Legal and Practical Considerations for Employers Weighing COVID-19 Vaccination as a Condition of Continued Employment

With the reality of FDA-authorized COVID-19 vaccines upon us, the wheels of the distribution channels moving, and vaccinations of priority populations beginning, many employers are grappling with the next big question: whether to make COVID-19 vaccinations mandatory for employees once vaccines are available for distribution to a broader population. Given the current political climate and perceptions about the speed with which the vaccines have been developed and authorized, both employee resistance and potential legal challenges to such a policy are genuine concerns. 

At the federal level, the Equal Employment Opportunity Commission ("EEOC") has determined that COVID-19 meets the direct threat standard, meaning that "a significant risk of substantial harm would be posed by having someone with COVID-19, or symptoms of it, present in the workplace at the current time." The EEOC also recently released guidance related to mandatory vaccinations, which neither explicitly endorses nor forecloses the viability of mandatory vaccination policies. The EEOC's guidance does, however, acknowledge without explanation that the FDA has an obligation to "[e]nsure that recipients of [a] vaccine under an EUA are informed … that they have the option to accept or refuse the vaccine." Based on the EEOC's guidance to date, a mandatory vaccination policy—with appropriate carve-outs for individuals with disabilities and sincerely held religious beliefs—may be permissible under federal law.  

But, even if it is, it may still be problematic for several reasons. Namely, no federal agency has endorsed employer-mandated COVID-19 vaccinations explicitly, and historically these agencies have stopped short of endorsing mandatory vaccinations outside of certain industries; courts may disagree with a conclusion by the EEOC that mandatory vaccination is lawful; and there is a lack of legal precedent supportive of across-the-board mandatory vaccinations for all job positions in all industries. Moreover, even if mandatory vaccination is found lawful under federal law, such a policy carries additional risks, including potential liability under state law and damage to employee relations. And notwithstanding workers' compensation exclusivity, there is an open question whether tort or similar liability could attach to an employer, and under what circumstances, if employees are harmed by an employer-mandated vaccine.  

Here, we offer guidance with respect to these various legal and practical concerns. Given the risks at play, we recommend employers consult with counsel in crafting any vaccination policies.

Authorization and Distribution of a COVID-19 Vaccine in the United States  

On December 11, 2020, the FDA issued an Emergency Use Authorization ("EUA") for the Pfizer-BioNTech COVID-19 vaccine. Two days later, the first shipment of the vaccine left the manufacturing plant. Vaccinations began on December 14, 2020. Subsequently, on December 18, 2020, the FDA issued an EUA for the Moderna COVID-19 vaccine. The first shipments of the Moderna vaccine left a distribution center on December 20, 2020. An FDA report issued on December 8, 2020, highlights the unknowns that exist when a vaccine receives an EUA, including the limited amount of data to support the effectiveness of the Pfizer-BioNTech vaccine against asymptomatic infection and its unknown effect against transmission of COVID-19 from individuals who are infected despite vaccination. 

In the initial months after approval, there will be a constrained supply environment. Following months of deliberations, the Director of the Centers for Disease Control and Prevention ("CDC") announced CDC's recommendations that health care workers and residents of long-term care facilities be prioritized for initial doses (Phase 1a recipients). On December 20, 2020, the Advisory Committee on Immunization Practices ("ACIP") voted to recommend prioritizing frontline essential workers (non-health care workers) and individuals age 75 and older in the second phase, Phase 1b.  

ACIP has classified the following non-health care essential workers as frontline workers: first responders (e.g., firefighters and police officers), corrections officers, food and agricultural workers, U.S. Postal Service workers, manufacturing workers, grocery store workers, public transit workers, and those who work in the education sector (teachers and support staff members) as well as childcare workers. ACIP also voted to recommend prioritizing non-frontline essential workers, individuals age 65 and older, and individuals with high-risk medical conditions in Phase 1c. However, states have the authority to make final decisions regarding allocation. According to the Kaiser Family Foundation, 45 states followed ACIP's Phase 1a recommendation.  

As employers prepare for greater availability of COVID-19 vaccines over the next several months, many are evaluating the costs and benefits to their business and society-at-large of mandating that their employees get vaccinated. 

