On December 11, 2020, the U.S. Food & Drug Administration authorized the emergency use of Pfizer-BioNTech’s COVID-19 vaccine for individuals 16 years of age and older. The vaccine was shipped out two days later to all fifty states. A Moderna vaccine was authorized on December 18, 2020. Inoculations have begun. But where does that leave employers? Can they mandate the vaccine for employees? Should they?
I. EEOC Guidance on Mandating Vaccines
On December 16, 2020, the Equal Employment Opportunity Commission (“EEOC”) updated its COVID-19 guidance, titled “What You Should Know About COVID-19 and the ADA, the Rehabilitation Act, and Other EEO Laws,” to include information regarding COVID-19 vaccination programs. The updated guidance is consistent with the agency’s historic approach to mandatory vaccine programs, including guidance issued during the H1N1 (“swine flu”) pandemic in 2009.
The main takeaway is that the EEOC generally considers mandatory vaccination programs lawful, subject to exemptions for disabilities and sincerely held religious beliefs.
Exemptions. Employers that implement a mandatory COVID-19 vaccination program must still consider providing exemptions for two categories of workers: (1) individuals with a disability that prevents them from safely getting the vaccine (this may include individuals with allergies, fevers, bleeding disorders, and those that are pregnant or immunocompromised); and (2) individuals with a sincerely held religious belief inconsistent with getting the vaccine. These protections arise under the Americans with Disabilities Act (ADA) and Title VII, respectively.
If an individual cannot be vaccinated due to a disability, then the employer must determine if that unvaccinated person poses a “direct threat” to the health and safety of himself or others. If the individual does pose a direct threat, then the employer must determine whether any reasonable accommodation would eliminate that threat.
Employers who decide to mandate COVID-19 vaccination in the workplace must treat any request for a reasonable accommodation on a case-by-case basis, and engage employees a flexible, interactive process to identify workplace accommodation options that do not constitute an “undue hardship” (i.e., a significant difficulty or expense under the ADA, and a more than de minimis cost/burden on the employer under Title VII). This process should include determining whether it is necessary to obtain supporting documentation about the employee’s disability or religious convictions and considering the possible options for accommodation given the nature of the workforce and the employee’s position.
A few things to consider during this process are:
- If the request is medical, has the employee adequately documented a disability?
- If the request is religious, are the beliefs religious, or simply moral/scientific?
- Is there any other available reasonable accommodation (e.g., transfer, social distancing, additional PPE, etc.) that would allow the employee to do his or her job without the vaccine and without exposing others to possible infection?
The bottom line is that an employer must provide a reasonable accommodation to an individual that is unable to get the vaccine due to a disability or religious belief, so long as the employer would not suffer undue hardship in providing such accommodation. This determination is fact-specific and should be made on a case-by-case basis.
FDA Emergency Use Authorization (EUA) Versus Approval. One note with respect to this analysis is that the only two vaccines currently available in the United States for COVID-19, the Pfizer-BioNTech COVID-19 Vaccine and the Moderna COVID-19 Vaccine, were authorized by the FDA under a special Emergency Use Authorization designation. This is different than a non-emergency approval process (e.g., a New Drug Application) in that, for example, the currently available vaccine necessarily lacks long-term safety data.
None of the documents issued by the FDA in its approval of the vaccines provide that the vaccines may be mandated. On the contrary, the approval letters and fact sheets for recipients provide that recipients of the vaccine must be instructed that “[i]t is your choice to receive the [Pfizer-BioNTech/Moderna] COVID-19 Vaccine.” The recent guidance from the EEOC suggests that the emergency nature of this designation does not affect how the EEOC views mandatory vaccination programs, though it remains unclear if that will be the case with other federal and state agencies as well. Because this is a developing legal issue, it is important for employers to consider the emergency nature of the current vaccine in evaluating their options.
II. Considering the Options
Because of the unique challenges presented by COVID-19, the legal landscape on these issues is novel and rapidly changing. It is important for employers to evaluate the potential risks and benefits to their unique operations in developing their individualized approach to the COVID-19 vaccine. Employers should consider, for example:
- Is my industry recommending vaccination? What is the latest guidance from the CDC, OSHA, EEOC, and other authorities on these issues?
- What are the risks of not requiring employees to be vaccinated?
- Can that risk be limited by a means other than mandatory vaccination (e.g., social distancing, PPE, etc.)?
- In lieu of a mandatory vaccine program, what sort of education and campaigning can be implemented to encourage voluntary vaccination?
- If a mandatory vaccine program is necessary, can it be limited to employees performing certain tasks or working with certain high-risk populations?
- If an employee is injured by a vaccine that has been mandated by the employer, would that be a worker’s compensation claim or another type of civil claim?
- How will the employer respond to individuals that choose not to be vaccinated? Especially if the employer has a mandatory vaccination program, this is a critical consideration, since operations will likely be disrupted if a large percentage of the workforce refuse the vaccine.
- How will the employer handle requests for exemptions to the vaccine based on employees’ religious beliefs or disabilities?
If an employer chooses not to mandate the vaccine, but highly recommend it instead, the employer can provide employees with educational materials, as well as consistent and repeated messaging around the reasons why the employer is recommending the vaccine.
Employers should also consider whether they will require proof of vaccination under their COVID-19 vaccination programs. According to the EEOC’s guidance, an employer may require proof that an employee has received the COVID-19 vaccination. However, to avoid implicating the ADA, employers should warn employees not to provide medical information as part of that proof. Employers should also be careful when asking follow-up questions about why, for example, an employee did not receive a vaccination, as those subsequent inquiries trigger the ADA and must be “job-related and consistent with business necessity.”
III. Administering a COVID-19 Vaccine
Employers that administer a COVID-19 vaccine directly to their employees, or enter into a contract with a third-party to have the third-party administer the vaccine, should read the EEOC’s guidance regarding pre-screening questions.
In making decisions about a vaccine program, employers should also be aware of any state laws that may apply to them. Some states, for example, require vaccinations for health care employees, while other states bar vaccination mandates for employees altogether.