States and employers, under federal law, can’t mandate emergency use products such as the Pfizer and Moderna COVID vaccines. But that doesn’t mean some won’t try.
There are many opaque current and future legal issues around COVID-19 and the measures to contain it. Fortunately, because the 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 (FDA) has issued them both Emergency Use Authorizations (EAU) but not yet full vaccine licenses.
New York State Assemblywoman Linda Rosenthal recently proposed a bill to mandate COVID-19 vaccines, but she apparently neglected to consult federal law on emergency use authorization.
“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.