Creating an Employee COVID-19 Vaccination Requirement: A Risk-Management Endeavor

Young waitress wearing protective FFP2 mask and gloves serving to a customer. She is wearing a badge showing that she is vaccinated against COVID-19.

Since the onset of the COVID-19 pandemic, the estimated direct financial costs to U.S. businesses from employees who have suffered from COVID-19 have been staggering: $50.5 billion, including $10.7 billion in disability wage payments, $15.5 billion in sick leave wages, and $22.7 billion in employee benefits as of April 2021 (Integrated Benefits Institute). These projections represent a 117% increase over findings from a similar study conducted in April 2020. In addition to these direct costs, businesses must grapple with the corresponding effects on productivity and morale that the surge in COVID–related work absenteeism continues to wreak.

In the context of these sobering figures, employers considering adopting mandatory employee vaccine policies must approach the decision as fundamentally a risk– management exercise, taking into account these direct costs as well as the potential reputational and employee relations implications that may flow from the polarized political environment in which 21% of Republicans and 5% of Democrats do not plan to be vaccinated (Monmouth University). One foundational principle underlying these deliberations is that employers are legally obligated, per The General Duty Clause, Section 5(a)(1) of the federal Occupational Safety and Health Act, to provide their workers a safe and secure environment in which to do their jobs. Another should be that businesses, particularly in the retail and food service sectors, incur substantial benefit where they can assure the public that patronizing them will not expose customers to risk of infection — an assurance made much more concrete where a business’s employees are required to be vaccinated.

Legal Considerations

Mandates for Vaccines Available Only Under Emergency Use Authorization are Subject to Legal Challenge
The Federal Food, Drug and Cosmetics Act (“the Act”) allows the FDA to issue Emergency Use Authorizations (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 (Reiss). However, the 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” (Fisher & Phillips LLP). The vaccines available in the U.S. as of May 2021 — Pfizer, Moderna and Johnson & Johnson — are all approved under EUAs.

At first blush, it would seem that because recipients must be told that they have the option to refuse the vaccine, it would not be permissible for employers 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 soon.

Moreover, in early 2021 a contrary view emerged, and some experts believe that the Food and Drug Act imposes limitations on the federal government and on vaccine manufacturers but does not intrude into the employer-employee relationship to bar employers from mandating COVID-19 vaccinations (U.S. Equal Employment and Opportunity Commission). Stated otherwise, the Act’s directive regarding the right to refuse the vaccination “seems to be directed at whether an individual can be forced to take the vaccine by a government entity…, not whether an employer can condition an individual’s continued employment on taking the vaccine.” Commentators note that the vast majority of employees in the U.S. are at-will and that vaccine mandates in the workplace have been imposed for decades. Perhaps most significantly, current  EEOC guidance notes the FDA’s obligation to notifiy recipients of the option to accept or refuse vaccines available under an EUA but proceeds to discuss options for employers who wish to mandate vaccines “when they are available,” and not when they are fully licensed by the FDA (Husch Blackwell). Included in such options (and discussed below) is excluding from the workplace an employee who declines to be vaccinated.

Constitutional Principles and Sources of Law and Policy
In 1905 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 employer may require COVID-19 immunizations will be found in state law.

Each of the 50 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 annually against flu.

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.

Employers should note that this is an area of intensive legislative activity, and bills addressing employer-mandated vaccinations are pending in many states. While some authorize such mandates, most would prohibit them — either by governmental employers or by all employers — if enacted (29 Code of Federal Regulations 1630.2 [r ]). Thus far, only Arkansas has adopted a COVID-specific statute that, among other things, prohibits state agencies and political subdivisions from mandating vaccination as a condition of employment (United States v. Seeger).

Federal Laws Affecting Employee Immunization Requirements: Title VII of the Civil Rights Act of 1964 and the Americans with Disabilities Act
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 state statutes 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 15 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).

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” (Fallon v. Mercy Catholic Medical Center).

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:

  1. the duration of the risk;
  2. the nature and severity of potential harm;
  3. the likelihood that the potential harm will occur; and
  4. 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.

Title VII
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” (U.S. Equal Employment and Opportunity Commission). Under this standard, views that were “essentially political, sociological, or philosophical” would not qualify one for conscientious objector status. 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.

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.

Fairly and Legally Implementating a Vaccination Requirement
Successful implementation of an employee vaccination requirement is also a risk management-driven process.

First, employers must design or adopt a system to verify that employees not eligible for waiver have indeed had the vaccine. The ADA generally prohibits employers from making “disability-related inquiries” of an employee unless they are job-related and consistent with business necessity. The EEOC has clarified that to meet this standard, employers would need to have a reasonable belief, based on objective evidence, that unvaccinated employees will pose a direct threat to the health or safety of themselves or others.  Asking an employee for proof of vaccination pursuant to a mandatory vaccination policy is not a “disability-related inquiry” for ADA purposes, but posing the screening questions that must precede administration of a vaccine would be, whether the questions are asked by the employer or by an entity contracting to administer vaccines on the employer’s behalf.  While a more common course of proceeding is probably for the employee to obtain the vaccination from a health care provider, pharmacy or public health agency, if the employer takes possession of the vaccination screening responses, the ADA requires that the information must be stored in a confidential, separate file from the employee’s general personnel file.

Employers must also verify that persons claiming exemption from vaccination are entitled to a waiver of the vaccination mandate. As noted above, such an inquiry may involve significant exposure to an employee’s private medical information or to personal beliefs that may or may not meet conventional notions of orthodoxy. Employers risk significant damage to employer-employee relations should they mishandle such information or obtain it in an insensitive or incautious way. At a minimum, handling waiver requests should be assigned to human resources staff rather than to line managers who work directly with the employee in question. Managers should be told that a waiver has been granted but need not know, absent some compelling reason, the basis for the waiver.

The near- and long-term consequences of a COVID-19 outbreak can be substantial for many organizations, particularly in business sectors where public confidence in the safety of the business’s facilities or products is paramount to continued viability. As with all risk-management decisions, employers must calibrate their willingness to adopt measures that may foster physical safety and wellbeing among their employees and can provide market advantages, but may also spark controversy and require the commitment of substantial resources to implement. Mandatory employee vaccination policies can help employers recoup the unanticipated costs incurred since March 2020 and boost consumer confidence in the business’s products or services, as well as ensure that the workplace meets federal and state safety standards — but only if implemented fairly and carefully, in full compliance with applicable law.

written by David Parker


Code of Federal Regulations 1630.2(r).

Fallon v. Mercy Catholic Medical Center, 877 F.3d 487 (3rd Cir. 2017).

Fisher & Phillips LLP. Top 7 Things You Need to Know as EEOC Says Employers May Mandate COVID-19 Vaccines. December 17, 2020.

Husch Blackwell LLP. 50-state Update on Pending Legislation Pertaining to Employer-mandated Vaccinations. March 5, 2021.

Integrated Benefits Institute. The Cost of Missed Work due to COVID-19. April 20, 2021.

Monmouth University. National: One in Five Still Shun Vaccine. April 14, 2021.

Reiss, Dorit. Can Employers Mandate a Vaccine Under Emergency Use Authorization? February 24, 2021.

United States v. Seeger, 380 U.S. 163, 184, 85 S.C.t 850, 13 L.Ed.2d 733 (1965)

U.S. Department of Labor. Occupational Safety and Health Act.

U.S. Equal Employment and Opportunity Commission, What You Should Know About COVID-19 and the ADA, the Rehabilitation Act, and Other EEO Laws. December 16, 2020.

U.S. Food and Drug Administration. Emergency Use Authorization for Vaccines Explained.

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