at 61,567.
166 42 U.S.C. § 1302(a). 166 42 U.S.C. § 1302(a).
167 167 Id. § 1395hh(a). § 1395hh(a).
168 168 See, e.g., 42 U.S.C. §§ 1395x(e)(9) (authorizing the Secretary to impose requirements on hospitals that he “finds , 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) 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). (similar for hospices), 1395x(aa) (rural health clinics), 1395i-3(d)(4)(B) (long-term care facilities).
169 169 See Florida v. Dep’t of Health & Human Servs., No. 3:21-cv-2722, 2021 WL 5416122 (N.D. Fla. Nov. 20, 2021); 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-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. 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). filed Nov. 15, 2021).
170 170 Florida, 2021 WL 5416122, at *1. , 2021 WL 5416122, at *1.
171 171 Id. at *3–4. at *3–4.
172 172 Missouri, 2021 WL 5564501, at *15; , 2021 WL 5564501, at *15; Louisiana, 2021 WL 5609846, at *17. , 2021 WL 5609846, at *17.
173 173 Missouri, 2021 WL 5564501, at *15; , 2021 WL 5564501, at *15; Louisiana, 2021 WL 5609846, at *17. , 2021 WL 5609846, at *17.
174 174 See Missouri, 2021 WL 5564501, at *3; , 2021 WL 5564501, at *3; Louisiana, 2021 WL 5609846, at *10-11., 2021 WL 5609846, at *10-11.
175 175 See Missouri, 2021 WL 5564501, at *5–6; , 2021 WL 5564501, at *5–6; Louisiana, 2021 WL 5609846, at *8–9., 2021 WL 5609846, at *8–9.
176 176 See Missouri, 2021 WL 5564501, at *12–13; , 2021 WL 5564501, at *12–13; Louisiana, 2021 WL 5609846, at *16. , 2021 WL 5609846, at *16.
Congressional Research Service Congressional Research Service

20 20

State and Federal Authority to Mandate COVID-19 Vaccination

the injunction to the 14 plaintiff states.177 Since the Fifth Circuit’s order, the U.S. District Court the injunction to the 14 plaintiff states.177 Since the Fifth Circuit’s order, the U.S. District Court
for the Northern District of Texas, in for the Northern District of Texas, in Texas v. Becerra, issued a preliminary injunction order , issued a preliminary injunction order
enjoining the IFR’s enforcement in that state.178 As of December 31, 2021, CMS is enjoined from enjoining the IFR’s enforcement in that state.178 As of December 31, 2021, CMS is enjoined from
enforcing the IFR in the 25 states that are plaintiffs in enforcing the IFR in the 25 states that are plaintiffs in Missouri, , Louisiana, or , or Texas. .
As noted by the Fifth Circuit in As noted by the Fifth Circuit in Louisiana, one key legal question on the merits concerning the , one key legal question on the merits concerning the
Medicare/Medicaid provider mandate litigation is whether the rule exceeds the agency’s statutory 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 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 vaccination. Characterizing this issue as a “close call,” the Fifth Circuit—in upholding the
preliminary injunction in the 14 plaintiff states—concluded that the government had not preliminary injunction in the 14 plaintiff states—concluded that the government had not
sufficiently demonstrated that the rule fell within the agency’s statutory authority.179 sufficiently demonstrated that the rule fell within the agency’s statutory authority.179
On this issue, a divided panel of the Eleventh Circuit, in considering Florida’s motion for an On this issue, a divided panel of the Eleventh Circuit, in considering Florida’s motion for an
injunction pending its appeal of the district court’s order in injunction pending its appeal of the district court’s order in Florida, concluded that the relevant , concluded that the relevant
Medicare and Medicaid provisions “plainly encompass[]” the IFR’s vaccination requirement.180 Medicare and Medicaid provisions “plainly encompass[]” the IFR’s vaccination requirement.180
In the Eleventh Circuit’s view, the relevant Medicare and Medicaid statutes expressly “authorized 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 the Secretary to set standards to protect the health and safety of patients” served by Medicare and
Medicaid facilities.181 The IFR’s vaccination requirements, according to the Eleventh Circuit, fell Medicaid facilities.181 The IFR’s vaccination requirements, according to the Eleventh Circuit, fell
squarely within this grant of authority, given that COVID-19 is a deadly, highly transmissible 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 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 diseases, and required vaccination is “a common-sense measure designed to prevent healthcare
workers . . . from making [patients] sicker.”182 Thus, in the Eleventh Circuit’s view, “when it workers . . . from making [patients] sicker.”182 Thus, in the Eleventh Circuit’s view, “when it
comes to vaccination mandates, there was no reason for Congress to be more specific than 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 authorizing the Secretary to make regulations for the ‘health and safety’ of Medicare and
Medicaid recipients.”183 To suggest otherwise, the court continued, “would mean that Congress Medicaid recipients.”183 To suggest otherwise, the court continued, “would mean that Congress
had to have anticipated both the unprecedented COVID-19 pandemic and the unprecedented had to have anticipated both the unprecedented COVID-19 pandemic and the unprecedented
politicization of the disease to regulate vaccination against it.”184 The dissent’s analysis, on the politicization of the disease to regulate vaccination against it.”184 The dissent’s analysis, on the
other hand, largely echoes that of the district courts in other hand, largely echoes that of the district courts in Missouri and and Louisiana.185 .185
On December 30, 2021, CMS announced that the IFR will be implemented and enforced, on a On December 30, 2021, CMS announced that the IFR will be implemented and enforced, on a
modified timeline, in the jurisdictions modified timeline, in the jurisdictions not subject to the preliminary injunctions in subject to the preliminary injunctions in Missouri, ,
Louisiana, and, and Texas.186 The deadline to receive the first dose of a vaccine is extended to January .186 The deadline to receive the first dose of a vaccine is extended to January
27, 2022, and the deadline to complete the vaccination series is extended to February 28, 2022.187 27, 2022, and the deadline to complete the vaccination series is extended to February 28, 2022.187
The government The government ~~has~~ filed an application with the Supreme Court seeking to stay the preliminary filed an application with the Supreme Court seeking to stay the preliminary
injunctions in both injunctions in both Louisiana and and Missouri. . ~~The Court held an oral argument regarding~~On January 13, 2022, the Supreme Court granted the the

177 Louisiana v. Becerra, 2021 WL 5913302, at *2–3 (5th Cir. Dec. 15, 2021). 177 Louisiana v. Becerra, 2021 WL 5913302, at *2–3 (5th Cir. Dec. 15, 2021).
178 Texas v. Becerra, 2021 WL 5964687, at *16. 178 Texas v. Becerra, 2021 WL 5964687, at *16.
179 179 See Louisiana, 2021 WL 5913302, at *1. , 2021 WL 5913302, at *1.
180 Florida v. Dep’t of Health & Human Servs., 2021 WL 5768796, at *12. 180 Florida v. Dep’t of Health & Human Servs., 2021 WL 5768796, at *12.
181 181 Id.
182 182 Id.
183 183 Id.
184 184 Id.
185 185 Id. at 24. at 24.
186 186 See Current Emergencies, CTRS. FOR MEDICARE & MEDICAID SERVS., https://www.cms.gov/About-CMS/Agency-, 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). Information/Emergency/EPRO/Current-Emergencies/Current-Emergencies-page (last accessed Dec. 30, 2021).
187 187 Id.
Congressional Research Service Congressional Research Service

