It has only been a few weeks since Pfizer and BioNTech announced that their COVID-19 vaccine had proven to be more than 95% effective at preventing the disease in Phase 3 clinical trials, and already front-line health care workers are receiving the vaccine at hospitals all over the country.
It will be many months before the vaccine will be available to the general public, but the speed with which the vaccine received emergency use authorization from the Food and Drug Administration has created understandable concerns about its safety and prompted questions about whether private employers can make the vaccine mandatory.
Back in 2009, when the H1N1 virus caused an outbreak of swine flu, the Equal Employment Opportunity Commission (EEOC) issued some guidance on mandatory vaccinations. In that guidance, the EEOC confirmed that employers can compel employees to receive the influenza vaccine unless they are entitled to an exemption as a reasonable accommodation for a disability or sincerely-held religious belief. But the flu vaccine took decades to develop and its contraindications and side effects are well known.
That certainly cannot be said about Pfizer’s vaccine or a second COVID-19 vaccine, developed by Moderna, which is likely to receive emergency use authorization from the FDA in the coming weeks. Which begs the question—can employers force their employees to receive a COVID-19 vaccine? Even before it has been formally licensed by the FDA? The answers to those questions were uncertain until yesterday when the EEOC issued fresh guidance for anxious employers. We’ve summarized the highlights below.
Employers May Require Employees to Receive a COVID-19 Vaccine
Under the Americans with Disabilities Act (ADA), employers are not allowed to make inquiries of employees, or to require employees to undergo medical examinations, for the purpose of determining whether they are disabled or identifying the nature or severity of a disability unless the exam or inquiry is “job-related and consistent with business necessity.”
For an exam or inquiry to be job-related and consistent with business necessity, the employer must have a reasonable belief, based on objective evidence, that an employee is not qualified for the job because he cannot perform the essential job functions or because he will pose a direct threat to the health or safety of himself or others.
The EEOC’s new guidance confirms that a vaccination is not a “medical examination” within the scope of the ADA because “the employer is not seeking information about an individual’s impairments or current health status.”
Similarly, requesting or even requiring that employees provide proof that they have received a vaccination is not a disability-related inquiry under the ADA because complying with the request or requirement is not likely to elicit information about a disability. Accordingly, employers are allowed to require their employees to obtain and provide proof that they have received the COVID-19 vaccination without running afoul of the ADA. There are, however, some important caveats to this.
First, if proof of vaccination is requested but not required, employers cannot ask employees who choose not to get vaccinated why they chose not to get vaccinated or any other questions that may elicit disability-related information.
Second, if proof of vaccination is required, employers are advised to warn employees not to provide any medical information with their proof of vaccination so as to avoid implicating the requirements of the ADA.
Third, and most importantly, there is a big difference between requiring proof of vaccination and requiring an employee to receive a vaccination that will be administered by the employer or a contractor of the employer. This is because the Centers for Disease Control and Prevention (CDC) recommend that health care providers ask certain “pre-screening” questions before administering vaccinations in order to make sure that there is no medical reason to withhold the vaccine, and those pre-screening questions are disability-related inquiries within the meaning of the ADA because they are likely to elicit information about disabling conditions.
According to the EEOC’s new guidance, therefore, an employer may not require employees to receive a vaccination that will be administered by the employer or its contractor unless the employer can demonstrate that it has a reasonable belief that an employee who fails to answer the pre-screening questions (and thus fails to receive the vaccine) will pose a direct threat to the health or safety of himself or others. More on that below.
What about Disabled Employees Who Cannot Obtain the Vaccination?
As noted above, employers are allowed to require their employees to obtain vaccinations under the EEOC’s new guidance. But what if a disabled person cannot get the required vaccination because of a disabling condition? Perhaps the vaccine might exacerbate the symptoms of an existing illness, reduce the efficacy of the employee’s medication or treatment, or cause side effects that the employee could not tolerate. What then? According to the EEOC, the employer must show that hiring or retaining an unvaccinated employee would meet what is called the “direct threat” standard.
Under long-standing ADA regulations, an employer can only show a direct threat if it can prove 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.”
To do so, employers are supposed to conduct an individualized assessment based on four factors: (1) the duration of the risk; (2) the nature and severity of the potential harm; (3) the likelihood that the potential harm will occur; and (4) the imminence of the potential harm. In its new guidance, however, the DOL takes the position that a disabled employee who is unable to receive a COVID-19 vaccine does not pose a direct threat unless the employer determines that the employee “will expose others to the virus at the workplace.”
