The requirement for vaccination with products under emergency use authorisation is new legal territory, finds Jennifer Block
For Joshua Hauser, a junior at the University of California Berkeley, the requirement to get a covid-19 vaccine before fall semester is like getting a plum campus housing assignment. “People are really excited about getting the vaccine on campus,” he says. “It will help us feel safe at school.” And he’s hopeful it will mean a return to normal. “On Zoom, that’s all we talk about—we just wish we were together in person.”
Beginning in late March, some US colleges and universities began issuing requirements for students to be fully vaccinated against covid-19 if they want to return to campus this autumn. Some policies include faculty and staff. What began as a handful of colleges soon turned into dozens by mid April, and to date, some 350 institutions1 have issued such policies—even though all three covid-19 vaccines available in the US remain under emergency use authorisation (EUA) status, and not approved.2
Broad mandates in the civilian population of an unapproved product are unprecedented, and the legality may ultimately be answered in court. So at some institutions, the mandates come with fine print. The University of California System policy, for example, is marked DRAFT in red3 and will go into effect4 only if a vaccine receives full approval.
Other institutions are using the word “approval” more loosely, leaving room for ambiguity. In its 25 March announcement,5 Rutgers, a public university in New Jersey, refers to “three vaccines currently approved in the United States.” The University of Massachusetts Lowell initially stated6 that a mandate would not be legal, then flipped to issue a requirement for students. In an email to The BMJ, the university clarified that “students do not need to get a covid-19 vaccination immediately, they simply need to be fully vaccinated with a US approved covid-19 vaccine before returning to campus in the fall.”
What if approval is granted the day before classes resume? If University of California students wait, they may find themselves excluded: “If the proposed policy is adopted as drafted, students who choose not to be immunised [and don’t qualify for an exemption] ... will be limited in course registration, will not be permitted to attend in-person classes or events, and will not be able to access campus facilities including housing,” UC stated in an email response to The BMJ.
At least one school offers an exemption for students who decline covid-19 vaccination specifically because of EUA status. “Based on legal review we felt that was important due to the ambiguity in the federal statute [law],” says Justin Sloan, vice president for institutional effectiveness at St Edward’s University in Austin, Texas.
Colleges may require immunisation records for measles and meningitis, but requiring a product under emergency use authorisation would, on the face of it, seem contrary to the law. The Federal Food, Drug, and Cosmetic Act, which authorises the Food and Drug Administration to issue EUA, requires that the recipient has “the option to accept or refuse administration of the product.”
For international students, the requirement to receive the U.S.-approved covid-19 vaccine can exclude some of the effective vaccines and lead to wasteful duplication of vaccines, not to mention the scarcity of vaccines in some countries and regions.