HHS Announces Intent to Amend the Declaration Under the PREP Act for Medical Countermeasures Against COVID-19

“Over the past three years, the PREP Act declaration has provided liability protection to manufacturers, distributors, and other organizations conducting countermeasure programs and providers administering COVID-19 countermeasures. This coverage includes liability protection for those entities engaged in manufacturing, distribution, or administration of COVID-19 countermeasures (such as tests, treatments, and vaccines) purchased by the Federal government for administration at pharmacies and other locations.

All COVID-19 vaccines and treatments for which distribution is currently directed by the United States Government (USG) are covered by PREP Act protections and flexibilities. Additionally, COVID-19 tests that are administered through the USG Increased Community Access to Testing (ICATT) program are covered by PREP Act protections and flexibilities.”

Key changes that Secretary Becerra plans to make under the upcoming amended declaration include:

  • Extending coverage for COVID-19 vaccines, seasonal influenza vaccines, and COVID-19 tests. PREP Act immunity from liability will be extended through December 2024 to pharmacists, pharmacy interns, and pharmacy technicians to administer COVID-19 and seasonal influenza vaccines (to those individuals three and over, consistent with other requirements), and COVID-19 tests, regardless of any USG agreement or emergency declaration.
  • Extending coverage through December 2024 for Federal agreements. This includes all activities related to the provision of COVID-19 countermeasures that are 1) provided based on a Federal agreement (including the vaccines and treatments purchased and provided by the USG), or 2) directly conducted by the USG, including by Federal employees, contractors or volunteers.”

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