The Coronavirus Disease 2019 (COVID-19) vaccines licensed or authorized by the U.S. Food and Drug Administration (FDA) are a critical tool to reduce the spread and severity of COVID-19.¹ Until August 2021, all COVID-19 vaccines were authorized under Section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act),² a regulatory pathway that allows certain medical products to be made available in the market prior to FDA approval under specified circumstances, including during public health emergencies.³ FDA issued the Emergency Use Authorizations (EUAs) under Section 564 after determining that the COVID-19 vaccines met the applicable statutory standards and the Agency's specific safety and efficacy standards.⁴ Among other information, data supporting the EUA requests show that the vaccines are effective at preventing symptomatic COVID-19 in vaccinated individuals.⁵ Since receiving the EUAs, each COVID-19 vaccine manufacturer, building on the clinical trial safety and effectiveness data previously submitted to FDA in support of their EUA requests, has submitted or is in the process of submitting a biologics license application (BLA) to obtain full approval of the vaccines for specified uses.⁶ In August 2021, FDA licensed the first COVID-19 vaccine, Pfizer's Comirnaty, for the prevention of COVID-19 in individuals 16 years of age and older, after determining that the vaccine, for the licensed use, meets the standards for safety, purity, and potency (i.e., effectiveness) under the Public Health Service Act (PHSA).⁷

Given the data supporting the safety and efficacy of the licensed and authorized COVID-19 vaccines, many public health experts view promoting high COVID-19 vaccination rates—along with continued engagement in community mitigation activities that prevent transmission, such as mask wearing in certain settings—as key components of the United States' pandemic response.⁸ One available legal tool for increasing vaccination rates is for governmental entities to require vaccination.⁹ During 2021, various state, local, and federal governmental entities instituted COVID-19 vaccination requirements to address the pandemic, particularly as the Delta variant—a highly contagious strain of SARS-CoV-2 (the virus that causes COVID-19)—spread in the United States.¹⁰ For instance, some states imposed COVID-19 vaccination requirements on certain state employees and/or health care workers;¹¹ many state entities, such as public universities, likewise imposed vaccination requirements on their staff and students.¹² Several cities issued ordinances or orders that require certain indoor business establishments to verify their patrons' proof of vaccination before permitting entry.¹³ The federal government issued several employment- or workforce-based mandates that either directly require certain employees to receive COVID-19 vaccinations or direct certain employers to impose a vaccination or vaccination-and-testing requirement on their employees or staff.¹⁴ With the exception of a few state health care worker vaccination requirements that provide only for medical exemptions, the governmental vaccination mandates issued to date generally provide exceptions from the vaccination requirements based on a disability, medical condition, or sincerely held religious belief.¹⁵

Under the United States' federalist system, states and the federal government share regulatory authority over public health matters, with states traditionally exercising the bulk of the authority in this area pursuant to their general police power.¹⁶ This power authorizes states, within constitutional limits, to enact laws "to provide for the public health, safety, and morals" of the states' inhabitants.¹⁷ In contrast to this general power, the federal government's powers are confined to those enumerated in the Constitution.¹⁸

This report provides an overview of state and federal authority to mandate vaccination. The first part of the report provides background on state and local authority to mandate vaccination under the states' general police power. It discusses the Supreme Court's long-standing recognition of state and local authority to mandate vaccination as an exercise of their police power, and modern courts' analyses of more recent challenges to state vaccination mandates based on the First Amendment's Free Exercise Clause. It then analyzes the Supreme Court's evolving Free Exercise Clause jurisprudence and the questions it raises regarding whether and when governments must provide for or grant religious exemptions to vaccination requirements.¹⁹ It then takes a look at how courts have addressed challenges to COVID-19-vaccination requirements imposed by state and state entities to date.²⁰

The second part of the report provides an overview of federal authority to mandate vaccination. It begins by discussing several sources of existing federal statutory authority that could serve, or have been invoked, as the basis for federal COVID-19 vaccination mandates. It then provides an overview of several employment-based civilian mandates issued to date by the executive branch directed at (1) most Medicare- and Medicaid-certified providers and suppliers; (2) employers with 100 or more employees; (3) federal executive agency civilian employees; (4) federal contractors for executive departments, agencies, and offices; and (5) staff of the Head Start program,²¹ before reviewing the extent of Congress's constitutional authority under the Spending and Commerce Clauses to potentially mandate vaccination.²²

The report concludes with a brief discussion of a legal issue specific to COVID-19 vaccination mandates, particularly before FDA's licensure of Comirnaty. Namely, it looks at how courts have addressed some litigants' argument that the EUA status of COVID-19 vaccines precludes entities from mandating COVID-19 vaccination.²³

State and Local Authority to Mandate Vaccination

Legal Background

State and local vaccination requirements—as government actions—are subject to constitutional constraints, including those that protect individual rights.²⁴ For instance, the government is prohibited by the Bill of Rights from infringing the free exercise of religion or violating due process of law.²⁵ For more than a century, however, the Supreme Court has recognized few rights-based constraints on states' ability to mandate vaccination, holding instead that the states' general police power to promote public health and safety encompasses authority to mandate vaccination.²⁶

In the early part of the 20^th century, the Supreme Court twice considered constitutional challenges to state vaccination mandates.²⁷ Each time, the Court rejected the challenges to the mandates and recognized such laws as falling squarely within the states' police power.²⁸ In 1905, the Supreme Court in Jacobson v. Massachusetts upheld a state law that gave municipal boards of health the authority to require the vaccination of persons over the age of 21 against smallpox, determining the vaccination program had a "real [and] substantial relation to the protection of the public health and safety."²⁹ In doing so, the Court rejected an argument that such a program violated a liberty interest that, under more modern jurisprudence, the plaintiff might have asserted as a substantive due process right.³⁰

Less than two decades later, in Zucht v. King, parents of a child who was excluded from school due to her unvaccinated status challenged the local ordinance requiring vaccination for schoolchildren, arguing that the ordinance violated the Fourteenth Amendment's Equal Protection and Due Process Clauses.³¹ Relying on Jacobson, the Supreme Court rejected the constitutional challenges, concluding "it is within the police power of a State to provide for compulsory vaccination" and that the ordinance bestowed "only that broad discretion required for the protection of the public health."³²

Based on the Supreme Court's recognition of this authority, states and localities have enacted vaccination mandates for certain populations and circumstances. All 50 states and the District of Columbia, for instance, currently have laws requiring all students enrolled in both public and private schools to receive specified vaccines as a condition of school entry.³³ With respect to adults, states—to the extent they have mandated vaccination—have typically limited the mandates to health care workers, who are required to be vaccinated against certain vaccine-preventable diseases as a condition of their employment.³⁴ These vaccination requirements are generally subject to certain exemptions, which vary from state to state.³⁵ While most vaccination mandates generally provide for some degree of medical exemption (i.e., when individuals have a contraindication to a vaccine that makes receipt of the vaccine harmful or unsafe),³⁶ many mandates also include exemptions for those whose religious beliefs counsel against immunization.³⁷ In the case of student vaccination mandates, several states also provide a broader philosophical exemption for those who object to immunizations because of personal, moral, or other beliefs.³⁸

These state and local vaccination mandates have withstood more recent legal challenges.³⁹ While the Supreme Court's constitutional jurisprudence has evolved substantially since Jacobson and Zucht,⁴⁰ modern courts have continued to rely on these cases to reject due process and equal protection claims against vaccination mandates, giving considerable deference to the states' use of their police power to require immunizations to protect public health.⁴¹

Prior to the COVID-19 pandemic, courts have also generally upheld state vaccination requirements that do not provide for a religious exemption. While most states' school vaccination requirements provide for religious exemptions, several states—some in response to concerns over outbreaks of vaccine-preventable diseases and/or declining vaccination rates—have eliminated those exemptions to permit only medical exemptions.⁴²

In the modern era, these mandates without religious exemptions have been subject to several legal challenges, in which plaintiffs have argued the applicable mandate violated their rights under the First Amendment's Free Exercise Clause.⁴³ Courts generally rejected these claims and concluded that a state is not constitutionally required to provide for a religious exemption.⁴⁴ The courts reasoned that, under Employment Division v. Smith and its progeny, the vaccination mandates at issue were neutral, generally applicable laws—i.e., laws that do not single out religion or selectively burden religiously motivated conduct.⁴⁵ As such, the vaccination mandates, in these courts' view, were not subject to heightened scrutiny under Smith.⁴⁶ Applying rational-basis review, a lenient standard under which courts generally uphold laws that reasonably further legitimate government interests, courts have held that "the right to free exercise of religion . . . [is] subordinated to society's interest in protecting against the spread of disease."⁴⁷

In 2021, however, the Supreme Court issued two decisions that potentially weaken these precedents involving free exercise challenges to vaccination mandates. In Tandon v. Newsom, the Court ruled that a law is not neutral and generally applicable if it treats "any comparable secular activity more favorably than religious exercise."⁴⁸ "[W]hether two activities are comparable for purposes of the Free Exercise Clause," the Court explained, depends on "the asserted government interest that justifies the regulation at issue."⁴⁹ Applying this standard, the Court concluded that the state regulations at issue in Tandon, which limited religious gatherings in response to the COVID-19 pandemic, treated some comparable secular activities—such as getting haircuts and retail shopping—more favorably without showing that these secular activities posed a lower risk of transmission of COVID-19.⁵⁰ Thus, the Court applied heightened scrutiny and granted a preliminary injunction, staying enforcement of the state regulations during pendency of the litigation.⁵¹

A few months after the Tandon ruling, the Supreme Court, in Fulton v. City of Philadelphia, considered whether a city's contract provision prohibiting sexual orientation discrimination by contractors violated a religious foster care agency's free exercise rights.⁵² The contract provision at issue generally prohibited providers from rejecting a child or family for services based on their sexual orientation unless a specified city official, at his "sole discretion," granted an exception.⁵³ Even though the City had never granted an exception under the provision, the Court held that this exemption system meant that the nondiscrimination policy was not generally applicable under Smith.⁵⁴ This system, in the Court's view, "incorporate[d] a system of individual exemptions" that invited the government "to decide which reasons for not complying with the policy are worthy of solicitude."⁵⁵ Because a law lacks general applicability "if it prohibits religious conduct while permitting secular conduct that undermines the government's asserted interest in a similar way," the Court held that the City "may not refuse to extend that exemption system to cases of religious hardship without compelling reason."⁵⁶ The Court concluded that the City failed to offer any compelling reason for "why it has a particular interest in denying an exception to [the plaintiff foster care agency] while making them available to others."⁵⁷

