FDA approval: Does it matter in vaccine mandate?
Of the more than 500 college and universities requiring COVID-19 vaccines for students in the fall, a small percentage have chosen to add the tagline “with FDA approval” because doses still have not surpassed emergency use authorization.
One of those, at least initially, was the University of California system. But on Tuesday, it announced it was reversing course and moving forward without it after consultations with student health directors and faculty as well as the efficacy of the vaccines. The California State University system, meanwhile, is still standing by those words in its mandate.
Does that safer strategy provide an added layer of protection for those requiring vaccination? Perhaps, but it probably wouldn’t prevent lawsuits from being filed.
“This is a highly politically charged atmosphere, and if somebody wants to sue, they’re going to sue,” says Michael Vernick, partner in the law firm Akin Gump Strauss Hauer & Feld LLP in Washington, DC. “One of the reasons that a university might condition a mandate on a vaccine obtaining full FDA approval is that in their mind, it may reduce their litigation risk because similar requirements have generally been based on vaccines with FDA approval.”
Delaying the mandate until vaccines are fully authorized by the FDA – the same as MMR and flu vaccines, for example – could provide some protection from those institutions compared with institutions going straight ahead with requirements based on EUA.
Two vaccine makers – Pfizer and Moderna – have applied for full FDA approval, a process that typically requires six months of efficacy data. Many institutions still weighing their decisions are hoping to have those approvals by the fall.
Full mandates under EUA are still tricky for students because “it’s an untested area from a legal perspective,” Vernick says, and there are differences between public and private institutions.
“One argument [a plaintiff] could advance is that the vaccines don’t have full FDA approval, but whether they prevail in that lawsuit is a different question,” Vernick says. But he notes, once a vaccine gets “full FDA approval, that specific argument would be off the table.”
Either way, it is best to continually consult with legal counsel for any guidance on vaccination requirements. It is also important for institutions that have “asked”, “encouraged” or “expected” their populations to be vaccinated stay true to those statements. Without an official mandate, colleges and universities should not then impose fines or punish students since they have not made vaccines a requirement.
“If you’re going to have a rule that says, we really encourage people to get vaccinated – and then you impose a cost on them if they don’t – then I could see that triggering some sort of legal challenge,” Vernick says.
Time should also be a consideration. The closer colleges and universities get to the fall, the more complicated imposing a late vaccine mandate can have on potential student opportunities, transfers and acceptance offers.
“There’s all sorts of issues that a last-minute decision could trigger,” Vernick says.
One potential precedent-setting case came Monday from a federal district court judge in Texas who ruled against suspended Houston hospital employees who refused to get vaccinated despite the company’s requirement. They claimed vaccines were not safe, but the judge said vaccines’ history show otherwise. The decision could have implications in higher ed, especially for at-will employees and staff.