DOJ Releases Memorandum Supporting Employers’ Right to Mandate Vaccines Approved by the FDA for Emergency Use
Growing numbers of private businesses and public entities have announced policies requiring employees and others to be vaccinated against COVID-19 as a condition of employment or as a condition of access to facilities or services. In response to this trend, some have argued that employers and other organizations may not lawfully mandate COVID-19 vaccines that have been only approved for use under an emergency use authorization (EUA) as opposed to full approval by the U.S. Food and Drug Administration (FDA). Commentators and legal advisors have been divided over whether the EUA approval precludes mandating the vaccine. On July 6, 2021, the Office of Legal Counsel of the U.S. Department of Justice (DOJ) issued a memorandum opining that private businesses and public entities are not prohibited from mandating COVID-19 vaccines that have only received approval for use under an EUA. The memorandum, “Whether Section 564 of the Food, Drug, and Cosmetic Act Prohibits Entities from Requiring the Use of a Vaccine Subject to an Emergency Use Authorization,” helps settle any remaining legal debate and affirms that employers may lawfully require employees to receive COVID-19 vaccinations.
Background and Prior Guidance
COVID-19 hit the shores of the United States in January 2020. Almost immediately, universities, hospitals, and media began to anticipate the development and deployment of effective vaccines. In May 2020 came the announcement of Operation Warp Speed—a public-private partnership between the U.S. government and private companies to develop vaccines to combat COVID-19. Then, in June 2020, the FDA announced that any vaccine would need to be at least 50 percent effective in combating COVID-19 before receiving approval from the agency. Vaccines with effective rates of over 90 percent were announced in late 2020. Shortly thereafter, the FDA issued EUAs for the Pfizer-BioNTech and Moderna vaccines, followed by the Johnson & Johnson/Janssen vaccine. Just as quickly, employers began considering whether to require employees to be vaccinated as a condition of employment or as a condition of performing work on-site at company facilities.
The question of whether an employer may require employees to get vaccinated is not new. For years, some employers in healthcare and other industries have required employees to receive vaccines against influenza and viruses in connection with their employment. In that context, the U.S. Equal Employment Opportunity Commission (EEOC) recognized an employer’s right to insist on vaccinations. For example, in 2009, in connection with the H1N1 pandemic, the EEOC issued guidance entitled “Pandemic Preparedness in the Workplace and the Americans with Disabilities Act.” There, the EEOC addressed the extent to which the Americans with Disabilities Act (ADA) and other federal employment laws restricted an employer’s ability to mandate influenza vaccines. The guidance, which has since been revised to address COVID-19, posed the question, “May an employer covered by the ADA and Title VII of the Civil Rights Act of 1964 compel all of its employees to take the influenza vaccine regardless of their medical conditions or their religious beliefs during a pandemic?” In answering “No,” the EEOC made the obvious observation that under the ADA and Title VII of the Civil Rights Act of 1964 reasonable accommodation must be provided to employees, absent an undue hardship, for their disabilities and religious beliefs, practices, or observances.
The EEOC again addressed the issue in an informal discussion letter dated March 5, 2012. In that letter, the EEOC was asked to advise on the extent to which Title VII required giving exceptions to an influenza vaccine for healthcare workers who requested exemptions due to religious beliefs. The EEOC again affirmed that an employer could require an influenza vaccine in certain circumstances, but that Title VII and other federal employment laws required providing reasonable accommodation based on religious beliefs, disability, and pregnancy. The EEOC’s ultimate position was that employers should encourage employees to receive an influenza vaccine rather than require vaccination.
In March 2020, in light of the COVID-19 pandemic, the EEOC updated its pandemic guidance. The EEOC reiterated that any vaccine requirement must provide for exemptions or other reasonable accommodations for employees who cannot get vaccinated due to a disability or a sincerely held religious belief, practice, or observance, absent an undue hardship. At the time the EEOC released its updated pandemic guidance, the agency noted, “there is no vaccine available for COVID-19.” The EEOC continued to opine that “ADA-covered employers should consider simply encouraging employees to get [a vaccine] rather than requiring them to take it.”
As the COVID-19 pandemic gained ground, the EEOC issued more detailed technical guidance entitled, “What You Should Know About COVID-19 and the ADA, the Rehabilitation Act, and Other EEO Laws.” The EEOC has updated the technical guidance multiple times, most recently on June 28, 2021. In that guidance, the EEOC confirmed that, subject to reasonable accommodation provisions under the ADA and Title VII, “federal EEO laws do not prevent an employer from requiring all employees physically entering the workplace to be vaccinated for COVID-19.”