21 21

State and Federal Authority to Mandate COVID-19 Vaccination

application application ~~on January 7, 2022, and, in issuing a decision on the application, may opt to clarify~~
~~the scope of CMS’s statutory authority with respect to the IFR.188~~.188 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, particularly given that the Secretary routinely imposes conditions of participation that relate to the qualification and duties of health care workers and the fact that vaccination requirements for health care workers are “a common feature of the provision of healthcare in America.”189 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.190 In these states, the deadline to receive the first dose of a vaccine is February 14, 2022, and the deadline to complete the vaccination series is March 15, 2022.191
OSHA’s Large-Employer Vaccination and Testing Mandate
On November 4, 2021, OSHA released an emergency temporary standard (ETS) that generally 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 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 either (1) requires all employees to receive a COVID-19 vaccination, subject to legally required
exceptions; or (2) requires employees to receive either a COVID-19 vaccination or provide proof 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 of regular COVID-19 testing and wear a face covering when indoors or occupying a vehicle with
another person.another person.~~189~~192 For the 26 states, Puerto Rico, and the U.S. Virgin Islands that have opted to 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 adopt their own OSHA-approved state plans, the ETS also applies to state agency and local
government employers.government employers.~~190~~193 To the extent a workplace is subject to both the ETS and one of the 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, 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 OSHA specifically states either that the ETS does not apply (in the case of federal contractors or
health care providers and suppliers)health care providers and suppliers)~~191~~194 or that compliance with the other mandate is deemed or that compliance with the other mandate is deemed
sufficient to meet the employers’ obligations under the ETS (in the case of executive agencies).sufficient to meet the employers’ obligations under the ETS (in the case of executive agencies).~~192~~195
Under the large-employer vaccination and testing mandate, employees who are not fully 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 vaccinated—including those who have been granted exceptions—generally must be tested at least
~~once every seven days if they report at least once every seven days to a work site where others are~~
~~present.193 Employees who do not report to such a workplace during a period of seven or more~~
~~days must be tested within seven days prior to returning to the workplace.194 Employees exempt~~
~~from the ETS’s requirements include (1) employees who work remotely or at a site where other~~
~~people are not present; and (2) employees who work exclusively outside.195 Covered employers~~
~~can, but are not required to, pay for any costs associated with testing,196 but they must provide~~
~~employees with paid leave to receive and recover from the vaccination.197 Covered employers~~
~~must establish and begin to implement the relevant vaccination policy by December 6, 2021, and~~
~~ensure their employees have completed a one-dose vaccine or a two-dose vaccine series by~~
~~January 4, 2022.198 After that, all covered employers must ensure that employees who are not~~

~~188 See U.S. SUPREME COURT, Docket, Becerra v. Louisiana, No. 21A241, https://www.supremecourt.gov/search.aspx?~~
~~filename=/docket/docketfiles/html/public/21a241.html (last accessed Jan. 10, 2022).~~
~~189 86 Fed. Reg. 61,402, 61,552 (Nov. 5, 2021) (adding 29 C.F.R. § 1910.501(d)).~~
~~190~~ 188 Biden v. Missouri, No. 21A240, 2022 WL 120950, *1 (Jan. 13, 2022) (per curiam). 189 Id. at *3. The Court acknowledged that not all statutory provisions invoked by CMS contain the “health and safety” statutory language. See id. at *2 n.*. Noting, 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%,” the Court saw no reason to let the 3% “wag the . . . dog.” Id. 190 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. 191 Id. at 3. 192 86 Fed. Reg. 61,402, 61,552 (Nov. 5, 2021) (adding 29 C.F.R. § 1910.501(d)). 193 Section 18 of the Occupational Safety and Health Act of 1970 (29 U.S.C. § 667) authorizes states, subject to 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 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 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, state agency and local government as employers, see 29 U.S.C. § 652(5), OSHA-approved state plans must provide 29 U.S.C. § 652(5), OSHA-approved state plans must provide
coverage for state agencies and local government entities as employers, coverage for state agencies and local government entities as employers, see 29 U.S.C. § 667. For more information 29 U.S.C. § 667. For more information
about OSHA’s jurisdiction and coverage of OSHA-approved state plans, see CRS In Focus IF11619, 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. , by Scott D.
Szymendera. Szymendera.
~~191~~194 See 86 Fed. Reg. 61,402, 61,447 (Nov. 5, 2021). 86 Fed. Reg. 61,402, 61,447 (Nov. 5, 2021).
~~192~~195 See id. at 61,402. Congressional Research Service 22 State and Federal Authority to Mandate COVID-19 Vaccination once every seven days if they report at least once every seven days to a work site where others are present.196 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.197 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.198 Covered employers can, but are not required to, pay for any costs associated with testing,199 but they must provide employees with paid leave to receive and recover from the vaccination.200 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, 2022.201 After that, all covered employers must ensure that employees who are not fully vaccinated are subject to regular COVID-19 testing.202 See id. at 61,402.
~~193 See id. at 61,553 (adding 29 C.F.R. § 1910.501(g)).~~
~~194 See id. at 61,553 (adding 29 C.F.R. § 1910.501(g)(ii)).~~
~~195 See id. at 61,419.~~
~~196 See id. at 61,553 (Note 1 to paragraph (g)(1)).~~
~~197 See id. at 61,553 (adding § 1910.501(f)).~~
~~198 See id. at 61,554 (adding § 1910.501(m)(2)).~~
~~Congressional Research Service~~

22

~~State and Federal Authority to Mandate COVID-19 Vaccination~~

~~fully vaccinated are subject to regular COVID-19 testing.199~~ Noncompliant covered employers Noncompliant covered employers
could face OSHA citations and civil monetary penalties.could face OSHA citations and civil monetary penalties.~~200~~203
The large-employer vaccination and testing mandate is based on OSHA’s authority under Section 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)).6(c) of the Occupational Safety and Health Act of 1970 (29 U.S.C. § 655(c)).~~201~~204 The provision The provision
authorizes the agency to issue an ETS that takes effect immediately upon publication in the 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 , without undergoing the APA’s rulemaking proceedings, if it determines
“(A) that employees are exposed to grave danger from exposure to substances or agents “(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 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.”standard is necessary to protect employees from such danger.”~~202~~205 OSHA issued the ETS upon its OSHA issued the ETS upon its
determination that unvaccinated workers face a grave danger from exposure to SARS-CoV-2 in 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 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 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 outcomes; and that evidence demonstrates the virus’s transmissibility in the workplace and the
prevalence of infections in employee populations.prevalence of infections in employee populations.~~203~~206 OSHA further determined that the ETS is OSHA further determined that the ETS is
necessary to protect unvaccinated workers from the risk of contracting COVID-19 given the 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 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 vaccination provides the most effective and efficient control available, with the use of other
mitigation measures further protecting workers who remain unvaccinated.mitigation measures further protecting workers who remain unvaccinated.~~204~~207
On the same day the ETS was issued, numerous petitioners—including covered employers, states, 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 and religious groups—moved to stay and permanently enjoin the mandate in several federal
~~courts of appeals.205 In response to a petition and motion to stay filed by several covered~~
~~employers and four states, the Fifth Circuit stayed the enforcement of the ETS the day after it was~~
~~issued.206~~
~~On November 12, 2021, the Fifth Circuit affirmed the stay, largely based on its conclusion that~~
~~the ETS “grossly exceeds OSHA’s statutory authority.”207 In the Fifth Circuit’s view, an airborne~~
~~virus like SARS-CoV-2 likely falls outside the scope of a “new hazard” within the meaning of~~
~~Section 6(c) under a canon of statutory construction known as noscitur a sociis, which counsels~~
~~that the more precise meaning of a word should be determined by the neighboring words with~~
~~which it is associated.208 Because “new hazard” is neighbored by “substances or agents” and~~
~~“toxic or physically harmful”—phrases that, in the court’s view, connote toxicity and~~
~~poisonousness—the term likely does not encompass an airborne virus that is both widely present~~

