The U.S. Food and Drug Administration (FDA) has now issued Emergency Use Authorizations (EUAs) for two COVID-19 vaccines, with more in the pipeline. With this encouraging development, employers and institutions of higher education (IHEs) must prepare to grapple with whether they can require employees or students to be immunized as a condition of employment or enrollment.
Given the array of federal and state laws and regulations affecting such practices, establishing and enforcing a mandatory immunization policy involves much more than a simple analysis based on principles of public health. The type of FDA approval granted to date, the politicized societal debate regarding COVID-19 response measures, and the availability of adequate supplies of vaccine to immunize broad segments of the population will all complicate the employer’s decisions regarding vaccination mandates.
Mandatory Vaccinations Not Feasible Under Emergency Use Authorization
The Federal Food, Drug and Cosmetics Act allows the FDA to issue EUAs to facilitate the availability of medical measures, including vaccines, during public health emergencies. Under an EUA, the FDA may allow the use of medical products that have met safety and efficacy requirements where there are no adequate, approved and available alternatives (21 U.S. Code § 360bbb-3). However, the Food, Drug and Cosmetic Act imposes significant conditions on EUAs, including that the patient receiving a product authorized under EUA must be informed that “FDA has authorized the emergency use of the vaccine, of the known and potential benefits and risks, the extent to which such benefits and risks are unknown, that they have the option to accept or refuse the vaccine, and of any available alternatives to the product” (Emergency Use Authorization for Vaccines Explained).
Because recipients must be told that they have the option to refuse the vaccine, and absent any guidance from the U.S. Department of Health and Human Services to indicate otherwise, it does not appear permissible for employers or IHEs currently to require employees or students to be vaccinated against COVID-19. However, the vaccine manufacturers are actively pursuing full licensure of their products, and there is every reason to believe that the FDA will be in a position to grant such approval within the next three to six months. Anticipating both full licensure and adequate supplies of vaccine to cover their workforce or student populations, employers and IHEs should begin now to prepare for imposing such requirements and handling requests for exemption in compliance with governing laws and regulations.
Constitutional Principles and Sources of Law and Policy
In 1922 the U.S. Supreme Court held in the case of Jacobson vs. Massachusetts that a state had the right to require citizens to be immunized against smallpox and to fine those who failed to comply. As long as such state laws are not arbitrary, unreasonable, or exceed what is necessary to maintain public safety, they are constitutional. As a matter of federal constitutional law, then, arguments that mandatory vaccination laws violate due process, equal protection, or First Amendment religious liberty principles are unavailing.
Jacobson applied to immunization requirements imposed by states through exercise of the police powers that are largely reserved to the states under the Constitution. While the federal government does exercise similar powers in regard to safety and public welfare, governmental vaccination requirements are in the first instance created under state law. As a consequence, with a few important exceptions discussed below, much of the authority guiding whether an IHE and to some extent whether an employer may require COVID-19 immunizations will be found in state law.
Each of the fifty states has enacted laws in this arena. Most are limited to requirements for childhood immunizations and tie enrollment in public (and in some cases private) schools and colleges to satisfactory proof of specified immunizations, but some states do regulate vaccination requirements for employers, often in industry-specific ways. For example, New York, Rhode Island, California and Massachusetts all require that health care workers be immunized against flu annually.
Though there are many similarities among the states in how they approach immunizations, significant variations in requirements and process mean that state law must always be consulted before imposing mandatory vaccination requirements. Every state provides exemptions for individuals with medical conditions that make immunization unsafe for them. In addition, 45 states and the District of Columbia grant religious exemptions from vaccination requirements, while an additional 15 states allow a broader exemption for those who object to immunization because of personal, moral or other beliefs—such as a philosophical objection to immunization, or a belief that the COVID-19 crisis is “manufactured” and not genuine, and thus vaccination is not justified. One state, Oregon, bars vaccination mandates for employees and allows parents to decline vaccination for their children without a requirement that the parents state a reason for their decision.
Immunization Requirements for Employees
As noted, employers should be aware of state laws that may regulate their ability to require their employees to be vaccinated against certain illnesses. Many states have laws on the books regarding mandatory vaccines for employees, particularly in health care sectors. Such statutes may provide specific criteria for evaluating medical exemption requests or may recognize philosophical as well as religious exemptions. Where state laws provide more protections for workers objecting to immunization than is the case under the federal laws discussed below, employers will need to comply with these additional requirements to avoid potential legal disputes.