That seems like an incredibly tall order for any employer—how can an employer ever be sure that an unvaccinated employee will expose others to the coronavirus? Putting that wrinkle aside, however, the EEOC also reaffirmed its 2009 opinion that employers may not terminate a disabled employee who is unable to be vaccinated without first considering whether it can make reasonable accommodations to eliminate or sufficiently reduce the risk that the employee will spread the virus.
This means the employer must engage in an interactive dialogue with the employee and consider whether the employee can work remotely, whether some other accommodations could be made to enable the employee to safely work on-site, and, if not, whether the employee is eligible for leave under the Families First Coronavirus Relief Act (FFCRA) (which is set to expire as of January 1, 2021), the Family and Medical Leave Act, or any other leave law or the employer’s own policies.
As part of this process, the EEOC recommends that employers consider the number of other employees who have already received the vaccination, the amount of contact the employee may or must have with others in the workplace, the CDC’s recommendations, and applicable safety standards and guidelines put out by the Occupational Safety and Health Administration (OSHA).
What about Employees Who Object on Religious Grounds?
The EEOC also reaffirmed its 2009 guidance with respect to requests for exemptions based on religious beliefs. Specifically, it confirmed that employers “must provide a reasonable accommodation for the religious belief, practice, or observance” unless doing so would have “more than a de minimis cost or burden on the employer.”
The EEOC did not offer any opinion as to when it would be sufficiently costly or burdensome for an employer to refuse to exempt an employee from a vaccination requirement for religious reasons. Presumably, a conclusion that the employee might expose others in the workplace would satisfy this standard, which is much lower than the “direct threat” standard, but employers should still go through the same type of interactive process with employees who refuse to be vaccinated for religious reasons as they would with an employee who cannot be vaccinated because of a disability, and consider whether telework or other accommodations are available to reduce or eliminate the perceived risk in the workplace.
For purposes of this dialogue, the EEOC suggests that employers 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 they have an objective basis to question the religious nature or sincerity of the employee’s professed belief.
Do Mandatory Vaccines Implicate Employee Rights under GINA?
The Genetic Information Nondiscrimination Act (GINA) prohibits employers from discriminating against employees based on their genetic information. The EEOC’s guidance addressed whether an employer who administers or requires proof of a COVID-19 vaccine implicates employee rights GINA.
The EEOC answered that question in the negative, stating that neither administering a COVID-19 vaccine nor requiring proof of a COVID-19 vaccine implicates GINA because “it does not involve the use of genetic information to make employment decisions, or the acquisition or disclosure of ‘genetic information’ as defined by the statute.”
The CDC-recommended “pre-screening” questions, however, may violate GINA if they seek genetic information, such as information about the employee’s genetic tests and family member medical histories. The EEOC noted that it is “not yet clear what screening checklists for contra-indications will be provided with COVID-19 vaccinations,” but said if the pre-screening questions do include questions about genetic information, then employers who want to ensure that employees have been vaccinated “may want to request proof of vaccination instead of administering the vaccine themselves” and should “warn the employee not to provide genetic information as part of the proof.”
Does it Matter that the Vaccine Has Not Been Formally Licensed by the FDA?
You might be wondering whether the EEOC considered the fact that the COVID-19 vaccine has so far received only emergency use authorization from the FDA, not formal licensure. The answer to that question is unknown, but if the EEOC did consider that fact, it appears not to have made a difference. Indeed, nothing in the guidance suggests that it was a factor in the EEOC’s position on these issues. In fact, the EEOC only mentioned the issue once—in an extraneous paragraph about where employers can learn more about emergency use authorization.
Specifically, the EEOC noted that COVID-19 vaccines may only be available via emergency use authorization for the foreseeable future and made a point to emphasize the FDA’s obligation to provide certain types of information to recipients of the vaccine, including the known and potential benefits and risks and the extent to which such benefits and risks are unknown.
It is somewhat odd that the EEOC called attention to the FDA’s duty to inform patients, particularly given that the lack of formal FDA licensure for the COVID-19 vaccine does not appear to have been a factor in its decision to bless the vaccine mandates by employers. Whatever the EEOC’s motivation, however, employers who decide to administer vaccines themselves or through a contractor should make sure that recipients receive the FDA’s patient fact sheet. (The fact sheet for the Pfizer-BioNTech vaccine is available here.)
If your business is considering requiring the COVID-19 vaccine, please feel free to reach out to any of our attorneys about your legal obligations when doing so.