Guidance on COVID-19 Vaccine Mandate Legality Informs Federal, State Authorities’ Vaccine Approaches

August 02, 2021

Despite initial ambiguity over the legality of an employer-imposed COVID-19 vaccine mandate in 2020, 2021 has brought a series of decisions and opinions from federal authorities and the judiciary clarifying that an employer vaccine mandate is legal, provided employers accommodate those who are unable to be vaccinated.

The US Department of Justice (DOJ) issued definitive guidance on July 26, 2021, in the form of a written opinion, specifically concluding that “federal law does not prohibit public or private entities from imposing vaccination requirements for vaccines that are subject to emergency use authorizations from the U.S. Food and Drug Administration.” This opinion is aligned with rapidly emerging legal precedent that supports employer vaccine mandates. Additionally, numerous governmental entities, including the US Department of Veteran Affairs, the State of California, the State of New York, and the cities of Los Angeles and New York have announced vaccination requirements for certain portions of their staff or a requirement that individuals take weekly COVID-19 tests in lieu of getting vaccinated. Many government officials (including President Joseph Biden), public health agencies, and employer industry groups have encouraged or recommended that private employers mandate vaccination for their workers.

As noted in our previous LawFlash, the US Equal Employment Opportunity Commission (EEOC) previously issued guidance on the legality of employer-issued COVID-19 mandates, making it the first agency to do so. In the wake of this guidance, many companies started exploring vaccine mandates for their personnel, particularly those working in person. However, given potential legal ambiguity and dropping COVID-19 case rates nationwide, many companies decided not to implement a COVID-19 vaccine mandate at that time. Now, there is an increasing focus on COVID-19 vaccine mandates as vaccination rates have stalled nationwide and the Delta variant’s rapid spread has reiterated concerns regarding mandatory in-person work. With the help of recent case law and federal and state actions, the legal landscape regarding COVID-19 mandates has now largely been clarified.

DOJ Guidance

On July 26, 2021, the DOJ issued an 18-page memorandum opinion focusing on whether public and private entities can require individuals to be vaccinated while the vaccines are approved under an Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) but have not been fully approved. The DOJ opinion is important because one of the leading arguments from those who are vaccine hesitant or anti-vaxxers is the fact that the FDA has not yet finally approved the vaccine.

The DOJ specifically explained that “[a]s access to the COVID-19 vaccines has become widespread, numerous educational institutions, employers, and other entities across the United States have announced that they will require individuals to be vaccinated against COVID-19 as a condition of employment, enrollment, participation, or some other benefit, service, relationship, or access.” The DOJ then noted that “[s]ome have questioned whether such entities can lawfully impose such requirements in light of the fact that the [Food, Drug, and Cosmetic Act (FDCA)] instructs that potential vaccine recipients are to be informed that they have the ‘option to accept or refuse’ receipt of the vaccine.” The DOJ further explained that it understood this language has been the subject of multiple lawsuits challenging vaccination requirements.

In response to these concerns, the DOJ concluded that the FDCA “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 explained that the law’s scope was limited to organizations that carry out activities for which an authorization is issued. Therefore, the DOJ explained that by its own terms, the law “expressly forecloses any limitation on the activities of the vast majority of entities who would insist upon vaccination requirements, because most do not carry out any activity for which an EUA is issued.” The DOJ summarily explained, “[W]e conclude that [the FDCA] does not prohibit public or private entities from imposing vaccination requirements, even when the only vaccines available are those authorized under EUAs.”

Legal Decisions

Separate from the DOJ guidance, two federal courts have upheld vaccine mandates imposed on individuals. In Bridges v. Houston Methodist Hospital, a district judge in Texas recently upheld a healthcare entity’s employer-issued COVID-19 vaccine mandate for its employees which the Seventh Circuit subsequently affirmed. In Klaassen v. Trustees of Indiana University, (which the Seventh Circuit subsequently affirmed), a district judge in Indiana permitted Indiana University, a state-run institution, to mandate that students be vaccinated as a condition for returning to campus. Notable takeaways from both of these cases are described briefly below.

Bridges v. Houston Methodist Hospital

In Bridges, Jennifer Bridges, a nurse at Houston Methodist Hospital, challenged the hospital’s requirement that employees be vaccinated against COVID-19 by June 7, 2021, along with 116 other employees. Ms. Bridges argued that the COVID-19 vaccines authorized only under an EUA are experimental and dangerous and that her termination for failing to be vaccinated would be unlawful under Texas state law and federal law. District Judge Lynn Hughes rejected these arguments and granted Houston Methodist Hospital’s motion to dismiss. In doing so, Judge Hughes cited to both the EEOC guidance and prior Supreme Court precedent from the smallpox vaccine in the early 1900s to explain that employers may mandate that employees be vaccinated as a condition of employment. Similar to the DOJ guidance, Judge Hughes held that the FDCA is not applicable to private employers and “neither expands nor restricts the responsibilities of private employers; in fact it does not apply at all to private employers like the hospital in this case. It does not confer a private opportunity to sue the government, employer, or worker.”

Judge Hughes equated a vaccine mandate to other employer policies and explained that employers have the ability to implement policies that relate to employee and visitor safety. Specifically, Judge Hughes explained that “[a]lthough her claims fail as a matter of law, it is also necessary to clarify that Bridges has not been coerced. Bridges says that she is being forced to be injected with a vaccine or be fired. This is not coercion. Methodist is trying to do their business of saving lives without giving them the COVID-19 virus. It is a choice made to keep staff, patients, and their families safer. Bridges can freely choose to accept or refuse a COVID-19 vaccine; however, if she refuses, she will simply need to work somewhere else.” Judge Hughes then explained that “[i]f a worker refuses an assignment, changed office, earlier start time, or other directive, he may be properly fired. Every employment includes limits on the worker’s behavior in exchange for his remuneration. That is all part of the bargain.”

