HHS Extends Certain PREP Act Immunity as COVID-19 PHE Ends
- May 12, 2023
The Department of Health and Human Services (HHS) is extending certain liability protections under the Public Readiness and Emergency Preparedness Act (PREP Act) for administering COVID-19 vaccines and treatment beyond the public health emergency (PHE), which officially ended on May 11.
In a Federal Register notice, the HHS Secretary said that COVID-19 continues to present a “credible risk of a future public health emergency.” Extending PREP Act coverage “is intended to help mitigate that credible risk,” the notice said.
The amendment to the PREP Act declaration extends coverage through December 31, 2024 for manufacturing, distribution, administration, and use of COVID-19 vaccines and treatments that are licensed or authorized for emergency use by the Food and Drug Administration.
The declaration also clarifies that the category of disease, health condition, or health threat includes the burden on health care providers “caused by coterminous seasonal influenza infections and COVID-19 infections.”
The amended declaration further extends PREP Act coverage through December 31, 2024 for licensed pharmacists, pharmacy interns, and qualified pharmacy technicians who administer COVID-19 vaccines, seasonal influenza vaccines, and COVID-19 tests.
HHS Secretary Xavier Becerra in April sent a letter and fact sheet to the nation’s governors announcing his intention to extend certain liability protections under the PREP Act. HHS also issued this week a fact sheet describing the post-PHE status of other regulatory flexibilities and policies put in place during the pandemic.