I have a question for our readers. Do you think it is legal for the president of the U.S. to mandate a vaccine to our citizens, that does not have FDA approval?
Once you have an Emergency Use Authorization (EUA), the federal government’s authority to institute a general vaccine mandate is unclear, and has not been tested in the courts, though it is limited at best.
The Commerce Clause of the U.S. Constitution gives Congress the power to regulate commerce between states as well as with foreign countries. Drawing on this authority, the Public Health Service Act (PHSA) authorizes the HHS Secretary to adopt quarantine and isolation measures to prevent the spread of communicable disease among states but does not specifically mention federal vaccine mandates. Read broadly, the PHSA might allow the federal government to mandate vaccines to prevent the transmission of infectious disease between states or from foreign countries, though such measures have not been adopted – or reviewed by courts – to date.
It is clear that the federal government does have authority to mandate vaccines for members of the military, and those targeted mandates have been upheld by courts. In addition, federal law mandates certain vaccinations for immigrants seeking to enter the U.S. General vaccine mandates, however, are generally within the purview of state and local governments, as explained below, with the federal government playing a supporting role.
For example, the increase in the number of states requiring vaccination to attend school is attributed to urging from the CDC after measles outbreaks in the 1960s. Otherwise, the federal government’s public health efforts have been largely focused on quarantine and isolation, rather than vaccine mandates.
It is unclear whether COVID-19 vaccination could be legally mandated while the FDA’s EUA is in place. Current mandates apply to vaccines that have been fully approved by the FDA. By contrast, COVID-19 vaccines have been authorized under the FDA’s temporary emergency use authority.
The EUA statue provides that 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.” Some commentators have interpreted this provision to mean that individuals cannot be required to receive a vaccine that is subject to an EUA.
Others have questioned whether the reference to “consequences” of refusing a vaccine subject to an EUA includes not only potential health consequences but also other adverse outcomes such as loss of employment.
The legislative history does not contain any references to mandates for vaccines under EUA. TheEUA law was created after the September 11th terrorist attacks, and to date, courts have not interpreted this provision.
Your comments are welcome.