Together, Fulton and Tandon could suggest that where a governmental requirement provides a secular exemption from the requirement (but no religious exemption), and the exemption system is to some extent discretionary, the requirement may not be neutral and generally applicable for purposes of the Free Exercise Clause.⁵⁸ This interpretation would mean that a governmental requirement with only a secular exemption—assuming that the secular exemption is comparable to a hypothetical religious exemption as measured against the asserted government interest underlying the requirement—may be subject to heightened scrutiny.⁵⁹

For state vaccination requirements—which typically provide, at a minimum, medical exemptions to those with contraindications—Fulton and Tandon thus raise a number of questions that potentially unsettle the law concerning vaccination requirements and religious freedom. These questions include whether a vaccination requirement that provides only for a medical exemption—a secular exemption—is not neutral and generally applicable; whether that analysis depends on the extent to which the medical exemption process is discretionary; and whether medical and religious exemptions—as measured against the relevant underlying government interest for vaccination requirements—are comparable exemptions in the context of this analysis. To the extent a vaccination requirement that provides only a medical exemption would be subject to heightened scrutiny, Fulton and Tandon also leave unanswered whether there are certain circumstances under which the requirement would survive such scrutiny.

While courts have historically upheld state vaccination requirements generally, more recent developments in the Supreme Court's free exercise jurisprudence raise questions regarding whether, when, and under what circumstances states must provide or grant religious exemptions to a vaccination requirement.

State COVID-19 Vaccination Mandates and Related Litigation

In 2021, various state and local entities instituted COVID-19 vaccination requirements to address the pandemic, particularly as the Delta variant began to cause surges in COVID-19 cases across the country. Many public universities, for instance, imposed vaccination requirements on their students and staff as a condition of in-person attendance and employment.⁶⁰ A few cities required certain indoor business establishments in their jurisdictions to verify their patrons' proof of vaccination before permitting their entry.⁶¹ To date, only a few states have imposed statewide vaccination requirements, and these requirements are generally limited to health care workers.⁶² Two states—California and Louisiana—and the District of Columbia announced in 2021 plans to add COVID-19 vaccination to their lists of required student vaccinations.⁶³ With the exception of several state health care worker mandates (as well as California's expected student vaccination requirements) that provide only for a medical exemption,⁶⁴ most of these state and local vaccination requirements provide for both medical and religious exemptions.

Many of these state COVID-19 vaccination requirements have drawn legal challenges. To date, consistent with the discussion in the preceding section, courts have generally upheld these requirements, particularly if the requirements provide for both medical and religious exemptions.⁶⁵ Some of the common claims raised in these challenges include, for instance, an alleged violation of the plaintiffs' substantive due process rights to bodily integrity or right to refuse unwanted medical treatment, or an alleged violation of their equal protection rights. Courts have generally rejected these claims, relying on Jacobson to conclude that a fundamental right or a suspect class is not implicated by the vaccination mandates, which reasonably further a legitimate government interest under rational-basis review.⁶⁶

The principal area of legal uncertainty as to state vaccination requirements, as explained in the preceding section, is whether and when state vaccination requirements must provide for religious exemptions, and the circumstances under which such exemptions may be granted or denied. On this issue, the federal courts of appeals have reached arguably conflicting results.

In Dahl v. Board of Trustees of Western Michigan University, the district court preliminarily enjoined (i.e., temporarily suspended) a state university's policy requiring student-athletes to be vaccinated in order to participate in team activities.⁶⁷ The university's policy—which applied only to student-athletes and not the student body at large—provided that "[m]edical or religious exemptions and accommodations will be considered on an individual basis."⁶⁸ Several student-athletes who were denied religious exemptions and barred from participation sued to challenge the policy, alleging, among other claims, that the policy violated their free exercise rights.⁶⁹ In considering the university's motion to lift the preliminary injunction, the U.S. Court of Appeals for the Sixth Circuit (Sixth Circuit) concluded that the university's discretionary exemption process provided a "mechanism for individualized exemptions" under Fulton that rendered the policy not generally applicable, subjecting it to heightened scrutiny.⁷⁰ Applying heightened scrutiny, the Sixth Circuit concluded that the student-athletes were likely to succeed on their free exercise claim because while the university had a compelling interest "in fighting COVID-19," the policy was not narrowly tailored to achieve that.⁷¹ The court reasoned that nonathlete students were not required to be vaccinated, undermining the university's stated interest in prohibiting conduct that created health risks.⁷² The court also drew comparisons to other university policies that allowed exemptions, suggesting the university's vaccination policy might have been unnecessarily "severe."⁷³

In Does v. Mills, the U.S. Court of Appeals for the First Circuit (First Circuit) considered Maine's August 2021 emergency regulation that added COVID-19 vaccination to the list of required vaccinations that employees of licensed health care facilities must receive.⁷⁴ The state legislature in 2019 eliminated all nonmedical exemptions to the state's health care worker and student vaccination requirements, citing declining vaccination rates and the need to protect those who are immunocompromised and reliant on others' vaccinations for protection.⁷⁵ In issuing the August 2021 regulation, the Maine Department of Health and Human Services and Maine's Center for Disease Control determined that the rule was necessary because the highly contagious Delta variant had caused a 300% increase in COVID-19 cases between June and July 2021; health care facilities are uniquely susceptible to outbreaks of infectious diseases like COVID-19; such outbreaks hamper the state's ability to care for its residents suffering from both COVID-19 and other conditions; the size of Maine's health care workforce is limited; alternatives to vaccination (such as regular testing or reliance on personal protective equipment) would not be as effective; and no health care facility types at the time—despite the states' various efforts at promoting voluntary vaccination—had achieved vaccination rates above 90%, which the state public health agency determined was the minimum rate required to prevent community transmission of the Delta variant.⁷⁶ Several then-unvaccinated health care workers sued to challenge the regulation, alleging, among other claims, that the COVID-19 vaccination requirement violates their free exercise rights because it lacks a religious exemption.⁷⁷

In affirming the district court's denial of a preliminary injunction, the First Circuit concluded that the plaintiffs were not likely to succeed on their free exercise claim. In the court's view, Maine's vaccination requirement was a neutral and generally applicable law that (1) did not "single[] out religious objections . . . because of their religious nature" and (2) "applie[d] equally across the board" without requiring the state government "to exercise discretion in evaluating individual requests for exemptions."⁷⁸ According to the First Circuit, the availability of a general medical exemption to employees who provide a written statement from specified licensed medical professionals that the vaccination is medically inadvisable did not render the vaccination requirement not generally applicable. Unlike the exemption system at issue in Fulton, the medical exemption, in the court's view, was "a single objective exemption" that did not call for discretionary evaluation, nor did it permit "secular conduct that undermines the government's asserted interests in a similar way" as would a religious exemption.⁷⁹ Instead, according to the court, exempting only those whose health would be endangered by vaccination reinforced the state's underlying interests in protecting the health and safety of its residents, including that of the health care workforce and those who are most vulnerable because they cannot be vaccinated for medical reasons.⁸⁰ Because the medical exemption is meaningfully different from a religious exemption—the availability of which would undermine the relevant state interests—the court concluded that Maine's vaccination requirement was generally applicable and subject to rational-basis review, which it "easily satisfie[d]."⁸¹

Even though the court did not need to reach this issue, the First Circuit further concluded that even if heightened scrutiny applied, the vaccination requirement would likely survive such scrutiny. According to the court, the state has a compelling interest in both stemming the spread of COVID-19 and in denying an exception to plaintiffs, who provide health care services, because exemptions from the requirement for non-health-related reasons threaten "the most vulnerable Mainers."⁸² The vaccination requirement, according to the court, was also sufficiently narrowly tailored to achieve those interests, given that (1) Maine considered alternatives such as testing, masking, and social distancing, but found them to be inadequate in meeting the state's goals particularly in the face of the spread of the Delta variant; (2) Maine "demonstrated that it ha[d] tried many alternatives to get its healthcare workers vaccinated short of a mandate" but such efforts failed to achieve the at least 90% vaccination rate necessary to halt community transmission; and (3) the requirement was not underinclusive—in that it applies to all except those who have a medical contraindication—or overinclusive—in that it was limited to "the narrow sphere of healthcare workers . . . who regularly enter healthcare facilities."⁸³

In We the Patriots USA, Inc. v. Hochul, the U.S. Court of Appeals for the Second Circuit (Second Circuit) considered an emergency rule adopted by the New York Department of Health, 10 N.Y.C.R.R. § 2.61, that directed specified health care facilities in the state to require certain employees to receive COVID-19 vaccines.⁸⁴ Like the Maine emergency regulation, New York's vaccination requirement provided only a medical exemption, which applied "only until such immunization is found no longer to be detrimental to [the employees'] health and must be supported by a certification from a licensed physician or nurse practitioner issued in accordance with generally accepted medical standards, including recommendations of the Advisory Committee on Immunization Practices."⁸⁵ Several health care workers sued to challenge New York's rule, asserting, among other claims, that it violated the Free Exercise Clause.⁸⁶

The Second Circuit concluded that the plaintiffs did not demonstrate a likelihood of success on their free exercise claim at the preliminary injunction phase.⁸⁷ Like the First Circuit, the Second Circuit concluded that the plaintiffs did not meet their burden to show that New York's rule—by providing a medical but not a religious exemption—was not a neutral, generally applicable law under Smith, or that the rule did not satisfy rational-basis review.⁸⁸ Similar to the First Circuit, the Second Circuit found that the medical and religious exemptions were not "comparable" exemptions relative to the asserted government interests—which included protecting the health of health care employees to reduce staffing shortages that can compromise patient safety—because a medical exemption furthered those interests while a religious exemption would undermine them.⁸⁹ Also similar to the First Circuit, the Second Circuit found that § 2.61's medical exemption did not create a system of individualized exemptions under Fulton because the rule "provide[d] for an objectively defined category of people to whom the vaccine requirement does not apply"—i.e., those who present the appropriate certification from a specified medical professional in accordance with generally accepted medical standards.⁹⁰ Because the plaintiffs, in the court's view, did not demonstrate that § 2.61 is not neutral or generally applicable, the court applied rational-basis review. An emergency rule that requires health care employees to be vaccinated in the face of an especially contagious variant of the virus that has claimed the lives of more than 750,000 in the United States and some 55,000 in New York, the court reasoned, "easily m[et] that standard."⁹¹

In sum, Dahl on one hand, and Does and We the Patriots on the other hand, highlight some of the unsettled questions raised by Fulton and Tandon as they apply to vaccination requirements and the circumstances under which states may be constitutionally required to provide for or grant religious exemptions. Whereas Dahl suggests that the availability of a medical exemption may render a vaccination requirement not generally applicable and thus subject to heightened scrutiny, Does and We the Patriots indicate that, at least in the health care employment context, a vaccination requirement providing for only a medical exemption is a generally applicable requirement subject to rational-basis review.

