The PREP Act allows the Secretary of the U.S. Department of Health and Human Services (HHS) to issue a declaration that extends liability protections to entities and individuals who manufacture, distribute, or administer covered medical countermeasures against a public health threat or emergency.
In March 2020, the Secretary issued a PREP Act Declaration covering COVID-19 tests, drugs, and vaccines providing liability protections to manufacturers, distributors, SLTTs, 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.
On March 12, 2021, the Acting Secretary of HHS issued the 7th Amendment to the PREP Act to extend liability protections to specified healthcare professionals who may not usually administer vaccines in their scope of practice or who have recently expired licenses, and students of specified healthcare professions who administer COVID-19 vaccines. The PREP Act also provides for a Countermeasure Injury Compensation Program for certain individuals who sustain serious injuries or die from receiving the countermeasures.