Legal Considerations and Exemptions

  1. Overview
  2. Exemptions Planning Checklist and Process Flow Chart (docx)
  3. Example Exemptions Forms

This information is not legal advice. It identifies issues that should be considered, but may not be comprehensive. Employers should consult their own attorneys when making decisions regarding implementing a policy of COVID-19 vaccination as a condition of employment. Posted July 15, 2021.

Download fillable document with the below information (docx).

  1. Identify who will be the primary reviewers of the following documents/resources and who will make the decisions.
      • FDA
        • The federal agency charged with enforcing the words of the emergency use authorization (EUA) regulation.
        • Emergency Use Authorization (EUA):
          • The language on page 56 of the ACIP summary report, “under an EUA, vaccines are not allowed to be mandatory” and that “individuals…cannot be mandated to be vaccinated” does not extend to a condition of employment (CoE). A condition of employment policy is not a requirement for anyone to receive the vaccine. A person can decline, although it means that they may not be able to participate in the job or business. The words of the EUA regulation do not state that employers cannot require their employees to be vaccinated (subject to certain exceptions required by law) as part of their job qualifications. FDA makes no comment about employment on its EUA Page, the EUA regulation says nothing about vaccination as a condition of employment.
          • The only court that has interpreted the words of the EUA regulation to-date in the specific context of employees’ legal challenge to the legality of their healthcare employer’s policy of COVID-19 vaccination as a condition of employment found that the EUA regulation does not prohibit vaccination as a CoE.
        • Informed consent:
          • 21 U.S.C. § 360bbb-3(e)(1)(A)(ii) requires that informed consent be obtained from an individual before administering the vaccine, referring to informed consent in the context of a patient fact sheet (not employer fact sheet), available on FDA’s website.
          • Recipients of the vaccine under an EUA must be informed, to the extent practicable given the applicable circumstances that FDA has authorized the emergency use of the vaccine, of known and potential benefits and risks and the extent to which such benefits and risks are unknown, that they have the option to accept or refuse the vaccine, of available alternatives to the product.
      • EEOC
        • The federal agency charged with enforcing federal employment laws.
        • Federal EEO laws do not prevent an employer from requiring all employees entering the workplace to be vaccinated for COVID-19, as long as employers comply with the reasonable accommodation provisions of the ADA and Title VII of the Civil Rights Act of 1964 and other EEO considerations.
          • Title VII: 42 U.S.C. § 2000e-2 is the federal statute prohibiting discrimination on the basis of religion, and regulates the employer’s treatment of employees as “individuals.” (EEOC, K.12.)
          • ADA: COVID-19 and the ADA, the Rehabilitation Act, and other EEO laws (Section K) refers employers to the FDA’s EUA page for guidance as to how to assess the legal implications of EUA or the FDA approach to vaccines.
        • From an EEO perspective, employers should keep in mind that because some individuals or demographic groups may face greater barriers to receiving a COVID-19 vaccination than others, some employees may be more likely to be negatively impacted by a vaccination requirement.
        • Privacy requirements, data storage (EEOC, K.4.)
      • CDC’s official recommendation is “All healthcare personnel are recommended to get vaccinated against COVID-19,” which is the same language they use of other vaccines such as influenza and MMR. Based on these statements, many hospitals require these vaccines as a condition of employment.
      • CMS: FAQs regarding enrollment, reimbursement, vaccine administration and cost-sharing under Medicaid, CHIP, billing
      • OSHA: Occupational exposure to COVID-19; Emergency Temporary Standard. June 21, 2021 ed. Federal Register. p. 32376-628.
      • State and local laws and regulations: not in EEOC’s jurisdiction, and may place additional restrictions on employers.
      • Organizational:
        • HR policies
        • Policies for other required vaccinations (e.g. flu)

Cases and Actions

Current as of July 15, 2021

Recent cases and actions related to COVID-19 vaccination as a condition of employment may help illustrate how others have applied the legal criteria outlined above:


Sample Exemption Forms

Example Medical Exemptions Process

Last updated August 10, 2021