Person receiving vaccine.

Complex Regulations Push Employers Toward Voluntary Vaccination Programs, Not Mandates

By Lauren Hammer Breslow, JD, MPH

As COVID-19 vaccines become increasingly available, employers have been thrust into the spotlight on the public health question of whether or not to mandate vaccination for employees.

Despite strong evidence that mandatory vaccines best serve public health, a rubric of laws making mandatory programs complicated to deploy is leading many employers to favor vaccine encouragement policies.

Emergency Use Statute Articulates Right to Refuse Vaccination

Somewhat buried in the background of discussion about employer vaccination policy is the level of approval currently approved vaccines have secured from the Food and Drug Administration (FDA).

So far, the COVID-19 vaccines in use in the United States have been given only Emergency Use Authorization (EUA), and not official FDA licensure. Whereas official licensure would likely provide employers with broad capacity to mandate vaccines (e.g., OSHA’s approval of employer mandated flu vaccines; Authorization for Medical Products for Use in Emergencies, 21 U.S. Code § 360bbb–3), EUAs trigger special protections for recipients.

Under the EUA Statute, the Secretary of Health and Human Services must ensure that individuals who take the “unapproved product” be informed of three facts.  First, the individual must be informed that the product has only emergency use authorization, not normal FDA licensure.  Second, the individual must be informed of the vaccine’s risks and benefits.  Third, and this is where we face confusion for a mandatory vaccination program, the individual must be informed 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.”  21 U.S. Code § 360bbb–3(e)(1)(A)(ii) (emphasis added).

Dr. Arthur Caplan, Director of NYU Langone’s Division of Medical Ethics, and Peter Meyers, Law Professor at George Washington University Law School, argue that the Statute’s “option to accept or refuse” negates the possibility of mandatory programs.

Further fine print supports the notion that vaccination must remain optional.

For products authorized with EUAs, the FDA issues fact sheets for providers and recipients.  Both the EUA-approved COVID-19 vaccines from Moderna and Pfizer-BioNTech include FDA facts sheets for providers and recipients that emphasize user choice.  The fact sheets for providers state that the recipient “has the option” to refuse the vaccine.  Similarly, the fact sheets for recipients and their caregivers include sections stating that it is the recipient’s “choice” to take the vaccine and refusal to accept it would not alter the standard of care for that person.

The Statute, combined with the FDA fact sheets, indicate that mandatory programs could be in jeopardy of legal attack.

EEOC Authorizes Employers to Mandate Vaccines

Despite the EUA language and FDA fact sheets, the U.S. Equal Employment Opportunity Commission (EEOC) issued guidance on December 16, 2020, allowing private employers to mandate vaccines.

The EEOC acknowledges that the EUA requires fact sheets that demarcate a user’s choice, but it does not suggest that this would interfere with a mandatory program.  See EEOC Guidance K.4.  The EEOC fails to provide guidance on how it navigates or overcomes this tension.

Read most narrowly and in favor of EUA optionality, the EEOC’s guidance could apply only to vaccines that ultimately receive full licensure.  This would mean, though, that the entire rest of the EEOC’s December 2020 guidance – so keenly awaited by employers – would not yet be applicable.  But the EEOC did not suggest this limitation.  The more likely scenario is that the EEOC intends for its guidance to apply to currently available vaccines authorized under the EUA.

The EEOC may justify employer-mandated programs based on the EUA’s language that a person may “accept or refuse” a product as long as they are informed of the “consequences” for failure to take that product. Professor Dorit Reiss, Law Professor at UC Hastings College of the Law, has emphasized that the term “consequences” frees employers to mandate vaccines. The EUA does not define the term “consequences”; presumably they could range in their nature and impact, up to and including the reduction of employment responsibilities or termination.

The EEOC would have done a greater service to employers if it had clarified the statutory basis or rationale for allowing mandatory programs.  Nonetheless, many employment law specialists are satisfied that the EEOC provides sufficient federal underpinning to permit mandated vaccines.

Requirements for Employer-Mandated Vaccine Programs

The EEOC requires employer-mandated vaccine programs to adhere to all necessary employee protections found in the American with Disabilities Act, the Rehabilitation Act, the Genetic Information Nondiscrimination Act, or Title VII of the Civil Rights Act, including the Pregnancy Discrimination Act.  See generally EEOC Guidance Section K.  Application of these laws depends on how the employer designs its program.

There are two ways that an employer can require a vaccine: it can administer the vaccine itself or it can ask employees to seek a vaccine from an unaffiliated third party.

