Article
Amicus Curiae Blog (June 21, 2021)

Can Employers Mandate the COVID Vaccine?: Assessing the Implications of Emergency Use Authorization

By Isaac Mamaysky*

As employers acclimate to our “new normal,” the COVID vaccine’s emergency status has led to extensive speculation about whether employers can mandate that their employees be vaccinated.1 While long-established immunizations have full approvals from the FDA, the COVID vaccine is currently approved only through an Emergency Use Authorization (EUA).2 This emergency process allows the use of unapproved medical products to prevent serious or life-threatening diseases when there are no adequate alternatives.3

Our immediate interest lies in the EUA’s implications for employer vaccine mandates. While the first judicial opinion on this topic is forthcoming, speculation abounds.4 “[I]n some corners of the internet,” writes Sarah Kopit for Bloomberg, “the EUA is having a moment. Once limited to discussions by drug policy wonks and health care officials, the intricacies of the EUA are now hotly debated by armchair lawyers in social media forums as the crux of claims that employers can’t make workers get the shot.”5

Are the “armchair lawyers” right, or can employers require their employees to take the COVID vaccine? To address this question, let us begin by taking a step back from the COVID context to briefly consider how employer mandates play out for fully licensed vaccinations—those which are not administered by EUA.

If an employer tells an employee that they must receive certain vaccines, the employee typically has two avenues to refuse the mandate: first, the employee can refuse based on a medical exemption under the Americans with Disabilities Act (ADA); and second, the employee can refuse based on a religious exemption under Title VII of the Civil Rights Act (Title VII).6

In December of 2020, the Equal Employment Opportunity Commission (EEOC), which enforces the federal anti-discrimination laws, issued specific guidance about how these potential exemptions apply to the COVID vaccine.7 The EEOC explains that, if an unvaccinated employee poses “a direct threat due to 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,” then the employer may not be obligated to accept the employee’s medical exemption.8

  The employer must first assess whether the unvaccinated employee indeed poses a direct threat to others.9 If the answer is yes, then the employer must determine if a reasonable accommodation could mitigate that threat without posing an undue hardship on the employer.10 When providing a reasonable accommodation is not possible, the EEOC states that it is permissible to exclude the employee from the workplace:

A conclusion that there is a direct threat would include a determination that an unvaccinated individual will expose others to the virus at the worksite. If an employer determines that an individual who cannot be vaccinated due to disability poses a direct threat at the worksite, the employer cannot exclude the employee from the workplace—or take any other action—unless there is no way to provide a reasonable accommodation (absent undue hardship) that would eliminate or reduce this risk so the unvaccinated employee does not pose a direct threat.11

While the outcome for employees who claim a religious exemption is similar, the analysis is not identical because Title VII does not include the “direct threat” language of the ADA.12 The EEOC explains that, if an employer is on notice that an employee’s sincerely held religious belief prevents them from being vaccinated, then the employer must provide a reasonable accommodation unless it would pose an undue hardship.13 In this context, “Courts have defined ‘undue hardship’ . . . as having more than a de minimis cost or burden on the employer.”14 This is an “easier standard for employers to meet than the ADA’s undue hardship standard.”15

The EEOC concludes as follows: “If an employee cannot get vaccinated for COVID-19 because of a disability or sincerely held religious belief . . . and there is no reasonable accommodation possible, then it would be lawful for the employer to exclude the employee from the workplace.”16 The EEOC intentionally uses the word “exclude,” which does not mean that the employer “may automatically terminate the worker.”17 An excluded employee still might be entitled to remote work as a reasonable accommodation, paid leave, or unpaid leave, depending on how relevant state and federal laws apply to the particular circumstances.18

Employers should also be aware of potential state legislation prohibiting vaccine mandates.19 However, where state law is silent, no leave entitlement is available, and no reasonable accommodation is possible, can the employee be separated for failing to comply with the employer’s vaccine mandate?

To answer that question, let us turn to the COVID vaccine’s Emergency Use Authorization. When a vaccine is authorized for emergency use, the Food, Drug, and Cosmetics Act requires that vaccine recipients are informed “of the option to accept or refuse administration of the product” and “of the consequences, if any, of refusing administration of the product.”20 Based on this language, some argue that employers cannot mandate the COVID vaccine because doing so takes away employee choice. “The argument looks good for about a half-second,” says law professor Nicholas Bagley, but “as soon as you start digging, it starts to look much, much worse.”21

Every individual who receives a COVID vaccine is first given a factsheet which states that they may choose to refuse the shot.22 Moreover, when a recipient’s employer has informed them of the employment consequences of refusing the vaccine, then the requirements of the law have been met: The employee has been given “the option to accept or refuse administration of the product” and has been “informed of the . . . consequences” of doing so.23  

Simply put, nothing about an employer’s mandate takes away an employee’s option to refuse the vaccine.24 Exercising that option may have certain employment consequences, but it remains the employee’s choice. A Society for Human Resource Management (SHRM) analysis makes this same point:

[M]any employment relationships in the private sector are at-will, which means either the employer or the worker can terminate the employment for any lawful reason. An employer that mandates a vaccine may argue the consequence of refusing a vaccine is being fired.

