Since the first COVID-19 vaccines were approved by the Food and Drug Administration in December, many companies have wrestled over whether to impose vaccine mandates on their employees. This is a difficult question with many considerations, including whether such a requirement is necessary or practical. Perhaps the most important consideration that businesses and lawyers have to contend with is whether such a requirement is “legal”.
On Monday, the US Department of Justice released a statement of position that appears to remove one of the most significant legal obstacles to employer vaccination mandates.
There are several legal issues related to employer vaccination mandates. For example, employers were initially concerned that local, state, and federal equal opportunity laws could potentially limit their ability to require workers to be vaccinated. These laws prohibit discrimination in the workplace on the basis of various protected traits, including disability (Americans with Disabilities Act) and religion (Title VII of the Civil Rights Act of 1964).
Fortunately, the Equal Employment Opportunity Commission, the federal agency charged with enforcing federal equal opportunity laws, has issued guidelines for employers to answer if vaccination regulations violate federal equal opportunity laws like Title VII or the ADA. The EEOC guidelines clearly state that employer vaccination orders are allowed under these laws as long as workers with disabilities or sincere religious beliefs are given reasonable accommodation, unless such arrangements would unduly burden the employer’s operations.
Unfortunately, the EEOC guideline does not end the investigation into whether vaccine mandates are permissible under other legal theories. As most people know, the three COVID-19 vaccines currently floating around in this country do not have full FDA approval. Rather, these vaccines have been approved by the FDA as part of an emergency approval. The EUA process is required by law and allows medical devices, including vaccines, to be used in emergencies without full FDA approval. The law authorizing the EEA process states that people receiving a vaccine through an EEA must be notified of certain information, including the “option to accept or decline the administration of the product”.
This has led employers to ask if they can prescribe the COVID-19 vaccine if everyone who is offered the vaccine must have the option to either accept or decline it. Attorneys for individuals challenging employer vaccination mandates have raised this issue in court cases across the country. For example, health workers at the Houston Methodist Hospital recently challenged an employer’s vaccine mandate, arguing, among other things, that the hospital cannot prescribe a vaccine to be used as part of an EEA. This argument was firmly dismissed by a judge in the Texas federal district court in a widespread statement. In that decision, the Texas judge stated that employees “could freely choose to accept or reject a COVID-19 vaccine; But if she refuses, she just has to work elsewhere. ”In other words, the decision to get vaccinated is voluntary, but it can have consequences.
In the memorandum opinion published on Monday, lawyers for the Justice Department wrote that employers are not prohibited from requiring the use of a vaccine that is subject to an EEA. The opinion analyzes the history of the EEA process, including the fact that in the years since the EEA process was first approved, the FDA has issued hundreds of EEAs in response to various public health emergencies, including more than 600 EEA for Products to fight COVID-19. The EUAs related to the COVID-19 pandemic have approved the use of various products, including drugs, tests, personal protective equipment and ventilators. DOJ lawyers concluded that the law authorizing the EEA process “only requires information to be provided to potential vaccine recipients and does not prohibit public or private entities from imposing vaccination requirements on vaccines subject to EEA”.
While not entirely positive, the DOJ opinion certainly indicated that one of the biggest hurdles for employers considering a vaccination mandate for their employees – the EEA – can be removed. There remain several other challenges to vaccination mandates currently pending in federal and state courts across the country, and these authorities are not bound by this opinion or the other court decisions to date. But for now, the federal government has weighed its opinion and added more authority in support of vaccine mandates.
Adam Mastroleo is a litigation attorney in the labor and employment law practice of Bond, Schoeneck & King.