Many news outlets have recently reported that the federal government has indicated that employers can mandate COVID-19 vaccines. They rely on updated guidance issued by the Equal Employment Opportunity Commission on May 28, 2021 (the “Guidance,” which can be found here), and more specifically, Section K of the Guidance regarding COVID-19 vaccines. What the EEOC did not do, though, contrary to many news reports, is authorize mandatory vaccines.
Emergency Use Authorization Status of COVID-19 Vaccines: Unlike influenza and similar vaccines, COVID-19 vaccines are currently being made available not through the formal approval process of the Food and Drug Administration (“FDA”), but rather through a more streamlined “emergency use authorization” (EUA) process. (See our prior client alert on this topic.) The statutory provisions governing the FDA’s emergency process include language that raises concerns about the potential legality of employers mandating vaccines authorized under an EUA. Specifically, the relevant provision requires that recipients of EUA products be informed, to the extent practicable, that they have “the option to accept or refuse administration of the [EUA] product…,” a requirement applicable to the EUA-authorized vaccines. (See Federal Food, Drug, and Cosmetic Act, Section 564(e)(1)(A)(ii)(III); “Drugs and Biological Products” and approval letters and fact sheets, found here.) 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.
The EEOC’s Position on Mandatory Vaccines: In its original Guidance issued in December 2020, the EEOC implied that employers can mandate COVID-19 vaccines. However, 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, incorporating into the EEOC Guidance a link to the FDA website regarding EUAs.
Keeping in line with its prior position, the EEOC continues to sidestep this issue in the updated Guidance. Specifically, the prefatory language to Section K of the updated Guidance states (emphasis added):
The EEOC has received many inquiries from employers and employees about the type of authorization granted by the U.S. Department of Health and Human Services (HHS) Food and Drug Administration (FDA) for the administration of three COVID-19 vaccines. These three vaccines were granted Emergency Use Authorizations (EUA) by the FDA. It is beyond the EEOC’s jurisdiction to discuss the legal implications of EUA or the FDA approach. Individuals seeking more information about the legal implications of EUA or the FDA approach to vaccines can visit the FDA’s EUA page. The EEOC’s jurisdiction is limited to the federal EEO laws as noted above…. The technical assistance on vaccinations below was written to help employees and employers better understand how federal workplace discrimination laws apply during the COVID-19 pandemic caused by the SARS-CoV-2 virus and its variants. The technical assistance here is based on and consistent with the federal civil rights laws enforced by the EEOC and with EEOC regulations, guidance, and technical assistance. Analysis of how it applies in any specific instance should be conducted on an individualized basis.
The EEOC’s Guidance is expressly limited to the interplay between vaccinations and federal civil rights/equal employment opportunity laws, such as the Americans with Disabilities Act (ADA), the Rehabilitation Act, the Genetic Information Nondiscrimination Act and Title VII of the Civil Rights Act, as amended by, among other things, the Pregnancy Discrimination Act. Thus, employers should derive no comfort from this Guidance as it pertains to the legality of mandating COVID-19 vaccines that remain under EUA status. Because the current legal context for COVID-19 vaccines is different from ordinary, time-tested vaccines (such as those for influenza), employers should carefully consider their potential legal liability when considering imposing vaccine mandates prior to full approval of such vaccines by the FDA.
Current Legal Landscape. At least four federal lawsuits have been filed against employers mandating COVID-19 vaccines. Most recently, on May 28, 2021, over 100 employees of Methodist Hospital asserted claims against their employer for imposing a vaccine mandate. (Jennifer Bridges, et al. v. The Methodist Hospital d/b/a the Methodist Hospital System, et al., filed in Texas state court in Montgomery County as Cause No. 21-06-07552, subsequently removed to U.S. District Court for the Southern District of Texas, Houston Division, as Case No. 4:21-cv-01774.)
This follows a case filed in New Mexico in which the plaintiff, an employee of the Dona Ana Detention Center, asserted that he was threatened with termination of employment due to his exercise of his federal right to refuse the EUA vaccine in the face of his employer’s vaccine mandate (Legaretta v. Fernando Macias, et al., Case No. 2:21-cv-00179, filed in federal district court in New Mexico on Feb. 28, 2021); a similar case in California, in which the plaintiffs assert that the defendants’ policy of mandating that all of its employees be vaccinated against COVID-19 constitutes prohibited “human experimentation without consent” in violation of the Nuremburg Code, among other things (California Educators for Medical Freedom, et al. v. The Los Angeles Unified School District, et al., Case No. 21-cv-02388, filed in federal court in the Central District of California on Mar. 17, 2021); and another in North Carolina, in which a former deputy claims he was wrongfully terminated for refusing to receive a COVID-19 vaccine (Neve v. Birkhead, Case No. 1:21-cv-00308, filed in federal court in the Middle District of North Carolina on Apr. 16, 2021).
