With the implementation of the largest adult vaccination program in U.S. history, with over 270 million people receiving at least one shot of a COVID-19 vaccine and 15 million courses of COVID-19 treatment administered, the U.S. Department of Health and Human Services has ended the COVID-19 public health emergency. However, PREP Act (Public Readiness and Emergency Preparedness Act, 42 U.S.C. 247d-6d) liability protections are still in place.
HHS amended its Public Readiness and Emergency Preparedness Act declaration for COVID-19 to extend liability protections for certain COVID-19 countermeasure activities beyond the May 11, 2023, end of the public health emergency. The PREP Act contains language which expressly preempts any state or local laws in conflict with HHS declarations, so that negligence, product liability and malpractice lawsuits or claims caused by, arising out of, relating to, or resulting from the manufacture, testing, development, distribution, administration, and use of a countermeasure, such as vaccines, aimed at responding to the COVID-19 pandemic, are precluded.
On May 9, 2023, HSS Secretary Xavier Becerra signed the 11th Amendment to the Declaration under the PREP Act for COVID-19 Medical Countermeasures. He issued this amendment to (1) clarify that COVID-19 continues to pose a credible risk of a future public health emergency, (2) add new limitations on distribution, (3) extend the time period of coverage for certain Covered Countermeasures and Covered Persons, (4) clarify the time period of coverage for Covered Persons authorized under the Declaration, and (5) extend the duration of the Declaration to December 31, 2024.
In issuing its latest amendment to the declaration under the PREP Act for COVID-19 Medical Countermeasures, HHS has declared the end of the COVID-19 Public Health Emergency Declaration does not automatically terminate PREP Act coverage. Under the amendment, PREP Act liability immunity will apply through December 31, 2024 to all COVID-19 medical countermeasure activities provided through a federal agreement; for the manufacture, testing, development, distribution, administration and use of covered countermeasures, including vaccines and drugs licensed, cleared or approved by FDA to treat the coronavirus, and to health care providers, including pharmacists, pharmacy interns and pharmacy technicians, who administer COVID-19 and seasonal flu vaccines and COVID-19 tests, regardless of a federal agreement or emergency declaration.