Klaassen v. Trustees of Indiana University

In this matter, District Judge Damon Leichty denied a request for a preliminary objection filed by eight students seeking to block Indiana University’s vaccine mandate. The primary challenge was on Fourteenth Amendment grounds. In a 100-plus-page opinion with in-depth analysis on the public policy implications of a vaccine mandate for in-person attendance, Judge Leichty explained that at that stage of the litigation, the record before him showed that the policy was implemented in a reasonable manner, made appropriate exemptions, and did so on the basis of seeking to protect the safety of the university’s students, staff, and communities. Judge Leichty specifically found that the students were not likely to succeed on the merits as there was no precedent to prohibit a public university from mandating vaccines, and there was support for mandatory vaccines in other settings, such as with measles, tetanus, and mumps. In fact, Indiana state law requires all public university students to receive these and other vaccinations, save for religious and medical exemptions.

With respect to the Fourteenth Amendment, Judge Leichty explained first that the Fourteenth Amendment’s guarantee of due process applies to Indiana University, which is a state actor. Judge Leichty noted that in other vaccination cases involving constitutional issues, courts have applied a rational basis review. In applying this analysis, Judge Leichty held that the “university policy isn’t forced vaccination. The students have options—taking the vaccine, applying for a religious exemption, applying for a medical exemption, applying for a medical deferral, taking a semester off, or attending another university. This policy applies for the fall 2021 semester only. Students may make their choice after being advised of the risks and benefits of the vaccines, thereby giving informed consent. The court recognizes that for certain students this may prove a difficult choice, but a choice, nonetheless. The choice isn’t so coercive as to constitute irreparable constitutional harm. Although it proves a condition to attend this fall, it is reasonable under the Constitution.”

As Judge Leichty concluded, “Recognizing the significant liberty interest the students retain to refuse unwanted medical treatment, the Fourteenth Amendment permits Indiana University to pursue a reasonable and due process of vaccination in the legitimate interest of public health for its students, faculty, and staff. Today, on this preliminary record, the university has done so for its campus communities. That leaves the students with multiple choices, not just forced vaccination.”

Government Mandates and Guidance

As legal precedents have begun to develop and more scientific information emerges on the prevalence of the Delta variant and the exposure that it poses to both vaccinated and unvaccinated people, government entities are increasingly mandating vaccination of their employees.

On July 26, the US Department of Veterans Affairs (VA) became the first federal agency to mandate that its employees be vaccinated for COVID-19. The VA will require that all of its approximately 115,000 frontline healthcare workers be fully vaccinated against COVID-19 in the next two months or face possible termination. Read the VA’s press release regarding the announcement. In making this decision, the VA noted that it was supported by numerous medical organizations and the fact that multiple VA employees who were unvaccinated had recently passed away, with at least three of those deaths due to the “increasingly prevalent Delta variant.” The VA is providing vaccines for free at its facilities for all employees and will provide four hours of paid leave to employees who demonstrate they have been vaccinated.

Separate from the federal government, and as listed in our prior LawFlash, New York City, New York State, the City of Los Angeles, and California all have announced that all public employees in their respective jurisdictions either need to be vaccinated or must submit to weekly COVID-19 testing. On July 29, President Biden announced that every federal government employee and onsite contractor will be asked to attest to their vaccination status. Anyone who does not attest to being fully vaccinated will be required to wear a mask on the job no matter their geographic location, physically distance from all other employees and visitors, comply with a weekly or twice-weekly screening/testing requirement, and be subject to restrictions on official travel.

While no state has mandated that private citizens be vaccinated, numerous states have issued written guidance, often in the form of frequently asked questions on their health department websites, advising or at least directly implying that private employers have the discretion to implement a vaccine mandate. Those states include California, Colorado, Illinois, Indiana, Maryland, Massachusetts, Nevada, New Jersey, North Carolina, Oregon, Pennsylvania, Virginia, and Washington, as well as the District of Columbia.  

Additionally, on July 26, a group of nearly 60 large medical organizations issued a joint statement that specifically called for “all health care and long-term care employers to require their employees to be vaccinated against COVID-19.”

Analysis and Key Dates

Businesses considering a COVID-19 vaccine mandate for their personnel should continue to monitor for additional guidance and seek input from qualified counsel. While there is a growing trend in legal guidance and court decisions to uphold vaccine mandates, these issues are nuanced and evolving.

Additionally, businesses considering a vaccine mandate should review local guidance and restrictions (for example, COVID-19 vaccine mandates are not permissible under Montana state law and other states may pass similar legislation), and ensure that if they do move forward with mandatory vaccination programs, they are prepared to handle exception and accommodation requests from their personnel, which also may vary based on local or state requirements.

Return to Work Resources

We have developed many customizable resources to support employers’ efforts in safely returning to work. These include mandatory and voluntary policy templates and guidelines for key topics such as vaccinations, social distancing procedures, accommodations, remote work, return to office best practices, event safety protocols, and webinar training on safety measures for return to work. View the full list of return to work resources and a workplace reopening checklist.


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If you have any questions or would like more information on the issues discussed in this LawFlash, please contact any of the following Morgan Lewis lawyers:

Stephanie L. Sweitzer 

Orange County
Daryl S. Landy

A. Klair Fitzpatrick

Washington, DC
Sharon Perley Masling