Employers Considering a Vaccine Mandate Must Be Cognizant of Legal Risks

The federal law most applicable to the legality of mandatory vaccinations is the Americans with Disabilities Act ("ADA"). Under the ADA, covered employers may not require employees to get a medical examination or make disability-related inquiries unless the examination or inquiry is shown to be "job-related and consistent with business necessity." In its updated guidance, the EEOC stated that administration of a vaccine does not constitute a medical examination and that asking for proof of vaccination is not a disability-related inquiry. While pre-vaccination screening questions are likely to elicit information about a disability, they need not meet the job-related and consistent-with-business-necessity standard if the vaccine is offered on a voluntary basis (the decision to answer the questions must also be voluntary) or if the employer only requires proof of vaccination that is administered by a third party (e.g., a pharmacy) that does not have a contract with the employer. If an employer chooses to administer the vaccine itself or via a third-party contractor, the employer must be able to establish that the pre-screening questions are job-related and consistent with business necessity. According to the EEOC, this standard is satisfied if an employer has a reasonable belief, based on objective evidence, that an employee who does not answer pre-screening questions and, thus, does not receive a vaccination, will pose a direct threat to the health and safety of him- or herself or others. 

While the EEOC's guidance provides that employers that do not administer employee vaccinations themselves or through a third-party contractor need not evaluate whether mandatory vaccinations are job-related and consistent with business necessity in connection with pre-screening questions associated with the vaccine, employers may be wise to do so anyway. The EEOC's guidance does not have the force of law, and it is unclear what deference, if any, courts will afford it. For example, a court could find that an employer that requires vaccination is "making" a disability-related inquiry by subjecting its employees to the pre-screening questions associated with vaccination through the third party. While the EEOC guidance draws a bright line between employers that administer a vaccine themselves or through a third-party contractor (those employers are likely to make disability-related inquiries in connection with pre-screening questions) and employers that require employees to receive the vaccine from an unrelated third-party (those employers are not making disability-related inquiries in connection with the pre-screening questions), a court may not respect that distinction.  

Moreover, the employer may eventually conduct disability-related inquiries of employees outside of the pre-screening context. For example, if employees alert the employer they cannot receive the vaccine due to a disability, that may lead to disability-related inquiries. As the EEOC guidance explains, "[s]imply requesting proof of receipt of a COVID-19 vaccination is not likely to elicit information about a disability and, therefore, is not a disability-related inquiry. However, subsequent employer questions, such as asking why an individual did not receive a vaccination, may elicit information about a disability and would be subject to the pertinent ADA standard that they be 'job-related and consistent with business necessity.'" 

To establish that a disability-related inquiry or medical examination pursuant to a mandatory vaccination policy is job-related and consistent with business necessity, the employer must show that it is vital to the business and no broader or more intrusive than necessary considering the job duties being performed by the employees who will be vaccinated. To the extent other health and safety measures, including remote work arrangements, social distancing, and masking have effectively limited workplace exposure and prevented outbreaks to date, a court may be reluctant to agree that it is necessary for an entire workforce to be vaccinated, particularly while the vaccine has not yet garnered full FDA approval.  

Employers that decide to move forward with a mandatory vaccination policy, even if narrowly drawn, must be prepared to accommodate employees who cannot be vaccinated because of a disability. The EEOC's recent guidance states that an employer may have a "qualification standard" that requires that individuals shall not pose a direct threat to others in the workplace. However, if such a qualification standard screens out or tends to screen out an individual with a disability, the employer must conduct an individualized assessment of four factors to determine whether a direct threat exists. The factors are as follows: the duration of the risk; the nature and severity of the potential harm; the likelihood that the potential harm will occur; and the imminence of the potential harm.  

If an unvaccinated employee poses a direct threat, the employer cannot take any job-related action with respect to the employee (including excluding the employee from the workplace) unless no reasonable accommodations are available that would eliminate or reduce the risk of adverse consequences without imposing undue hardship on the employer. New considerations may factor into the undue hardship analysis as the pandemic evolves, including the prevalence of employees in the workplace who have already been vaccinated. If an employee must be excluded from the workplace, employers should draw on their experience with employees who have been forced to leave the workplace due to COVID-19, and determine whether remote work or leave (for example, under the Family First Coronavirus Response Act or state or local law) is available. Before considering termination, employers must first ensure compliance with potentially applicable federal, state, or local EEO and other laws. 

In addition to the ADA, Title VII of the Civil Rights Act of 1964 ("Title VII") requires employers to accommodate employees' sincerely held religious objections unless doing so would impose an undue hardship. The standard for undue hardship is significantly lower than it is under the ADA—under Title VII, an accommodation that would impose more than a de minimis cost on an employer constitutes an undue hardship. With regard to religious-based accommodation requests, EEOC guidance emphasizes that an employer should ordinarily assume that an employee's request for religious accommodation is based on a sincerely held religious belief, but may request additional supporting information if the employer has an objective basis for questioning the employee. 

