The PREP Act's liability immunity applies to “covered persons" with respect to administration or use of a “covered countermeasure." Qualified persons are one category of covered person. “Qualified person" is defined in the PREP Act as:
- A licensed health professional or other individual who is authorized to prescribe, administer, or dispense covered countermeasures under the law of the state in which the countermeasure was prescribed, administered, or dispensed; or
A person within a category of persons identified as qualified in the Secretary's declaration.
Thus, the current PREP Act Declaration covers any provider authorized under state law, as well as additional categories of persons identified in the declaration.
Additional qualified persons identified in the declaration include any individual acting in accordance with the authority having jurisdiction to respond to a declared emergency, such as those authorized under state emergency authorities responding to a state emergency, individuals identified under certain authorities under the Federal Food, Drug & Cosmetic (FD&C) Act, and persons.
Qualified persons include specified active and recently retired healthcare professionals and students of healthcare professions, with specified training and/or supervision specified in the declaration who administer vaccines and therapeutics against smallpox (variola virus), mpox virus, and other orthopoxviruses via subcutaneous, intradermal, or intramuscular injections, via dermal/percutaneous scarification, or administered orally or intranasally during a federal, state, regional, or local declared emergency.
These specified professionals and students include any dentist, advanced or intermediate emergency medical technician, licensed or certified professional midwife, nurse, advanced practice registered nurse, registered nurse, licensed practical nurse, optometrist, paramedic, pharmacist, pharmacy intern, pharmacy technician, physician, physician assistant, podiatrist, respiratory therapist, or veterinarian
Covered countermeasures may include vaccines, therapeutics, drugs or diagnostics that are used in accordance with certain authorizations provided by the Food and Drug Administration (FDA) (i.e., license, clearance, approval, emergency use authorization (EUA), or authorization for investigational use) or emergency use instructions provided by the CDC and respiratory protection devices regulated by the National Institute of Occupational Safety and Health. Active and recently retired healthcare professionals and students of healthcare professions are authorized to administer vaccines and therapeutics during a declared emergency under the conditions stated in the declaration. Other qualified persons, such as providers authorized under state law, may administer any countermeasure covered by the declaration.
For full list of covered and qualified persons please see section V of the declaration, as amended, for
PREP Act Coverage for Countermeasures against Smallpox, Monkeypox, and other Orthopoxviruses.