~~199~~ ~~See id.~~
~~200~~ 196 See id. at 61,553 (adding 29 C.F.R. § 1910.501(g)). 197 See id. at 61,553 (adding 29 C.F.R. § 1910.501(g)(ii)). 198 See id. at 61,419. 199 See id. at 61,553 (Note 1 to paragraph (g)(1)). 200 See id. at 61,553 (adding § 1910.501(f)). 201 See id. at 61,554 (adding § 1910.501(m)(2)). 202 See id. 203 See id. at 61,443; at 61,443; see also OSHA Penalties,, OCCUPATIONAL SAFETY & HEALTH ADMIN., https://www.osha.gov/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, 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 , by Scott D. Szymendera; and CRS Legal
Sidebar LSB10658, Sidebar LSB10658, Fifth Circuit Stays OSHA Vaccination and Testing Standard, by Jon O. Shimabukuro. , by Jon O. Shimabukuro.
~~201~~204 86 Fed. Reg. 61,402, 61,402 (Nov. 5, 2021). 86 Fed. Reg. 61,402, 61,402 (Nov. 5, 2021).
~~202~~205 29 U.S.C. § 655(c)(1). 29 U.S.C. § 655(c)(1).
~~203~~206 See 86 Fed. Reg. 61,402, 61,402–61,403 (Nov. 5, 2021).86 Fed. Reg. 61,402, 61,402–61,403 (Nov. 5, 2021).
~~204~~207 See id. at 61,403. Under 29 U.S.C. § 655(f), any person adversely affected by an ETS may file a petition to 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. challenge the validity of the standard in the federal court of appeals in which the person resides.
~~205 See BST Holdings, LLC v. Occupational Safety & Health Admin., 17 F. 4th 604, 610 (5th Cir. 2021).~~
206 See id.
~~207 Id. at 612.~~
~~208 Id. at 613.~~
~~Congressional Research Service~~

23

~~link to page 28~~ ~~State and Federal Authority to Mandate COVID-19 Vaccination~~

~~in society and “non-life-threatening to a vast majority of employees.”209~~Congressional Research Service 23 link to page 29 State and Federal Authority to Mandate COVID-19 Vaccination courts of appeals.208 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.209 On November 12, 2021, the Fifth Circuit affirmed the stay, largely based on its conclusion that the ETS “grossly exceeds OSHA’s statutory authority.”210 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.211 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.”212 Moreover, the court Moreover, the court
concluded that COVID-19 does not pose the required “grave danger” for purposes of Section 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 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 COVID-19, the effects of COVID-19 could be mild, and the status of the virus’s spread has
changed over time.changed over time.~~210~~213 The ETS, in the court’s view, was also not “necessary” to protect 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 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 overinclusive—applying to employers and employees in virtually all industries and workplaces in
America without an attempt to account for differences in COVID-19 exposure—and America without an attempt to account for differences in COVID-19 exposure—and
underinclusive—disregarding workplaces with 99 or fewer employees.underinclusive—disregarding workplaces with 99 or fewer employees.~~211~~214
Pursuant to 28 U.S.C. § 2112, which specifies the procedures for review when an agency order is 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, 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 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 pending petitions will be consolidated for review. Under § 2112(a)(4), the Sixth Circuit may
modify, revoke, or extend the Fifth Circuit’s stay.modify, revoke, or extend the Fifth Circuit’s stay.~~212~~215
On December 17, 2021, a divided panel of the Sixth Circuit, in 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., granted the government’s motion to dissolve the stay issued by the Fifth Circuit.~~213~~216 In the In the
Sixth Circuit’s view, based on the OSH Act’s language, structure, and direct instances of 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 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 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.best possible solution to ensure the health and safety of all workers” under the OSH Act.~~214~~
217 208 See BST Holdings, LLC v. Occupational Safety & Health Admin., 17 F. 4th 604, 610 (5th Cir. 2021). 209 See id. 210 Id. at 612. 211 Id. at 613. 212 Id. 213 Id. at 613–14. 214 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 228, the Sixth Circuit disagreed with this conclusion. 215 28 U.S.C. § 2112(a)(4). 216 2021 WL 5989357, at *1 (6th Cir. Dec. 17, 2021). 217 Id. at *5–6. Congressional Research Service 24 State and Federal Authority to Mandate COVID-19 Vaccination According to the Sixth Circuit, the text of Section 6(c) expressly encompasses the authority to 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 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.physically harmful (i.e., causes bodily harm) within the meaning of the provision.~~215~~218 This This
authority to regulate viruses and infectious diseases, the court continued, is reinforced by other 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 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 hazards,” as well as a provision that contemplates “medical examination, immunization, or
treatment” as possible measures the agency may employ.treatment” as possible measures the agency may employ.~~216~~219 This interpretation, in the court’s This interpretation, in the court’s
view, is further consistent with several instances of Congress’s approval of OSHA’s authority to 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.regulate bloodborne pathogens and viruses such as HIV, hepatitis B, and hepatitis C.~~217~~220 According According
to the Sixth Circuit, this clear authority to regulate viruses necessarily encompasses “the authority 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.”to regulate infectious diseases that are not unique to the workplace.”~~218~~221 Because “no virus—HIV, Because “no virus—HIV,
[hepatitis B], COVID-19—is unique to the workplace and affects only workers,” the court [hepatitis B], COVID-19—is unique to the workplace and affects only workers,” the court

~~209~~ ~~Id.~~
~~210 Id. at 613–14.~~
~~211 Id. at 611, 615. In addition to its statutory analysis, the court commented that the ETS likely exceeds the federal~~
~~government’s authority under the Constitution’s Commerce Clause. Id. Characterizing the relevant regulated activity as~~
~~compulsory vaccination, the Fifth Circuit expressed the view that the ETS impermissibly “regulates noneconomic~~
~~inactivity that falls squarely within the States’ police power.” Id. As discussed infra in note 225, the Sixth Circuit~~
~~disagreed with this conclusion.~~
~~212 28 U.S.C. § 2112(a)(4).~~
~~213 2021 WL 5989357, at *1 (6th Cir. Dec. 17, 2021).~~
~~214 Id. at *5–6.~~
~~215 Id. at *4.~~
~~216 Id. (citing, for instance, 29 U.S.C. §§ 651(a), 651(b)(1), 669(a)(5)).~~
~~217 Id. at *5.~~
~~218 Id. at *6.~~
~~Congressional Research Service~~

24

~~State and Federal Authority to Mandate COVID-19 Vaccination~~

reasoned, OSHA’s authority to regulate hazards extends to those that “co-exist in the workplace 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.”and in society but are at heightened risk in the workplace.”~~219~~222 In the court’s view, OSHA’s In the court’s view, OSHA’s
issuance of the ETS “[was] not a novel expansion of OSHA’s power; it [was] an existing 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.”application of authority to a novel and dangerous worldwide pandemic.”~~220~~223
After concluding that OSHA did not exceed its statutory authority, the Sixth Circuit further 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 concluded that the agency’s determination that the ETS was warranted was supported by
substantial evidence, including the agency’s determination that employees were exposed to 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 “grave danger” from COVID-19 and that the ETS was “necessary to protect employees from such
danger.”danger.”~~221~~224 Under Section 6(f) of the OSH Act, the Secretary’s determinations are “conclusive if 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.”supported by substantial evidence in the record considered as a whole.”~~222~~225
As to the existence of “grave danger,” the Sixth Circuit found, for instance, that OSHA has 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 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 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; 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 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 hospitalizations over the next six months; and that voluntary guidance on vaccination proved
inadequate, particularly in the face of the Delta variant.inadequate, particularly in the face of the Delta variant.~~223~~226 As to the necessity of the ETS, the As to the necessity of the ETS, the
court found, for instance, that OSHA sufficiently demonstrated that the evolving course of 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 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 time and that extensive evidence cited by the agency showed that vaccination reduces the
presence and severity of COVID-19 cases in the workplace.presence and severity of COVID-19 cases in the workplace.~~224~~227 The choice to limit the ETS to The choice to limit the ETS to
employers with 100 or more employees, in the court’s view, did not undermine the standard’s 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 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 underlying regulatory problem, given that “larger employers are better able to implement the
~~policies, are at heightened risk, and regulating them will be a significant step in protecting the~~
~~entire workforce from COVID-19 transmission.”225~~
~~In the dissent’s view, OSHA lacked statutory authority to issue the ETS because the agency did~~
~~not appropriately establish the standard’s “necessity” or the existence of a “grave danger” in the~~
~~workplace. According to the dissent, an ETS is “necessary” within the meaning of Section 6(c)~~
~~only if it is an “indispensable” means of addressing COVID-19 in the workplace.226 Because~~
~~OSHA “failed to explore whether other feasible alternatives would have allowed [it] to tackle the~~
~~problem,” the dissent reasoned that the agency cannot show the ETS was “necessary” for~~

