Ever since COVID-19 vaccines became widely available to the public, U.S. businesses, newsrooms, and employees alike have debated whether vaccine mandates would be coming to the workplace. As discussed in more detail below, various federal agencies have issued guidance indicating that mandating vaccines — including those vaccines still administered under emergency use authorization (EUA) — is permissible under federal law. Even so, the relative dearth of legal precedent regarding mandating vaccines under EUA status has caused many employers to hesitate before implementing a mandate in their own workplaces. Individuals opposed to mandates argue that not only does EUA status mean the vaccines are not fully tested and confirmed to be safe, but the language of the statute authorizing use of drugs under EUAs, which states, in part, that recipients must be informed of “the option to accept or refuse administration of the product,” cautions against mandates.
The recent approval by the U.S. Food and Drug Administration (FDA) on August 23, 2021, of the Pfizer-BioNTech COVID-19 vaccine, now marketed as Comirnaty, the first approval of a vaccine of its kind, changed the conversation. This FDA approval, combined with the recent significant spike in COVID-19 cases due to the Delta variant and hopes of minimizing pandemic-related disruptions to business and the workplace, has encouraged an increasing number of employers to implement vaccine mandates for in-office employees. Still, two of the COVID-19 vaccines available in the U.S. — Moderna and Johnson & Johnson — continue to operate under EUA status rather than full FDA approval, potentially complicating vaccination mandates. Even with full FDA approval for at least one vaccine, many Americans remain unvaccinated, with some adamant to remain so. As such, employers will continue to face difficult practical and legal considerations regarding mandating COVID-19 vaccines for employees.
Current Federal Law and Guidance Regarding the COVID-19 Vaccine
FDA Approval. The FDA’s issuance of full approval for the Pfizer vaccine for use in individuals ages 16 years and older was likely just the first step. Other vaccine providers have indicated their intent to file for full FDA approval as well, with Moderna completing its submission for full approval on August 25, 2021; however, there is no known timeline for full approval of these vaccines. In addition, while the Pfizer and other vaccines remain available to children ages 12-15 under the EUA, further testing regarding the vaccine’s use in younger children continues, with the aim of eventual FDA approval there as well. Finally, Pfizer has announced that it will seek FDA approval for a third, “booster” shot in the recently announced plan recommended by the Centers for Disease Control and Prevention (CDC) to offer third doses of the vaccines to fully vaccinated individuals.
Agency Guidance Regarding Vaccination Mandates:
- DOJ Memorandum of Opinion. Guidance from the Department of Justice (DOJ) has been largely supportive of an employer’s ability to require that employees receive the vaccine (subject to certain accommodation requirements) under federal law. In July 2021, the DOJ issued a memorandum opining that the federal law concerning EUA status “concerns only the provision of information to potential vaccine recipients and does not prohibit public or private entities from imposing vaccination requirements for vaccines that are subject to EUAs.” (emphasis added). In other words, the DOJ has stated that employers may lawfully require employees be vaccinated — even with EUA vaccines — as a condition of employment under federal law, subject to any medical or religious exemptions that may be also be required under the Americans with Disabilities Act (ADA) or Title VII.
The DOJ also distinguished the (few) previous cases where EUA vaccine mandates were challenged. For example, with respect to one case, Doe v. Rumsfeld, 341 F. Supp. 2d 1 (2004), in which U.S. servicemembers challenged a Department of Defense mandate regarding an anthrax vaccine, the DOJ noted that the mandate (1) was specific to the military, which involves different provisions of law than what apply to other public or private employers, and (2) was also based on a provision of federal law “inapplicable to EUAs.” As such, the DOJ stated that Doe v. Rumsfeld would not support a bar on public or private employers mandating COVID-19 vaccines, even insofar as certain vaccines (or boosters) remain under EUA status.
- EEOC Guidance. While the Equal Employment Opportunity Commission (EEOC) has so far refrained from weighing in on how a vaccine’s EUA status intersects with federal equal opportunity employment (EEO) laws, it has recently reinforced an employer’s general right to mandate vaccinates for in-person employees under those same laws. In May 2021, the EEOC updated its December 2020 guidance to state that “[t]he federal EEO laws do not prevent an employer from requiring all employees physically entering the workplace to be vaccinated for COVID-19, subject to the reasonable accommodation provisions of Title VII and the ADA and other EEO considerations ….” (emphasis added). Put simply, under the ADA, Title VII, and other federal employment nondiscrimination laws, an employer may require employees entering the workplace to be vaccinated for COVID-19 as long as it provides reasonable accommodations for employees who do not get vaccinated because of a disability or sincerely held religious belief, practice, or observance.
