In order to expand the workforce available and authorized to administer COVID-19 vaccines, the Public Readiness and Emergency Preparedness Act (PREP Act) provides immunity to qualified individuals.
Professionals and Entities Covered by Immunity
When the Secretary determines that a threat or condition constitutes a present or credible risk of a future public health emergency, the Secretary may issue a PREP Act declaration. The declaration provides immunity from liability (except for willful misconduct) for claims of loss caused by, arising out of, relating to, or resulting from the administration or use of covered countermeasures to diseases, threats and conditions identified in the declaration.
When Immunity from Liability Applies
When the Secretary determines that a threat or condition constitutes a present or credible risk of a future public health emergency, the Secretary may issue a PREP Act declaration. The declaration provides immunity from liability (except for willful misconduct) for claims of loss caused by, arising out of, relating to, or resulting from the administration or use of covered countermeasures to diseases, threats and conditions identified in the declaration.
Professionals and Entities Covered by Immunity
PREP Act immunity applies to:
licensed health professionals authorized to administer covered medical countermeasures under the law of the state where the countermeasure is administered, and
other individuals identified in the declaration by the Secretary of Health and Human Services (HHS) to prescribe, dispense, or administer covered countermeasures, including the COVID-19 vaccine
Qualified Persons
In March 2020, the Secretary issued a PREP Act Declaration covering COVID-19 tests, drugs and vaccines providing liability protections to manufacturers, distributors, states, localities, licensed healthcare professionals, and others identified by the Secretary (qualified persons) who administer COVID-19 countermeasures. The Declaration has been amended several times to expand liability protections, including prior amendments to cover licensed healthcare professionals who cross state borders and federal response teams.
In March 2020, the HHS Secretary issued a PREP Act Declaration covering COVID-19 tests, drugs and vaccines providing liability protections to manufacturers, distributors, states, localities, licensed healthcare professionals, and others identified by the Secretary (qualified persons) who administer COVID-19 countermeasures. The Declaration has been amended several times to expand liability protections, including prior amendments to cover licensed healthcare professionals who cross state borders and federal response teams. Under the PREP Act, a qualified person is a covered person. Except for willful misconduct, a covered person is immune from lawsuits and liability under federal and state law with respect to all claims for loss resulting from the administration or use of a covered countermeasure, such as a COVID-19 vaccine, if they meet criteria stated in a declaration under the PREP Act issued for the health emergency or threat and covered countermeasure.
The seventh PREP Act amendment expands the list of professionals who are qualified to administer vaccines and are protected from liability as follows:
Non-Traditional Licensed or Certified Health Professionals:Listed healthcare providers who are licensed or certified prescribe, dispense and/or administer COVID-19 vaccines.
Previously Active and Recently Retired Professionals: Any retired professional whose license or certification expired within the past five years to prescribe, dispense and/or administer COVID-19 vaccines in any state or U.S. territory so long as the license or certification was active and in good standing prior to the date it went inactive.
Healthcare Students: Any student who has proper training in administering vaccine from their school or training program and are under supervision by a currently practicing healthcare professional experienced in intramuscular injections.
Impacts on State, Local, Tribal, and Territorial Health Agencies
The PREP Act Declaration amendments preempt requirements that would result in a qualified person being unable to prescribe, dispense, or administer vaccines as authorized by the state or U.S. territory. Licensing laws that are less restrictive than those in the Declaration amendments are not preempted. States and U.S. territories determine authorized vaccinators in their jurisdiction.
Protection for Individuals
The PREP Act also provides for a
Countermeasure Injury Compensation Program for certain individuals who sustain serious injuries or die from receiving the countermeasures.