Plaintiffs’ lawyers have wasted no time jumping on this issue, filing lawsuits and issuing demand letters around the country. The dearth of case law on these issues, coupled with the legal requirements of the EUA process, will doubtless lead to more such suits in the face of employer mandates. Such claims will be short-lived, however; both Pfizer and Moderna have recently applied for “full” FDA approval. The FDA indicates that, although this process usually takes 6 months to a year or more, it will act as quickly as reasonably possible to work through the process. Thus, the vaccines could receive full FDA approval before year-end. This full approval would put the brakes on future lawsuits related to EUA status of mandatory vaccines, but we’ll likely see a proliferation of cases alleging failure to accommodate medical conditions, disabilities and religious objections in their stead.
What the EEOC Guidance Does Say: Once the vaccine is fully approved, we expect that more employers will consider mandating—and actually mandate—vaccines for employees. The EEOC Guidance confirms that federal civil rights laws do not prohibit such mandates, provided certain requirements are met. Summarized below are some of the key issues addressed in the updated Guidance.
Required Accommodations: Employers must take into account accommodations that may be required under the ADA, or due to certain medical conditions (such as pregnancy or strong allergies to vaccine components), or for religious reasons. Requests for religious accommodation may be based on objections to the concept of vaccines generally, or specific to a particular vaccine (e.g., gene-based vaccines). This requires a similar analysis to that required of employers with respect to, for instance, flu shots.
Documentation and Confidentiality: Employers may request proof of vaccination of employees on a non-discriminatory basis, and requiring proof of vaccination does not, in and of itself, violate the ADA or other civil rights laws. However, although requesting proof of vaccination is not a medical inquiry, the information received by the employer (e.g., a copy of a CDC vaccination card) is considered medical information that must be treated in a confidential manner and maintained in a file separate from the employee’s personnel file.
Collection of such information also may be required under applicable state or local law. For example, both the existing and proposed versions of the Emergency Temporary Standards (“ETS”) promulgated by the California Occupational Safety and Health Standards Board define “fully vaccinated” employees, subject to less stringent protocols as outlined in the ETS, to mean that the employer has documentation showing that the employee received, at least 14 days prior, either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. And Santa Clara County, California, by Order of the County Health Officer dated May 18, 2021, requires that employers track employee vaccination status, with violation or failure to comply constituting a misdemeanor punishable by a fine of up to $5,000 per day and/or imprisonment.
Incentives: The EEOC Guidance outlines, among other things, the parameters of incentives that may be provided by employers to employees for obtaining the vaccine. As expected, and in keeping in line with the proposed regulations issued by the EEOC last year, incentives may be offered to employees obtaining the vaccine through the employer, but the incentives cannot be so substantial as to be considered coercive. What’s the reasoning for this? Administering the vaccine requires prescreening questions that would be prohibited under the ADA unless they are voluntary; excessive incentives undermine the voluntary aspect of responding to the screening questions. Notably, this concern is not present to the same extent when employees are rewarded for obtaining vaccines through their own health care providers rather than directly through the employer. (Employers should keep in mind, though, that incentives, regardless of size, generally are taxable to the employee.)
Takeaways: At present, it is very risky for employers to mandate COVID-19 vaccines. In addition to the prospect of litigation as outlined above, it is questionable whether workers’ compensation would cover employee side effects or death from mandatory vaccines if employers cannot legally require such vaccines in the first instance. The legal issues surrounding mandatory COVID-19 vaccines are currently unsettled, but will doubtless be fleshed out in the coming months through the pending litigation and the anticipated full FDA approval of the existing vaccines.
At this juncture, given the uncertainty surrounding the legality of mandating EUA-status vaccines, the safer course of action is to encourage employees to get the vaccine rather than mandating it, providing facts about the vaccine and legally permissible 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 and other public health agencies have 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 and regularly updating their vaccine strategy and policies.