The Supreme Court rejected applications to stay the Maine and New York emergency rules at issue in Does and We the Patriots, allowing for their implementation.⁹² In February 2022, the Court also denied the Does plaintiffs' petition for certiorari.⁹³

Federal Authority to Mandate Vaccination

Like state vaccination requirements, federal vaccination requirements are government actions subject to constitutional constraints.⁹⁴ In addition to constitutional constraints based on individual rights—which apply in broadly similar ways to both state and federal vaccination mandates—federal vaccination requirements must fall within the powers granted to the federal government in the Constitution.⁹⁵ Federal requirements imposed by the executive branch are also subject to statutory constraints. Such requirements generally must rely on the federal government's existing statutory authorities.⁹⁶ Depending on the circumstances, the requirements may also be subject to statutory requirements under the Administrative Procedure Act (APA), the Religious Freedom Restoration Act of 1993 (RFRA),⁹⁷ or other context-specific statutory limits.⁹⁸

This part begins by discussing the executive branch's authority to mandate vaccination, including the asserted statutory authority for the non-military federal COVID-19 vaccination mandates issued to date, and the state of the litigation challenging these mandates. This part then reviews the extent of Congress's constitutional authority under the Constitution's Spending and Commerce Clauses to mandate vaccination.

Executive Branch Authority to Mandate Vaccination

Prior to the COVID-19 pandemic, federal vaccination requirements were primarily limited to the immigration,⁹⁹ military,¹⁰⁰ and certain federal health care employment contexts.¹⁰¹ Certain existing statutory authorities, however, could potentially encompass the authority to mandate vaccination in specified contexts.

Earlier in the COVID-19 pandemic, and even before the pandemic, some commentators believed that one likely source of authority for federal public health orders—including those related to vaccination requirements—may be Section 361(a) of the PHSA.¹⁰² This provision, codified at 42 U.S.C. § 264(a), grants the Secretary of HHS the authority—delegated in part to the Centers for Disease Control and Prevention (CDC)¹⁰³—to make and enforce regulations necessary "to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the States or possessions, or from one State or possession into any other State or possession."¹⁰⁴ Following this text, Section 361(a) states that "[f]or purposes of carrying and enforcing such regulations," the Agency "may provide for such inspection, fumigation, disinfection, sanitation, pest extermination, destruction of animals or articles found to be so infected or contaminated as to be sources of dangerous infection to human beings, and other measures, as in [its] judgment may be necessary."¹⁰⁵ Based on this statutory text, some have argued that a broad construction of CDC's Section 361(a) authority may permit CDC to issue regulations requiring vaccination in circumstances that would prevent the foreign or interstate transmission of COVID-19.¹⁰⁶

Before the COVID-19 vaccines became available under EUAs during the Trump Administration, the CDC invoked PHSA Section 361 to issue a nationwide eviction moratorium in September 2020. CDC based the moratorium on its findings that evictions threatened to increase the spread of COVID-19 as they would force people to live in new shared housing or congregate settings.¹⁰⁷ Numerous legal challenges to the eviction moratorium followed. By June 2021, the U.S. Court of Appeals for the District of Columbia Circuit (D.C. Circuit) and the Sixth Circuit—in the context of reviewing procedural motions to stay or lift the stay of the district courts' preliminary injunction orders¹⁰⁸—had reached different conclusions as to the CDC's statutory authority to issue the order. The D.C. Circuit, adopting a broad construction of Section 361, concluded that "the CDC's eviction moratorium f[ell] within the plain text of 42 U.S.C. § 264(a)."¹⁰⁹ The Sixth Circuit, in contrast, characterized the enumerated measures under Section 361(a) as "property interest restrictions" and concluded that the eviction moratorium was "radically unlike" such restrictions and thus "f[ell] outside the scope of the statute."¹¹⁰

The eviction moratorium litigation introduced much legal uncertainty over the scope of CDC's authority under PHSA Section 361(a), including the agency's authority to issue regulations relating to public health measures, such as vaccination, that arguably bear more directly on infectious disease control than eviction moratoria. Uncertainty as to the reach of Section 361(a) deepened after August 2021, when the Supreme Court—in the context of granting a procedural motion to lift a stay of the eviction moratorium in Alabama Ass'n of Realtors v. Department of Health and Human Services—concluded that the plaintiffs challenging the eviction moratorium were likely to succeed on their statutory claim.¹¹¹ Characterizing the enumerated measures under Section 361(a) as measures "directly relate[d] to preventing the interstate spread of disease by identifying, isolating, and destroying the disease itself," the Court concluded that the eviction moratorium "relate[d] to interstate infection far more indirectly" and the sheer scope of CDC's claimed authority counseled against the government's interpretation. The government has since voluntarily dismissed its appeal, and a final decision on the merits is not expected in the case. In short, while the eviction moratorium litigation indicates that the CDC's authority under Section 361(a) does not extend to issuing eviction moratoriums, it leaves unresolved the precise scope of the agency authority under the provision to take other measures to prevent the spread of communicable diseases.

To address the spread of the Delta variant in 2021, the President and several executive agencies—including the Centers for Medicare and Medicaid Services (CMS) and the Occupational Safety and Health Administration (OSHA)—ultimately invoked several other statutory authorities to issue several employment- or workforce-based COVID-19 vaccination mandates for civilians. These vaccination requirements include those that apply to (1) most Medicare- and Medicaid-certified providers and suppliers (CMS's Medicare/Medicaid provider mandate);¹¹² (2) employers with 100 or more employees (OSHA's large-employer vaccination and testing mandate);¹¹³ (3) federal executive agency civilian employees (federal employee mandate);¹¹⁴ (4) federal contractors for executive departments, agencies, and offices (federal contractor mandate);¹¹⁵ and (5) staff of the Head Start program, which provides comprehensive early childhood education and development services to low-income children (Head Start mandate).¹¹⁶ Subject to accommodations required by federal law for medical disabilities and religious beliefs, these employment-based mandates either directly require certain employees to receive COVID-19 vaccinations or direct certain employers to impose a vaccination or vaccination-and-testing requirement on their employees or staff.¹¹⁷ (See Table 1 for a summary of these mandates.)

CMS's Medicare/Medicaid Provider Mandate

On November 4, 2021, CMS released an Interim Final Rule (IFR), effective November 5, 2021, that requires specified Medicare- and Medicaid-certified providers and suppliers to establish a policy that requires all eligible staff (subject to legally required exceptions) to receive the first dose of a two-dose COVID-19 vaccine or a one-dose COVID-19 vaccine by December 6, 2021, and to complete their vaccination series by January 4, 2022.¹¹⁸ This mandate applies to 15 provider and supplier types that participate in Medicare and Medicaid, including hospitals, long-term-care facilities, and rural health clinics.¹¹⁹ The mandate does not apply to other health care entities such as physician offices, organ procurement organizations, and portable X-Ray suppliers.¹²⁰

For providers and suppliers subject to the IFR, their vaccination policy must apply to all staff who directly provide any care, treatment, or other services for the facility and/or its patients, including (1) employees (including administrative staff as well as facility leadership); (2) licensed practitioners; (3) students, trainees, and volunteers; and (4) individuals who provide care, treatment, or other services for the facility and/or its patients under contract or other arrangements (including housekeeping and food services).¹²¹ Individuals who provide services 100% remotely from sites of patient care and away from staff who work at sites of care—such as fully remote telehealth or payroll services—are not subject to the vaccination requirements.¹²² CMS states that noncompliant providers and suppliers will be subject to enforcement remedies based on the level of noncompliance and available remedies, which may include civil monetary penalties, denial of payment for new admissions, and termination of the Medicare/Medicaid provider agreement.¹²³

According to CMS, the Medicare/Medicaid provider mandate is based on its determination that a vaccination mandate for health care workers is an essential component of the nation's COVID-19 pandemic response, particularly in light of several factors, including (1) the failure to achieve sufficiently high levels of vaccination based on voluntary efforts and patchwork requirements; (2) potential harm to patients from unvaccinated health care workers; (3) continuing strain on the health care system; and (4) known efficacy and safety of available vaccines.¹²⁴ The agency found "good cause" to waive the notice-and-comment rulemaking procedures under the APA and Section 1871(b) of the Social Security Act (SSA).¹²⁵ The agency based that determination on several considerations, including (1) that Delta-variant outbreaks showed that current levels of COVID-19 vaccination coverage have been inadequate to protect health care consumers and staff; (2) the pandemic's strain on the health care system; (3) that respiratory infections typically circulate more frequently during the winter months; and (4) the onset of the 2021-2022 influenza season.¹²⁶

