Under federal law, can your employer make you get the COVID-19 vaccine?

Are state governments and private employers about to mandate COVID-19 vaccines?

There are many opaque current and future legal issues around COVID-19 and the measures to contain it. Pfizer and Moderna vaccines are emergency use products, and as such, not fully licensed. The law is clear: States may not mandate the vaccines, and private entities do so at the peril of violating federal law.

The law governing vaccines approved for emergency use

For the time being, there are only two COVID-19 vaccines available in the United States: the Pfizer-BioNTech vaccine and the Moderna vaccine. The U.S. Food and Drug Administration has issued them both Emergency Use Authorizations but not yet full vaccine licenses.

New York State Assemblywoman Linda Rosenthal recently proposed a bill to mandate COVID-19 vaccines, but the federal law on emergency use authorization prohibits the mandate.

“Emergency Use Authorization” means that any product with this designation must be voluntary. Under 21 U.S.C. § 360bbb-3, “Authorization for medical products for use in emergencies”:

(ii) Appropriate conditions designed to ensure that individuals to whom the product is administered are informed –

(I) that the Secretary [of Health and Human Services] has authorized the emergency use of the product

(II) of the significant known and potential benefits and risks of such use, and of the extent to which such benefits and risks are unknown and

(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.

Under federal preemption doctrine, this federal EUA law trumps state law, meaning that states and municipalities may not mandate EUA products. As the FDA stated:

“FDA believes that the terms and conditions of an EUA issued under section 564 preempt state or local law, both legislative requirements and common-law duties, that impose different or additional requirements on the medical product for which the EUA was issued in the context of the emergency declared under section 564 … In an emergency, it is critical that the conditions that are part of the EUA or an order or waiver issued pursuant to section 564A – those that FDA has determined to be necessary or appropriate to protect the public health – be strictly followed, and that no additional conditions be imposed.”

This was also confirmed in August 2020 at a Centers for Disease Control and Prevention published meeting of the Advisory Committee on Immunization Practices, where its Executive Secretary Dr, Amanda Cohn, stated (at 1:14:40):

“I just wanted to add that, just wanted to remind everybody, that under an Emergency Use Authorization, an EUA, vaccines are not allowed to be mandatory. So, early in this vaccination phase, individuals will have to be consented and they won’t be able to be mandated.”

Governors may not mandate EUA vaccines, or EUA tests for COVID infection. States cannot override federal law or set up their own mandatory scheme. See for example, Lorillard Tobacco Co. v. Reilly, 533 U.S. 525, 570-71 (2001), which overturned a state public health law because it was already the subject of a comprehensive federal scheme to manage public health, and Department of the Navy v. Egan, 484 U.S. 518, 530 (1988). For more information on state and local law, see this Emergency Use Authorization Toolkit from the Association of State and Territorial Health Officials.

What about private employers?

A private party, such as an employer, school or hospital, cannot circumvent the EUA law. For example, this Fact Sheet (https://www.fda.gov/media/144414/download) approved last month by the FDA for the Pfizer vaccine stated:

“It is your choice to receive or not receive the Pfizer-BioNTech COVID-19 Vaccine. Should you decide not to receive it, it will not change your standard medical care.”

The previously referenced section of the Federal Food, Drug, and Cosmetic Act governing medical products approved for emergency stated that the FDA-approved fact sheet must state “the consequences, if any, of refusing administration of the product.”

Nowhere in the fact sheet does it specify that a person may be fired from their employment, denied education, disciplined or otherwise discriminated against for refusal.

With that said, the law on private entities is likely to be litigated. Even the most ardent advocates for COVID-19 vaccines acknowledge that employer mandates would be “problematic” and would likely lead to litigation.

Indeed, the EUA law preventing mandates is so explicit that we found only one precedent case regarding an attempt to mandate an EUA vaccine, and the court held that the vaccine could not be mandated, even to people in the military. In Doe #1 v. Rumsfeld, 2005 U.S. Dist. LEXIS 5573 (D.D.C. Apr. 6, 2005).

In that case, six soldiers challenged the U.S. Department of Defense, which at the time mandated EUA anthrax vaccines, often leading to what has been called Gulf War Syndrome. Six soldiers sued DOD to refuse the vaccination and won. A federal court held that because the anthrax vaccine was an EUA product, the soldiers had the right to accept or refuse vaccination.

It’s a solid precedent showing that because a federal court upheld soldiers’ rights to decline EUA vaccines, it’s likely that courts would uphold employees’ rights to refuse EUA vaccines as well.

The FDA Fact Sheet for the Pfizer-BioNTech COVID-19 vaccine stated:“It is your choice to receive or not receive the Pfizer-BioNTech COVID-19 vaccine. Should you decide not to receive it, it will not change your standard medical care.” In other words, people cannot lose healthcare coverage for refusal.

The Informed Consent Action Network’s legal team is offering to help individuals challenge employers or schools that are requiring COVID-19 vaccinations.

Reprinted by permission from the Children’s Health Defense The views and opinions expressed in this article are those of the authors and do not necessarily reflect the views of Children's Health Defense.

Greg Glaser, J.D. is a vaccine rights attorney with a litigation and transactional law background.

Mary Holland is president of Children's Health Defense. She was research scholar and director of the Graduate Legal Skills Program at New York University School of Law. She is a founding board member of EBCALA.