~~219~~ ~~Id.~~
~~220 Id. at *7.~~
~~221 Id. at *8, 10–16.~~
~~222 29 U.S.C. § 655(f).~~
~~223~~ 218 Id. at *4. 219 Id. (citing, for instance, 29 U.S.C. §§ 651(a), 651(b)(1), 669(a)(5)). 220 Id. at *5. 221 Id. at *6. 222 Id. 223 Id. at *7. 224 Id. at *8, 10–16. 225 29 U.S.C. § 655(f). 226 In re MCP No. 165, 2021 WL 5989357, at *10–13. , 2021 WL 5989357, at *10–13.
~~224~~227 Id. at *14. Congressional Research Service 25 State and Federal Authority to Mandate COVID-19 Vaccination policies, are at heightened risk, and regulating them will be a significant step in protecting the entire workforce from COVID-19 transmission.”228 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.229 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).230 Id. at *14.
~~225 Id. at *15. The Sixth Circuit also found that OSHA sufficiently determined that the ETS is economically feasible,~~
~~including considering the Standard’s costs in relation to the financial health of the affected industries and its impact on~~
~~consumer prices. Id. at *15–16. The Sixth Circuit also disagreed with the Fifth Circuit’s view that the ETS likely~~
~~exceeded the federal government’s Commerce Clause authority because it regulates noneconomic inactivity. Id. at *16.~~
~~In the Sixth Circuit’s view, the ETS regulates employers that are “indisputabl[y] . . . engag[ing] in commercial activity~~
~~that Congress has the power to regulate.” To hold otherwise, according to the Sixth Circuit, “would upend nearly a~~
~~century of precedent upholding laws that regulate employers to effectuate a myriad of employee workplace policies.”~~
~~Id.~~
~~226 See id. at 22.~~
~~Congressional Research Service~~

25

~~State and Federal Authority to Mandate COVID-19 Vaccination~~

~~purposes of Section 6(c).227~~ Additionally, the dissent found that OSHA had not provided Additionally, the dissent found that OSHA had not provided
substantial evidence that all covered employees faced a “grave danger” from COVID-19 because 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 not all employees have a high risk both of contracting COVID-19 and suffering severe
consequences from it.consequences from it.~~228~~231 Finally, in the dissent’s view, OSHA’s authority under the OSH Act is 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 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 virus that is not uniquely a workplace condition, particularly when the agency “cannot state with
precision the total number of workers in our nation who have contracted COVID-19 at work.”precision the total number of workers in our nation who have contracted COVID-19 at work.”~~229~~232
The authority to protect “employees” from a “grave danger” under Section 6(c), in the dissent’s 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.”view, is limited to regulating “workplace hazards with workplace solutions.”~~230~~233 Thus, the dissent Thus, the dissent
reasoned, this authority does not encompass the authority to mandate safety measures beyond the 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.”workplace boundary, “even if taking such precautions would save many ‘employee’ lives.”~~231~~234
Following the Sixth Circuit’s dissolution of the stay, Following the Sixth Circuit’s dissolution of the stay, ~~OSHA announced that it is resuming~~
~~implementation of the ETS and exercising its enforcement discretion with respect to the~~
~~compliance dates of the ETS.232 To give employers sufficient time to comply with the standard,~~
~~OSHA will not issue citations for noncompliance with any requirements of the ETS before~~
~~January 10 and will not issue citations for noncompliance with the standard’s testing~~
~~requirements before February 9, so long as an employer is exercising reasonable, good faith~~
~~efforts to comply with the standard.233~~
~~Several petitioners have filed an application with the Supreme Court seeking to stay the ETS. The~~
~~Court held an oral argument regarding the application on January 7, 2022, and, in issuing a~~
~~decision on the application, may opt to clarify the scope of OSHA’s statutory authority with~~
~~respect to the ETS.234~~

~~227 Id. at *23–24.~~
~~228 Id. at *25.~~
~~229 Id. at *26 (quoting 86 Fed. Reg. at 61,424).~~
~~230 Id. at *27.~~
~~231~~ ~~Id.~~
~~232 See Emergency Temporary Standard: COVID-19 Vaccination and Testing ETS, OCCUPATIONAL SAFETY & HEALTH~~
~~ADMIN., https://www.osha.gov/coronavirus/ets2 (last accessed Dec. 20, 2021).~~
~~233~~ ~~Id.~~
~~234 See U.S. SUPREME COURT, Docket, Ohio v. Dep’t of Labor, No. 21A247, https://www.supremecourt.gov/~~
~~search.aspx?filename=/docket/docketfiles/html/public/21a247.html (last accessed Jan. 10, 2022).~~
~~Congressional Research Service~~

26

~~link to page 32~~ ~~State and Federal Authority to Mandate COVID-19 Vaccination~~

