Here, the Pfizer-BioNTech and Moderna vaccine EUAs require that recipients be advised of the option to accept or refuse the vaccine. However, the EUAs do not include a condition that recipients be advised of any potential consequences (if they exist) of declining the vaccine, which is more limited than what FDA could have authorized under the Statute. See 21 U.S.C. §360bbb-3(e)(1)(A)(ii)(III). Consequently, a mandatory vaccination policy that does not allow an employee to refuse the vaccine without suffering any consequences might be interpreted as improperly adding an unauthorized “condition” that could bar accessing protection under the PREP Act. Future regulatory guidance and litigation on this issue may provide insight until the vaccines are approved by FDA outside the EUA context.

Employers should expect (and prepare for) some degree of employee opposition to vaccine policies, whether or not mandatory. Here, employers have the benefit of existing (and familiar) legal frameworks such as the ADA or Title VII—as recently interpreted by the EEOC in its Dec. 16, 2020 guidance—to address potential requests for medical or religious accommodations (supported by appropriate documentation). Under those frameworks, employers will need to determine whether any potential accommodation either (1) would not sufficiently reduce or eliminate the “direct threat” posed by the pandemic or (2) would impose an undue hardship on the employer.

But even with a requirement to provide employees accommodations under a mandatory policy, the exceptions need not swallow the rule. Current vaccines are only medically-discouraged for individuals with severe allergies to the vaccine’s ingredients (the Pfizer-BioNTech and Moderna vaccines each have seven ingredients) or to the vaccines themselves. And nearly all religions permit vaccination, with the exception of the Dutch Reformed congregations and certain Christian denominations that emphasize faith healing to the complete exclusion of modern medicine.

Even when a medical or religious accommodation is granted, EEOC guidance advises that employers may exclude employees from the workplace as a medical or religious accommodation. Just as COVID-19’s direct threat to workers’ health justified employers’ medical examinations of employees—including more in-depth health-related questions, medical screening before allowing employees to report to work and other similar conduct—the EEOC guidance suggests that the direct threat may justify a mandatory vaccination policy (when one can be implemented consistent with FDA guidance) with exclusion from the workplace for non-compliant workers.

Communicating Policy Effectively

Mitigating legal risk also involves an effective communication strategy—in addition to a legally-sound policy—to build and maintain employee trust. Thus, a successful policy should articulate a specific goal (e.g., full vaccination of customer-facing employees by May) and should tailor its message to differing audiences by appealing to appropriate considerations (e.g., protecting family or community members), working around pre-existing barriers (e.g., misinformation about and mistrust of vaccines) and delivery through different media by trusted communicators (e.g., FAQs and small group meetings). Employers can build further trust by explaining and emphasizing the benefits of the vaccination—in addition to any consequences from non-compliance—by focusing on the trusted scientists behind the vaccine development and by inviting employees to participate in active dialogue, with employers open to answering questions without judgment of concern or skepticism.

Practical Considerations

While employers await further guidance on COVID-19 vaccination from applicable state and federal authorities, some practical issues exist for consideration now regarding an approach to vaccination, including:

  • While vaccination policies present challenges related to medical and religious accommodations, the absence of a policy is problematic. Without a vaccination program, employers may face claims under OSHA, or tort or workers’ compensation claims for failing to meet the obligation to provide a safe and healthy work environment.
  • Employers should actively encourage and consider incentivizing workers to get vaccinated. Measures to promote employee vaccination could include: (1) outreach to company group health insurers to inquire whether the vaccine is covered by the group policy, (2) stipends or reimbursements for vaccination, (3) guidance on obtaining vaccines (when more widely available), (4) allowing employees to use PTO and other applicable leave to get vaccinated or manage the side effects of vaccination, (5) sharing educational materials and providing a forum for answering employee questions, (6) demonstrations of personal commitment by company executives (e.g., testimonials concerning vaccination and express appreciation to employees for getting vaccinated).
  • Requiring employees to get vaccinated at independent third-party providers, such as physicians’ offices or pharmacies, limits risk under the ADA and Title VII but may implicate wage or sick leave laws.
  • Create a thoughtful vaccination policy (incorporated into existing reopening plans) and enforce this policy as consistently and uniformly as possible. Work within existing frameworks to consider religious and medical accommodations on a case-by-case basis.
  • Communicate company policy to employees effectively, bearing in mind employees’ differing views and perspectives and using risk-communication strategies to build consensus and mutual trust.
  • Stay mindful of state and local laws, regulations and orders concerning vaccinations and reopening plans. Employers with locations across multiple jurisdictions should tailor policies to account for variations among state and local authorities.
  • For employers in a unionized setting, consider whether a vaccination policy fits within applicable collective bargaining agreements or triggers bargaining obligations.

In the current vacuum of clear and controlling federal, state and local guidance and with many questions unanswered regarding the safety and efficacy of COVID-19 vaccines for those who receive doses, employers considering vaccine policies as part of their return-to-work plans or as an enhancement to workplace health and safety as the vaccines become increasingly available should consult with legal advisers to evaluate appropriate policies and accommodations issues.

Mitch Boyarsky and Jennifer Mallory are partners at Nelson Mullins Riley & Scarborough. Shannon R. Magari holds a Doctor of Science in Environmental Health from Harvard University with a concentration in Occupational Epidemiology and serves as Vice President of Health Sciences at Colden Corporation. Nick Ladin-Sienne, an associate, assisted with the preparation of this article.