A Look Ahead: Legal and Practical Considerations for Employers Regarding the COVID-19 Vaccine

Current Federal Guidance Regarding the COVID-19 Vaccine

Although federal agencies have provided various guidelines on managing COVID-19 in the workplace, vaccine-specific guidance for employers has been limited thus far. Notably, there is no federal guidance at this time that expressly gives employers carte blanche authority to mandate the COVID-19 vaccine — although federal guidance generally emphasizes the importance and utility of the vaccine, and the EEOC’s recent guidance implies employers may require the vaccine subject to certain exceptions. However, employers should not overlook the fact that the U.S. Food and Drug Administration’s (FDA’s) current authorization of COVID-19 vaccines to date is limited to an EUA, which has significance in the employment arena.

CDC Guidance 

On April 28, 2021, the U.S. Centers for Disease Control and Prevention (CDC) issued updated guidance, “Key Things to Know About COVID-19 Vaccines.” This general guidance states that everyone 16 years of age and older is now eligible to get a COVID-19 vaccination and encourages vaccination as a critical tool to help stop the pandemic. Additionally, the CDC states that “COVID-19 vaccines are safe and effective” and notes that “[p]eople who have been fully vaccinated can start to do some things that they had stopped doing because of the pandemic.” Nevertheless, the CDC also explains that the agency is “still learning” how long the COVID-19 vaccines protect people and how effective the vaccines are against new variants of the virus that cause COVID-19, among other things. Although the CDC has issued resources and guidance about the COVID-19 vaccines, the CDC has not to date addressed the issue of whether employers may mandate vaccines. 

OSHA Guidance 

The Occupational Safety and Health Administration (OSHA) issued guidance on January 29, 2021, titled “Protecting Workers: Guidance on Mitigating and Preventing the Spread of COVID-19 in the Workplace.” The guidance reiterates that employers have certain roles and responsibilities in providing a safe and healthy workplace free from recognized hazards likely to cause death or serious physical harm. In this vein, OSHA states that the most effective COVID-19 prevention programs will include “[m]aking a COVID-19 vaccine or vaccination series available at no cost to all eligible employees” and “[n]ot distinguishing between workers who are vaccinated and those who are not.” With regard to the latter guidance, OSHA states that “[w]orkers who are vaccinated must continue to follow protective measures, such as wearing a face covering and remaining physically distant . . . .” Additionally, OSHA recently released updated answers to its “Frequently Asked Questions” on COVID-19 to address whether adverse reactions to the vaccine are recordable on the OSHA recordkeeping log. Specifically, OSHA stated that adverse reactions to the vaccine are work-related and recordable if an employer requires employees to be vaccinated as a condition of employment — but not if an employer merely recommends the COVID-19 vaccines such that the decision as to whether to get vaccinated is “truly voluntary.” Accordingly, while OSHA encourages employers to make vaccines available and also highlights the heightened recording obligation if an employer does decide to mandate the vaccine, 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.  

EEOC Guidance 

In December 2020, the EEOC issued updates to its guidance, “What You Should Know About COVID-19 and the ADA, the Rehabilitation Act, and Other EEO Laws,” regarding the interplay and impact of the Americans with Disabilities Act, Title VII of the Civil Rights Act, and the Genetic Information Nondiscrimination Act on the administration of the COVID-19 vaccine. Among other things, the EEOC makes clear that employers must exempt from a vaccine requirement or provide a reasonable accommodation for employees who cannot receive a COVID-19 vaccine due to a disability or sincerely held religious belief. Where an accommodation is not available, the EEOC notes that employees cannot automatically be terminated for failure to get the vaccine. In its guidance, the EEOC seems to assume that employers can require a COVID-19 vaccine, framing scenarios in terms of “[i]f an employer requires vaccinations when they are available.” Quite notably, nowhere in the guidance does the EEOC state unequivocally that employers definitively can mandate that their employees receive the vaccine. Given the current EUA status of available COVID-19 vaccines, this omission is not surprising. Of note, the EEOC previously took the position, in the flu vaccine context and before the COVID-19 vaccine was made available, that employers should consider “simply encouraging” employees to get the flu vaccine rather than requiring them to get it. 

Emergency Use Authorization (EUA) Status of the COVID-19 Vaccine

The COVID-19 vaccines available at this time are marketed under EUA — meaning, they are not fully approved by the FDA, but have been approved for use in an emergency after satisfying certain criteria. The EEOC highlighted in its guidance that, given the vaccines’ EUA status, the FDA has an obligation to “ensure that recipients of the vaccine under an EUA are informed, to the extent practicable under the applicable circumstances, that FDA has authorized the emergency use of the vaccine, of the known and potential benefits and risks, the extent to which such benefits and risks are unknown, that they have the option to accept or refuse the vaccine, and of any available alternatives to the product.” This obligation — including notification of the “option to accept or refuse” the vaccine — derives from the federal Food, Drug, and Cosmetic Act, which dictates certain conditions for recipients of an unapproved product disseminated under emergency use.