~~Table 1. Summary of Federal Nonmilitary COVID-19 Vaccination Mandates~~
~~As of January 12~~several petitioners filed an application with the Supreme Court seeking to stay the ETS. On January 13, 2022, the Supreme Court granted the application and stayed the enforcement of the ETS.235 The Court concluded that 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, which authorizes the agency “to set workplace safety standards, not broad public health measures.”236 Because the ETS does not distinguish between workplaces that pose a heightened risk of COVID-19 exposure because of the particular features of an employee’s job or the nature of the workplace, and workplaces that pose a generalized risk of exposure from COVID-19 that is not different in kind from the risk presented by other nonwork settings in which people gather, it is, in the Court’s view, an impermissible general public health measure rather than a permissible occupational safety or health standard.237 The Court suggested, for instance, that targeted regulations that address workplaces that face a 228 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. 229 See id. at 22. 230 Id. at *23–24. 231 Id. at *25. 232 Id. at *26 (quoting 86 Fed. Reg. at 61,424). 233 Id. at *27. 234 Id. 235 Nat’l Fed. of Ind. Bus. v. Dep’t of Labor, No. 21A244, 2022 WL 120952, at *1 (Jan. 13, 2022) (per curiam). 236 Id. at *3. 237 Id. Congressional Research Service 26 link to page 32 State and Federal Authority to Mandate COVID-19 Vaccination heightened risk of contracting COVID-19 beyond the everyday risk that all face “are plainly permissible.”238 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.”239 The Court’s decision stays enforcement of the ETS while the consolidated cases proceed before the Sixth Circuit. In the meantime, the comment period for the ETS, which also acts a notice of proposed rulemaking for a permanent standard, remains open through January 19, 2022.240 As part of this notice-and-comment rulemaking process, OSHA may consider the comments as well as the Court’s decision and issue a more narrowly tailored permanent rule. OSHA may also opt to withdraw the ETS in its entirety. Table 1. Summary of Federal Nonmilitary COVID-19 Vaccination Mandates As of January 18, 2022 , 2022
Covered
Federal
Statutory
Individuals/
Vaccination
Compliance
Mandate
Authority
Entities
Requirement
Deadline(s)
Status
Federal
5 U.S.C. 5 U.S.C.
Federal Federal
Employees must be Employees must be
Receive a one- Receive a one-
In effect In effect
Employee
§§ 3301, §§ 3301,
executive branch ful y vaccin executive branch ful y vaccinated,a
dose vaccine or dose vaccine or
Mandate
3302, 7301 3302, 7301
employees employees
unless granted a unless granted a
legally two-dose two-dose
(Executive (Executive
~~legally required~~required exception
vaccine series vaccine series
by Order Order
14,043) ~~exception~~ based on a based on a
disability/ ~~by November 8,~~
~~14,043)~~
~~disability/medical~~
~~2021.~~
~~condition or a~~
~~Be ful y~~
~~sincerely held~~
~~vaccinated by~~
~~religious belief.~~
~~November 22,~~
~~Remote-working~~
~~2021.~~
~~employees are~~
~~subject to~~
~~requirement.~~November 8, medical condition or a 2021. sincerely held religious Be ful y belief. vaccinated by Remote-working November 22, employees are subject 2021. to requirement. 238 Id. at *4. 239 Id. 240 See Covid-19 Vaccination and Testing ETS, OCCUPATIONAL SAFETY & HEALTH ADMIN. (Jan. 13, 2022), https://www.osha.gov/coronavirus/ets2. Congressional Research Service 27 link to page 32 State and Federal Authority to Mandate COVID-19 Vaccination Covered Federal Statutory Individuals/ Vaccination Compliance Mandate Authority Entities Requirement Deadline(s) Status Federal 40 U.S.C. Federal Covered contractors As of January 18,
~~Federal~~
~~40 U.S.C.~~
~~Federal~~
~~Covered contractors~~
~~As of January~~
Enjoined by Enjoined by
Contractor
§ 101 § 101 et
contractors/ contractors/
must ensure covered must ensure covered
~~18, 2022,~~
2022, covered courts: courts:
(Executive (Executive
seq.; .;
subcontractors subcontractors
contractor- contractor-
~~covered~~
employees contractor- Kentucky v. Kentucky v.
Order Order
14,042) 3 U.S.C. 3 U.S.C.
that have a that have a
~~employees~~ are ful y are ful y
~~contractor-~~
vaccinated, employees must Biden, No. 21- Biden, No. 21-
~~14,042)~~
§ 301 § 301
covered covered
~~vaccinated, except in~~
~~employees must 6147), 2022 WL~~
~~contract with~~
~~circumstances where~~
~~be ful y~~
~~43178 (6th Cir.~~
~~executive~~
~~an employee is legally~~
~~vaccinated on~~
~~Jan. 5, 2022)~~
~~departments and entitled to an~~
~~the first day of~~
~~(declining to~~
~~agencies~~
~~exemption based on a performance on~~
~~stay the district~~
~~disability/medical~~
~~a new contract~~
~~court’s~~
~~condition or a~~
~~or the renewal,~~
~~preliminary~~
~~sincerely held~~
~~extension, or~~
~~injunction in KY,~~
~~religious belief.~~
~~exercised~~
~~OH, and TN);~~
~~Remote-working~~
~~option of an~~

~~covered contractor-~~
~~existing~~contract except in be ful y 6147), 2022 with executive circumstances where vaccinated on WL 43178 departments and an employee is legally the first day of (6th Cir. Jan. agencies entitled to an performance on 5, 2022) exemption based on a a new contract (declining to disability/medical or the renewal, stay the condition or a extension, or district court’s sincerely held religious exercised option preliminary belief. of an existing injunction in Remote-working contract. KY, OH, and covered contractor- TN); employees are subject to requirement
~~employees are~~
~~contract~~. .
Georgia v. Georgia v.
~~subject to~~
Biden, No. Biden, No. 1:21-~~1:21-~~
~~requirement.~~
cv-00163 2021 cv-00163 2021
WL 5779939 WL 5779939
(S.D. Ga. Dec. 7, (S.D. Ga. Dec. 7,
2021) (enjoined 2021) (enjoined
the the vaccination requirement nationwide). ~~vaccination~~
~~requirement~~
~~nationwide).~~
~~Congressional Research Service~~

27

~~State and Federal Authority to Mandate COVID-19 Vaccination~~

~~Covered~~
~~Federal~~
~~Statutory~~
~~Individuals/~~
~~Vaccination~~
~~Compliance~~
~~Mandate~~
~~Authority~~
~~Entities~~
~~Requirement~~
~~Deadline(s)~~
~~Status~~
CMS’s
42 U.S.C. 42 U.S.C.
Specified Specified
Covered providers Covered providers
By January 27, By January 27,
~~Enjoined by~~In effect in all
Medicare/
§§ 1302, §§ 1302,
provider and provider and
and suppliers must and suppliers must
2022, 2022,
~~courts in 25~~jurisdictions
Medicaid
1395hh, and supplier types 1395hh, and supplier types
ensure covered staff ensure covered staff
(1) covered (1) covered
~~states:~~except TX.
Provider
other other
that participate that participate
who directly provide who directly provide
providers and providers and
~~Missouri v.~~(Preliminary
Mandate
provider- provider-
in Medicare and in Medicare and
care or other care or other
services suppliers must suppliers must
~~Biden, No. 4:21-~~
injunctions in (CMS IFR) CMS IFR)
or supplier- or supplier-
Medicaid Medicaid
~~services~~ for their for their
facilities establish and establish and
~~cv-1329, 2021~~24 states
specific specific
~~facilities and/or~~
and/or patients are begin to begin to
~~WL 5564501~~stayed by the provisions ful y vaccinated, except implement the U.S. Supreme in circumstances vaccination Court in where a staff member policies and Biden v. is legally entitled to an (2) covered staff Missouri, No. exemption based on a must receive 21A240, 2022 disability/medical first dose of a WL 120950 condition or a two-dose (Jan. 13, sincerely held religious vaccine or a 2022))b belief. one-dose Staff who work 100% vaccine. remotely from sites of Covered staff
~~provisions~~
~~patients are ful y~~
~~implement the~~
~~(E.D. Mo. Nov.~~
~~vaccinated, except in~~
~~vaccination~~
~~29, 2021)~~
~~circumstances where~~
~~policies and~~
~~(enjoining the~~
~~a staff member is~~
~~(2) covered staff IFR in AK, AR,~~
~~legally entitled to an~~
~~must receive~~
~~IA, KS, MO, NE,~~
~~exemption based on a first dose of a~~
~~NH, ND, SD,~~
~~disability/medical~~
~~two-dose~~
~~and WY);~~
~~condition or a~~
~~vaccine or a~~
~~sincerely held~~
~~one-dose~~
~~Louisiana v.~~
~~religious belief.~~
~~vaccine.~~
~~Becerra, No. 21-~~
~~30734, 2021 WL~~
~~Staff who work 100%~~
~~Covered staff~~
~~5913302, at *2-3~~
~~remotely from sites~~
~~must complete~~
~~(5th Cir. Dec.~~
~~of patient care or~~
~~two-dose~~
~~15, 2021)~~
~~away~~ patient care or away must complete from onsite staff are two-dose ~~from onsite staff vaccine series~~
~~(enjoining the~~
~~are not subject to the~~
~~by February 28,~~
~~IFR in AL, AZ,~~
~~requirement.~~
~~2022.~~
~~GA, ID, IN, KY,~~
~~LA, MS, MT,~~
~~OH, OK, SC,~~
~~UT, and WV);~~
~~Texas v.~~
~~Becerra, No.~~
~~2:21-cv-229,~~
~~2021 WL~~
~~5964687 (N.D.~~
~~Tex. Dec. 15,~~
~~2021) (enjoining~~
~~the IFR in TX).~~