Reasonable Accommodation

Under either scenario, the employer must reasonably accommodate, absent undue hardship, employees who (1) cannot receive the vaccine safely due to a disability or (2) decline a vaccine due to a sincerely held religious belief, per the Americans with Disabilities Act and Title VII of the Civil Rights Act, respectively.

The EEOC further warns that even if the non-vaccinated, protected individual cannot be accommodated, an employer does not have an automatic pathway to terminate that employee.  Other laws may protect that individual, including the Families First Coronavirus Response Act, Occupational Safety and Health Administration rules, and state and local laws.

Employers should also consider that any mandatory programs may implicate worker’s compensation for individuals who suffer adverse effects from vaccination.  (An interesting question for the future is if vaccines are proved to prevent transmission, will employees seek worker’s compensation for the opposite harm:  contraction of COVID-19 from an unvaccinated employee.  Listen to Professor Reiss’s WNYC Interview for further discussion.)

Employers who administer the vaccine in-house face several additional compliance mandates.

While the vaccine itself is not considered a medical exam, the pre-screening questions will be, and, therefore, “may implicate the ADA’s provision on disability-related inquiries.” See EECOC Guidance, Section K.1.  Per the ADA, then, the employer will need to show that the questions are “job-related and consistent with business.”

Additionally, all medical information that the employer procures during the vaccine process will need to be confidentially maintained.  The pre-screening questions may also trigger the Genetic Information Nondiscrimination Act’s prohibition against employers seeking genetic data.  See EEOC Guidance, Section K-9.

Given these complexities, in-house mandated employer programs may be worthwhile for large employers that can manage the administrative process correctly and those employers that have clear and pressing needs for staff to be vaccinated.  Hospitals, nursing homes, and meat-packing plants, for example, might avail themselves of this approach.

Most employers seeking to mandate COVID-19 vaccinations may ultimately find it easier overall to require proof of vaccination from a third-party.  In this case, the employer comes into far less contact with medical information.  The employer needs to be aware, however, that when asking why an employee has refused vaccination, it may elicit medical or disability information that is subject to confidentiality and protection.

Voluntary Vaccination Programs Are Easier to Implement

Given the complexity of instituting mandatory programs, many employers will opt for voluntary programs.  Again, the least onerous option for employers is to encourage employees to obtain their vaccinations from a third party. But the EEOC explains that employers can provide in-house voluntary vaccination programs without triggering many of the ADA provisions. Given the voluntary nature of the program, the employer can ask pre-screening questions without having to satisfy that those questions are job-related and consistent with business necessity.  EEOC Guidance, K-2. However, if an employee declines to answer the pre-screening questions and, by result, declines the vaccine, the employer should not ask any questions about this decision or retaliate against the employee.

Current Approaches

The EEOC’s approach has led many employment law experts to conclude that voluntary programs are the wisest approach, at least from an employment law standpoint.

Not surprisingly, many of the first publicly-announced and widely-known corporate COVID-19 policies are voluntary.  For example, Unilever, McDonald’s, Target, Chobani, and Dollar General have announced policies of vaccine encouragement.

Employers who opt for policies of vaccine encouragement are deploying a range of tactics to achieve widespread vaccination of their employees. In my work advising a nonprofit on its vaccine policy, I conducted an anonymous survey with a small group of companies that indicated their use of the following approaches:

  • Providing educational information to employees about the benefits and risks of the available COVID-19 vaccines
  • Offering additional (over and above normal) paid time off to obtain the vaccine(s)
  • Offering additional (over and above normal) paid sick days off for those who fall ill after vaccination
  • Providing a cash/bonus incentive
  • Discounting company health insurance
  • Requiring continued testing of employees who do not show proof of vaccination, while discontinuing for vaccinated employees
  • Requiring non-vaccinated personnel to work remotely or stay socially distanced from other employees, and continued use of PPE while at the workplace

Employer policies are likely to evolve in light of further federal guidance and increased vaccine supply.

At present, though, debates over mandatory vaccination programs highlight an uneasy juncture. The public health objective of mandatory vaccination programs has, ironically, taken a back seat to employment law concerns. At least some frontline employees are not keen to accept the new vaccines, with many nursing home staff members declining vaccines.  And many employers may not feel ethically or legally comfortable deploying the “consequence” of failure to comply with a mandatory program:  termination of employment.

Employee opinions may change over time, as longer-term safety data are revealed and better education campaigns are launched, with assurances to racial minorities and historically marginalized communities.

Lauren Breslow

Lawyer, with focus on public health and the sciences. Nonprofit Executive. Philanthropic Advisor. Graduate of Harvard Law School, T.H. Chan Harvard School of Public Health, and Harvard College.

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