EUA status for a vaccine is relatively unprecedented — and mandating a vaccine with only EUA approval is even more so. In the early 2000s, the U.S. Department of Defense mandated that certain service members receive an anthrax vaccine that had not received full FDA approval for anthrax inhalation, but this policy was challenged by the service members and enjoined by a federal district court in Doe v. Rumsfeld, 341 F. Supp. 2d 1 (2004). The Department ultimately changed its policy to make the EUA anthrax vaccine voluntary. Moreover, the FDA took the position when the anthrax vaccine was issued under EUA that it could not be required. Thus, there does not appear to be any precedent for mandating an EUA vaccine. (It is noteworthy that even in the case of the U.S. armed troops, only the President of the United States can waive the requirement that troops are informed of the option to accept or refuse the administration of a product that has only EUA and must do so in writing. See 10 U.S.C. § 1107a.)

Moreover, the FDA stated in a December 10, 2020 briefing document that issuance of an EUA for the vaccine means “it would still be considered unapproved and it would be under further investigation (under an Investigational New Drug Application) until it is licensed under a Biologics License Application (BLA).” Just a few months after rolling out the initial vaccines under EUA, the FDA and CDC recommended that distribution of one of the COVID-19 vaccines be paused due to a small number of reports of a rare and severe type of blood clot reported after use of this particular vaccine. While the use of this COVID-19 vaccine has since resumed, this news may further underscore the investigatory phase of vaccines issued under EUA and that they have not gone through the more rigorous and time-intensive process of obtaining full FDA approval. 

In light of this background, and federal law requiring that individuals be informed of the option to refuse an unapproved product under EUA status, mandating the current COVID-19 vaccines could pose legal and/or reputational risks. Note, however, that certain of the vaccine providers are beginning the process of obtaining full FDA approval. As such, employers should also monitor this process, given that FDA-approval status may affect legal and practical considerations. While this process has been lengthy in the past, given the rapidity with which the vaccine was approved for emergency use and the current emphasis on getting the American population vaccinated, the process may be expedited with unprecedented speed.

State and Local Law Considerations

In addition to considering federal guidance and other authority, employers must review and comply with applicable state and/or local laws that could apply to employer vaccination programs. To date, many states are considering (and some have adopted) legislation that addresses whether employers can require a COVID-19 vaccine. For example, the California Department of Fair Employment and Housing recently issued guidance stating that “an employer may require employees to receive an FDA-approved vaccination against COVID-19 so long as the employer does not discriminate against or harass employees or job applicants on the basis of a protected characteristic, provides reasonable accommodations related to disability or sincerely-held religious beliefs or practices, and does not retaliate against anyone for engaging in protected activity (such as requesting a reasonable accommodation).” (Note, however, that this California guidance applies only to FDA-approved vaccines and is silent on EUA vaccines.) A Maryland lawmaker introduced legislation that would prevent employers from requiring that employees receive the COVID-19 vaccine, but would also prevent employees who refuse the vaccine from suing their employer if they later contract COVID-19 at work. The Texas House is likewise considering legislation that would prohibit employers, unions, or employment agencies from discriminating against an individual who has not received a COVID-19 vaccine, and an Illinois state legislator has introduced a bill that would prohibit employers from requiring that employees receive any EUA vaccine. Additionally, Arkansas recently passed a law prohibiting state employers from mandating vaccines as a condition of returning to work, and Montana is poised to enact a similar law that would prevent even private employers from mandating EUA vaccines. Although it is difficult to say what amount of traction other pending legislation regarding the vaccine will receive or how any legal challenges will resolve, it is clear that the state and local landscape is far from uniform. Employers with multi-state workforces will have to monitor all of these developments.

Separate from the discussion around mandating the vaccine, states and localities have also been issuing orders and guidances that loosen restrictions for those who have been fully vaccinated. For example, some jurisdictions have followed CDC guidance by relaxing quarantine requirements for those who have been exposed to someone with suspected or confirmed COVID-19 but who are asymptomatic and have been fully vaccinated. Additionally, some jurisdictions have relaxed travel advisories regarding quarantine following travel for those who are fully vaccinated. The lifting of such restrictions could have a significant effect on the bottom line for businesses as having fully vaccinated employees generally would mean, subject to applicable law, less time such employees need to be away from work due to illness or mandatory quarantine. Even more, some states have issued authority on how to maintain information regarding vaccination — such as proof of vaccination — and whether it must be stored separately as confidential medical information. Employers should closely monitor the developing laws and guidances in states and localities in which they have employees when considering how to develop an approach to the COVID-19 vaccine.   