~~Supreme Court~~
~~heard oral~~
~~argument on the~~
~~government’s~~
~~application to~~
~~stay injunctions~~
~~on January 7,~~
~~2022.~~
not subject to the vaccine series by requirement. February 28, 2022. Congressional Research Service Congressional Research Service

28 28

link to page 6 link to page 6 State and Federal Authority to Mandate COVID-19 Vaccination

Covered
Federal
Statutory
Individuals/
Vaccination
Compliance
Mandate
Authority
Entities
Requirement
Deadline(s)
Status
OSHA’s
29 U.S.C. 29 U.S.C.
In all In all
A covered employer A covered employer
Covered Covered
~~In effect.~~
Stayed by the Large-
§ 655(c) § 655(c)
jurisdictions, jurisdictions,
must establish and must establish and
employers must employers must
(See In re ~~MCP~~U.S. Supreme
Employer
private private
enforce a policy that enforce a policy that
establish and establish and
~~No. 165,~~
Court. Vaccination
employers with employers with
either (1) ensures either (1) ensures
begin to begin to
~~Occupational~~(See Nat’l Fed.
and Testing
100 or more 100 or more
employees are ful y employees are ful y
implement the implement the
~~Safety and~~of Indep. Bus.
Mandate
employees. employees.
vaccinated, except in vaccinated, except in
vaccination vaccination
~~Health Admin.,~~v. Dep’t of
(OSHA ETS) (OSHA ETS)
In 26 states, In 26 states,
circumstances where circumstances where
policies by policies by
~~Interim Final~~Labor, No.
Puerto Rico, and Puerto Rico, and an employee is legally an employee is legally
January 10, January 10,
~~Rule: COVID-19~~21A244, ---S.
the U.S. Virgin the U.S. Virgin
entitled to an entitled to an
2022. 2022.
~~Vaccination and~~Ct.---, 2022
Islands with Islands with
exemption based on a exemption based on a Covered Covered
~~Testing, 2021~~WL 120952
OSHA-approved OSHA-approved disability/medical disability/medical
employees must employees must ~~WL 5989357~~ (Jan. 13,
state plans, state state plans, state
condition or sincerely condition or sincerely receive either areceive either a ~~(6th Cir. Dec.~~
2022)) and local and local
held religious belief; held religious belief;
or one-dose one-dose
~~17, 2021)~~
government government
or (2) requires (2) requires
employees vaccine or a vaccine or a
~~(dissolving a~~
employers with employers with
~~employees~~ to be ful y to be ful y
vaccinated two-dose two-dose
~~prior stay of the~~
100 or more 100 or more
~~vaccinated~~ or provide provide
proof of vaccine series, employees. regular COVID-19 or begin regular testing and wear a face testing by covering when February 9, indoors. 2022. Employees who work remotely, at a site where other people are not present, or exclusively outside are not subject to the requirements ~~vaccine series,~~
~~ETS by the U.S.~~
~~employees.~~
~~proof of regular~~
~~or begin regular~~
~~Court of~~
~~COVID-19 testing~~

~~testing by~~
~~Appeals of the~~
~~and wear a face~~
~~February 9,~~
~~Fifth Circuit))~~
~~covering when~~
~~2022.~~
~~indoors.~~

~~Employees who work~~
~~Supreme Court~~
~~remotely, at a site~~
~~heard oral~~
~~where other people~~
~~argument on~~
~~are not present, or~~
~~petitioners’~~
~~exclusively outside~~
~~application to~~
~~are not subject to the~~
~~stay the ETS on~~
~~requirements.~~
~~January 7, 2022~~. .
Source: CRS analysis of the relevant Executive Orders, CMS IFR, and OSHA ETS, as well as related litigation. 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 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 vaccinated” for COVID-19 two weeks after they have received either a one-dose vaccine or a two-dose
vaccine series. vaccine series.
b. As of January 18, 2022, the IFR remains enjoined in Texas, where a district court issued a separate preliminary injunction that was not before the Supreme Court. The government’s motion to stay the preliminary injunction, based on the Supreme Court’s order in Biden v. Missouri, is pending before the district court. Congress’s Constitutional Authority to Mandate Vaccination
Although states have traditionally exercised the bulk of authority over public health matters, 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 including vaccination, Congress shares certain concurrent authority in this area emanating from
its enumerated powers in the Constitution.its enumerated powers in the Constitution.~~235~~241 This authority derives from, among other sources, This authority derives from, among other sources,
the Constitution’s Spending and Commerce Clauses, which may be used by Congress to clarify the Constitution’s Spending and Commerce Clauses, which may be used by Congress to clarify
~~existing statutory authorities as they relate to vaccination requirements, or create additional~~
~~sources of authority for or limitations on such requirements.236~~

~~235~~241 McCuskey, McCuskey, supra no note 16, at 113–20. For instance, while the Supreme Court has long recognized the states’ central 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 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 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 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. operate upon interstate and foreign commerce” and “could not be effective otherwise.” Minnesota Rate Cases, 230 U.S.
352, 406 (1913). 352, 406 (1913).
~~236 See id. at 116–19.~~
Congressional Research Service Congressional Research Service

29 29

link to page 6 link to page 6 link to page 6 link to page 33 link to page 6 link to page 6 link to page 6 link to page 33 ~~link to page 6~~ State and Federal Authority to Mandate COVID-19 Vaccination

existing statutory authorities as they relate to vaccination requirements, or create additional sources of authority for or limitations on such requirements.242 The Spending Clause empowers Congress to tax and spend money for the general welfare.The Spending Clause empowers Congress to tax and spend money for the general welfare.~~237~~243
Under this authority, which is subject to several limitations, Congress may offer federal funds to 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 nonfederal entities and prescribe the terms and conditions under which the funds are accepted and
used by recipients.used by recipients.~~238~~244 Over the past century, Congress has frequently invoked this authority in the Over the past century, Congress has frequently invoked this authority in the
public health context, including for purposes of controlling specified diseases, establishing public health context, including for purposes of controlling specified diseases, establishing
neighborhood or community health centers, and creating federal health insurance programs, neighborhood or community health centers, and creating federal health insurance programs,
including Medicare and Medicaid.including Medicare and Medicaid.~~239~~245
Applying its spending authority in the context of a vaccination mandate, Congress could, for 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 instance, encourage states to enact a vaccination mandate meeting certain federal requirements by
imposing it as a condition of receiving certain federal funds.imposing it as a condition of receiving certain federal funds.~~240~~246 This use of Spending Clause This use of Spending Clause
authority, assuming it falls within the broad parameters of being for the “general welfare,” would 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 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 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 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 Constitution; and (4) the amount of federal funds offered is not “so coercive as to pass the point at
which pressure turns into compulsion.”which pressure turns into compulsion.”~~241~~247
In addition, the Commerce Clause grants Congress the power “[t]o regulate Commerce with In addition, the Commerce Clause grants Congress the power “[t]o regulate Commerce with
foreign Nations, and among the several States, and with the Indian Tribes.”foreign Nations, and among the several States, and with the Indian Tribes.”~~242~~248 This authority This authority
empowers Congress to regulate “three broad categories of activities”: (1) “channels of interstate empowers Congress to regulate “three broad categories of activities”: (1) “channels of interstate
commerce,” like roads and canals; (2) instrumentalities of, or persons or things in, interstate commerce,” like roads and canals; (2) instrumentalities of, or persons or things in, interstate
commerce; and (3) activities that substantially affect interstate commerce.commerce; and (3) activities that substantially affect interstate commerce.~~243~~249 Congress relied on Congress relied on
the Commerce Clause to enact some of the earliest federal health laws aimed at protecting the the Commerce Clause to enact some of the earliest federal health laws aimed at protecting the
public from contagion and products posing health concerns.public from contagion and products posing health concerns.~~244~~250 As the federal government As the federal government
increased its role in public health, Congress relied on the Commerce Clause to pass more increased its role in public health, Congress relied on the Commerce Clause to pass more
comprehensive national health regulations, beginning with the Food and Drug Act of 1906.comprehensive national health regulations, beginning with the Food and Drug Act of 1906.~~245~~251
While Congress’s authority under the Commerce Clause is expansive, a majority of the Supreme While Congress’s authority under the Commerce Clause is expansive, a majority of the Supreme
Court in Court in National Federation of Independent Business (NFIB) v. Sebelius agreed that there is a agreed that there is a
~~discrete limit to this authority—it cannot compel individuals to engage in commercial activity.246~~
~~According to Chief Justice John Roberts, in a portion of the opinion not joined by other Justices~~