As a result of this guidance and the increasing burden of COVID-19 in the workplace, a number of employers have contemplated or put into place policies requiring that employees get vaccinated against COVID-19, either as a condition of employment or as a condition of returning to the office for in-person work activities. This policy has been more prevalent among hospitals and other healthcare providers. Similarly, a number of colleges and universities have announced requirements for staff and students to get vaccinated, and a growing number of federal and state agencies are requiring employees to get vaccinated.
The Dispute Over EUA-Approved Vaccines
Even before COVID-19 vaccines were released, political and legal challenges to mandatory vaccines developed, many of which were based on the notion that employees and others should not be compelled to receive any COVID-19 vaccine that had only received EUA approval from the FDA. For example, Montana enacted House Bill 702, which prohibits discrimination based on vaccination status and provides that “[a]n individual may not be required to receive any vaccine whose use is allowed under an emergency use authorization or any vaccine undergoing safety trials.” Multiple lawsuits have also been filed against employer vaccine mandates, though none have been success as of yet. One such lawsuit is Bridges v. Houston Methodist Hospital, which was filed in the U.S. District Court for the Southern District of Texas by employees of a hospital after the hospital issued a requirement that all employees must get vaccinated against COVID-19 as a condition of employment. In the lawsuit, the employees claimed that requiring them to receive the COVID-19 vaccine (or risk being discharged) violated numerous laws including: (1) section 564 of the Food, Drug, and Cosmetic Act (FD&C Act) (the EUA provision); (2) FDA regulations that require informed consent before human subjects may participate in human trials; and (3) the Nuremburg Code. Other lawsuits in the United States have similarly argued against mandatory vaccine policies based on the notion that the COVID-19 vaccines are “experimental” absent full FDA approval.
The legal challenges based on the EUA status of COVID-19 vaccinations arise from a misinterpretation of the relevant provisions of the FD&C Act. In 2004, the U.S. Congress amended the FD&C Act to allow for EUA approvals as a way to more rapidly deploy protections and countermeasures against chemical, biological, nuclear, or radiological threats. The statute provides that in connection with an EUA approval, the secretary of the U.S. Department of Health and Human Services must establish certain conditions on an EUA “to protect the public health” and ensure that “individuals to whom the product is administered are 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.” Some have argued that this provision should be interpreted to mean that private and public entities may not mandate EUA-approved vaccines, while others have argued that the statute refers only to health consequences and/or that the FDA does not have the authority to regulate the employment consequences imposed by an employer due to an employee’s refusal to comply with a mandatory vaccine policy. In other words, the FD&C Act may require that vaccine providers and administrators advise recipients of their right to refuse the vaccine and that they will not suffer any healthcare consequences for doing so, but there is a compelling argument that nothing prohibits an employer from conditioning employment on an employee’s choice to get vaccinated.
The July 26, 2021, DOJ memorandum addresses the argument. There, the DOJ notes that the EUA provision requires informed consent from those receiving the vaccine and that the EUA approval given to the currently available COVID-19 vaccines requires that recipients receive an FDA-approved “Fact Sheet for Recipients and Caregivers,” which states: “It is your choice to receive or not receive the … COVID-19 Vaccine.” In assessing whether the FD&C Act and the fact sheet language prohibit mandatory vaccine policies, the DOJ concluded that “[the EUA provision] 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.” The DOJ further reasoned:
Indeed, if Congress had intended to restrict entities from imposing EUA vaccination requirements, it chose a strangely oblique way to do so, embedding the restriction in a provision that on its face requires only that individuals be provided with certain information (and grouping that requirement with other conditions that are likewise informational in nature). Congress could have created such a restriction by simply stating that persons (or certain categories of persons) may not require others to use an EUA product.
The DOJ memorandum is helpful to employers contemplating mandatory vaccine programs. While the DOJ memorandum is not binding on courts and does not carry the weight of law, it nevertheless affirms the interpretation offered by many that the EUA status of COVID-19 vaccines does not preclude a private or public employer’s ability to mandate that employees get vaccinated. Rather, as noted in EEOC guidance, federal law does not prohibit mandating vaccines, provided employers comply with the requirements of federal employment laws, such as the “direct threat” and reasonable accommodation provisions of the ADA and Title VII.
Employers seeking to mandate COVID-19 vaccines may also want to take into account any restrictions arising from applicable state laws, as some states have passed or are considering legislation that would nevertheless restrict an employer’s ability to mandate vaccines. Employers may also wish to carefully consider the practical and legal implications of ADA and Title VII restrictions and assess whether their organizations have in place effective and compliant processes for identifying and addressing reasonable accommodations.