Public Readiness and Emergency Preparedness (PREP) Act Coverage

The Public Readiness and Emergency Preparedness (PREP) Act authorizes the Secretary of the Department of Health and Human Services (Secretary) to issue a PREP Act declaration. The PREP Act Declaration for Smallpox, Monkeypox, and Other Orthopoxvirus Countermeasures, as amended:

• Reflects a determination by the Secretary that there is a credible risk that smallpox (variola virus), monkeypox virus (formerly known as mpox), or other orthopoxviruses and the resulting disease or conditions in the future may constitute a public health emergency and that the 2022 outbreak of monkeypox cases in the United States presents a public health emergency;

• Provides liability immunity (except for willful misconduct) to entities and individuals involved in the development, manufacture, testing, distribution, administration, and use of such countermeasures;

• Authorizes additional providers to administer vaccines and therapeutics for the identified diseases, threats, and conditions during a declared emergency; and

• Provides liability immunity for claims of loss caused, arising out of, relating to, or resulting from administration or use of countermeasures to the identified diseases, threats and conditions.

A PREP Act declaration is specifically for the purpose of providing immunity from liability, and is different from, and not dependent on, other emergency declarations.

Yes, the 2022 declaration, as amended, for PREP Act Coverage for Countermeasures against Smallpox, Monkeypox, and other Orthopoxviruses includes liability coverage for countermeasures against smallpox (variola virus), monkeypox virus, and other orthopoxviruses. Prior to the 2022 amendment, the January 2016 amendment to the PREP Act Declaration for Smallpox Countermeasures included liability coverage for "smallpox countermeasures against variola virus or other orthopoxviruses". The virus causing monkeypox is an orthopoxvirus, and therefore monkeypox countermeasures were covered under the January 16 amendment, even though the amendment did not explicitly refer to monkeypox.

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), monkeypox 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.

Under section 564 of the FD&C Act, when the Secretary declares that an EUA is appropriate, FDA may authorize unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by chemical, biological, radiological, and nuclear (CBRN) threat agents when certain criteria are met, including when the known and potential benefits of the authorized use outweigh the known and potential risks.

The EUA authority allows FDA to help strengthen the nation's public health protections against CBRN threats including infectious diseases, by facilitating the availability and use of medical countermeasures needed during public health emergencies.

On August 9th, 2022, an EUA was issued for the JYNNEOS vaccine, an FDA-licensed vaccine approved for the prevention of smallpox and monkeypox, to provide for an unapproved use of the product. Specifically, the EUA allows: (i) two doses (0.1 mL each) of JYNNEOS 4 weeks apart via the intradermal route of administration to individuals 18 years and older determined to be at high risk for monkeypox infection; and (ii) two doses (0.5 mL) of JYNNEOS 4 weeks apart via a subcutaneous route of administration to individuals younger than 18 years of age determined to be at high risk for monkeypox infection. 
 

Section 564A of the FD&C Act authorizes HHS to take other emergency actions to facilitate availability and use of medical countermeasures during public health emergencies, such as issuing emergency dispensing orders, or issuing emergency use instructions.

The PREP Act provides liability immunity against all claims for loss caused by, arising out of, relating to, or resulting from the administration to or the use by an individual of a covered countermeasure for which a PREP Act declaration has been issued by the Secretary. Under the PREP Act, "loss" means any type loss, including (i) death; (ii) physical, mental, or emotional injury, illness, disability, or condition; (iii) fear of physical, mental, or emotional injury, illness, disability, or condition, including any need for medical monitoring; and (iv) loss of or damage to property, including business interruption loss.

The only exception to liability immunity under the PREP Act is a claim for willful misconduct, which is defined in the PREP Act as an act or omission that is taken (i) intentionally to achieve a wrongful purpose; (ii) knowingly without legal or factual justification; and (iii) in disregard of a known or obvious risk that is so great as to make it highly probable that the harm will outweigh the benefit. The PREP Act specifies that criteria for willful misconduct must be construed to establish a standard for liability that is more stringent than a standard of negligence in any form or recklessness. 
 

The PREP Act authorizes the Countermeasures Injury Compensation Program (CICP) to provide benefits to certain individuals or estates of individuals who sustain a serious physical covered injury as the direct result of the administration or use of the Covered Countermeasures and/or benefits to certain survivors of individuals who die as a direct result of the administration or use of the Covered Countermeasures. The causal connection between the countermeasure and the serious physical injury must be supported by compelling, reliable, valid, medical and scientific evidence in order for the individual to be considered for compensation. The CICP is administered by the Health Resources and Services Administration, within the Department of Health and Human Services. Information about the CICP is available at 855-266-2427 (toll-free) or http://www.hrsa.gov/cicp/.