By Dorit Rubinstein Reiss
Several months ago, I wrote a post asking whether employers can mandate the uptake of a vaccine under an Emergency Use Authorization (EUA). My view then was that there was substantial legal uncertainty, but that the balance indicated that at the least, they may be possible, at the discretion of the Secretary of the Department of Health and Human Services (HHS).
Much of that discussion is still relevant, but developments and new points brought to my attention since have changed my view.
At this point, while there is still legal uncertainty, my view is that the balance of factors supports the ability of employers (or states) to require EUA vaccines. Courts vary, but my current assessment is that most courts would be inclined to uphold an employer mandate for an EUA COVID-19 vaccine.
The relevant statutory provision at issue is section 360bbb-3 (e)(1)(A)(ii)(III) of the Food, Drug and Cosmetics Act – 21 U.S.C. 564, “Authorization for medical products for use in emergencies.”
This EUA statute includes a “required condition,” which stipulates that the Secretary of HHS (or, in practice now, the FDA Commissioner) must “ensure that individuals to whom the product is administered are informed –
(III) of the option to accept or refuse administration of the product, of the consequences, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks.” (emphasis added)
Additionally, there is a specific exception allowing the President to waive this requirement of choice, but only for people in the armed forces, and only in certain specific circumstances. 10 U.S.C. §1107a (The first vaccine authorized under an EUA was an anthrax vaccine for the armed forces, so this was of relevance early on.)
Together, these two provisions were the basis of a longstanding belief of federal agencies — FDA and CDC — that vaccines cannot be mandated under an EUA. That belief, however, has never been formally set out in an administrative action, which would usually get high deference.
Practically, the federal government has consistently seen products under emergency authorization as not suitable for mandating. The ethical argument is that these products are still experimental, and therefore should not be mandated.
However, the question has never been tested in court, and there are very strong legal arguments against this view.
First, the EUA statute itself mentions that there may be consequences to the failure to take an EUA vaccine.
While the EUA fact sheets put forth Pfizer and Moderna do not inform recipients of any potential employment consequences, the general legal reality is that employment in the United States is at-will, and employers can fire employees for almost any reason, with few exceptions from anti-discrimination laws.
Employers can certainly fire employees for violating a health and safety requirement, or for outright refusing to follow it. Vaccine mandates in the workplace are such a requirement, and have been used for a long time, for example, to require influenza vaccines for health care providers. Employers can generally mandate vaccines, with potential exceptions from the Americans with Disabilities Act, and the Civil Rights Act of 1964. Employers may also have to negotiate with a union, depending on collective bargaining agreements.
States can also impose vaccine mandates, at least to some degree.
The EUA act addresses the Secretary of HHS, providers of the authorized product, and its recipients. It says nothing about employers or states. Arguing that the act can overturn a legal reality by implication alone, that employers are now prohibited from doing something they have been doing for decades, is a tall order. Especially when the statute is not clear: by suggesting there could be consequences for refusing the vaccine, it clearly sees that the right to refuse is not absolute.
In its guidance on the issue, the Equal Employment Opportunities Commission (EEOC) did not say expressly that it is permissible to mandate a vaccine under an EUA on the same terms as other vaccines, but the guidance strongly implies that such vaccines may be treated like regularly-approved vaccines. That was how it was interpreted by other readers, as well.
Further, we know that many employers have mandated COVID-19 testing as part of their work routine — and at least some tests are still under an EUA, so there is some precedent in practice for mandating an EUA product, though it has not been tested in the courts.
The ethical picture is also far from one sided. First, it’s important to remember that COVID-19 vaccines were authorized under an EUA-plus standard, requiring more than usual EUAs.
Further, the data behind them so far is extraordinarily strong, showing high levels of safety and effectiveness. This data is as strong as the data behind fully authorized vaccines, weakening the claim that the vaccines should not be mandated because they are experimental.
Not allowing employers to mandate vaccines can, in the wrong circumstances, have dramatically high costs. We know there has been hesitancy in long-term care facilities, where cases and deaths are high, and the population vulnerable — and often unable to just leave. If a long-term care facility concludes that mandating the vaccines would prevent deaths and harms to residents, saying they cannot mandate it (without a clear legal prohibition) means accepting these deaths and harms. That’s problematic.
If a small business concludes a vaccine mandate would help it stay afloat, that may be less glaring than death and harm, but can be crucial to that business and the economic viability of both owners and employees. People can face eviction and economic ruin when business need to close; that much we have already seen in this pandemic.
Businesses that require vaccines under EUA are taking a legal risk, but, given the circumstances, also have good legal arguments for the mandates. And whether it is appropriate or not is very fact dependent. I do not expect many businesses to require a vaccine in these conditions; but claiming they cannot legally do so is inaccurate, and can increase harms.