Consensus in the legal community has been that, at least in the private sector, employers may require at-will employees to be vaccinated, subject to accommodations that may be required for medical or religious reasons.25

Professor Dorit Reiss makes a similar argument in an article for Harvard Law School’s Petrie-Flom Center for Health Law: “The general legal reality is that employment in the United States is at-will, and employers can fire employees for almost any reason, with few exceptions from anti-discrimination laws. Employers can certainly fire employees for violating a health and safety requirement, or for outright refusing to follow it.”26 Reiss observes that in other contexts, such as the flu vaccine for health care workers, employers have the latitude to mandate vaccines.27 The COVID vaccine should be no different.28

Moreover, the language of the Food, Drug, and Cosmetics Act is not directed to private employers. “The EUA act addresses the Secretary of [the Department of Health and Human Services], providers of the [vaccine], and its recipients,” Reiss explains. “It says nothing about employers or states. Arguing that the act can overturn a legal reality [of at-will employment] by implication alone, that employers are now prohibited from doing something they have been doing for decades, is a tall order.”29

While we wait for the first case law to come down on this topic, we may speculate that courts will adopt a similar line of reasoning. In any event, the entire question will become moot as soon as the FDA grants a full license to the first COVID vaccine, a process which is already underway for Pfizer.30

So where does this leave us? What should employers do? As I frequently explain to clients, sometimes the legal answer should not dictate the business outcome. Employers certainly have strong legal arguments for mandating the vaccine. However, the strength of their position does not mean that vaccine mandates are immune from legal challenges.31

Employees can challenge whether an unvaccinated individual in the workplace poses a direct threat to others, whether a reasonable accommodation is possible as an alternative to the vaccine, and whether the EUA allows for a vaccine mandate altogether. “As with any employment policy,” explains the EEOC, “employers that have a vaccine requirement may need to respond to allegations that the requirement has a disparate impact on—or disproportionately excludes—employees based on their race, color, religion, sex, or national origin under Title VII (or age under the Age Discrimination in Employment Act (40+).”32

The consequences of vaccine mandates also go beyond mere legal challenges. As one practitioner observes: “What if 10 percent of your workforce refuses? Are you prepared to lay off that 10 percent? Or what if it’s someone high-level or in a key role, would you be prepared to impose consequences?”33

Some employers are choosing to take those risks, consequences be damned.34 Many others opt for a “carrot over stick” approach, which is the typical recommendation I make to clients.35 Those employers are strongly encouraging vaccines, offering paid time off for employees to receive the vaccine, giving bonuses to employees when they provide proof they took the vaccine, and launching education programs about the benefits of the vaccine—stopping just short of actually mandating the vaccine.36

President Biden recently announced his goal to have 70% of the population receive the first dose of the vaccine by July 4th, and experts widely agree that high vaccination rates are critical to reaching the light at the end of the COVID tunnel.37 Whether employers mandate, incentivize, or strongly encourage the vaccine, they are in a unique position to influence people who have been hesitant to take the COVID vaccine—and thereby bring us one step closer to a return to normalcy.38

Footnotes

* Isaac Mamaysky is a Partner in the national Employment Law and Human Resources practice of Potomac Law Group PLLC. He is also an adjunct professor of law at Albany Law School, where he teaches at the intersection of employment law, management, and human resources. ↩︎

