U.S. Continues Prepping Medical Countermeasures Against COVID-19

PREP Act extensions against COVID-19
Vaccine preparations
by Gerd Altmann
Washington DC (Precision Vaccinations News)

The U.S. HHS Secretary Xavier Becerra today announced that in the coming weeks, he would issue an amendment to the declaration under the Public Readiness and Emergency Preparedness (PREP) Act for medical countermeasures against COVID-19.

"While COVID-19 is not over, we are in a position to end the emergency phase of our response because of the Administration's whole-of-government approach to combatting the virus," wrote Secretary Becerra in a letter to U.S. governors on April 14, 2023.

And HHS confirmed on April 14, 2023; it is extending coverage through December 2024 for Federal agreements.

The PREP Act declaration has ensured Americans have broad access to critical COVID-19 countermeasures, including vaccines, tests, and treatments.

And the PREP Act declaration has provided flexibilities and protections for those individuals and entities involved in delivering these critical tools.

This means the "Test to Treat" program that empowers pharmacists to test people for COVID-19 and prescribe antivirals will continue.

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 in our response, even after certain products transition to traditional healthcare pathways.

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 program are covered by PREP Act protections and flexibilities. 

Even once vaccines, tests, and treatments move away from being distributed under a USG agreement as they transition to traditional procurement, distribution, and payment pathways, PREP Act coverage will not automatically terminate in all instances.

Instead, the duration of PREP Act coverage for COVID-19 countermeasures will be determined by the terms of the PREP Act declaration in place at the time.

The end of the COVID-19 public health emergency alone does not automatically terminate PREP Act coverage for countermeasures.

This unedited Fact Sheet explains some fundamental changes that partners can expect regarding PREP Act coverage and some of what will not change.

Note: All HHS press releases, fact sheets, and other news materials are available at https://www.hhs.gov/news.

The article was updated on April 17, 2023, with related links.

Our Trust Standards: Medical Advisory Committee