Judge Damon R. Leichty of the U.S. District Court for Northern Indiana ruled on Monday, July 19, that Indiana University could require that its students be vaccinated against the COVID-19 virus before coming to campus. With the Delta variant on the rise in the United States, hospitals in states where vaccination rates are now seeing a sharp rise of new COVID cases, and some counties reinstating mask requirements, the pandemic continues. Here, Stanford health law experts Michelle Mello and David Studdert discuss the ongoing pandemic, proof of vaccination “passports” at the state and federal levels, Judge Leichty’s decision, and how the law is developing.
Former head of HHS Kathleen Sebelius recently strongly advocated for proof of vaccination as a way for those who are vaccinated to get on with their lives. Is there a legal reason the Biden administration—or states like California—aren’t moving forward with vaccine “passports?” What are the legal downsides?
The legal path to establishing vaccine certification systems, and using them to regulate access to congregate settings, looks fairly clear. States and counties have the legal authority to do this, provided the public health threat is real and substantial—and the surge we are seeing today in infections and hospitalizations in almost every state puts that issue beyond doubt.
But there are a few wrinkles. First, any such program must be implemented evenhandedly, and can’t be used as a pretext for invidious discrimination. So, for example, businesses that insist on certification for their employees or customers may need to allow for exemptions on medical and religious grounds, and make some accommodations—for example, allowing unvaccinated employees back to workplaces if they mask and undergo regular testing.
Second, the path isn’t so smooth in the 15 or so states that, like Florida, have passed bans on vaccine certification requirements or vaccination mandates. The legality of some of those bans, particularly the ones passed by an executive order from the governor rather than a legislative process, is questionable. Expect some legal challenges.
Finally, there is a lingering question about whether it is lawful to insist on vaccination while the vaccines remain under an Emergency Use Authorization from the FDA, as opposed to full approval. Most public health law experts do not regard this as a meaningful impediment to passports, but perceptions of illegality have taken root. In any case, this concern will become moot later this year when two of the vaccines are expected to receive full approval.
When mask mandates and social distancing were lifted, some saw it as a missed opportunity to not tie it into a vaccine passport plan, using a return to “normal” as an incentive for vaccinations. What do you think?
Initially, this was probably more of a timing issue than anything else. Restrictions began to be lifted in many states before large segments of the population had access to vaccines, so it seemed unfair to condition privileges on vaccination at that time. But that has changed as vaccines have essentially become available to anyone 12 or older in the United States who wants one.
Why aren’t we hearing about more states requiring vaccine passports?
New York State was quick to adopt a passport system. Hawaii is now exempting vaccinated entrants from testing and quarantine requirements. And the European Union and several European countries are going all in on various vaccine passport systems. Why they have not taken off more in the US at this point is surprising, and something of a mystery.
One explanation is the perception, mentioned a moment ago, that they are somehow illegal. This is largely a misperception; there is a great deal of misinformation circulating in the media on this point.
But we suspect the main explanation is that a sort of equilibrium has been operating. The unvaccinated are obviously not going to agitate for vaccine passports. As for vaccinated people, the COVID-19 vaccines turned out to be so effective that many of them seem to feel reasonably comfortable shopping, dining, worshiping, and traveling alongside unvaccinated people.
We do not expect this equilibrium to last. The meteoric rise of the highly transmissible Delta variant in the United States, studies suggesting somewhat lower vaccine efficacy levels against Delta, and worries about young children who cannot yet access vaccines may prompt renewed calls for more of a shield from people who have chosen forgo vaccination.
Can people across the U.S. expect more vaccine passport programs soon?
A lot depends on where vaccination coverage tops out. As things stand now, vaccine certification programs could help nudge along a group that is a big contributor to COVID-19 spread: young adults. In an April 2021 survey, about 40% of unvaccinated adults aged 18-29 said they would be more likely to get the vaccine if it were required for air travel or attending concerts, sporting events, or other large gatherings. Certification requirements could also make a difference for the 38% of American adults who said in June that a major reason they haven’t gotten the vaccine is that they simply don’t think they need it. If Delta doesn’t convince them, perhaps their desire to take a flight or go watch their favorite team play will.
