Mandatory COVID-19 Vaccination Policies Could Carry Risks In Light of FDA Authorization Status

Writtten by Jeremy Mittman and Shanda Lowe

A year after many businesses in the United States were forced to reduce or shut down operations because of the COVID-19 pandemic, the availability of multiple vaccines is giving hope that a return to “normal” is finally on the horizon. Although most employers have not adopted a mandatory vaccination policy (and to do so now would likely be premature in light of still-limited availability), some are grappling with the tough decision of whether to require vaccinations before workers can return to their job sites—but navigating the rules and risks of vaccine mandates is not a simple task. 

Since December 2020, the U.S. Food and Drug Administration (“FDA”) has granted Emergency Use Authorizations (EUA) to three vaccines for the prevention of the coronavirus disease. This qualified authorization allows the FDA to facilitate the availability and use of vaccines before reaching the benchmarks required for FDA approval. Because of the vaccines’ EUA status, it is now somewhat unclear as to whether and what extent employers may require their employees to get vaccinated against COVID-19.

EEOC/DFEH Guidance

In December 2020, the Equal Employment Opportunity Commission (EEOC) determined that employers may require COVID-19 vaccines, subject to offering exemptions and reasonable accommodations based on religion or disability, and bar employees from the workplace if they refuse.  On March 4, 2021, the California DFEH reached a similar conclusion when it seemingly provided some clarification for California employers, stating that employers could require “FDA-approved” vaccines. However, the relief over the guidance from these agencies may be premature.

FDA Rules Raise a Question as to Whether Employers Can Mandate an EUA Vaccine

Generally, under the Federal Food, Drug and Cosmetic Act, an Emergency Use Authorization (“EUA”) product must be voluntary,[1] meaning that the FDA is required to ensure that recipients are informed that they have the option to accept or refuse the EUA product and of any consequences of refusing administration of the product. At first blush, FDA guidance seems to preclude businesses from imposing vaccine mandates. But the law also provides that the Secretary of Health and Human Services (“HHS”) can change this requirement in the event that it is not “practicable given the applicable circumstances” of the emergency justifying the EAU in question. 

To date, the FDA and Secretary have not addressed this issue in December and February guidance about the COVID vaccines. However, the “Fact Sheets for Vaccination Providers and Recipients” that Moderna, Pfizer, and Johnson and Johnson are required to provide, in accordance with the conditions of their EUAs, currently explain that vaccination provider must inform the recipients that they, or their caregiver, has the option to accept or refuse the vaccine. This suggests that, for the time being, the general rule of voluntariness likely applies unless and until the Secretary of HHS determines that the circumstances of the COVID-19 emergency justifies changing the conditions of the existing EUAs.

Of course, the Food, Drug, and Cosmetics Act imposes a duty on the FDA and drug makers and does not explicitly require private employers to give their workers the option to accept or refuse the vaccine.  However, one could imagine an employee who is terminated for refusing to take the vaccine attempting to allege, for example, a claim of wrongful termination in violation of public policy, premised on the above-mentioned FDA regulations concerning voluntariness.   Another possibility, however remote, would be an employee suing his or her employer and attempting to obtain an injunction preventing the employer from instituting a mandatory vaccination policy.  Thus, the best that can be said is that until the FDA (and/or EEOC or DFEH) weighs in on this issue, there is some degree of risk in adopting a mandatory vaccination policy.

Practical Factors to Consider In Connection with Mandatory Vaccination Policies

FDA considerations aside, a contemplated mandated vaccine policy should be balanced with overall risk to the organization, consideration of particular job functions and the importance of the vaccine to the employer’s operations.  Additionally, although public sentiment regarding the vaccines is increasing, workers are clearly divided over getting the vaccine; for example, a survey of 1,000 workers by people analytics firm Perceptyx found 53% of workers surveyed said employers should not require vaccination and 43% of all respondents said they would consider leaving their employers if they were required to be vaccinated. On the other hand, 56% said they would get vaccinated if encouraged by their employers and, 60%, would do so if their employers offered an incentive of $100 or more.   Additionally, a recent survey by Gartner, Inc., a global research and advisory firm, found only 8% of organizations surveyed plan to institute mandatory vaccine policies.

            Ultimately, it is too soon to tell how the courts will treat employees’ claims stemming from a mandatory vaccination policy. For now, few companies plan to require vaccines, and many are opting instead to consider incentive programs, access to regular COVID testing services, and continuing remote work and reduced staffing.

Employers wishing to institute a mandatory vaccination program should tread carefully in light of the above, and consult their trusted employment counsel.

[1] Section 564(e)(1)(A)(ii) of the Federal Food, Drug, and Cosmetic Act states:

With respect to the emergency use of an unapproved product, the Secretary, to the extent described in subsection (b)(1), shall … establish such conditions on an authorization under this section as the Secretary finds necessary or appropriate to protect the public health, including the following:

(ii)Appropriate conditions designed to ensure that individuals to whom the product is administered are informed—

(III) of the option to accept or refuse administration of the product, of the consequences, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks.

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