CMS relied on several layers of statutory authorities in issuing the IFR.¹²⁷ Across all providers and suppliers, CMS invokes SSA Section 1102, a provision that grants the Secretary of HHS general authority to issue rules "as may be necessary to the efficient administration of the functions" with which the Secretary is charged under the SSA.¹²⁸ For Medicare providers and suppliers, CMS additionally relies on SSA Section 1871, which authorizes the Secretary to prescribe regulations "as may be necessary to carry out the administration" of the Medicare programs.¹²⁹ Finally, for each provider and supplier, CMS also relies on certain provider- and supplier-specific provisions, many of which authorize the Secretary to impose requirements he finds necessary to protect the health and safety of individuals who receive services from the relevant entities.¹³⁰

At least 25 states, on behalf of certain state-run health care facilities that may be subject to the vaccination requirements, filed four separate suits to challenge the IFR shortly after its issuance.¹³¹ Plaintiffs in each case filed a motion for preliminary injunction seeking to enjoin the IFR while the litigation proceeds. In November 2021, one district court, in Florida v. Department of Health & Human Services, declined to enjoin the IFR, concluding the state had not shown "irreparable harm" to justify an injunction.¹³² In the court's view, the state had not provided sufficient factual evidence to demonstrate that the vaccination requirements' alleged likely adverse impact, such as potential staffing shortages, would result if the requirements were not halted.¹³³

Later in the same month, however, two district courts—in Missouri v. Biden and Louisiana v. Becerra—granted the plaintiffs' motions for preliminary injunctions in each respective case.¹³⁴ The Missouri court enjoined the IFR in 10 plaintiff states, while the Louisiana court enjoined the rule in the remaining states.¹³⁵ Among other determinations, both courts concluded that CMS likely exceeded its statutory authority in issuing the IFR because the applicable provisions do not specifically authorize the agency to mandate vaccination;¹³⁶ the agency likely lacked "good cause" to waive notice-and-comment rulemaking procedures;¹³⁷ and the plaintiffs sufficiently demonstrated they would suffer irreparable harm—including in the form of significant staffing shortages—if the IFR was not enjoined.¹³⁸ The U.S. Court of Appeals for the Fifth Circuit (Fifth Circuit), in considering the government's motion to stay the preliminary injunction in Louisiana, narrowed the scope of the injunction to the 14 plaintiff states.¹³⁹ Since the Fifth Circuit's order, the U.S. District Court for the Northern District of Texas, in Texas v. Becerra, issued a preliminary injunction order enjoining the IFR's enforcement in that state.¹⁴⁰ As of December 31, 2021, CMS was enjoined from enforcing the IFR in the 25 states that are plaintiffs in Missouri, Louisiana, or Texas.

As noted by the Fifth Circuit in Louisiana, one key legal question on the merits concerning the Medicare/Medicaid provider mandate litigation is whether the rule exceeds the agency's statutory authority because the relevant provisions do not explicitly authorize the agency to mandate vaccination. Characterizing this issue as a "close call," the Fifth Circuit—in upholding the preliminary injunction in the 14 plaintiff states—concluded the government had not sufficiently demonstrated that the rule fell within the agency's statutory authority.¹⁴¹

On this issue, a divided panel of the U.S. Court of Appeals for the Eleventh Circuit (Eleventh Circuit), in considering Florida's motion for an injunction pending its appeal of the district court's order in Florida, concluded that the relevant Medicare and Medicaid provisions "plainly encompass[]" the IFR's vaccination requirement.¹⁴² In the Eleventh Circuit's view, the relevant Medicare and Medicaid statutes expressly "authorized the Secretary to set standards to protect the health and safety of patients" served by Medicare and Medicaid facilities.¹⁴³ The IFR's vaccination requirements, according to the Eleventh Circuit, fell squarely within this grant of authority, given that COVID-19 is a deadly, highly transmissible disease, health care workers have long been required to obtain inoculations for infectious diseases, and required vaccination is "a common-sense measure designed to prevent healthcare workers . . . from making [patients] sicker."¹⁴⁴ Thus, in the Eleventh Circuit's view, "when it comes to vaccination mandates, there was no reason for Congress to be more specific than authorizing the Secretary to make regulations for the 'health and safety' of Medicare and Medicaid recipients."¹⁴⁵ To suggest otherwise, the court continued, "would mean that Congress had to have anticipated both the unprecedented COVID-19 pandemic and the unprecedented politicization of the disease to regulate vaccination against it."¹⁴⁶ The dissent's analysis, on the other hand, largely echoes that of the district courts in Missouri and Louisiana.¹⁴⁷

On December 30, 2021, CMS announced that the IFR would be implemented and enforced, on a modified timeline, in the jurisdictions not subject to the preliminary injunctions in Missouri, Louisiana, and Texas.¹⁴⁸ The deadline to receive the first dose of a vaccine was extended to January 27, 2022, and the deadline to complete the vaccination series was extended to February 28, 2022.¹⁴⁹

The government filed an application with the Supreme Court seeking to stay the preliminary injunctions in both Louisiana and Missouri. On January 13, 2022, the Supreme Court granted the application.¹⁵⁰ Among other determinations, the Court concluded that the IFR "fits neatly" within the Secretary's statutory authority to impose necessary conditions to protect the "health and safety" of patients served by the relevant providers and suppliers, as well as the Secretary's general authority to issue necessary regulations to support the "efficient administration" of Medicare and Medicaid.¹⁵¹

In so concluding, the Court rejected the dissent's view that the Secretary's authority under these provisions is limited to issuing "bureaucratic rules regarding the technical administration of Medicare and Medicaid"; it also rejected the dissent's view that the catchall authority to issue necessary "health and safety" regulations is limited to measures similar to the enumerated "administrative requirements"—such as maintaining clinical records on all patients or providing 24-hour nursing service—that precede the catchall provision.¹⁵² In the Court's view, such a limited construction is inconsistent with the Secretary's historical and ongoing use of this authority to impose "a host of conditions" that address the safe and effective provision of health care, as well as the qualifications and duties of health care workers themselves.¹⁵³ This "longstanding litany" of health-related participation conditions, the Court concluded, amply illustrates the Secretary's authority to address infection problems in Medicare and Medicaid facilities.¹⁵⁴ Given that vaccination requirements for health care workers are "a common feature of the provision of healthcare in America" and a well-recognized means of infection control in the health care setting, a vaccination mandate—even though it "goes further than what the Secretary has done in the past to implement infection control"—nevertheless falls within the Secretary's statutory authority, particularly given the COVID-19 pandemic's unprecedented scale and scope.¹⁵⁵

As of January 19, 2022, the IFR was in effect nationwide. Following the Court's decision, CMS issued an updated guidance on the IFR for the 24 states previously subject to the preliminary injunctions in Missouri and Louisiana.¹⁵⁶ In these states, covered staff must receive the first dose of a vaccine by February 14, 2022, and complete the vaccination series by March 15, 2022.¹⁵⁷ On January 20, 2022, CMS issued an updated guidance on the IFR for Texas, after the district court granted the state's request to voluntarily dismiss Texas. In Texas, covered staff must receive the first dose of a vaccine by February 22, 2022, and complete the vaccine series by March 21, 2022.¹⁵⁸

Since the Supreme Court's order issued, both Missouri and Louisiana have been remanded to the district courts where the government has sought, or is expected to seek, dismissal of the cases.

OSHA's Large-Employer Vaccination and Testing Mandate

On November 4, 2021, OSHA released an emergency temporary standard (ETS) that generally requires private employers with 100 or more employees to establish and enforce a policy that either (1) requires all employees to receive a COVID-19 vaccination, subject to legally required exceptions; or (2) requires employees to receive either a COVID-19 vaccination or provide proof of regular COVID-19 testing and wear a face covering when indoors or occupying a vehicle with another person.¹⁵⁹ For the 26 states, Puerto Rico, and the U.S. Virgin Islands that have opted to adopt their own OSHA-approved state plans, the ETS also applies to state agency and local government employers.¹⁶⁰ To the extent a workplace is subject to both the ETS and one of the preceding mandates, the non-OSHA-ETS mandate generally applies. For those workplaces, OSHA specifically states either that the ETS does not apply (in the case of federal contractors or health care providers and suppliers)¹⁶¹ or that compliance with the other mandate is deemed sufficient to meet the employers' obligations under the ETS (in the case of executive agencies).¹⁶²

Under the large-employer vaccination and testing mandate, employees who are not fully vaccinated—including those who have been granted exceptions—generally must be tested at least once every seven days if they report at least once every seven days to a work site where others are present.¹⁶³ Employees who do not report to such a workplace during a period of seven or more days must be tested within seven days prior to returning to the workplace.¹⁶⁴ Employees exempt from the ETS's requirements include (1) employees who work remotely or at a site where other people are not present; and (2) employees who work exclusively outside.¹⁶⁵ Covered employers can, but are not required to, pay for any costs associated with testing,¹⁶⁶ but they must provide employees with paid leave to receive and recover from the vaccination.¹⁶⁷ Covered employers must establish and begin to implement the relevant vaccination policy by December 6, 2021, and ensure their employees have completed a one-dose vaccine or a two-dose vaccine series by January 4, 2022.¹⁶⁸ After that, all covered employers must ensure that employees who are not fully vaccinated are subject to regular COVID-19 testing.¹⁶⁹ Noncompliant covered employers could face OSHA citations and civil monetary penalties.¹⁷⁰

The large-employer vaccination and testing mandate is based on OSHA's authority under Section 6(c) of the Occupational Safety and Health Act of 1970 (29 U.S.C. § 655(c)).¹⁷¹ The provision authorizes the agency to issue an ETS that takes effect immediately upon publication in the Federal Register, without undergoing the APA's rulemaking proceedings, if it determines "(A) that employees are exposed to grave danger from exposure to substances or agents determined to be toxic or physically harmful or from new hazards, and (B) that such emergency standard is necessary to protect employees from such danger."¹⁷² OSHA issued the ETS upon its determination that unvaccinated workers face a grave danger from exposure to SARS-CoV-2 in the workplace, given that COVID-19 has killed more than 725,000 people in the United States in fewer than two years; that unvaccinated individuals remain at much higher risk of severe health outcomes; and that evidence demonstrates the virus's transmissibility in the workplace and the prevalence of infections in employee populations.¹⁷³ OSHA further determined that the ETS is necessary to protect unvaccinated workers from the risk of contracting COVID-19 given the potential severe health consequences from occupational exposure to COVID-19 and the fact that vaccination provides the most effective and efficient control available, with the use of other mitigation measures further protecting workers who remain unvaccinated.¹⁷⁴