Encouraging Vaccination in Lieu of a Mandate 

Even if mandating the vaccine is permissible, many employers are considering the alternative of encouraging rather than requiring employees to be vaccinated. This approach has several advantages. First, it avoids the administrative burdens of tracking vaccines and the privacy considerations that accompany obtaining medical information; possessing medical information carries obligations regarding storage of and access to personal medical information. OSHA’s recent guidance on recording employees’ adverse reactions to mandatory COVID-19 vaccines only compounds these burdens. Second, from a practical standpoint, it is unlikely that employers want to simply terminate portions of their workforce who simply do not want to be vaccinated, particularly where the lack of a vaccine does not pose a direct threat to the workplace if, for example, most of the workforce is vaccinated, rates of COVID-19 are low in a community, and there are other methods for keeping the workplace COVID-free that do not involve a vaccine. Furthermore, there is the administrative burden of having to evaluate the inevitable requests for religious and disability accommodations that will ensue as well as the risk of discrimination claims from those excluded from the workplace.

While the CDC has suggested that employers consider offering vaccination clinics on site to encourage and facilitate vaccinations for employees during working hours, there are many other ways to encourage vaccines without doing so. The CDC has recommended allowing employees to get vaccinated during work hours, providing paid leave, providing transportation to and from vaccine sites, and assisting with appointments as some of the ways employers can encourage vaccinations for their workforce. Some employers are appointing vaccine ambassadors to speak positively about their experience getting the vaccine or to speak about their experience with the disease before the vaccines became available. In particular, having workplace leaders make statements encouraging vaccinations, and encouraging leaders to be vaccine champions by getting vaccinated, creating a communication plan through posters, emails, and other channels, and providing regular updates on topics like the benefits, safety, side effects, and effectiveness of vaccination can all be effective methods for promoting without requiring vaccines. These kinds of communications can help debunk any misinformation, focus on the science, and increase employee confidence in the vaccine, particularly when they are delivered by a trusted coworker or respected leader.

Other methods of encouraging vaccines implemented by employers include providing financial incentives such as extra paid time off, one-time cash bonuses, and gift cards. The EEOC has promised, but not yet issued, guidance on “the extent to which employers may offer employees incentives to vaccinate without running afoul of the Americans with Disabilities Act [ADA] and other laws enforced by the EEOC.” Given the uncertainty around permissible incentives for wellness programs, such as COVID-19 vaccination programs, employers should carefully proceed when incentivizing employees to get the vaccine until the EEOC issues its anticipated guidance.  

Returning Employees to the Workplace With or Without Vaccination  

As a practical matter, employers should consider whether a mandatory vaccine policy is wise in light of the uncertainty of the EUA, the other avenues available for keeping a workplace safe, the difficulties of enforcing a mandatory vaccine rule, and the practicalities if valuable employees simply refuse to obtain the vaccine. While some employers have considered and/or implemented a hybrid model where vaccinated employees can return to work and unvaccinated employees may work remotely, this could raise issues of discrimination, for example, with respect to individuals who have a medical or religious reason for not obtaining a vaccine. This hybrid approach should also be reviewed in the context of state and local legislation, which may prohibit discrimination based on vaccine status. Moreover, employers with unionized workforces will also need to consider the requirements of the applicable collective bargaining agreements, which may require employers to bargain with the union before instituting vaccination as a new condition of employment. Failure to comply with the terms of such agreement could likewise spell legal trouble for an employer considering vaccine requirements. Additionally, morale issues must be considered as a practical matter.

Even with the vaccine, COVID-19 infections remain a possibility, particularly with increased travel and socialization. The CDC and OSHA continue at this time to recommend that, in most settings, even fully vaccinated individuals wear masks, practice social distancing, and follow other health and safety protocols to mitigate against the spread of COVID-19. Many state and local jurisdictions are taking a similar approach. Therefore, returning only vaccinated individuals to the workplace likely would not, at least at this time, obviate the need to continue COVID-19 protocols and monitor for potential infection. However, employers may find there are other benefits to a largely vaccinated workplace, including employee comfort with an in-office return, as well as (in certain jurisdictions) more flexible capacity limits where fully vaccinated individuals are present. This analysis will be context-specific and would depend greatly on the actual dynamics of the workforce, as well as applicable state and local law.

COVID-19 as an epidemic continues to evolve, and, with this evolution, employers must continue to consider their risk tolerance, the legal issues, and the practical implications of their decisions.