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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.

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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.

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.

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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.

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.

Dorit R. Reiss is a professor of law at UC Hastings College of Law. Carmel Shachar is the executive director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. I. Glenn Cohen is deputy dean and a professor of law at Harvard Law School and director of the Petrie-Flom Center.

  • These aren’t vaccines though. Either they don’t provide immunity or it isn’t known if they do which is the only logical reason vaccinated people would still be required to social distance and wear masks in states where these things are required.

  • My employment is “at will”. As result, it seems from review of this topic, my employer can require that I have full COVID-19 vaccination prior to my return to my place of employment. Perhaps I have some religious belief that prevents me from accepting vaccinations, and my employer must allow an exception for that, but otherwise, currently it seems my employer can mandate I be vaccinated in a reasonable timeframe, or terminate me.
    I’m not saying I like this or I don’t. I’m trying to accurately draw the current legal line in this sand.
    I understand the EUA behind these vaccines specifically stipulates I must be informed that can opt out of getting this vaccine. The EUA is by context directed towards federal administrators, however, and not a private CEO or a dean of a private university. Seems my boss (and perhaps my State Governor), can determine a workplace specific policy (State specific policy) that best suits my place of employment (and perhaps my State of residence), until a point in time when a federal law is passed or precedent is set on a federal case that expressly prohibits private institutions from mandating COVID-19 or other EUAuthorized vaccinations as prerequisites for entry to a privately run business/State/university.

  • Shame on you. The laws around EUA’s were put into place to protect the public from this exact situation. You are using your opinion and numbers rooted in their own truncated data to try and give legal argument to take away, yet more, choices from people.

  • Hello Authors,
    Thank you for your time spent in providing this information.
    Quick question or clarification against employer “discrimination” based on “religious beliefs” provision/clause during the EUA period? Does the protection against discrimination apply to all 50 states? I recently read a brief (US Sup Crt.) stating that employers in California and a few other states can mandate/require their residents to take a vaccine based on the overall safety or protection of its residents (public safety supersedes individual rights). The brief did not cite the EUA or any language from the EEOC.

    Thank you in advance for any feedback.
    VR

  • My understanding of the EUAs for these vaccines is that the vaccine can only be administered on a voluntary basis and requiring someone to be vaccinated is explicitly prohibited by the EUA. Your article doesn’t address this. “…likely legal” seems like a weak argument when compared to an explicit prohibition. It’s either legal or not. Make the call and not a waffle.

    Postscript: I have received the vaccine and wish for my employer to only allow those vaccinated to return to the work place. I also support mask mandates for public places and within the work place.

  • Follow the science we are told. Well, if these vaccines are as effective as they say then the balance of the population should have nothing to fear from the relatively few of us who are uneasy about these particular vaccines for any reason. One of our local hospitals has been fully vaccinated, yet employees cannot have meetings to discuss patient care and other topics. WHY? They are ALL vaccinated. Someone please explain to me why, if these vaccines are so safe and effective, they have not returned to normal in that facility? Spare me the “will they can still catch it” line. THAT WILL ALWAYS BE TRUE. So do we then NEVER go back to normal because God forbid someone might get sick? Do we mandate yearly flu shots next?

    I refuse to accept a world where I have to “show my papers” to go to work, eat at a restaurant, or attend a concert. We tried that once. It was Nazi Germany. And yes, this IS a valid comparison because once this door is opened it will NEVER be closed again. It is also funny how HIPPA means that I cannot know if the person sitting next to be has TB, yet I have to PROVE I had a vaccine against a COMMON coronavirus to go to work? GIVE ME A BREAK

    • Agree with Paul-it’s not the “safe and effective” it is the “for the common good” argument. That often gets out of control-and anyone who doesn’t think so should go work in a LTC for a year and THEN tell me something done “for their own good” (the locking away for a year of the elderly) without FULL discussion of risks/benefits.
      Besides-which vaccine is OK? One shot or two-what if UK finds that only one shot of mRNA is good but US deems two is needed to be considered “vaccinated”? What about the “less effective” AZ one? Is that good enough? What about kids who have LOWER risk of covid than flu? Should we SELFISHLY HOARD yet MORE of the vaccine to get a super low risk group forcibly vaccinated while HIGH risk populations in less wealthy nations go without? Moral and ethical issues of this are NOT being discussed, just the usual liberal voices screeching “but we need vax for travel already” 100% willfully ignoring that is NOT what is being talked about. Having to show your “code” or be refused entry to shop/events/restaurant etc WILL create a segregated society. And this same group thinks they are for everyone’s equal rights

    • YES. This. 100%.

      We had Ebola in the US 6 years ago, and it was barely a blip on the radar. Freakin EBOLA, people! And now, if I sneeze on an airplane, I have to show my credentials and buy everyone a round of hand sanitizer. I mean…I just can’t even…

      I understand that it is serious for a segment of the population. I am not discounting that. But, folks – we have ventured far enough into Hysteriatown. It’s time to come back towards some form of sustainable rationalization.

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