On the same day the ETS was issued, numerous petitioners—including covered employers, states, and religious groups—moved to stay and permanently enjoin the mandate in several federal courts of appeals.¹⁷⁵ In response to a petition and motion to stay filed by several covered employers and four states, the Fifth Circuit stayed the enforcement of the ETS the day after it was issued.¹⁷⁶

On November 12, 2021, the Fifth Circuit affirmed the stay, largely based on its conclusion that the ETS "grossly exceeds OSHA's statutory authority."¹⁷⁷ In the Fifth Circuit's view, an airborne virus like SARS-CoV-2 likely falls outside the scope of a "new hazard" within the meaning of Section 6(c) under a canon of statutory construction known as noscitur a sociis, which counsels that the more precise meaning of a word should be determined by the neighboring words with which it is associated.¹⁷⁸ Because "new hazard" is neighbored by "substances or agents" and "toxic or physically harmful"—phrases that, in the court's view, connote toxicity and poisonousness—the term likely does not encompass an airborne virus that is both widely present in society and "non-life-threatening to a vast majority of employees."¹⁷⁹ Moreover, the court concluded that COVID-19 does not pose the required "grave danger" for purposes of Section 6(c), given that the agency cannot demonstrate that all covered workplaces are in fact exposed to COVID-19, the effects of COVID-19 could be mild, and the status of the virus's spread has changed over time.¹⁸⁰ The ETS, in the court's view, was also not "necessary" to protect unvaccinated workers given its "staggering[] overb[readth]," such that it was both overinclusive—applying to employers and employees in virtually all industries and workplaces in America without an attempt to account for differences in COVID-19 exposure—and underinclusive—disregarding workplaces with 99 or fewer employees.¹⁸¹

Pursuant to 28 U.S.C. § 2112, which specifies the procedures for review when an agency order is challenged in more than one federal appellate court, the Judicial Panel on Multistate Litigation, on November 16, 2021, randomly selected the Sixth Circuit as the court in which all of the pending petitions will be consolidated for review. Under § 2112(a)(4), the Sixth Circuit may modify, revoke, or extend the Fifth Circuit's stay.¹⁸²

On December 17, 2021, a divided panel of the Sixth Circuit, in In re: MCP No. 165, Occupational Safety and Health Administration, Interim Final Rule: COVID-19 Vaccination and Testing, granted the government's motion to dissolve the stay issued by the Fifth Circuit.¹⁸³ In the Sixth Circuit's view, based on the OSH Act's language, structure, and direct instances of congressional approval following the law's enactment, OSHA has a "clear and exercised authority to regulate viruses" and wide discretion under this authority "to form and implement the best possible solution to ensure the health and safety of all workers" under the OSH Act.¹⁸⁴

According to the Sixth Circuit, the text of Section 6(c) expressly encompasses the authority to regulate viruses because a virus is an "agent" (i.e., a biologically active principle) that is physically harmful (i.e., causes bodily harm) within the meaning of the provision.¹⁸⁵ This authority to regulate viruses and infectious diseases, the court continued, is reinforced by other provisions of the OSH Act that reference "illnesses arising out of work situations" and "health hazards," as well as a provision that contemplates "medical examination, immunization, or treatment" as possible measures the agency may employ.¹⁸⁶ This interpretation, in the court's view, is further consistent with several instances of Congress's approval of OSHA's authority to regulate bloodborne pathogens and viruses such as HIV, hepatitis B, and hepatitis C.¹⁸⁷ According to the Sixth Circuit, this clear authority to regulate viruses necessarily encompasses "the authority to regulate infectious diseases that are not unique to the workplace."¹⁸⁸ Because "no virus—HIV, [hepatitis B], COVID-19—is unique to the workplace and affects only workers," the court reasoned, OSHA's authority to regulate hazards extends to those that "co-exist in the workplace and in society but are at heightened risk in the workplace."¹⁸⁹ In the court's view, OSHA's issuance of the ETS "[was] not a novel expansion of OSHA's power; it [was] an existing application of authority to a novel and dangerous worldwide pandemic."¹⁹⁰

After concluding that OSHA did not exceed its statutory authority, the Sixth Circuit further concluded that the agency's determination that the ETS was warranted was supported by substantial evidence, including the agency's determination that employees were exposed to "grave danger" from COVID-19 and that the ETS was "necessary to protect employees from such danger."¹⁹¹ Under Section 6(f) of the OSH Act, the Secretary's determinations are "conclusive if supported by substantial evidence in the record considered as a whole."¹⁹²

As to the existence of "grave danger," the Sixth Circuit found, for instance, that OSHA has demonstrated "the pervasive danger that COVID-19 poses to workers—unvaccinated workers in particular—in their workplaces," explaining why traditional indoor workplaces place workers at heightened risk of contracting COVID-19; evidence of the severity of the harm from COVID-19; the likelihood that the ETS would save over 6,500 worker lives and prevent more than 250,000 hospitalizations over the next six months; and that voluntary guidance on vaccination proved inadequate, particularly in the face of the Delta variant.¹⁹³ As to the necessity of the ETS, the court found, for instance, that OSHA sufficiently demonstrated that the evolving course of the pandemic—and in particular, the emergence of the Delta variant—necessitated an ETS at this time and that extensive evidence cited by the agency showed that vaccination reduces the presence and severity of COVID-19 cases in the workplace.¹⁹⁴ The choice to limit the ETS to employers with 100 or more employees, in the court's view, did not undermine the standard's necessity because the agency demonstrated the relationship between this chosen threshold and the underlying regulatory problem, given that "larger employers are better able to implement the policies, are at heightened risk, and regulating them will be a significant step in protecting the entire workforce from COVID-19 transmission."¹⁹⁵

In the dissent's view, OSHA lacked statutory authority to issue the ETS because the agency did not appropriately establish the standard's "necessity" or the existence of a "grave danger" in the workplace. According to the dissent, an ETS is "necessary" within the meaning of Section 6(c) only if it is an "indispensable" means of addressing COVID-19 in the workplace.¹⁹⁶ Because OSHA "failed to explore whether other feasible alternatives would have allowed [it] to tackle the problem," the dissent reasoned that the agency cannot show the ETS was "necessary" for purposes of Section 6(c).¹⁹⁷ Additionally, the dissent found that OSHA had not provided substantial evidence that all covered employees faced a "grave danger" from COVID-19 because not all employees have a high risk both of contracting COVID-19 and suffering severe consequences from it.¹⁹⁸ Finally, in the dissent's view, OSHA's authority under the OSH Act is limited to "the workplace walls," and thus, such authority does not extend to the regulation of a virus that is not uniquely a workplace condition, particularly when the agency "cannot state with precision the total number of workers in our nation who have contracted COVID-19 at work."¹⁹⁹ The authority to protect "employees" from a "grave danger" under Section 6(c), in the dissent's view, is limited to regulating "workplace hazards with workplace solutions."²⁰⁰ Thus, the dissent reasoned, this authority does not encompass the authority to mandate safety measures beyond the workplace boundary, "even if taking such precautions would save many 'employee' lives."²⁰¹

Following the Sixth Circuit's dissolution of the stay, several petitioners filed an application with the Supreme Court seeking to stay the ETS. On January 13, 2022, the Supreme Court, in National Federation of Independent Business (NFIB) v. Department of Labor, granted the application and stayed enforcement of the ETS once again.²⁰² The Court concluded a stay was warranted because the applicants were likely to succeed on the merits of their claim that the ETS exceeded OSHA's statutory authority.²⁰³ According to the Court, because the ETS applies to roughly 84 million workers across industries, it undoubtedly qualifies as an exercise of authority "of vast economic and political significance."²⁰⁴ Such a use of authority would only be permissible, the Court found, if "plainly authorize[d]" by the OSH Act.²⁰⁵ In the Court's view, however, the OSH Act authorizes the agency "to set workplace safety standards, not broad public health measures."²⁰⁶ Because the ETS does not distinguish between (1) workplaces that pose a heightened risk of COVID-19 exposure based on a job's particular features or the nature of the workplace and (2) workplaces that pose a generalized exposure risk that is not different in kind from the risk presented by other nonwork settings in which people gather, the Court concluded it was an impermissible general public health measure, rather than a permissible occupational safety or health standard.²⁰⁷ Allowing OSHA to regulate the hazards of daily life untethered to occupation-specific risks, in the Court's view, would significantly expand OSHA's authority without "clear congressional authorization."²⁰⁸ This conclusion was bolstered by the fact that OSHA never before adopted a regulation that was similarly untethered causally from the workplace.²⁰⁹

The Court clarified, however, that OSHA may exercise more targeted authority to address workplaces that face a heightened risk of contracting COVID-19 beyond the everyday risk that all workplaces face.²¹⁰ As examples, the Court stated that "OSHA could regulate researchers who work with the COVID-19 virus" or "regulate risks associated with working in particularly crowded or cramped environments."²¹¹

On January 25, 2022, OSHA announced that the agency was withdrawing the ETS as an enforceable emergency temporary standard.²¹² The agency, however, further noted it was not withdrawing the ETS as a proposed rule, but was prioritizing its resources to focus on finalizing a permanent COVID-19 Healthcare Standard.²¹³ On February 18, 2022, the Sixth Circuit granted the government's motion to dismiss the consolidated proceedings as moot in light of OSHA's withdrawal of the ETS.²¹⁴

