By Holly Fernandez Lynch and Govind Persad / Special To The Washington Post
As businesses, universities and other organizations ponder a return to something like normal operations, the ethics and legality of coronavirus-vaccine mandates have become the subject of intense debate.
Dozens of universities say they will require students and staff members to be vaccinated (typically with medical and other exemptions), and some school districts are requiring vaccination of their employees; as are some private employers. Other organizations have held off, worried about legal challenges to requiring vaccines that have been only conditionally approved for “emergency use.” The University of California system, for instance, says it will delay mandates until coronavirus vaccines gain the full imprimatur of the Food and Drug Administration.
In the face of this debate, several states are considering barring coronavirus-vaccine requirements, or have already done so, including for employees or students. Some of these efforts also seek to block “vaccine passports,” which (if adopted) would condition access to a variety of “goods and services” on vaccination status. Where vaccine mandates have been implemented, legal challenges have followed close behind, including cases filed by a group of Los Angeles teachers and a corrections officer in New Mexico. We believe these and similar lawsuits broadly challenging coronavirus vaccine requirements are likely to fail. Just as schools and private employers can require vaccines for the measles, flu and other diseases, they can require coronavirus vaccines; even before those vaccines have full approval.
In general, both public and private entities have well-established legal authority to impose vaccination requirements. The question is whether that holds when a vaccine is available only via a temporary “emergency use authorization.” In a recent article for STAT, attorney Aaron Siri warned that this temporary status blocks organizations from doing anything more than strongly encouraging people to get the jab.
It’s true that the three coronavirus vaccines available in the United States, from Pfizer-BioNTech, Moderna and Johnson & Johnson, have not yet received traditional approval. The FDA nonetheless allows their use because it determined that the vaccines’ known and potential benefits outweigh their known and potential risks and that they “may be effective” in preventing covid-19. Each vaccine demonstrated safety and efficacy in clinical studies to the FDA’s satisfaction under this exceptional emergency standard.
Soon the companies will apply for full approval on the basis of more extensive data. When that’s granted, the question of coronavirus-vaccine mandates will no longer be unique. But can the vaccines be required in the meantime? Writers such as Siri, as well as those challenging mandates in court, point to language in FDA’s emergency use authorization statute indicating that people receiving such products must be informed “of the option to accept or refuse administration.” The FDA’s guidance on the law contains similar language. But the relevant text doesn’t stop there (although Siri’s quoting of it does). Patients also must be given information about “the consequences, if any, of refusing administration of the product.” Clearly, then, consequences for refusal can coexist with the option to refuse. The FDA doesn’t specify what those consequences might be, but it also doesn’t limit them. If Congress or FDA had meant to remove the authority to mandate vaccines — an authority traditionally left to state and local governments — the Emergency Use Authorization statute and guidance would have needed to be much clearer on that point.
Keep in mind that although coronavirus-vaccine requirements are often described as “mandates,” there are significant limitations to these edicts. They don’t encompass any physical compulsion to be vaccinated: No one is going to hold you down to give you the shot. Instead, these mandates might better be viewed as choices with consequences; consequences those refusing vaccination might not like, such as job loss, fines, one more year of Zoom college, or exclusion from flights, concerts or bars, but these are choices nonetheless.
Before you shout, “That’s coercion!,” it’s not; at least not in any problematic sense. Problematic coercion goes beyond merely constraining choice. Instead, it involves threats to violate someone’s rights to get them to comply. You might feel “coerced” into paying your mortgage if the bank threatens foreclosure, but you have no right to maintain the benefits of possession free. Similarly, there’s no general right to be free of vaccine mandates. Although some states may be seeking to grant that freedom, FDA’s required option to refuse vaccines authorized for emergency use doesn’t itself do so. To the contrary, those subject to an emergency-use vaccine mandate retain the option to refuse and accept the consequences. That’s all FDA law requires.
The Centers for Disease Control and Prevention and the Equal Employment Opportunity Commission also contemplate coronavirus vaccine mandates as a legitimate possibility not limited to fully approved products. In its guidance to employers, for instance, the CDC mentions that “whether a state, local government, or employer … may require or mandate covid-19 vaccination is a matter of state or other applicable law.” For its part, the EEOC offers extensive guidance to employers who impose coronavirus-vaccine mandates, with no reference to any emergency use limitation. The commission does say that employers may first have to offer reasonable accommodations to an employee who refuses vaccination on the basis of religion or disability, such as the option to work remotely, if possible, but that’s not specific to the coronavirus vaccine.
Despite all this evidence to the contrary, an organization suing on behalf of a group of L.A. public-school teachers asserts that mandating coronavirus vaccination before full approval amounts to nonconsensual medical experimentation, and the New Mexico detention center officer alleges he’s being forced to be a “human guinea pig.” These claims are also wrong. Codes of research ethics and FDA regulations do generally require a special consent process for medical research. But coronavirus vaccines are not being mandated as a mechanism to study them. They’re being mandated because we’re facing a public health emergency, and the FDA determined that there was adequate evidence of safety and efficacy to justify the use of these products without further delay; in fact, it required even more evidence for emergency use of vaccines than the relevant law technically demands. That law also explicitly states that providing a product under emergency use authorization “shall not be considered to constitute a clinical investigation.” Even when FDA grants full approval, that doesn’t mean all uncertainties about a product have been resolved; and the presence of some residual uncertainty doesn’t mean that widespread use of a product amounts to experimentation.
Most important, freedom of choice prevails even in the face of coronavirus vaccine mandates. You get to decide whether emergency-use authorization products are safe and effective enough for you, while employers, schools, businesses and others can decide whether you’re safe enough to have around without being vaccinated.
Vaccine mandates may be more critical in some settings such as nursing homes, than others. Anyone considering imposing a mandate should carefully assess their costs and benefits. In some cases, convenient vaccine access, information campaigns, or incentives — such as West Virginia’s $100 payments — may be enough. But decision-makers who judge mandates to be the best option to protect those in their orbit should not be dissuaded by legal concerns, even before full FDA approval.
Holly Fernandez Lynch is the Dr. John Russell Dickson presidential assistant professor of medical ethics in the department of medical ethics and health policy at the Perelman School of Medicine, University of Pennsylvania. Govind Persad is an assistant professor at the Sturm College of Law at the University of Denver.