- CDC Guidance. On August 19, 2021, the Delta variant and increased transmission of COVID-19 around the country (and the world) prompted the CDC to release updated guidance. This guidance continues to recommend that the unvaccinated wear a mask in indoor public settings and adds the following recommendation even for fully vaccinated individuals: “[T]o maximize protection from the Delta variant and prevent possibly spreading it to others, wear a mask indoors in public if you are in an area of substantial or high transmission.” To assist in determining masking requirements, the CDC provides this website, which shows the rate of transmission by state and county. As of the date of writing this article, most U.S. cities — including Chicago, New York City, and Los Angeles — are considered high-transmission areas.
As noted, the CDC also recently announced plans to administer booster shots to recipients of the mRNA vaccines starting eight months after an individual’s second dose to bolster the vaccines’ continued effectiveness and hopefully increase vaccinated individuals’ protection against the highly contagious Delta variant. It is unclear whether these booster shots will qualify for full FDA approval or remain under EUA status; as such, some questions remain regarding employer vaccine mandates for these shots.
- OSHA Guidance. Like the CDC, the Occupational Safety and Health Administration (OSHA) recommends that employers implement COVID-19 safeguards for all employees, regardless of vaccination status. OSHA’s issued guidance, first issued in January 2021, reiterates that employers have a responsibility to provide a safe and healthy workplace free from recognized hazards likely to cause death or serious physical harm. OSHA has not yet stated outright whether employers can or should mandate the vaccine as part of their general duty to maintain a safe and hazard-free workplace. Yet OSHA “strongly encourages” employers to grant paid time off for their employees to get vaccinated.
On August 13, OSHA updated its guidance to reflect CDC reports of increased transmission of the virus among even vaccinated individuals. OSHA now recommends that employees wear a mask in public indoor settings in areas of substantial or high transmission. The guidance also provides that employees may choose to continue to wear a mask “regardless of level of transmission, particularly if individuals are at risk or have someone in their household who is at increased risk of severe disease or not fully vaccinated.” Employers will need to continue to take these recommendations into account when setting vaccine and masking policies in the workplace.
What Does This Mean? The full approval of the Pfizer vaccine opens the door, under federal law, for employers to mandate the vaccine without the uncertainty of the EUA status. However, even though federal guidance has stated that federal law may allow employers to mandate vaccines, there are state law and other considerations to account for before deciding whether to do so. In particular, while vaccine mandates are likely to have the practical effect of reducing the spread of COVID-19 in the workplace, employers following CDC and OSHA recommendations may not be able to eliminate various COVID-19 workplace safeguards, including requiring masks and social distancing.
COVID-19 Vaccine Mandate Litigation
Thus far, challenges to vaccine mandates by employers and other institutions have proven unsuccessful. On June 12, 2021, a federal district court in Texas dismissed a complaint against a Houston hospital that mandated COVID-19 vaccines, reasoning that Texas employment laws did not prohibit an employer from terminating employees for refusing to be vaccinated, notwithstanding the EUA status of — at that time — all of the COVID-19 vaccines. See Bridges v. Houston Methodist Hospital, No. 4:21-cv-01774 (U.S. District Court for the Southern District of Texas). The court further concluded that mandating the vaccine would not violate the federal law requiring the Secretary of Health and Human Services to ensure that EUA product recipients are informed of “the option to accept or refuse administration of the product” because this provision “does not apply at all to private employers like the hospital in this case.” The decision is being appealed to the U.S. Court of Appeals for the Fifth Circuit; meanwhile, numerous employees (including at least some of the plaintiffs) have been terminated or resigned from the hospital over the vaccination policy. A similar claim is pending against Dona Ana County in New Mexico, where a detention center employee alleges he has been threatened with termination for refusing to receive the vaccine. See Legaretta v. Macias, No. 21-cv-00179 (D.N.M. May 4, 2021). It remains to be seen how courts will view these challenges or how employees may react to mandates now in light of the recent FDA approval of one of the vaccines.
Additionally, numerous educational institutions have succeeded in maintaining their COVID-19 vaccine requirements for faculty, staff, and students so far. Most notably, the Supreme Court recently declined to hear a request by students at Indiana University to enjoin the school from enforcing its COVID-19 vaccine mandate. The denial leaves in place the Seventh Circuit Court of Appeals’ decision not to enjoin the school from enforcing the requirement while the students’ case goes forward. The Seventh Circuit noted: “Vaccination is … a condition of attending Indiana University. People who do not want to be vaccinated may go elsewhere.” Although the decision deals directly with an educational institution, such reasoning may be of interest to employers, particularly given that it aligns with the DOJ’s analysis, which provides that while federal law requires recipients of an EUA vaccine be informed about its EUA status and the option not to receive it, they may nevertheless face consequences if they do elect not to receive it, up to and including being disallowed from enrolling at a university or maintaining employment.