The different results reached by the Supreme Court in NFIB, as to the OSHA ETS, and in Missouri, as to the CMS IFR, highlight the contextual nature of statutory interpretation. Although the statutory provisions at issue in both cases, at a high level of generality, authorize both agencies to issue certain health and safety regulations governing regulated entities, the different language, context, and scope of the two statutory schemes—as well as the scope of the rules at issue—appear to have contributed to the different case outcomes. In Missouri, the Court approved the vaccination requirement as fitting neatly within a general statutory authority to issue "health and safety" regulations—or perhaps even a broader authority to "administer" Medicare and Medicaid—when the requirement is imposed on a single, heavily regulated industry that faces a recognized, heightened risk of exposure to COVID-19 and in which vaccination requirements—even though never federally required before—are generally a common requirement in the industry.²¹⁵ In concluding that relevant statutory authorities plainly authorized the vaccination requirement, the Court gave significant weight to the numerous, detailed, health and safety-related federal requirements, including those related to infectious disease control, that the Secretary of HHS already imposes on these regulated entities.²¹⁶

By contrast, in NFIB, the Court invalidated the vaccination-and-testing requirement as not "plainly" authorized by a general statutory authority to protect "employees" exposed to grave danger from a physically harmful agent when the requirement—though less stringent than the CMS vaccination requirement—is imposed across all industries by an agency that historically has not issued a regulation of this scale before. According to the Court, this "lack of historical precedent, coupled with the breadth of authority that the Secretary [of Labor] now claims, is a telling indication that the mandate extends beyond the agency's legitimate reach."²¹⁷

These cases tend to suggest that in considering whether an applicable statutory provision "clearly" authorizes the agency to impose an unprecedented requirement (e.g., vaccination) on regulated entities to address an unprecedented circumstance (e.g., the pandemic), some of the factors that may inform this determination include the scope of the rule, whether it targets specific sectors or entities, the extent to which the targeted entities have been subject to other health-related regulations by the applicable agency, and whether vaccination requirements are a common requirement within the relevant sectors.²¹⁸ As litigation concerning other federal vaccination mandates continue, courts may provide further insight or clarification on the relevant statutory analysis.

Federal Employee Mandate

Executive Order 14,043, issued on September 9, 2021, instructs each executive agency to implement a program to require COVID-19 vaccination for all federal employees, subject to exceptions required by law, including those based on a disability, medical condition, or a sincerely held religious belief.²¹⁹ The federal employee mandate directs the Safer Federal Workforce Task Force (Task Force) to issue guidance on this requirement's implementation.²²⁰ The mandate is based on the President's statutory authority under 5 U.S.C. §§ 3301, 3302, and 7301.²²¹ These provisions grant the President general authority to prescribe rules and/or regulations for executive branch employees.²²²

Under the Task Force's guidance, federal employees must have been fully vaccinated (i.e., two weeks after completing either a one-dose vaccine or a two-dose vaccine series) or have obtained an exception by November 22, 2021.²²³ The vaccination requirement applies to employees who are under maximum telework or remote-work arrangements.²²⁴ Employees who refuse to be vaccinated or provide proof of vaccination, and have neither an exception nor an exception request under consideration, are subject to disciplinary measures, up to and including removal or termination.²²⁵ Under the guidance, any removal or termination would be preceded by a brief period of education and counseling and a suspension period of generally up to 14 days.²²⁶

Several federal employees and at least one employee union have sued to challenge the federal employee mandate.²²⁷ These suits raise a variety of claims, including some claims common to challenges to state vaccination requirements.²²⁸ As discussed above, courts have generally rejected these claims.²²⁹

In several cases filed before the compliance deadline, plaintiffs also asserted several claims specific to the federal employee mandate. One set of claims, for instance, challenged the agencies' alleged denial of religious exemption requests as violating RFRA and the First Amendment's Free Exercise Clause.²³⁰ In a November 2021 decision, however, the district court considering these claims rejected them as unripe—or too early—for review, given that each plaintiff had a pending request for exemption and had not suffered any adverse employment consequence.²³¹ Another claim, raised by an employee union, challenges the manner by which the mandate was implemented. According to the plaintiffs, the vaccination requirement was implemented without undergoing the notice-and-comment rulemaking procedures required by the APA.²³² The district court in December 2021 dismissed the case for lack of standing, concluding, among other determinations, that the plaintiff failed to allege that any of its members had suffered an injury-in-fact because it was "speculative as to whether [they] would be disciplined for failure to become vaccinated because, for example, they may choose to become vaccinated or receive an exemption."²³³

Following the expiration of the compliance deadline, the White House stated that as of December 8, 2021, the federal government achieved 97.2% compliance with the mandate, with 92.5% of employees having received at least one COVID-19 vaccination dose. For employees who had not yet complied, agencies were undertaking the first step in the enforcement process with education and counseling.²³⁴ On December 21, 2021, before agencies began to implement additional enforcement actions, a nonprofit federal employee organization, a federal employee union, and several individual federal employees filed suit to challenge the mandate on various grounds, including that the mandate exceeds the President's statutory authority.

On January 21, 2022—the earliest date on which the government informed the court that noncompliant employees would face disciplinary actions—the district court, in Feds for Medical Freedom v. Biden, granted the plaintiffs' request for preliminary injunction and suspended enforcement of the federal employee vaccination mandate nationwide.²³⁵ Among other determinations, the court concluded the mandate likely exceeded the President's statutory authorities under 5 U.S.C. §§ 3301, 3302, and 7301, as well as his constitutional authority over the executive branch under Article II of the Constitution.²³⁶ Specifically, according to the court, § 3301, by its own terms, applies only to civil service "applicants" and could not be invoked to impose requirements on current federal employees; the rules the President may prescribe governing the competitive service under § 3302 are limited to providing necessary exceptions to certain Title 5 requirements, such as certain reporting, examination, and antidiscrimination requirements.²³⁷

Relying on the Supreme Court's OSHA ETS decision in NFIB, the district court further concluded that the President's authority under § 7301 to "prescribe regulations for the conduct of employees in the executive branch" is limited to regulating "workplace conduct."²³⁸ Because, in the court's view, COVID-19 presents a "universal risk" and not a workplace risk under NFIB, the mandate falls outside of the President's § 7301 authority.²³⁹ Applying similar reasoning, the court further concluded that the mandate exceeds the President's constitutional authority over federal officials under Article II because to conclude otherwise would grant the President unlimited power over federal employees "in [and] out of the workplace."²⁴⁰

It is unclear whether other courts would agree that the Supreme Court's reasoning in NFIB applies directly to the federal employee mandate. Unlike the OSHA ETS, which implicates a workplace safety statutory scheme that authorizes an agency to regulate third-party employers, the federal employee mandate concerns the federal government's authority, as an employer itself, to set the conditions of employment for its workforce. In general, employers—unless specifically prohibited by applicable state law—may impose vaccination requirements as a condition of employment, subject to constraints under federal antidiscrimination laws.²⁴¹

During the pandemic, many workplaces—including both private and public state employers—have in fact imposed such requirements,²⁴² which have withstood legal challenges.²⁴³ Through this lens, the scope of the federal employee mandate could be characterized as a work rule or condition of employment implemented by a single employer. Given this limited scope, and absent clearer statutory language stating otherwise, some courts may consider it more reasonable to construe the relevant general grant of authority—including the authority to regulate "the conduct of employees" under 5 U.S.C. § 7301—as encompassing no less authority than other employers enjoy in imposing work rules or conditions during the pandemic,²⁴⁴ particularly given the Supreme Court's prior acknowledgment that the federal government "has a much freer hand in dealing with citizen employees than it does when it brings its sovereign power to bear on citizens at large."²⁴⁵ At least one judge expressed the view that the federal employee mandate also falls within the President's Article II duty to "take Care that the Laws be faithfully executed."²⁴⁶ In his view, discharging such duties as "CEO of the federal workforce," the President issued the mandate to ensure, for instance, the continued provision of vital governmental services by agencies such as the Transportation Security Administration.²⁴⁷

On April 7, 2022, a divided panel of the Fifth Circuit vacated the district court's preliminary injunction without reaching the question on the merits concerning the President's authority to issue the federal employee mandate.²⁴⁸ Instead, the court held, as a threshold matter, the district court lacked subject matter jurisdiction under the Civil Service Reform Act of 1978 (CSRA) to consider the case.²⁴⁹ The CSRA, according to the court, established "the comprehensive and exclusive procedures for settling work-related controversies between federal civil-service employees and the federal government," including an "elaborate" remedial scheme that specified the manner by which federal employees may obtain administrative and judicial review of specified adverse employment actions.²⁵⁰ In light of this remedial scheme, the Fifth Circuit rejected plaintiffs' argument that the CSRA does not apply until the plaintiffs suffer an adverse employment action, agreeing with the government that such an interpretation "would allow federal employees to circumvent the CSRA by filing suit before their employer disciplines or discharges them, thereby 'gutting the statutory scheme.'"²⁵¹ Accordingly, the court concluded that the CSRA provided the exclusive avenue for judicial review of the federal employee mandate: once an employing agency finalizes an adverse action, the aggrieved employee may appeal to the Merit Systems Protection Board (MSPB), and an employee who is dissatisfied with the MSPB's decision is entitled to judicial review in the U.S. Court of Appeals for the Federal Circuit, which has exclusive jurisdiction over such appeals and is "fully capable of providing meaningful review."²⁵² For these reasons, the Fifth Circuit concluded that the district court lacked subject matter jurisdiction over the plaintiffs' action and directed the district court to dismiss the case.²⁵³

Federal Contractor Mandate

Executive Order 14,042, also issued on September 9, 2021, directs federal executive departments and agencies to include in certain contracts a clause requiring compliance with the Task Force's workplace safety guidance.²⁵⁴ The Task Force guidance, issued on September 24, 2021, requires federal contractors and subcontractors with a covered contract to conform to several workplace safety protocols, including COVID-19 vaccination of covered contractor-employees, subject to exceptions required by law.²⁵⁵ Covered contractor-employees include those working on or in connection with a covered contract or working at a covered contractor workplace.²⁵⁶ Covered contractor-employees working remotely are subject to the vaccination requirements.²⁵⁷

Consistent with the executive order, the federal contractor mandate sets forth a phase-in period for the new clause to be added to federal contracts.²⁵⁸ Generally, new contracts awarded on or after November 14, 2021, must include the new clause, while contracts awarded prior to October 15, 2021, would incorporate the new clause only at the point at which the government renews the contract or exercises an option.²⁵⁹ By January 18, 2022, covered contractors must ensure that their covered employees are fully vaccinated by the first day of performance of a new contract or when there is a renewal, extension, or exercised option on an existing contract.²⁶⁰ The Task Force guidance instructs that "significant actions, such as termination of the contract," should be taken if a contractor does not take steps to comply with the requirements.²⁶¹