Regardless of state, all employers with fifteen or more employees must comply with Title VII of the Civil Rights Act of 1964 (Title VII) and with the Americans with Disabilities Act (ADA). Under the ADA, an employer’s requirement that an employee be immunized must be job–related, consistent with business necessity, and no more intrusive than necessary. Thus, whether a private employer may require mandatory vaccines is determined first by the nature of the employer’s business. For health–care employers, such a requirement is an obvious business necessity, at least as to many of their employees. However, even for health–care employers, together the ADA and Title VII require that employers reasonably accommodate an employee’s sincerely held religious beliefs (Title VII) and an employee’s medical condition or disability (ADA).
Medical exemption requests are relatively straightforward and subject to concrete verification. The ADA allows an employer to require that an employee not pose a direct threat to the health or safety of individuals in the workplace. Where such a requirement screens out an employee with a disability, the employer must be able to show that the employee, unless vaccinated, would pose a direct threat in the workplace due to a “significant risk of substantial harm to the health or safety of the individual or others that cannot be eliminated or reduced by reasonable accommodation” (29 Code of Federal Regulations 1630.2(r)).
Employers must take care to avoid a one–size–fits–all approach here: to determine that a direct threat exists from an unvaccinated employee, the ADA requires an individualized assessment of four factors:
- the duration of the risk
- the nature and severity of potential harm
- the likelihood that the potential harm will occur
- the imminence of the potential harm
If a direct threat exists, an employer may exclude the employee from the workplace. However, that does not mean that the employee may be discharged. The ADA requires that the employer provide reasonable accommodation to the unvaccinated employee—meaning that the employer must assign the employee to alternate duties unless such an accommodation would impose an undue hardship on the employer. Undue hardship under the ADA is highly fact–driven, and the employer must be able to show that the proposed accommodation would cause it substantial operational difficulties or expense. Obviously, this exception to accommodation is more readily available in health–care settings where an employee may be exposed to vulnerable populations, but even health–care employers should conduct an individualized analysis to establish the unavailability of accommodation without undue hardship before moving to terminate employment.
Religious exemption requests present a thornier problem, because courts have held that Title VII’s prohibition of discrimination based on one’s religion does not extend to non–religious beliefs, no matter how sincerely held. (However, as noted above, employers should be aware of any state laws that protect employees asserting philosophical objections to vaccination.) Thus, employers must sometimes grapple with whether a particular set of ideas constitutes a religion.
Fortunately, the courts have provided some guidance. In regard to whether someone could legitimately claim conscientious objector status and avoid military service, the U.S. Supreme Court has held that the standard should be whether “the claimed belief occup[ies] the same place in the life of the objector as an orthodox belief in God holds in the life of one clearly qualified for exemption” (United States v. Seeger, 380 U.S. 163, 184, 85 S.C.t 850, 13 L.Ed.2d 733 (1965)). Under this standard, views that were “essentially political, sociological, or philosophical” would not qualify one for conscientious objector status (Id. At 165, 85 S.Ct. 850). In later Title VII cases, courts have expanded the definition of religion in the face of claims from adherents to nontraditional or nontheistic religious beliefs, such as the following from the Third Circuit U.S. Court of Appeals:
First, a religion addresses fundamental and ultimate questions having to do with deep and imponderable matters. Second, a religion is comprehensive in nature; it consists of a belief–system as opposed to an isolated teaching. Third, a religion often can be recognized by the presence of certain formal and external signs.
Fallon v. Mercy Catholic Medical Center, 877 F.3d 487 (3rd Cir. 2017).
In addition, because to establish a Title VII case of religious discrimination an employee must first demonstrate that he or she held a sincere religious belief that conflicted with a job requirement, employers may inquire further where they are aware of indications that an employee’s claimed religious beliefs are not sincerely held—for example where an employee raises a general objection to immunization, is turned down, and only then alleges that she adheres to a religion that prohibits immunizations. These are perilous waters indeed, and employers would be well advised to avoid such inquiries unless it is clear based on known, objective circumstances either that an employee’s claim that the religion he or she follows proscribes immunizations is untrue or that the employee’s purported religious belief is not sincerely held.
