Vaccine mandates don’t violate federal food and drug law

The Food, Drug, and Cosmetic Act (FDCA), which authorizes emergency use authorization (EUA) for vaccines, doesn’t prohibit entities, including employers, from requiring COVID-19 vaccinations even if the shots are authorized for emergency use only, according to a recent legal opinion from the U.S. Department of Justice (DOJ).

Background

All currently available COVID-19 vaccines (Pfizer, Moderna, and Johnson & Johnson) were approved in the United States on an expedited basis under an FDCA provision that permits an EUA for a medical product, such as a vaccine, under certain emergency circumstances. One of the most common legal challenges employer vaccine mandates have faced is that because the three vaccines currently have only emergency-use status, employers can’t lawfully require them.

Challengers have relied on a Food and Drug Administration (FDA) regulation providing that with respect to vaccines subject to EUA status, individuals must be informed “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.”

DOJ position consistent with recent rulings