‘Authorization’ status is a red herring when it comes to mandating Covid-19 vaccination
Covid-19 vaccines offer a way out of the global crisis that has upended — and cut short — lives for more than a year. Three vaccines have now received emergency use authorization (EUA) from the FDA.
One question that employers and universities must rapidly consider and act upon is whether to mandate that returning employees and students be vaccinated.
Some employers are starting to require Covid-19 vaccines, and Rutgers University became the first university to mandate them for students and employees.
One argument against mandates is that individuals cannot be required to get a vaccine that is being distributed under an EUA, as opposed to a full license, an argument made in a recent First Opinion. That would potentially delay Covid-19 vaccine mandates until the FDA approved the first vaccine under a biologics license application (BLA) — and so far the timing of that is unknown.Related:
Federal law prohibits employers and others from requiring vaccination with a Covid-19 vaccine distributed under an EUA
Important nuances lead us to a very different conclusion: There are few to no legal barriers to employers or schools requiring vaccines being distributed under EUAs.
A little context to begin: This is new ground. The FDA has never before granted an EUA for a vaccine for the entire population, so there is no perfect precedent here. Employers, especially health care entities, and universities have, however, historically mandated vaccines. These mandates, which are designed to increase safety, stand on solid legal ground, though accommodations may be legally required for those with disabilities or religious beliefs.
Among those who believe that EUA vaccines cannot be mandated, the best two arguments are a legal argument and a policy one. The legal argument is that the law setting out the requirements for emergency use authorization contains language requiring the Secretary of Health and Human Services to ensure that people know they can refuse or accept the vaccine. The same language requires the informational materials accompanying EUA vaccines to tell people that “It is your choice to receive” the relevant vaccine.
The policy argument against mandates is that the standards for emergency use authorization are lower than the standards for full approval, that the vaccines are “experimental” and not enough is known about them, and it is therefore unfair to mandate them. Two lawsuits have already been filed making both the legal and policy arguments, one by a corrections officer in New Mexico, and one by employees of the Los Angeles United School District.
There are good reasons to reject both of these arguments, though. On the legal side, the EUA statute says nothing directed at employers or universities. Instead, it addresses the actions of federal officials, such as the HHS secretary and the president — not private actors. Private employees are generally “at will,” meaning they can be terminated for any reason that is not explicitly illegal. Those arguing that the EUA statute prohibits mandates by at-will employers are claiming that this federal law is changing existing state employment law on the topic by mere implication. They are reading in a broad prohibition covering all employers and universities in the U.S. that is not, in fact, in the statute. Such broad preemption would require, at a minimum, clearer language.Related:
Resistance from health experts and business owners could doom ‘vaccine passports’ even before they launch
During the pandemic, employers and universities have already required Covid-19 tests, many of which are being provided under emergency use authorization, for their in-person employees and returning students. If mandating products like tests under an EUA is unlawful, then every employer or university requiring the use of those tests has been flagrantly violating the law.
Before the pandemic, the general position of the relevant federal agencies, such as the Food and Drug Administration and the Centers for Disease Control and Prevention, was that vaccines provided under emergency use authorization cannot be mandated. But that guidance was not binding. When confronted with pandemic realities, the federal government took the position that “[w]hether an employer may require or mandate Covid-19 vaccination is a matter of state or other applicable law.” Legally, there is nothing to prevent such a reasonable position shift.
Critics of mandating Covid-19 vaccines often cite their “experimental” nature and EUA status. It is true that, formally, the emergency use authorization requires substantially less evidence than does approval of a biologics license application. But Covid-19 vaccines were held to a high standard, which the FDA has described as EUA-plus.
These emergency use authorizations were issued based on data from clinical trials including tens of thousands of people — as comprehensive as the data generally submitted for licensed vaccines. Further, the data supporting their use are extremely strong. mRNA vaccines are more than 90% effective. Not only did the trials not raise safety concerns but now, with tens of millions of doses given in what is probably the most closely observed vaccination effort in the United States, the vaccines’ safety record is very strong. mRNA vaccines do cause higher rates of allergic reactions than routine vaccines, but even those are rare — 2 to 11 per million doses. Other than that, no serious harms have been convincingly linked to the Covid-19 vaccines authorized in the United States.
The federal government has traditionally regulated employers and universities in two ways. It has used regulations to increase safety in the workplace. The federal government generally does not intervene to prohibit safety measures or, in other words, to decrease safety. It also regulates employers and universities to prevent some types of discrimination against those with disabilities or based on religion. Along those lines, the Equal Employment Opportunity Commission has made it clear that employers may exclude from the workplace employees who refuse to be vaccinated, but should not discriminate against those who cannot receive Covid-19 vaccines because of an underlying disability or religious belief.
A vaccine requirement is a safety measure, in that it is meant to protect the health of employees, clients, students, and others in workplaces or schools. Employment in the U.S. is largely at will, allowing employers wide latitude in setting workplace rules. Without clear indications that requiring Covid-19 vaccination is legally forbidden, employers and universities should be allowed to do that — which isn’t to say a vaccine mandate is the right choice for a university or employer. That is a more complex question that will depend on expectations of how many employees or students will get vaccinated without a mandate and the effect of mandates on vaccine hesitancy.
But it is likely a legal choice, despite the EUA status of these vaccines.