  1. Sarah Kopit, Refusing the Covid Vaccine is Legal but Could Still Cost You Your Job, Bloomberg, May 3, 2021, https://www.bloomberg.com/news/articles/2021-05-03/refusing-the-vaccine-is-legal-but-could-still-cost-you-your-job [https://perma.cc/9VTX-R72R]. ↩︎
  2. Vaccines Licensed for Use in the United States, U.S. Food and Drug Admin., https://www.fda.gov/vaccines-blood-biologics/vaccines/vaccines-licensed-use-united-states [https://perma.cc/4688-3KMX]; Disease Eradication, Colls. of Physicians of Phila., https://www.historyofvaccines.org/content/articles/disease-eradication [https://perma.cc/QEA6-ATGJ]; Emergency Use Authorization for Vaccines Explained, U.S. Food and Drug Admin., https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained [https://perma.cc/T9KM-AS6W]. ↩︎
  3. Id. ↩︎
  4. Richard Meneghello & Kevin Troutman, First Lawsuit Challenging Mandatory COVID-19 Vaccine May Shed Light on Employer Parameters, JD Supra, Mar. 8, 2021, https://www.jdsupra.com/legalnews/first-lawsuit-challenging-mandatory-7190156/ [https://perma.cc/6VS9-7JB2]. ↩︎
  5. Kopit, supra note 1. ↩︎
  6. Workplace Vaccination Program, Vaccine Mandates & Exemptions, U.S. Ctrs. for Disease Control, Mar. 25, 2021, https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/essentialworker/workplace-vaccination-program.html#anchor_1615585395585 [https://perma.cc/U4AJ-PBBM]. ↩︎
  7. What You Should Know About COVID-19 and the ADA, the Rehabilitation Act, and Other EEO Laws, EEOC, Dec. 16, 2020, https://www.eeoc.gov/wysk/what-you-should-know-about-covid-19-and-ada-rehabilitation-act-and-other-eeo-laws [https://perma.cc/GK72-S342] [hereinafter What You Should Know]. ↩︎
  8. Id. (internal citations and quotations omitted). ↩︎
  9. Id. ↑ ↩︎
  10. Id. ↑ ↩︎
  11. Id. ↑ ↩︎
  12. Title VII of the Civil Rights Act of 1964, 42 U.S.C.A. §§2000e et seq., available at https://www.eeoc.gov/statutes/title-vii-civil-rights-act-1964 [https://perma.cc/RYN8-YYA6]. ↩︎
  13. What You Should Know, supra note 7. ↩︎
  14. Id. ↩︎
  15. Id. ↩︎
  16. Id. ↩︎
  17. Id. ↩︎
  18. Id. ↩︎
  19. Lowell Perason et al., 50-state Update on Pending Legislation Pertaining to Employer-mandated Vaccinations, Husch Blackwell, Apr. 20, 2021, https://www.huschblackwell.com/newsandinsights/50-state-update-on-pending-legislation-pertaining-to-employer-mandated-vaccinations [https://perma.cc/4T6Y-9EUB] (observing that state law may prohibit employer-mandated vaccines). ↩︎
  20. Emergency Use Authorization for Vaccines Explained, U.S. Food and Drug Admin., https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained [https://perma.cc/4CCX-RDNY] (emphasis added); Food, Drug and Cosmetics Act, 21 U.S.C. 564, 360bbb-3 (e)(1)(A)(ii)(III); see also Fact Sheet for Recipients and Caregivers, Pfizer, https://www.fda.gov/media/144414/download [https://perma.cc/G6QD-2NAH] (In practice, this means that vaccine manufacturers provide a fact sheet saying that vaccine recipients can refuse the vaccine. For example, Pfizer’s Fact Sheet for Recipients and Caregivers says the following on this topic: “It is your choice to receive or not receive the Pfizer-BioNTech COVID-19 Vaccine. Should you decide not to receive it, it will not change your standard medical care.”). ↩︎
  21. Kopit, supra note 1. ↩︎
  22. See Fact Sheet for Recipients and Caregivers, supra note 20. ↩︎
  23. See Food, Drug, and Cosmetics Act, supra note 20. ↩︎
  24. Emergency Use Authorization for Vaccines Explained, supra note 20. ↩︎
  25. Lisa Nagele-Piazza, Can Employers Mandate a Vaccine Authorized for Emergency Use?, SHRM, Mar. 23, 2021, https://www.shrm.org/resourcesandtools/legal-and-compliance/employment-law/pages/employer-mandate-covid-vaccine-eua.aspx [https://perma.cc/7EA8-VJUF] (citing Meneghello & Troutman, supra note 4) (internal citations and quotations omitted). ↩︎
  26. Dorit Reiss, Can Employers Mandate a Vaccine Under Emergency Use Authorization?, Bill of Health, Harv. L. Petrie-Flom Ctr., Feb. 24, 2021, https://blog.petrieflom.law.harvard.edu/2021/02/24/employer-mandate-covid-vaccine-eua [https://perma.cc/G8WF-S5Y8]. ↩︎
  27. Id. ↩︎
  28. See id. ↩︎
  29. Id. ↩︎
  30. Robert Hard, Full FDA Approval of Pfizer’s Covid Shot Could Make Vaccine Mandates More Likely, Forbes, May 7, 2021, https://www.forbes.com/sites/roberthart/2021/05/07/full-fda-approval-of-pfizers-covid-shot-could-make-vaccine-mandates-more-likely/?sh=6bcbf5a53a76 [https://perma.cc/57Y9-VS4X]. ↩︎
  31. Meneghello & Troutman, supra note 4. ↩︎
  32. What You Should Know, supra note 7. ↩︎
  33. Andrew Ross Sorkin et al., Can Companies Require Vaccination, and Should They?, N.Y. Times, May 7, 2021, https://www.nytimes.com/2021/05/07/business/dealbook/companies-vaccines-employees.html [https://perma.cc/JF6X-9FJF]. ↩︎
  34. Ryan Beene, No Vaccine, No Desk: Firms Weigh Whether to Make COVID Shots Mandatory, Seattle Times, May 9, 2021, https://www.seattletimes.com/business/no-vaccine-no-desk-firms-weigh-whether-to-make-covid-shots-mandatory/ [https://perma.cc/KV95-RN7Y]. ↩︎
  35. Id. ↩︎
  36. Nagele-Piazza, supra note 25. ↩︎
  37. Peter Sullivan, Biden Sets Goal of at Least One Shot to 70 Percent of Adults by July 4, The Hill, May 4, 2021, https://thehill.com/policy/healthcare/551741-biden-to-set-goal-of-at-least-one-shot-to-70-percent-of-adults-by-july-4 [https://perma.cc/DVM5-XNUA]. ↩︎
  38. Id. ↩︎