The Federal Contractor executive order is based on the President's authorities under 3 U.S.C. § 301 and the Federal Property and Administrative Services Act (Procurement Act), including 40 U.S.C. § 121.²⁶² The Procurement Act empowers the President to "prescribe policies and directives that the President considers necessary to carry out" the Act if they are consistent with the Act,²⁶³ the purpose of which is to provide "an economical and efficient system" for, among other objectives, federal procurement.²⁶⁴ The Federal Contractor executive order states that it was issued to promote this purpose "by ensuring that the parties that contract with the Federal Government provide adequate COVID-19 safeguards to their workers" performing on or in connection with a covered contract.²⁶⁵ The President determined that the safeguards would "decrease worker absence, reduce labor costs, and improve the efficiency of contractors and subcontractors at sites where they are performing work for the Federal Government."²⁶⁶

The executive order, pursuant to 3 U.S.C. § 301, tasked the Director of the Office of Management and Budget (OMB) with determining whether the Task Force's guidance "will promote economy and efficiency in Federal contracting."²⁶⁷ In accordance with this delegation, the OMB Director made an affirmative determination in a Federal Register notice published on the same date of the Task Force guidance's release.²⁶⁸ The executive order also directs the Federal Acquisition Regulatory Council to make corresponding amendments to the Federal Acquisition Regulation, and to issue guidance to federal agencies on how to comply with the federal contractor mandate in the interim.²⁶⁹ The Council issued the guidance on September 30, 2021.²⁷⁰

More than 20 states, on behalf of their state agencies and political subdivisions that may have a contract subject to the federal contractor mandate, have filed at least four separate suits in different district courts to challenge the mandate.²⁷¹ Plaintiffs in each case filed a motion for preliminary injunction seeking to enjoin the mandate while the litigation is pending. In November 2021, one district court—in Kentucky v. Biden, a challenge filed by Kentucky, Ohio, and Tennessee—granted the states' motion and enjoined the mandate in those three states while litigation is pending.²⁷² In December 2021, another district court—in Georgia v. Biden, a challenge filed by Georgia and six other states—granted the states' motion and issued a nationwide injunction.²⁷³ Among other determinations, both district courts concluded that the President likely exceeded his statutory authority under the Procurement Act in imposing the vaccination requirement, including because the relevant Procurement Act provisions do not empower the President to require a public health measure such as a vaccination.²⁷⁴ Since the nationwide injunction went into effect, several other district courts, including the Western District of Louisiana, Eastern District of Missouri, the Middle District of Florida, and the District of Arizona, have further enjoined the mandate in certain states.²⁷⁵

The government appealed the district courts' orders in both cases. On January 5, 2022, the Sixth Circuit denied the government's application to stay the injunction in Kentucky.²⁷⁶ Among other determinations, the Sixth Circuit agreed with the district court that the federal contractor mandate likely exceeded the President's statutory authority.²⁷⁷ In the Sixth Circuit's view, the relevant Procurement Act provisions authorize the President "to implement an 'economical and efficient' method of contracting . . . to obtain nonpersonal services," and this authority does not permit the President to "impose whatever medical procedure deemed 'necessary' on the relevant services personnel" after those services have been acquired.²⁷⁸

In contrast to the Sixth Circuit's arguably narrow construction, which appears to preclude the President from regulating any post-contract conduct by federal contractors, other courts that have assessed the validity of federal contractor requirements under the Procurement Act have arguably interpreted the President's Procurement Act authorities more broadly. Applying a lenient, rational-basis-like standard, those courts have upheld the validity of executive orders that have "a 'sufficiently close nexus' to the values of providing the government an 'economical and efficient' system for . . . procurement and supply."²⁷⁹ Past court decisions, for example, have upheld the President's use of Procurement Act authority to prohibit federal contractors from discriminating against any employees or applicants for employment because of race, creed, color, or national origin;²⁸⁰ require contractors to adopt certain wage and price standards;²⁸¹ require contractors to adopt an electronic employment verification system to confirm the eligibility of employees to work in the United States;²⁸² and require contractors to post certain public notices informing employees that they could not be forced to join a union.²⁸³

Under the more lenient standard, courts at times upheld requirements despite an arguably "attenuated" link between such a requirement and economy and efficiency in federal procurement, deferring instead to the President's judgment.²⁸⁴ In the case involving the public notice requirement, for instance, the D.C. Circuit accepted the President's rationale that the requirement would promote economy and efficiency in federal procurement because "[w]hen workers are better informed of their rights . . . their productivity is enhanced[,] [and] [t]he availability of such a workforce from which the United States may draw facilitates the efficient and economical completion of its procurement contracts."²⁸⁵ Acknowledging that the link "may seem attenuated," particularly because unions already had a duty to inform employees of these rights, the court nevertheless upheld the requirement under the more lenient standard.²⁸⁶ In contrast to the public notice requirement in that case, there is arguably a stronger link between the vaccination requirement—a regulation of the contractors' employment practices—and economy and efficiency in federal procurement, given the pandemic's significant impact on workplace operations and absenteeism.²⁸⁷

The government's appeal in Georgia is pending before the Eleventh Circuit.²⁸⁸ Among other issues, the parties' briefs addressed not only pre-pandemic case law on the Procurement Act, but also the application of the Supreme Court's decisions in NFIB and Missouri to the federal contractor mandate. According to the government, like the CMS mandate, which was an implementation of the HHS Secretary's "longstanding practice" of imposing federal health-related requirements under the Medicare and Medicaid statutes, the federal contractor mandate reflected a "longstanding practice" by Presidents to use their Procurement Act authority to issue executive orders directed at improving the economy and efficiency of contractors' operations.²⁸⁹

As examples of prior, similar uses of the Presidents' Procurement Act authority, the government pointed to the antidiscrimination requirements for contractors, the required use of an electronic employment verification system, as well as a requirement on contractors to provide employees with paid sick leave.²⁹⁰ Thus, according to the government, under Missouri and prior cases in which courts of appeals have applied the lenient standard to afford Presidents "necessary flexibility and broad-ranging authority" in setting procurement policies, the federal contractor mandate reflects the required nexus to the statutory objective of "an economical and efficient system" for contracting and procurement, given the mandate would, as the President determined, reduce absenteeism and improve efficiency of contractors at sites where they are performing work for the federal government.²⁹¹

The state plaintiffs, in contrast, argued that the President's Procurement Act authority, consistent with the Sixth Circuit's interpretation, is limited to prescribing the federal government's own internal procurement policies and does not extend to regulations that would improve the efficiency of federal contractor operations.²⁹² Moreover, the state plaintiffs argued that the federal contractor mandate, like the OSHA ETS, was "a significant encroachment in the lives—and health of a vast number of employees" that "involves billions of dollars of economic activity."²⁹³ Thus, in the state plaintiffs' view, the Procurement Act, like the OSHA Act, does not provide a clear grant of authority to impose a vaccination requirement.²⁹⁴

The Eleventh Circuit heard oral argument on the government's appeal on April 8, 2022. The government's appeals of other preliminary injunctions are pending in the Fifth, Eighth, Eleventh, and Ninth Circuits.

Head Start Mandate

On November 30, 2021, the Office of Head Start within HHS's Administration for Children and Families issued an IFR that imposed both vaccination and masking requirements for grantees of the Head Start program.²⁹⁵ Established in 1965, the Head Start program awards funds directly to public and private non-profits and for-profits, governmental agencies, and schools to promote school readiness for infants, toddlers, and preschool-aged children from low-income families, subject to certain federal performance standards.²⁹⁶ The IFR adds to the federal performance standards to require all Head Start employees, as well as contractors and volunteers who have contact with or provide direct services to children (collectively, Head Start staff), to receive a one-dose COVID-19 vaccine or a two-dose vaccine series by January 31, 2022, subject to legally required exceptions based on a disability, medical condition, or sincerely held religious belief.²⁹⁷ Those who are granted exceptions are required to undergo weekly COVID-19 testing.²⁹⁸ Additionally, the IFR requires universal masking, with some exceptions, for all individuals two years of age and older when indoors. For those who are not fully vaccinated, the IFR also requires masking outdoors if the setting is crowded or involves close contact with others.²⁹⁹

According to the Office of Head Start, the Head Start mandate is based on the Secretary of HHS's determination, after consulting with child health experts and CDC and FDA recommendations, that additional health and safety standards are necessary and appropriate to ensure the reduction in SARS-CoV-2 transmission; avoid severe illness, hospitalization, and death among program participants; and reduce program closures, which impose multiple hardships on Head Start children and families that rely on the program to meet their health, nutrition, and early learning needs.³⁰⁰ Given the Secretary's determination that COVID-19 vaccines are the safest and most effective way to protect individuals and the people with whom they live and work from infection and severe illness and hospitalization, and the fact that most program participants are too young to be vaccinated at this time, the Secretary concluded that additional health and safety standards—in the form of required masking and vaccination among everyone who is eligible—are the best defenses against COVID-19, especially in light of the spread of the Delta and other variants.³⁰¹

The Head Start mandate is based on the Secretary's authority under Section 641A of the Head Start Act to "modify, as necessary, program performance standards by regulation applicable to Head Start agencies and programs," including "administrative and financial management standards"; "standards relating to the condition and location of facilities (including indoor air quality assessment standards, where appropriate) for such agencies, and programs"; and "such other standards as the Secretary finds to be appropriate."³⁰² Prior to the IFR, the Secretary has used this authority to impose standards related to staff health and wellness, including a requirement that grantees ensure their staff undergo an initial health examination and periodic reexamination as recommended by their health care provider in accordance with state, local, and tribal law.³⁰³

