NAICU Washington Update

Colleges Consider Whether to Mandate COVID Vaccines on Campus

April 09, 2021

Amidst widespread uncertainty about vaccine mandates and conflicting legal advice, several colleges have recently announced that they will require students to get vaccinated for COVID-19 before returning to campuses, while other institutions have chosen to encourage, but not mandate, the vaccine. 

Much of the debate about mandatory vaccines appears to have arisen because the COVID-19 vaccines currently available have been granted emergency use authorization (EUA) by the Food and Drug Administration (FDA). An EUA is not the same as formal approval by the FDA. Rather, the EUA process was created after 9/11 as a temporary mechanism to rapidly bring a drug to market in emergency situations. Once the government’s public health emergency declaration expires, so too will the EUAs for COVID vaccines. 

Although it appears to be clear that institutions can mandate approved vaccines, there is debate about whether it’s permissible to mandate one that is authorized for emergency use, due to statutory language in the Federal Food, Drug, and Cosmetic Act (FFDCA) that suggests individuals must be allowed to opt out of vaccines authorized under an EUA. It is not clear when drug manufacturers will submit applications for formal approval of their COVID vaccines, but the FDA cannot grant such approval until and unless manufacturers do so.

Adding to the confusion, state laws on vaccine mandates vary, and several other federal agencies have issued guidance on this topic, including the Equal Employment Opportunity Commission (EEOC) and the Centers for Disease Control. The federal guidance, however, has focused on whether employers can require their employees to take the vaccines. The EEOC guidance, for example, addresses federal employment laws only, not the FFDCA or the relationship between institutions and their students. A similar legal debate about whether employers can mandate vaccines appears to be taking place, with legal analysts offering conflicting opinions on the issue. 

Ultimately, the legality of mandating COVID vaccines authorized for emergency use has not been tested in the courts. Some institutions may decide that the benefits of mandating such vaccines outweighs the risk of litigation. For institutions that do not want to risk litigation on this issue, however, the more prudent course of action appears to be encouraging, rather than mandating, the vaccine, given the legal uncertainty.

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