HHS Amends PREP Act Declaration to Facilitate Vaccine Rollout

On January 28, 2021, Norris Cochran, the acting secretary of the U.S. Department of Health and Human Services (HHS), amended the Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19 (PREP Act Declaration) in order to address the need to expand the pool of COVID-19 vaccinators to increase access to COVID-19 vaccinations. As background, the PREP Act (42 U.S.C. § 247d-6d) authorizes the secretary of HHS to issue a declaration to immunize certain individuals — including “qualified persons” — and entities (Covered Persons) against any claim of loss related to “Covered Countermeasures.” Former Secretary Alex Azar issued his initial COVID-19 PREP Act Declaration on March 10, 2020. 

Given the emphasis on vaccine distribution and administration, as anticipated, the amendment, the first issued by the Biden administration, broadens the definition of Covered Persons entitled to immunity to add categories of qualified persons authorized to prescribe, dispense and administer COVID-19 vaccines. More specifically, the amendment:

• Authorizes health care providers licensed or certified in any state to prescribe, dispense and administer COVID-19 vaccines in any other state in the U.S.

   

• Authorizes physicians, registered nurses or practical nurses whose license or certification expired within five years to prescribe, dispense and administer COVID-19 vaccines in any state in the U.S., as long as the license or certification was active and in good standing prior to the date it went inactive.

These health care professionals must also complete the Centers for Disease Control and Prevention’s (CDC) COVID-19 Vaccine Training to qualify for PREP Act immunity. Providers who are not currently practicing or whose license or certification has expired also are required to undergo an on-site observation period by a currently practicing health care professional to qualify as a Covered Person under the PREP Act Declaration.

This expanded definition of Covered Person is expected to alleviate some of the hurdles to more effective and expedited vaccine administration. The extension of PREP Act coverage to relevant individuals will hopefully assist in achieving that goal, but is not likely to be the last amendment to the PREP Act Declaration issued by the new administration.

Faegre Drinker’s Coronavirus Resource Center is available to help you understand and assess the legal, regulatory and commercial implications of COVID-19.