Even if we can reach 70 percent vaccination coverage nationally by late fall, vaccine certification programs are coming to some sectors, such as travel and live sports and entertainment venues. Private employers are the group to watch. If a large number of them decide to insist on vaccination as a condition of returning to work, like more than 400 colleges have now done for their students and faculty, that will go a long way to establishing certification as a norm in the community. It will also provide cover for other establishments, like restaurants and bars, that may want to ask this of employees and customers but worry about a backlash.
Now, a bit about Monday’s decision. What was the plaintiff’s main argument—and why didn’t it prevail?
Several students, some of whom had obtained an exemption from the university’s vaccination requirement and some of whom hadn’t requested one, asked the court to issue a preliminary injunction to block implementation of the mandate. They argued that it violated their substantive due process rights (basically, their personal liberty) and, for some, their right to free exercise of religion.
Prevailing on a motion for a preliminary injunction is tough: the plaintiffs have to show, among other things, that they’re likely to win on the merits of the case and that if they don’t get relief now they’ll be irreparably harmed. Judge Leichty said in no uncertain terms that their claims lacked merit.
Can you explain the main points of the decision?
Two aspects of the ruling are particularly notable.
First, the plaintiffs invited the judge to view this as a case where their fundamental rights were being abridged, but he instead chose to follow a long line of cases characterizing a person’s interest in refusing vaccination as a lesser liberty interest. This meant that the plaintiffs weren’t entitled to strict scrutiny, the most searching form of judicial review—only the far more deferential standard called rational basis review. Under that standard, the government will prevail unless the plaintiffs can show the regulation is not reasonably related to a legitimate government interest. Frankly, this was a no-brainer: The Supreme Court has already held that preventing the spread of COVID-19 is a compelling purpose, and it’s pretty clear that vaccination advances that interest. Even so, the judge took the time to digest the available data about the risks from COVID-19, risks associated with the vaccines, and benefits of vaccination, and easily concluded that the university’s decision was reasonable.
Second, the judge rejected the plaintiffs’ suggestion that the mandate violated their religious liberty. After all, students with religious objections could easily get an exemption. They argued they didn’t want to comply with the university’s alternative measures for students with vaccination exemptions: masking and testing. But the court didn’t credit their religious objection to those measures.
The key aspect of this part of the ruling is that the court concluded, without laboring over the issue, that the mandate was a neutral law of general applicability. That is, it applies to everyone regardless of religion. Such laws only get rational basis review, under a 1990 Supreme Court precedent called Employment Division v. Smith. The Smith holding has been under pressure—in a Court decision in June called Fulton v. City of Philadelphia, five justices voiced complaints about it. The Fulton Court said that it didn’t need to decide in that case whether to overrule Smith, but it held that any law that allows for individualized exemptions isn’t generally applicable and therefore should get strict scrutiny. That raises the question, if a vaccination mandate law allows for religious or personal belief exemptions, does that now vault it out of the land of rational basis review? The judge in the Indiana case didn’t comment on this possibility, which is pretty intriguing.
If an appeal goes to the Supreme Court, how do you expect it to play out there?
It’s unlikely that if the Supreme Court chooses to take a vaccination mandate case, this will be the one it selects. There are some issues that are unique to COVID-19 vaccines, and some that may be moot by the time the case reached the Court—for example, the fact that the vaccines are currently marketed only under an Emergency Use Authorization. Additionally, the main reason the Court would be interested in considering vaccination mandates is to resolve an issue that has long been percolating in the lower courts: whether they need to provide a religious exemption. Indiana University’s mandate does, so it’s not the right case to test that issue.
Circling back to the Florida law and other states that have banned vaccine passports, will today’s ruling affect those laws?
The ruling doesn’t speak to these laws. The Indiana law is about what a state can require individuals to do in order to protect public health. The Florida law—which contains a bunch of other controversial rules in addition to the vaccination provision—raises a different issue: may a state block localities and private businesses from adopting reasonable measures to protect public health? Laws like Florida’s are the latest—and most dangerous—salvo in a longstanding campaign by groups opposed to the expanding reach of public health law to preempt actions by local governments.
David Studdert and Michelle Mello are experts in the fields of health law and empirical legal research. Both are professors of law at Stanford Law School and professors of medicine at the Stanford University School of Medicine.