~~237~~ 242 See id. at 116–19. 243 U.S. CONST. art. I, § 8, cl. 1. U.S. CONST. art. I, § 8, cl. 1.
~~238~~244 See Nolan & Lewis, Nolan & Lewis, supra no note 18, at 29–31 (discussing South Dakota v. Dole, 483 U.S. 203, 207–08 (1987)). at 29–31 (discussing South Dakota v. Dole, 483 U.S. 203, 207–08 (1987)).
~~239~~245 See James G. Hodge, Jr., James G. Hodge, Jr., The Role of New Federalism and Public Health Law, 12 J.L. & HEALTH 309, 335–37 , 12 J.L. & HEALTH 309, 335–37
(1998); McCuskey, (1998); McCuskey, supra no note 16, at 118–19. at 118–19.
~~240~~246 See Dole, 483 U.S. at 211–12 (holding that 23 U.S.C. § 158, which conditioned the provision of certain federal , 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 highway funds upon a state’s enactment of a minimum drinking age of 21, was a valid exercise of Congress’s spending
clause authority). clause authority).
~~241~~247 See id. at 207–08, 211 (internal quotations omitted). at 207–08, 211 (internal quotations omitted).
~~242~~248 U.S. CONST. art. I, § 8, cl. 3. U.S. CONST. art. I, § 8, cl. 3.
~~243~~249 United States v. Lopez, 514 U.S. 549, 558–59 (1995). United States v. Lopez, 514 U.S. 549, 558–59 (1995).
~~244~~250 McCuskey, McCuskey, supra no note 16, at 116–19 (noting that the Commerce Clause enabled several early federal health laws, 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 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). and food products posing health concerns).
~~245~~251 See id.; ; see also Medtronic, Inc. v. Lohr, 518 U.S. 470, 475 (1996); Hodge, Medtronic, Inc. v. Lohr, 518 U.S. 470, 475 (1996); Hodge, supra nonote ~~239~~245, at 335–36 (noting that 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, “[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 tobacco advertising, pesticide production and sales, consumer product safety, occupational health and safety, and
medical care”)medical care”).
~~246 See Nolan & Lewis, supra note 18,~~ ~~at 10~~. .
Congressional Research Service Congressional Research Service

30 30

link to page 6 link to page link to page 6 link to page 6 link to page 8 link to page 9 link to page 11 8 link to page 9 link to page 11 State and Federal Authority to Mandate COVID-19 Vaccination

discrete limit to this authority—it cannot compel individuals to engage in commercial activity.252 According to Chief Justice John Roberts, in a portion of the opinion not joined by other Justices but largely echoed in the view of the four dissenting Justices, the Commerce Clause did not but largely echoed in the view of the four dissenting Justices, the Commerce Clause did not
empower Congress “to regulate individuals precisely because they are doing nothing.”empower Congress “to regulate individuals precisely because they are doing nothing.”~~247~~253 While it While it
is uncertain whether this conclusion constitutes binding precedent,is uncertain whether this conclusion constitutes binding precedent,~~248~~254 it suggests that a direct it suggests that a direct
federal mandate on individuals to receive a vaccine may be susceptible to challenge because such federal mandate on individuals to receive a vaccine may be susceptible to challenge because such
mandates could be construed as compelling individuals who are “doing nothing” to engage in the mandates could be construed as compelling individuals who are “doing nothing” to engage in the
commercial activity of receiving a specified health care service.commercial activity of receiving a specified health care service.~~249~~255 On the other hand, a federal On the other hand, a federal
mandate that requires vaccination as a condition to engage in existing economic activities, such as mandate that requires vaccination as a condition to engage in existing economic activities, such as
employment or interstate travel, may raise fewer constitutional concerns.employment or interstate travel, may raise fewer constitutional concerns.~~250~~256
Even if a vaccine mandate falls within Congress’s enumerated powers, other constitutional Even if a vaccine mandate falls within Congress’s enumerated powers, other constitutional
provisions may constrain the government’s action.provisions may constrain the government’s action.~~251~~257 In the context of public health regulations, In the context of public health regulations,
the key constraints are those grounded in federalism and the protection of individual rights.the key constraints are those grounded in federalism and the protection of individual rights.~~252~~258 For For
example, the Supreme Court has interpreted the Tenth Amendment to prevent the federal example, the Supreme Court has interpreted the Tenth Amendment to prevent the federal
government from commandeering or requiring states or localities to adopt or enforce federal government from commandeering or requiring states or localities to adopt or enforce federal
policies.policies.~~253~~259 In the context of vaccination, this principle prevents Congress from directly requiring 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.states or localities to pass mandatory vaccination laws or implement federal vaccination laws.~~254~~260
It does not, however, impede Congress from using its Spending Clause authority to incentivize 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 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.functionally commandeer, states into enacting the mandate.~~255~~261
As to protection of individual rights, courts have recognized few rights-based constraints on the As to protection of individual rights, courts have recognized few rights-based constraints on the
ability to impose mandatory vaccination requirements.ability to impose mandatory vaccination requirements.~~256~~262 As explained above, courts have largely As explained above, courts have largely
rejected due process and equal protection challenges to compulsory vaccination under rejected due process and equal protection challenges to compulsory vaccination under Jacobson
and and Zucht. As with state vaccination requirements, the principal area of legal uncertainty as to . 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 rights-based constraints on federal requirements is whether and under what circumstances states
must provide religious exemptions to a vaccination requirement.must provide religious exemptions to a vaccination requirement.~~257~~263

~~247~~252 See Nolan & Lewis, supra note 18, at 10. 253 See id. at 10–11 (quoting NFIB v. Sebelius, 567 U.S. 519, 551 (2012) (opinion of Roberts, C.J.)). at 10–11 (quoting NFIB v. Sebelius, 567 U.S. 519, 551 (2012) (opinion of Roberts, C.J.)).
~~248~~254 S See id. at 11. at 11.
~~249~~255 See NFIB, 567 U.S. at 551. , 567 U.S. at 551.
~~250~~256 See In re MCP No. 165, Occupational Safety & Health Admin., Interim Final Rule: COVID-19 Vaccination and 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 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 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 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”); regulate employers to effectuate a myriad of employee workplace policies”); see also Liberty Univ., Inc. v. Lew, 773 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 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 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). the requirement merely regulates an existing commercial activity). But see BST Holdings, LLC v. Occupational Safety 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 & 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”). mandate impermissibly “regulates noneconomic inactivity that falls squarely within the States’ police power”).
~~251~~257 See Nolan & Lewis, Nolan & Lewis, supra no note 18, at 24–25. at 24–25.
~~252~~258 See id. at 19, 24–25. at 19, 24–25.
~~253~~259 Id. at 25. at 25.
~~254~~260 See id.
~~255~~261 See id.
~~256~~262 See supra nonotes 39–47 and accompanying text. and accompanying text.
~~257~~263 See supra “State COVID-19 Vaccination Mandates and Related Litigation.” ”
Congressional Research Service Congressional Research Service

