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Summer 2023 - Vaccines

HHS Issues Amendment to PREP Act for Medical Countermeasures Against COVID-19

The PREP Act declaration ensures Americans have broad access to critical COVID-19 countermeasures.

The U.S. Department of Health and Human Services (HHS) has issued an amendment to the declaration under the Public Readiness and Emergency Preparedness (PREP) Act for medical countermeasures against COVID-19. The PREP Act declaration ensures Americans have broad access to critical COVID-19 countermeasures, including vaccines, tests and treatments, and has provided flexibilities and protections for those individuals and entities who have been involved in providing the tools that have helped the United States get to a better place with COVID-19.

For the past three years, much of the healthcare landscape — including pharmacies — has relied on these flexibilities and liability protections. By issuing this amendment, the Secretary of HHS intends to allow pharmacies to continue their critical roles, even after certain products transition to traditional healthcare pathways. However, the end of the COVID-19 public health emergency alone does not automatically terminate PREP Act coverage for countermeasures.

Key changes to the PREP Act include:

  • Extending coverage for COVID-19 vaccines, seasonal influenza vaccines and COVID-19 tests.
  • Extending coverage through December 2024 for federal agreements, including 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 United States government [USG]), or 2) directly conducted by the USG, including by federal employees, contractors or volunteers.
  • Ending coverage for certain activities. Once products are no longer distributed under a USG agreement, PREP Act coverage will no longer extend to COVID-19 vaccination by nontraditional providers (e.g., recently retired providers and students) and COVID-19 vaccinations across state lines by licensed providers and pharmacists and pharmacy interns.
  • Ending coverage for routine childhood vaccinations.


HHS Announces Intent to Amend the Declaration Under the PREP Act for Medical Countermeasures Against COVID-19. U.S. Department of Health and Human Services press release, April 14, 2023. Accessed at

BSTQ Staff
BioSupply Trends Quarterly [BSTQ] is the definitive source for industry trends, news and information for the biopharmaceuticals marketplace. With timely and critical information, each themed issue covers topics ranging from product breakthroughs, industry insights and innovations, up-to-the-minute news on the latest clinical trials, accessibility, and service and safety concerns.