Further, even where an employer's mandatory vaccination policy is lawful under federal law, employers must be cognizant of state law concerns, especially discrimination and privacy laws. Some state laws impose a greater duty to accommodate employees' religious objections than federal law, and others define "disability" more broadly than the ADA. And, various states recognize rights to privacy arising from state constitutions, statutes, and tort law.  

In most states, to survive a privacy challenge, an employer will need to demonstrate that a mandatory vaccination policy is justified by the public interest and the employer's legitimate business needs. Likewise, employers in certain states may have increased notice requirements—such as in California—to explain to employees what personal information may be collected about them and the business purposes for which such personal information will be used in connection with a mandatory vaccination policy. Employers also must follow pending legislation in the coming terms, as states are likely to consider vaccine-related legislation that may provide additional clarity or levy restrictions on mandatory vaccinations. Indeed, this past year, legislative proposals were introduced in state legislatures exempting employees from employers' vaccine requirements (e.g., Louisiana) and prohibiting employment discrimination against individuals who do not receive vaccines (e.g., Rhode Island). 

For employers with a unionized workforce, the applicable collective bargaining agreement already may vest the employer with the management right to unilaterally develop and implement a vaccine program. If the employer does not possess the negotiated right to do so, it likely will have to bargain with the union over its desire to do so, as vaccine programs are a mandatory subject of bargaining under the National Labor Relations Act ("NLRA"). Even if the employer already negotiated the management right to implement a vaccine program, it may want to consult with the union in the interests of fostering goodwill and employee acceptance. Employers also should keep in mind that concerted activity by employees (whether unionized or not) to protest a vaccine program (or the lack of a vaccine program) may be deemed to be activity protected by the NLRA and spawn unfair labor practice charges if the employer disciplines employees for their protest. 

There are also unanswered questions regarding the degree to which an employer can be held liable for any adverse effects an employee suffers as the result of a mandated vaccine. It is likely that an employee's claim for damages could be pursued only through the workers' compensation process, but that may vary by state. To the extent a tort claim exists outside the workers' compensation framework, while an employee is unlikely to be able to meet the requisite causation standard in a voluntary vaccination program, if the employer is forcing an employee to receive a vaccine or lose her job, an argument that the employer proximately caused harm that resulted from the vaccine itself becomes an easier (but by no means straightforward) claim to make.  

For all of these reasons, employers must approach implementation of a mandatory vaccination policy with caution and a full understanding of the legal framework in their jurisdiction. For many employers, the prudent course of action will be to implement policies that facilitate and/or encourage, but do not mandate, employee vaccinations. And, for employers that do intend to implement a mandatory vaccination policy, consultation with counsel in crafting such a policy is strongly advised. 

Consider Related Practical and Legal Consequences of a COVID-19 Vaccination Policy As Well  

As employees begin to get vaccinated in accordance with an employer vaccination policy, employers should anticipate increased time-off requests. FDA has determined based on the data available that local site reactions and solicited systemic events after vaccination were frequent and mostly mild to moderate. According to Pfizer's briefing document for the FDA advisory committee, some subjects who received the vaccine reported feeling ill—more so after receiving the second dose—with fatigue and headache among the most commonly reported symptoms. Employers should prepare for the possibility of workers' compensation liability for potential vaccine-related injuries, too. 

Further, tracking compliance and determining what type of proof of vaccination will be required should be carefully planned in advance of rolling out any policy. Any employee medical information obtained by the employer should be treated as a confidential medical record under the ADA and maintained in separate medical files. To anticipate potential vaccine supply issues, employers must consider how to account for employees who are unable to get vaccinated through no fault of their own.  

Wage-hour concerns are present as well. If vaccination is required, employers should compensate employees for the time required to get vaccinated, and for employers in certain states (such as California and Illinois), compensation may be required to cover the cost of vaccination under state expense reimbursement laws. Under federal law and many state laws, if the cost of vaccination is not covered by the employer, employers must ensure the cost of the vaccine does not reduce the employee's wages below the applicable minimum wages in a workweek. 

Employers also should assess any potential discriminatory impact of a narrowly tailored vaccination requirement. For example, if vaccines are required only for employees who cannot telework, this may disproportionately impact lower-income workers.  

Finally, as with any decision of this magnitude, employers should be mindful of the potential impact on employee relations and morale, especially while the vaccine is relatively new. A Pew Research poll from November 2020 found that 39% of U.S. adults responded that they would "probably" or "definitely" not get vaccinated. These results suggest that employers that wish to implement a mandatory vaccination policy might consider including an education and awareness component into their program.