Following the issuance of the IFR, 25 states, in two separate lawsuits, sued to challenge the Head Start mandate. In each case, plaintiff states filed a motion for preliminary injunction to block the mandate while litigation is pending. On December 31, 2021, the district court, in Texas v. Becerra, granted the motion and enjoined the mandate in Texas.³⁰⁴ The next day, the district court, in Louisiana v. Becerra, also granted the motion and enjoined the mandate in the 24 plaintiff states.³⁰⁵ Among other determinations, both courts concluded that the plaintiff states are likely to succeed on their claim that the mandate exceeds the Secretary's statutory authority.³⁰⁶

According to the Texas court, the mandate cannot be an "administrative standard" under Section 641A(a)(1)(C) because such standards are limited to those related to executive duties and management; nor can it be a standard "related to the condition . . . of facilities" because such standards must relate to physical conditions of buildings and equipment.³⁰⁷ The court further reasoned that the mandate cannot fall within the Secretary's catchall authority under Section 641A(a)(1)(E) to modify "such other standards as the Secretary finds to be appropriate" because such standards refer to "performance standards" that are limited to those that "measure the quality of Head Start programs" in achieving the program's purpose to promote school readiness of low-income children.³⁰⁸ According to the court, because the vaccine and masking mandate does not measure staff's ability to enhance children's development, the mandate cannot be a performance standard that the Secretary has authority to modify under Section 641A.³⁰⁹ The Louisiana court, on the other hand, more broadly concluded that the Secretary lacks statutory authority to issue a vaccination and masking mandate because Section 641A does not specifically authorize him to do so.³¹⁰

A few days before the Head Start mandate's January 31 compliance deadline, four Michigan school districts filed suit to challenge the mandate in Livingston Educational Service Agency v. Becerra.³¹¹ In contrast to the Texas and Louisiana courts, the district court presiding over Livingston denied the plaintiffs' motion for preliminary injunction. The court held that the mandate "plainly falls within the Secretary's [Section 641A] authority," including the authority to issue necessary administrative standards to safely carry out day-to-day Head Start program operations; the authority to regulate "the condition and location of facilities" given that COVID-19 spreads through the air via respiratory droplets; and "the broad grant of authority" given to the Secretary to issue appropriate standards to promote school readiness in a learning environment.³¹²

This conclusion, according to the district court, is supported by the Supreme Court's decisions in NFIB and Missouri. The district court reasoned that the Head Start mandate is more like the CMS mandate affirmed in Missouri because both mandates "are tailored to protect those who work in places with or provide services to at-risk individuals—Medicare and Medicaid patients [in the case of the CMS mandate] and children, often from minority and low income backgrounds, who are too young to be vaccinated."³¹³ Like the relevant Medicare and Medicaid statutory authorities with respect to the CMS mandate that the Secretary had long used to implement federal health-related regulations for providers and suppliers, the district court noted that the authority under Section 641A has long been used by the Secretary to implement past health and safety standards related to the Head Start program. These include standards requiring staff to be screened for communicable diseases, providing for appropriate treatment of children with HIV, requiring minimal spacing between infant cribs, and requiring exclusion of children with certain contagious illnesses.³¹⁴ Plaintiffs have appealed the district court's order to the Sixth Circuit.

Congress's Constitutional Authority to Mandate Vaccination

Although states have traditionally exercised the bulk of authority over public health matters, including vaccination, Congress shares certain concurrent authority in this area emanating from its enumerated powers in the Constitution.³¹⁵ This authority derives from, among other sources, the Constitution's Spending and Commerce Clauses, which may be used by Congress to clarify existing statutory authorities as they relate to vaccination requirements, or create additional sources of authority for or limitations on such requirements.³¹⁶

The Spending Clause empowers Congress to tax and spend money for the general welfare.³¹⁷ Under this authority, which is subject to several limitations, Congress may offer federal funds to nonfederal entities and prescribe the terms and conditions under which the funds are accepted and used by recipients.³¹⁸ Over the past century, Congress has frequently invoked this authority in the public health context, including for purposes of controlling specified diseases, establishing neighborhood or community health centers, and creating federal health insurance programs, including Medicare and Medicaid.³¹⁹

Applying its spending authority in the context of a vaccination mandate, Congress could, for instance, encourage states to enact a vaccination mandate meeting certain federal requirements by imposing it as a condition of receiving certain federal funds.³²⁰ This use of Spending Clause authority, assuming it falls within the broad parameters of being for the "general welfare," would be permissible so long as (1) Congress provides clear notice of the vaccination mandate that states (or other funding recipients) must enact or implement; (2) the mandate is related to the purpose of the federal funds; (3) this conditional grant of funds is not otherwise barred by the Constitution; and (4) the amount of federal funds offered is not "so coercive as to pass the point at which pressure turns into compulsion."³²¹

In addition, the Commerce Clause grants Congress the power "[t]o regulate Commerce with foreign Nations, and among the several States, and with the Indian Tribes."³²² This authority empowers Congress to regulate "three broad categories of activities": (1) "channels of interstate commerce," like roads and canals; (2) instrumentalities of, or persons or things in, interstate commerce; and (3) activities that substantially affect interstate commerce.³²³ Congress relied on the Commerce Clause to enact some of the earliest federal health laws aimed at protecting the public from contagion and products posing health concerns.³²⁴ As the federal government increased its role in public health, Congress relied on the Commerce Clause to pass more comprehensive national health regulations, beginning with the Food and Drug Act of 1906.³²⁵

While Congress's authority under the Commerce Clause is expansive, a majority of the Supreme Court in National Federation of Independent Business (NFIB) v. Sebelius agreed that there is a discrete limit to this authority—it cannot compel individuals to engage in commercial activity.³²⁶ According to Chief Justice John Roberts, in a portion of the opinion not joined by other Justices but largely echoed in the view of the four dissenting Justices, the Commerce Clause did not empower Congress "to regulate individuals precisely because they are doing nothing."³²⁷ While it is uncertain whether this conclusion constitutes binding precedent,³²⁸ it suggests that a direct federal mandate on individuals to receive a vaccine may be susceptible to challenge because such mandates could be construed as compelling individuals who are "doing nothing" to engage in the commercial activity of receiving a specified health care service.³²⁹ On the other hand, a federal mandate that requires vaccination as a condition to engage in existing economic activities, such as employment or interstate travel, may raise fewer constitutional concerns.³³⁰

Even if a vaccine mandate falls within Congress's enumerated powers, other constitutional provisions may constrain the government's action.³³¹ In the context of public health regulations, the key constraints are those grounded in federalism and the protection of individual rights.³³² For example, the Supreme Court has interpreted the Tenth Amendment to prevent the federal government from commandeering or requiring states or localities to adopt or enforce federal policies.³³³ In the context of vaccination, this principle prevents Congress from directly requiring states or localities to pass mandatory vaccination laws or implement federal vaccination laws.³³⁴ It does not, however, impede Congress from using its Spending Clause authority to incentivize states to do so, as long as the amount offered is not so significant as to effectively coerce, or functionally commandeer, states into enacting the mandate.³³⁵

As to protection of individual rights, courts have recognized few rights-based constraints on the ability to impose mandatory vaccination requirements.³³⁶ As explained above, courts have largely rejected due process and equal protection challenges to compulsory vaccination under Jacobson and Zucht. As with state vaccination requirements, the principal area of legal uncertainty as to rights-based constraints on federal requirements is whether and under what circumstances states must provide religious exemptions to a vaccination requirement.³³⁷

Emergency Use Authorization and Vaccination Mandates

Prior to the COVID-19 pandemic, all vaccines subject to governmental mandates were licensed under a biological license application (BLA), the standard regulatory framework under which vaccines are typically introduced into interstate commerce.³³⁸ By contrast, as of December 2021, only one COVID-19 vaccine—Pfizer's Comirnaty—is licensed by FDA under a BLA.³³⁹ Several other COVID-19 vaccines are authorized for emergency use under the FD&C Act's EUA provision, which allows the Secretary of HHS to permit patient access to an unlicensed vaccine for emergency use under specified conditions, including during a public health emergency.³⁴⁰

Before FDA licensed Pfizer's COVID-19 vaccine, some commentators raised a legal issue unique to COVID-19 vaccination mandates. Specifically, they argued that Section 564(e)(1) of the EUA provision precludes entities—including governmental entities—from mandating the COVID-19 vaccines.³⁴¹ Section 564(e)(1) directs the Secretary of HHS, when issuing an EUA for a medical product, to impose such necessary conditions to protect the public health, including appropriate conditions designed to inform individuals "of the option to accept or refuse administration of the product, of the consequences, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks."³⁴² Because each individual must be provided with "the option to accept or refuse," some commentators asserted that this provision "suggests that mandates are categorically prohibited."³⁴³

After some state and private entities began mandating COVID-19 vaccinations in 2021, some litigants advanced this argument in court, asserting that COVID-19 vaccination requirements violated Section 564(e) of the FD&C Act. Courts have generally rejected this claim, holding that Section 564(e) imposes only an informed consent requirement on medical providers administering the vaccines to inform would-be recipients of the vaccines' risks and their right to refuse it.³⁴⁴ As a result, courts generally have concluded that the provision does not prohibit entities from requiring individuals, duly informed by their medical providers, to be vaccinated.³⁴⁵ Now that FDA has fully licensed Comirnaty, a COVID-19 vaccine, legal challenges to COVID-19 vaccination requirements based on the EUA statute are largely moot.³⁴⁶

Considerations for Congress

A vaccination mandate is one available legal tool that governments could use to increase COVID-19 vaccine uptake. Whether the federal government has existing statutory authority to mandate COVID-19 vaccination in certain contexts is an issue in several pending lawsuits.³⁴⁷ Depending on whether Congress determines that the executive branch's use of these authorities, including provisions of the Procurement Act, the SSA, and the OSH Act, appropriately reflects congressional intent, Congress—subject to constitutional limits—can generally clarify the scope of these statutory provisions as they apply to vaccination requirements.

To the extent Congress determines that a federal vaccination mandate may be necessary to address the evolving pandemic, Congress could also impose a mandate through other legislative actions. Any such legislation, however, must be grounded in Congress's enumerated constitutional authority and structured consistently with constitutional due process and religious freedom guarantees.