31 31

link to page 4 link to page 35 link to page 4 link to page 35 State and Federal Authority to Mandate COVID-19 Vaccination

Emergency Use Authorization and Vaccination
Mandates
Prior to the COVID-19 pandemic, all vaccines subject to governmental mandates were licensed 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 under a biological license application (BLA), the standard regulatory framework under which
vaccines are typically introduced into interstate commerce.vaccines are typically introduced into interstate commerce.~~258~~264 By contrast, as of December 2021, By contrast, as of December 2021,
only one COVID-19 vaccine—Pfizer’s Comirnaty—is licensed by FDA under a BLA.only one COVID-19 vaccine—Pfizer’s Comirnaty—is licensed by FDA under a BLA.~~259~~265 Several Several
other COVID-19 vaccines are authorized for emergency use under the FD&C Act’s EUA 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 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.for emergency use under specified conditions, including during a public health emergency.~~260~~266
Before FDA licensed Pfizer’s COVID-19 vaccine, some commentators raised a legal issue unique 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 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 provision precludes entities—including governmental entities—from mandating the COVID-19
vaccines.vaccines.~~261~~267 Section 564(e)(1) directs the Secretary of HHS, when issuing an EUA for a medical 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 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 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 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.”alternatives to the product that are available and of their benefits and risks.”~~262~~268 Because each Because each
individual must be provided with “the option to accept or refuse,” some commentators asserted individual must be provided with “the option to accept or refuse,” some commentators asserted
that this provision “suggests that mandates are categorically prohibited.”that this provision “suggests that mandates are categorically prohibited.”~~263~~
269 264 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. 265 For more information about FDA’s approval of Comirnaty, the Pfizer-BioNTech COVID-19 vaccine, see Hickey, Ward & Bodie, supra note 7. 266 See id.; see also Hickey et al., supra note 2, at 12–14. 267 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/. 268 21 U.S.C. § 360bbb-3(e)(1)(A)(ii)(III). 269 Parasidis & Kesselheim, supra note 267. Congressional Research Service 32 link to page 16 State and Federal Authority to Mandate COVID-19 Vaccination After some state and private entities began mandating COVID-19 vaccinations in 2021, some 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 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 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 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 administering the vaccines to inform would-be recipients of the vaccines’ risks and their right to
refuse it.refuse it.~~264~~270 As a result, courts generally have concluded that the provision does not prohibit 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.entities from requiring individuals, duly informed by their medical providers, to be vaccinated.~~265~~

~~258 See, e.g., CRS Report R46593,~~ ~~Vaccine Safety in the United States: Overview and Considerations for COVID-19~~
~~Vaccines, by Kavya Sekar and Agata Bodie, at 15, 34–35.~~
~~259 For more information about FDA’s approval of Comirnaty, the Pfizer-BioNTech COVID-19 vaccine, see Hickey,~~
~~Ward & Bodie, supra note 7.~~
~~260 See id.; see also Hickey et al., supra note 2, at 12–14.~~
~~261 See Efthimios Parasidis & Aaron S. Kesselheim,~~ ~~Assessing the Legality of Mandates for Vaccines Authorized Via an~~
~~Emergency Use Authorization, HEALTH AFFAIRS (Feb. 16, 2021), https://www.healthaffairs.org/do/10.1377/~~
~~hblog20210212.410237/full/.~~
~~262 21 U.S.C. § 360bbb-3(e)(1)(A)(ii)(III).~~
~~263 Parasidis & Kesselheim, supra note 261.~~
~~264~~271 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.272 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.273 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. 270 See, e.g., Valdez v. Grisham, No. 21-cv-783, 2021 WL 4145746, at *4–5 (D.N.M. Sept. 13, 2021); Norris v. , 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 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 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”); 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 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 “conditions of informed consent only relate to . . . the medical providers who administer the vaccine, not those who
issue vaccine mandates”). issue vaccine mandates”).
~~265~~271 See Valdez, 2021 WL 4145746, at *4–5; , 2021 WL 4145746, at *4–5; Norris, 2021 WL 4738827, at *3 n.2; , 2021 WL 4738827, at *3 n.2; Johnson, 2021 WL 4846060, at *18; , 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) 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 (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”); Services in an emergency,” such that “[i]t neither expands nor restricts the responsibilities of private employers”); see
~~Congressional Research Service~~

32

~~link to page 16~~ ~~State and Federal Authority to Mandate COVID-19 Vaccination~~

~~Now that FDA has fully licensed Comirnaty, a COVID-19 vaccine, legal challenges to COVID-~~
~~19 vaccination requirements based on the EUA statute are largely moot.266~~
~~Considerations for Congress~~
~~A vaccination mandate is one available legal tool that governments could use to increase COVID-~~
~~19 vaccine uptake. Whether the federal government has existing statutory authority to mandate~~
~~COVID-19 vaccination in certain contexts is an issue in several pending lawsuits.267 Depending~~
~~on whether Congress determines that the executive branch’s use of these authorities, including~~
~~provisions of the Procurement Act, the SSA, and the OSH Act, appropriately reflects~~
~~congressional intent, Congress—subject to constitutional limits—can generally clarify the scope~~
~~of these statutory provisions as they apply to vaccination requirements.~~
~~To the extent Congress determines that a federal vaccination mandate may be necessary to~~
~~address the evolving pandemic, Congress could also impose a mandate through other legislative~~
~~actions. Any such legislation, however, must be grounded in Congress’s enumerated~~
~~constitutional authority and structured consistently with constitutional due process and religious~~
~~freedom guarantees.~~

~~Author Information~~

~~Wen W. Shen~~

~~Legislative Attorney~~

also U.S. DEP’T OF JUSTICE, OFF. OF LEGAL COUNS., WHETHER SECTION 564 OF THE FOOD, DRUG, AND COSMETIC ACT 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. 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 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 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 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. no longer being distributed under an EUA, rendering this claim moot as to that vaccine. See, e.g., , Valdez, 2021 WL , 2021 WL
4145746, at *4. 4145746, at *4.
~~266~~272 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 , 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 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, . . . .”). 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. however, as no vaccine is licensed under a BLA for use in this age group, as of the time of this writing.
~~267~~273 See supra “Executive Branch Authority to Mandate Vaccination.”
Congressional Research Service Congressional Research Service

33 33

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 This document was prepared by the Congressional Research Service (CRS). CRS serves as nonpartisan
shared staff to congressional committees and Members of Congress. It operates solely at the behest of and shared staff to congressional committees and Members of Congress. It operates solely at the behest of and
under the direction of Congress. Information in a CRS Report should not be relied upon for purposes other 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 than public understanding of information that has been provided by CRS to Members of Congress in
connection with CRS’s institutional role. CRS Reports, as a work of the United States Government, are not connection with CRS’s institutional role. CRS Reports, as a work of the United States Government, are not
subject to copyright protection in the United States. Any CRS Report may be reproduced and distributed in subject to copyright protection in the United States. Any CRS Report may be reproduced and distributed in
its entirety without permission from CRS. However, as a CRS Report may include copyrighted images or its entirety without permission from CRS. However, as a CRS Report may include copyrighted images or
material from a third party, you may need to obtain the permission of the copyright holder if you wish to material from a third party, you may need to obtain the permission of the copyright holder if you wish to
copy or otherwise use copyrighted material. copy or otherwise use copyrighted material.

Congressional Research Service Congressional Research Service
R46745 R46745 · VERSION 46 · UPDATED
34 34