Can Public and Private Entities Impose COVID-19 Vaccination Requirements? DOJ Weighs In

Statutory Framework

Pursuant to the Federal Food, Drug, and Cosmetic Act (FDCA), the United States Food and Drug Administration (FDA) may issue an emergency use authorization that allows the use of unapproved medical products, including vaccines, during a public health emergency. 21 U.S.C. § 360bbb-3(a)(1). Among other things, the FDCA requires that FDA impose appropriate conditions to ensure that individuals to whom an EUA product is offered are informed of the option to accept or refuse administration of the product. 21 U.S.C. § 360bbb-3(e)(1)(A)(ii)(III). FDA has therefore required that potential recipients of any of the three COVID-19 vaccines currently subject to an EUA be supplied with a Fact Sheet stating that an individual may accept or refuse the vaccine (more details here and here).

The Word From the Department of Justice

In July 2021, the United States Department of Justice (DOJ) published a memorandum addressing whether the authorization condition allowing individuals to accept or refuse a COVID-19 vaccine prohibits entities from imposing vaccination requirements.

At the heart of DOJ’s memorandum is the following conclusion: the section of the FDCA regarding the imposition of the accept or refuse condition “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.”

In reaching this finding, DOJ focused on the plain language of the statute itself, noting that, “[b]y its terms, the provision directs only that potential vaccine recipients be ‘informed’ of certain information, including ‘the option to accept or refuse administration of the product.’”  DOJ further explained that it seemed contrary to Congressional intent to read into the provision either a requirement beyond the mere conveyance of certain factual information or a restriction on the imposition of EUA vaccination requirements.

While DOJ and FDA align on this conclusion and further agree that the FDCA allows FDA some discretion to modify or omit the notification regarding the option to accept or refuse in certain circumstances, the issue becomes more complicated in the context of the armed forces. Per DOJ, the United States Department of Defense (DOD) interprets federal military law as preventing DOD from requiring service members to take an EUA product subject to a condition allowing the option to refuse, unless the President waives the condition. Accordingly, and while DOJ explicitly noted that this did not change its interpretation of the relevant FDCA section, DOJ nonetheless advised that DOD should seek a presidential waiver before imposing a vaccination requirement.

The “Answer” for Your Entity

So, can your public or private entity impose vaccination requirements as a condition of employment, enrollment, or other activities? To quote your friendly neighborhood lawyer: it depends.

While DOJ found that the mere fact that a vaccine is subject to an EUA does not prevent public or private entities from imposing vaccination requirements, DOJ’s conclusion was limited to just that. Indeed, DOJ did not address whether other federal, state, or local laws or regulations might restrict the ability of entities to adopt certain vaccination policies. This same caveat has been echoed in other contexts: the United States Equal Employment Opportunity Commission (EEOC) concluded that “federal [equal employment opportunity (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 [Americans with Disabilities Act] and other EEO considerations … . ” EEOC cautioned, however, that other federal, state, and local laws and regulations govern COVID-19 vaccination of employees, including requirements for the federal government as an employer.

In sum, the EUA status of the three COVID-19 vaccines currently available in the United States does not prohibit public or private entities from imposing vaccination requirements as a condition of employment, enrollment, participation in other activities, or receipt of certain benefits and services. However, any entity seeking to impose such a requirement should take care that they do not run afoul of other applicable federal, state, and local laws and regulations.

If you are interested in more information about other laws and regulations related to COVID-19 vaccination requirements, please contact Arent Fox’s FDA Practice Group.