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Will there be liability protection for administering vaccines?

Yes. According to “The PREP Act and COVID-19: Limiting Liability for Medical Countermeasures,” during a public health emergency, the Secretary of Health and Human Services (HHS) is authorized to limit legal liability for losses related to the administration of medical countermeasures. As a result of the pandemic, the HHS Secretary invoked the PREP Act on February 4, 2020, and declared COVID-19 to be a public health emergency.

This protection provides immunity from legal liability for losses relating to the administration of medical countermeasures, such as diagnostics, treatments, and vaccines. The sole exception to PREP Act immunity is for death or serious physical injury caused by “willful misconduct.”

If you engage in COVID-19 vaccine administration, federal law under the PREP Act protects you from civil liability.

You are entitled to PREP Act immunity when:

  1. You are a “Covered Person,” because you are a licensed medical provider or a facility/practice;
  2. You are engaging in a “recommended activity,” because you are administering an FDA-approved COVID-19 vaccine;
  3. The alleged injury is causally related to the administration of the COVID-19 vaccine; and
  4. The COVID-19 vaccine is administered in accordance with the public health and medical response of the jurisdiction where the vaccine is administered.

The PREP Act provides immunity from suit and liability to licensed medical providers (including those practicing outside their scope of practice, out-of-state practitioners, and volunteer practitioners); persons and corporate entities who supervise or administer COVID-19 vaccine programs; and facilities administering the COVID-19 vaccine. They are covered when administering an FDA-approved COVID-19 vaccine and when the vaccine is obtained or administered through a federal or private distribution channel or pursuant to authorization by the state or locale as part of their public health and medical response.

Immunity from suit and liability will apply when the alleged injury or death is caused by, arises out of, relates to, or results from the administration of the COVID-19 vaccine. This piece is broad enough to include those injuries sustained by a person who, for example, might fall on the premises while seeking to obtain the vaccine.

For a more detailed discussion of COVID-19 PREP Act immunity, please see this resource on “Federal Healthcare Worker Immunity Pursuant to COVID-19 PREP Act Declaration” by Hall Booth Smith, P.C.

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All Curi recommendations are based on current CDC criteria at the time of publication. CDC guidance for SARS-CoV-2 infection may, or may not, be adopted by state and local health departments to respond to rapidly changing local circumstances. Providers should always check with their local health department to see if the CDC’s guidance on any given topic has been modified (particularly if more restrictive) from the CDC’s recommended guidelines. Follow this link https://www.cdc.gov/publichealthgateway/healthdirectories/index.html for contact information to your state/local health department. If local recommendations vary from those of the CDC, and you are unsure what recommendations to follow, then it is safer to follow the more restrictive guidelines/recommendations.