C.Ovid-19 vaccines offer a way out of the global crisis that has changed and shortened lives for more than a year. Three vaccines have now received Emergency Use (EUA) approval from the FDA.
One question that employers and universities need to quickly review and address is whether or not vaccination should be mandatory for returning workers and students.
Some employers are starting to require Covid-19 vaccines, and Rutgers University was the first university to commission them for students and employees.
One argument against mandates is that individuals cannot be required to obtain a vaccine sold under an EEA as opposed to a full license, an argument made recently in an initial statement. This would potentially delay the vaccine mandates for Covid-19 until the FDA approves the first vaccine as part of a biologics license application (BLA) – and the timing is as yet unknown.
Key nuances lead us to a very different conclusion: there are few or no legal barriers for employers or schools requiring vaccine distribution under EUAs.
A little context to start with: This is new territory. The FDA has never before issued an EEA for a vaccine to the whole population, so there is no perfect precedent here. However, employers, especially health institutions and universities, have historically mandated vaccines. These mandates, which are designed to increase safety, have a solid legal foundation, although accommodation for people with disabilities or religious beliefs may be required by law.
Among those who believe EUA vaccines cannot be prescribed, the two best arguments are legal and political. The legal argument is that the law laying down the requirements for authorization to use in emergencies contains a language in which the Minister of Health and Human Services is required to ensure that people know they are rejecting the vaccine or can accept. That same language requires that the informational materials that come with EEA vaccines tell people that “You have a choice to get the appropriate vaccine”.
The political argument against mandates is that the standards for emergency use authorization are lower than the standards for full authorization, that the vaccines are “experimental” and not well known about them and therefore it is unfair to mandate them. Two lawsuits have been filed, both legal and political, one by a correction officer in New Mexico and one by employees of the Los Angeles United School District.
However, there are good reasons to reject both of these arguments. On the legal side, the EEA statute says nothing that is aimed at employers or universities. Instead, it is about the actions of federal officials like the HHS secretary and president – not private actors. Private employees are usually “at will”, ie they can be terminated for a reason that is not explicitly illegal. Those who argue that the EEA law prohibits mandates from arbitrary employers claim that this federal law only implicitly changes existing state labor law on the issue. You are reading a broad prohibition that covers all employers and universities in the United States and that is not included in the law. Such a broad advance payment would at least require clearer language.
During the pandemic, employers and universities have already requested Covid-19 tests for their personal employees and returning students, many of which are provided under emergency authorization. If mandating products such as tests under an EEA is illegal, then any employer or university requiring the use of those tests has openly broken the law.
Prior to the pandemic, the general position of federal agencies such as the Food and Drug Administration and Centers for Disease Control and Prevention was that vaccines that are provided under emergency authorization cannot be mandated. However, these instructions were not binding. When the federal government was confronted with pandemic realities, it took the position that “[w]Whether an employer requires or requires a Covid-19 vaccination is a matter of state or other applicable law. “Legally, there is nothing that could prevent such a sensible shift in position.
Critics of the mandate of Covid-19 vaccines often cite their “experimental” character and EEA status. It is correct that authorization for emergency use formally requires much less evidence than authorization of a license application for biologics. However, Covid-19 vaccines have been kept to a high standard, which the FDA has termed EUA-plus.
These emergency clearances were based on data from clinical trials involving tens of thousands of people – as extensive as the data generally submitted for approved vaccines. In addition, the data that supports its use is extremely strong. mRNA vaccines are more than 90% effective. Not only have the studies not raised any safety concerns, but now the vaccine safety record is very high, with the tens of millions of doses given in what is perhaps the most closely monitored vaccination effort in the United States. While mRNA vaccines cause a higher rate of allergic reactions than routine vaccines, even these are rare – 2 to 11 per million doses. Other than that, no serious harm has been convincingly linked to the US-approved Covid-19 vaccines.
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 usually does not intervene to ban security measures or, in other words, to reduce security. It also regulates employers and universities to prevent certain types of discrimination against people with disabilities or based on religion. With that in mind, the Equal Employment Opportunity Commission has made it clear that employers may exclude workers who refuse to be vaccinated from the workplace but should not discriminate against those who are not receiving Covid-19 vaccines because of an underlying disability or religious belief can.
A vaccine requirement is a safety measure in that it is designed to protect the health of employees, customers, students, and others in the workplace or school. Employment in the United States is largely ad libitum, giving employers a lot of leeway in setting workplace rules. Without clear evidence that the requirement of a Covid-19 vaccination is prohibited by law, employers and universities should be allowed to do so – which does not mean that a vaccine mandate is the right choice for a university or an employer. This is a more complex question, based on expectations of how many unmandated staff or students will be vaccinated and the impact of mandates on vaccine hesitation.
Despite the EEA status of these vaccines, this is likely a legal choice.
Dorit R. Reiss is Professor of Law at UC Hastings College of Law. Carmel Shachar is the executive director of the Petrie Flom Center for Health Policy, Biotechnology and Bioethics at Harvard Law School. I. Glenn Cohen is Associate Dean and Professor of Law at Harvard Law School and Director of the Petrie Flom Center.