Ever since the Food and Drug Administration granted emergency use authorization for two new vaccines, employers, schools, and other organizations are grappling with whether to require Covid-19 vaccination.
While organizations are certainly free to encourage their employees, students, and other members to be vaccinated, federal law provides that, at least until the vaccine is licensed, individuals must have the option to accept or decline to be vaccinated.
Knowing what an organization can or cannot do with respect to Covid-19 vaccines can help them keep their employees, students, and members safe and also save the them from costly and time-consuming litigation.
The same section of the Federal Food, Drug, and Cosmetic Act that authorizes the FDA to grant emergency use authorization also requires the secretary of Health and Human Services to “ensure that individuals to whom the product is administered are informed … of the option to accept or refuse administration of the product.”
Likewise, the FDA’s guidance on emergency use authorization of medical products requires the FDA to “ensure that recipients are informed to the extent practicable given the applicable circumstances … That they have the option to accept or refuse the EUA product …”
In the same vein, when Dr. Amanda Cohn, the executive secretary of the CDC’s Advisory Committee on Immunization Practices, was asked if Covid-19 vaccination can be required, she responded that under 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 mandatory.” Cohn later affirmed that this prohibition on requiring the vaccines applies to organizations, including hospitals.
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As a point of reference I have received my 2 Pfizer shots