May employers and universities require employees and students to obtain COVID-19 vaccinations before they return to workplaces and campuses? Back in February, attorney Aaron Siri argued that such requirements would be illegal because current vaccines only have emergency use authorizations. Siri wrote in Statnews’ First Opinion:
The same section of the Federal Food, Drug, and Cosmetic Act that authorizes the FDA to grant emergency use authorization also requires the secretary of Health and Human Services to “ensure that individuals to whom the product is administered are informed … of the option to accept or refuse administration of the product.”
Likewise, the FDA’s guidance on emergency use authorization of medical products requires the FDA to “ensure that recipients are informed to the extent practicable given the applicable circumstances … That they have the option to accept or refuse the EUA product …” . . .
When the FDA grants emergency use authorization for a vaccine, many questions about the product cannot be answered. Given the open questions, when Congress granted the authority to issue EUAs, it chose to require that every individual should be allowed to decide for himself or herself whether or not to receive an EUA product. The FDA and CDC apparently consider this fundamental requirement of choice important enough that even during the height of the Covid-19 pandemic they reinforced that policy decision when issuing their guidance related to the Covid-19 vaccines.
Whatever one makes of this argument as a policy matter, I find Siri’s arguments wholly unconvincing as a legal matter, and I am not alone.
Dorit R. Reiss, I. Glenn Cohen, and Carmel Shachar have an essay in Statnews’ First Opinion this morning explaining why Siri’s argument is wrong.
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.
This is an important point. The argument the private institutions may not require vaccinations of their employees or others is based upon reading the relevant statute extremely broadly to give it a sweeping preemptive effect. Such statutory interpretations are generally disfavored, and for good reason.
The authors also note that this legal argument sweeps quite broadly, and would suggest that universities and employers that require testing for those on-site (as my employer does) are also violating federal law.
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.
As the authors note, the policy question of whether a given employer or university should mandate vaccinations may be a more complex question, and there may well be jurisdictions in which such a requirement might be legally questionable, but federal law does not bar the adoption of such policies.
At my university, weekly testing has been required for everyone on campus since last fall. This policy is designed to help the university ensure a safe learning and working environment. A mandatory vaccination requirement, with a reasonable exemption for those with legitimate health or religious objections, would serve a similar purpose. There may be reasonable counter-arguments to the adoption of such a policy, but “federal law prohibits it” is not among them.
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