On April 7, 2021, the University of Notre Dame announced it will require all students to be vaccinated against COVID-19 to enroll for the 2021-2022 school year, and on May 20, the university announced a similar requirement for faculty and staff, making the school part of a growing list of colleges across the country mandating the COVID-19 vaccine.
The school will “accommodate documented medical and religious exemptions.” Vaccinated students will be permitted to go without masks in residence halls this summer, although masking policies for the fall have yet to be announced.
The law firm Siri and Glimstad sent a letter to University President Rev. John Jenkins arguing that Notre Dame’s mandate is not lawful because the vaccines are not U.S. Food and Drug Administration-approved. They’re only available via Emergency Use Authorization (EUA), which allows the Health and Human Services secretary to authorize in emergencies products that have yet to meet legally established thresholds for approval. Never before has a vaccine been authorized for the entire population under a EUA.
One important condition for EUA products is the basis of legal arguments against university mandates such as those at Notre Dame. The relevant statute requires the HHS secretary to “ensure that individuals to whom the product is administered are informed of the option to accept or refuse administration of the product.” This option to refuse is mentioned again in the FDA fact sheet for Pfizer vaccine providers.
It very likely is lawful for a university to mandate coronavirus vaccination for students and employees. The statute places requirements on the conduct of government officials, not private entities. For this reason, professors from Harvard University and the University of California at Hastings law schools conclude, “There are few to no legal barriers to employers or schools requiring vaccines being distributed under EUAs.”
While mandating that students take an emergency authorized vaccine may be lawful for private colleges and universities, the fact that it is, for the time being, available only under EUA provides good reason not to do so. After all, the language in the statute requiring HHS to make the
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