State and Local Law Considerations
In addition to considering federal guidance and other authority, employers must still review and comply with applicable state and/or local laws that could apply to employer-mandated vaccination programs. To date, many states are considering (and some have adopted) legislation that addresses whether employers can require a COVID-19 vaccine. Some state guidance (e.g., California) applies only to FDA-approved vaccines and is silent on EUA vaccines. As of the date of writing this article, only one COVID-19 vaccine has received full FDA approval. Nevertheless, California has recently adopted mandates for certain employees to be vaccinated, including public and private school faculty and staff, healthcare workers, and state employees. These mandates were adopted days before the FDA issued full approval of the Pfizer vaccine. More mandates from California or other states may be forthcoming in light of the vaccine’s FDA approval and continued spread of Delta.
On the other hand, several other states have pending or passed legislation banning “vaccine passports” and prohibiting businesses from requiring customers or employees to show proof of vaccination. For example, Arkansas enacted a law prohibiting state employers from mandating COVID-19 vaccines and does not appear to be limited to those with EUA status. Similarly, the Governor of Texas issued an executive order on August 25, 2021, maintaining a prohibition on state and local governmental entities implementing vaccine mandates for their employees. As of September 7, 2021, Montana is the only state that has gone so far as to ban private employers from making employment decisions based on vaccine status; notably, the law applies to all vaccinations, not just the COVID-19 vaccines. It does, however, provide an exemption for healthcare facilities that must mandate vaccines to comply with federal law or guidance. Ohio also considered legislation that would prohibit employers from mandating EUA status vaccines; it remains to be seen whether this bill will be enacted or what the consequences of enacting it would be in light of the recent FDA approval of the Pfizer vaccine. Texas considered similar legislation, but it, too, was not enacted.
Cities have also entered the fray over vaccine mandates, although their mandates currently focus only on city employees. In Chicago, for example, Mayor Lori Lightfoot announced that all city workers must be fully vaccinated by October 15. While these local and state actions — apart from Montana, as noted above — currently leave private employers free to mandate vaccines, employers should continue to pay attention to further developments, as they are mounting rapidly in response to Delta and other COVID-19-related concerns across the country.
Mandating vs. Encouraging: Are Incentives Enough?
Given concerns over potential litigation and having to account for potentially conflicting federal, state, and local laws, numerous employers have chosen the alternative of encouraging rather than requiring employees to be vaccinated. Methods of incentivizing the vaccine have varied widely, including offering vaccination clinics onsite; allowing employees to get vaccinated during work hours; providing transportation to and from vaccine sites; appointing vaccine ambassadors; and creating a communications strategy.
This approach has several apparent advantages. First, from a practical standpoint, many employers are unwilling to terminate portions of their workforce who simply do not want to be vaccinated. Second, there is the administrative burden of evaluating the inevitable requests for disability and religious accommodations that will ensue as well as the risk of discrimination claims from those excluded from the workplace. Thus, encouraging and not requiring employee vaccination may help avoid the administrative burdens of tracking vaccines and the privacy considerations that accompany obtaining and storing personal medical information. In this vein, the EEOC’s May 2021 guidance did confirm that employers generally may offer incentives to employees for receiving the COVID-19 vaccine or providing proof of vaccination. In the context of an employer-administered vaccine, the EEOC stated that any incentive cannot be “so substantial as to be coercive” but did not offer more guidance on what could be considered “coercive.”
Yet with transmission rates on the rise and vaccination rates largely stagnant across the country in recent months, many employers are wondering whether incentives are enough. Certain employers have decided to up the ante — increasing benefits of receiving the COVID-19 vaccine by, for example, awarding bonuses to employees who receive them. Others have given up on the incentive front and are turning to mandates. Some U.S. employers have elected to mandate vaccination by this fall for at least portions of its workforce. For example, some companies have elected to mandate vaccines for office workers while continuing to merely encourage them for front-line workers, such as retail or food service employees. Moreover, some employers have also adopted a compromise position, allowing employees who are adamant against vaccination to use other precautions — such as masking, social distancing, and undergoing weekly COVID-19 testing,— rather than terminating employees who fail to comply with the mandate. These decisions may reflect a calculus of necessity: Employers simply cannot afford to lose large segments of workers if such individuals choose to walk off the job rather than comply with the vaccine mandate.
In addition, it remains to be seen whether the current uptick in vaccination rates (particularly in those areas hardest hit by the Delta variant) will persist and perhaps be bolstered by increased confidence in a vaccine that is fully approved by the FDA. As such, even with COVID-19 concerns returning to center stage, practical considerations continue to weigh on employers. Ultimately, with different federal, state, and local laws in play, as well as these practical considerations to contend with, the decision to mandate remains a business decision that will be necessarily individualized to each employer and its particular workforce, location(s), and preferences.
At Sidley Austin LLP, our Employment and Labor lawyers are well versed in the complex and rapidly changing environment surrounding COVID-19 and vaccine mandates. We regularly advise employers of all sizes regarding these issues. Please contact us with any questions or if we may be assistance in these regards.