Index Entries

December 11, 2024
U.S. Federal Government: Health and Human Services, Administration for Strategic Preparedness and Response (ASPR)

"Update

Twelfth Amendment to the Declaration under the PREP Act for COVID-19 Medical Countermeasures

On December 11, 2024, Secretary Becerra signed the 12th amendment to the declaration under the PREP Act for COVID-19 Medical Countermeasures.  The Secretary issues this amendment pursuant to section 319-3 of the Public Health Service Act to extend the duration of the Declaration to December 31, 2029, and to republish the Declaration in full...

The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of the Department of Health and Human Services (Secretary) to issue a PREP Act declaration. The declaration provides immunity from liability (except for willful misconduct) for claims:

  • of loss caused, arising out of, relating to, or resulting from administration or use of countermeasures to diseases, threats and conditions
  • determined by the Secretary to constitute a present, or credible risk of a future public health emergency
  • to entities and individuals involved in the development, manufacture, testing, distribution, administration, and use of such countermeasures

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...

COVID-19 PREP Act Declarations

The end of the COVID-19 Public Health Emergency Does not automatically terminate PREP Act coverage..."

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COVID-19,manufacturers liability legal immunity,vaccines