Employers Should Think Carefully Before Mandating COVID-19 Vaccines
By Christine Samsel Attorney, Brownstein Hyatt Farber Schreck | March 28, 2021
This article was co-authored by Peter Goodloe, Consulting Attorney, Brownstein Hyatt Farber Schreck
Contending with the polarization of vaccine skepticism and the country's desire to return to "normal" in the wake of a global pandemic, many are wondering: Can employers require employees to get vaccinated against COVID-19? The answer, at least in the near future, is likely "no."
Ordinary Mandatory Vaccine Considerations
Ordinarily, employers can require vaccinations (such as influenza vaccines) subject to business considerations, taking into account accommodations that may need to be granted with respect to the Americans with Disabilities Act (ADA), certain medical conditions (such as pregnancy or strong allergies to vaccine components) and religious accommodations.
Requests for religious accommodation may be based on objections to the concept of vaccines generally, or a particular vaccine (e.g., gene-based vaccines). These are the standard considerations in analyzing whether vaccines like those for influenza may be mandated. Generally, the vaccines involved have been approved by the Food and Drug Administration (FDA) through its formal process under which, after consideration of evidence from human studies, the agency determines that vaccines are safe and effective.
For example, the FDA has formally approved many influenza vaccines, which in turn have been mandated by some employers (e.g., health care providers) in accordance with EEOC guidance.
EEOC Guidance regarding COVID-19 Vaccines
In December 2020, the EEOC issued guidance ("Guidance") in which it implied that employers can mandate COVID-19 vaccines. However, unlike influenza and similar vaccines, COVID-19 vaccines are currently being made available not through the FDA's formal approval process, but rather through a more streamlined "emergency use authorization" (EUA) process.
In its Guidance, the EEOC carefully sidestepped the issue of whether employers may mandate vaccines authorized under an EUA, versus those approved pursuant to the FDA's formal approval process. The statutory provisions governing the FDA's emergency process, however, include language that raises concern about the potential legality of employers mandating vaccines authorized under an EUA. Specifically, the language appears to provide individuals with a federal statutory right to refuse administration of vaccines authorized under an EUA.
The FDA's EUA Process
In the aftermath of the Sept. 11, 2001 terrorist attacks, Congress decided that, in emergency situations, the FDA should be permitted to authorize the market entry of drugs (including vaccines) that have not been approved through the FDA's full formal process. Specifically, Congress created Section 564 of the Federal Food, Drug, and Cosmetic Act (FDCA), which gives the FDA authority to allow the marketing of unapproved drugs if the Department of Health and Human Services (HHS), through the secretary of HHS, has issued a declaration that there is a public health emergency.
The premise presumably is that, in an emergency situation, the FDA will allow a greater degree of risk, in part by not requiring the full range of clinical studies that would be necessary for formal approval. An EUA, therefore, is very different than a formal approval by the FDA.
Section 564 imposes conditions upon the emergency use of FDA-regulated products, including vaccines. Importantly, these have always included the requirement that recipients be informed, to the extent practicable, that they have "the option to accept or refuse administration of the [EUA] product [and] of the consequences, if any, of refusing administration of the product." This is a logical requirement, given the increased level of potential risk involved in taking an EUA drug as compared to a drug approved through the formal FDA process.
There is only one exception to these requirements, when the U.S. president determines, in writing, that complying with such requirements with respect to the armed forces is not in the interests of national security. The clear implication is that in the absence of such a written waiver by the president, each member of the armed forces has the right of refusal and must be informed of such right. Given that Congress has not enacted any other exceptions, it stands to reason that the general rule is that each individual in the United States has the same rights.
COVID-19 Vaccines Under EUAs
The FDA letters granting the EUAs for the first two authorized COVID-19 vaccines state, among other things, that the manufacturers are required to give a "fact sheet" to health care providers who administer the vaccines that instruct them to inform vaccine recipients of the right to refuse the vaccine. Notably, upon termination of the current HHS declaration of a public health emergency under Section 564, the further marketing and administration of an EUA vaccine will become illegal (unless and until the vaccine is formally approved by FDA).
Employer Vaccine Mandates and EUAs
Given these facts, can an employer mandate employees to get vaccinated under threat of termination or other employment action? The law regarding EUAs is unclear and as yet untested. However, such a scenario could give rise to a claim for wrongful termination in violation of public policy, given the clear right of refusal under Section 564. The FDCA does not address this issue, but it would be difficult to argue that the required disclosures of the "consequences" of refusing administration of the vaccine contemplate things like termination of employment (as opposed to health-related consequences).
