Hogan Lovells Publications | Product Liability Alert | February 2021

Fifth Amendment to PREP Act Declaration expands "covered persons" to increase workforce authorized to administer COVID-19 vaccines

On 28 January 2021, the U.S. Department of Health and Human Services (HHS) issued its fifth amendment to the Declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) related to COVID-19 (the Declaration), entitled "Fifth Amendment to the Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19 and Republication of the Declaration" (hereinafter the Fifth Amendment).

This latest amendment adds additional categories of qualified persons authorized to prescribe, dispense, and administer FDA-authorized, approved, or licensed COVID-19 vaccines in an effort to help states and U.S. territories "meet the demand for vaccines and protect their communities as quickly as possible" as vaccine supply becomes more widely available. In turn, where the applicable requirements have been met (and subject to certain limitations), these additional "qualified persons," as covered persons under the PREP Act, will be afforded liability protections in accordance with the PREP Act and the terms of the amended Declaration.

Read More: Fifth Amendment to PREP Act Declaration expands "covered persons" to increase workforce authorized to administer COVID-19 vaccines

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