As with the ADA medical exemption, under Title VII, if an employee establishes the need for a medical or religious exemption, employers must reasonably accommodate the employee. However, the two statutes impose slightly different accommodation standards. Under Title VII, an employer need not provide a requested accommodation for employees with religious objections to immunization if the accommodation would create more than a minimal burden on the operation of the business—a threshold that is easier to meet than with ADA claims.
Immunizations for College and University Students
Most states regulate immunization requirements for college and university students as well as for K–12 students, so the first source of authority for an IHE considering a COVID-19 vaccination requirement will be state law. IHEs will want to know whether the laws of their state require COVID-19 immunization as a condition of enrollment and, if their legislatures or public authorities have not adopted an explicit COVID-19 vaccine requirement, whether state law allows them to create their own lists of required vaccinations.
Title VII regulates discrimination in employment, so its religious exemption requirements do not apply to IHEs as to their students—though state law may well provide for such exemption. Administrators may wish to create similar procedures for requests for religious exemptions and require some evidence that the student is practicing a bona fide religion and not merely attempting to circumvent immunization requirements for philosophical or political reasons. As with employers, this an area ripe for overreach by IHE administrators concerned about protecting the health and safety of their workforce, other students and, in some cases, patients. Thus, while it may be permissible for IHEs to ask a student seeking exemption to provide details regarding the tenets of her or his religious beliefs, or where appropriate to probe the sincerity of claimed beliefs, engaging in comparative judgment as to whether one religion is as legitimate as another will lead to legal challenges. It is also important to remember that in some states, a philosophical rather than religious objection to vaccines will suffice to justify an exemption for a student.
The ADA does provide protections for students claiming medical exemption from vaccination, and IHEs will want to adopt similar policies and procedures for students seeking medical exemption as they put in place for employees.
Preparing for COVID-19 Vaccines
While we await further vaccine guidance from regulatory agencies in the United States, IHEs and employers should review their policies and procedures regarding mandatory immunizations, and those who do not have such policies and procedures should get to work right away, with assistance of legal counsel. Key questions and issues to have in mind are:
- Do such policies and procedures comply with state and federal law? Specifically, do the policies comply with state law immunization exemption for religious beliefs? Philosophical beliefs?
- Do they articulate a legitimate business necessity for requiring all or some students or employees to be immunized?
- To the extent that such requirements are imposed on some, but not all students or employees, is the distinction tied to business necessity and not discriminatory on any illegal basis?
- Are managers and supervisors adequately trained on the policy and procedures, particularly on definitions they will be called upon to apply?
A key issue that IHEs and employers should anticipate is supply constraints. We already know that production of vaccine quantities sufficient to inoculate most Americans will take many months. Meanwhile the Centers for Disease Control and Prevention (CDC) has issued some guidance on which segments of the population should receive priority in vaccination, with more on the way.
To the extent that IHEs and employers hew to CDC guidance in determining where they will impose mandatory immunization requirements, they are more likely to survive allegations that their approach illegally discriminates against certain classes of employees or is arbitrary. Those guidelines will not help where vaccine requirements are imposed but no vaccine is readily available. The fluidity in supply and likely regional and business sector discrepancies may force IHEs and employers to operate under hybrid approaches, where certain groups of employees must be immunized but for other employees, immunization may be delayed until adequate supply of vaccine is available. Such approaches should be constructed in partnership with public health experts and legal counsel to assure that they are science–based and do not inadvertently run afoul of applicable laws and regulations.
Finally, data privacy and security will present complicated management challenges for both employers and for IHEs in regard to their students and require discussion and analysis beyond the scope of this article. Depending on what entity provides immunizations and what information is captured in that process, federal statutes such as the Family Educational Rights and Privacy Act (FERPA) and Health Insurance Portability and Accountability Act (HIPAA) may impose significant confidentiality and sequestration requirements on IHEs and employers. And especially where proof of vaccination may be the entry ticket to classrooms, laboratories, libraries and events as well as to the job site, employers and IHEs will want to ensure that they provide reliable and up–to–date information tracking systems that meet federal and state confidentiality and privacy requirements.