Moreover, once the current HHS declaration of a public emergency under Section 564 is terminated, an employer mandating that employees receive an EUA vaccine will do so knowing (or presumed to know) that such a mandate is unlawful.
Preemption and State Laws
Many states are currently considering legislation concerning vaccinations, with some seeking to prohibit mandatory vaccines and others contemplating imposing vaccine mandates under certain circumstances. It remains to be seen whether laws mandating vaccines will pass, and if so, whether they would survive a legal challenge asserting that the right to refuse the vaccine in the FDCA preempts conflicting state law.
Other Vaccine Considerations
Assuming the EUA issue is resolved, mandating vaccines raises other potential issues, several of which were addressed by the EEOC Guidance. While vaccines will not be considered a "medical examination" for purposes of the ADA, where the employer mandates the vaccine and either administers it directly or through a contracted third party, prescreening questions may implicate the ADA. In that case, the employer would have to show that the screening inquiries were "job-related and consistent with business necessity."
To meet this standard, the employer would need to have a reasonable belief, based on objective evidence, that an employee who does not answer the questions, and as a result does not receive the vaccination, will pose a direct threat to the health or safety of the employee or others. Prescreening questions also may implicate the Genetic Information Nondiscrimination Act (GINA), depending on the nature of the questions. However, allowing employees to obtain the vaccine through their chosen health care provider does not implicate the ADA, nor does merely requiring employees to show proof of vaccination.
Where the employer does mandate vaccination, whether the employer can exclude from the workplace an employee who cannot or will not obtain a vaccine requires an individualized determination of whether a direct threat exists, and an assessment through the interactive process of what accommodations, if any, can be provided to reduce the risk to an acceptable level.
The EEOC Guidance indicates that the prevalence in the workplace of employees who already have received COVID-19 vaccinations, and the amount of contact with others whose vaccination status could be unknown (e.g., customers or the general public), may impact the analysis. Employers are advised to look to guidance from the Centers for Disease Control and Prevention (CDC) and the Occupational Safety and Health Administration (OSHA).
If an employee cannot safely be allowed in the workplace even with reasonable accommodations, the employer must look to other potential accommodations, such as remote work or providing leave, prior to terminating employment. The EEOC Guidance also reminds employers about maintaining confidentiality of medical information obtained, as well as prohibitions on retaliation for seeking an accommodation.
Even if employers can mandate the vaccine, the real question is whether they should. That question is currently premature for many employers, given that the vaccine is not expected to be widely available until late July. The legal issues surrounding mandatory COVID-19 vaccines are currently unsettled, but are likely to be fleshed out in the coming months.
Moreover, mandating the vaccine raises a host of issues with which employers must wrestle. For example, there will be an impact on employee morale either way (in other words, if the employer does mandate vaccines, or elects not to require them). Studies show that there is still a large portion of the population that is unwilling or reluctant to get the vaccine. Is the employer prepared to terminate employees who decline to get the vaccine, even if it is a large percentage of the workforce?
Other questions abound: Will time spent getting vaccinated be compensable work time? Will time that an employee may be unable to work due to side effects be covered by federal, state or local COVID-19-related paid sick leave? Will the employer be responsible for adverse reactions and if so, will workers' compensation cover that? Will employees or employers have a choice as to which vaccine they get (e.g., whether it is one that involves messenger RNA (mRNA) technology or otherwise, the most effective vaccine or the one with fewest side effects)? How will employers logistically handle the accommodation request process for those who cannot get the vaccine for protected reasons?
At this juncture, given the uncertainty surrounding the legality of mandating EUA-status vaccines, plus the other issues raised by mandatory vaccines, the safer course of action for employers is to encourage employees to get the vaccine rather than mandating it, providing facts about the vaccine and legally permitted incentives to do so, and accommodating those who are unable to get the vaccine for religious, medical or disability-related reasons. The EEOC recommends this course of action, and the CDC has created toolkits to assist employers in encouraging vaccinations.
Employers should continue to monitor this evolving situation, consider these issues, as well as the additional considerations that doubtless will arise, and work with legal counsel in developing their vaccine strategy.
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