On January 28, 2021, HHS issued a fifth amendment to the Declaration under the Public Readiness and Emergency Preparedness Act (PREP Act), expanding the categories of persons able to prescribe, dispense, and administer COVID-19 vaccines under the protections of the PREP Act (the Fifth Amendment).

HHS first issued a Declaration under the PREP Act in March 2020, providing liability immunity for medical countermeasures against COVID-19. There have since been four amendments to the Declaration, expanding liability immunity for various actions taken by “qualified persons” in furtherance of the COVID-19 countermeasures. In the Fifth Amendment, HHS now amends Section V of the Declaration to add additional categories of persons covered under the PREP Act as qualified to prescribe, dispense, and administer COVID-19 vaccines. The Fifth Amendment specifically permits the following:

• Any healthcare provider who is licensed or certified in a state to prescribe, dispense, and/or administer COVID-19 vaccines in any other state or U.S. territory “so long as the license or certification of the healthcare professional has not been suspended or restricted by any licensing authority, surrendered while under suspension, discipline or investigation by a licensing authority or surrendered following an arrest . . . .”

• Any physician, registered nurse, or practical nurse whose license or certification expired within the past five years to prescribe, dispense and/or administer COVID-19 vaccines in any state or U.S. territory “so long as the license or certification was active and in good standing prior to the date it went inactive, expired or lapsed and was not revoked by the licensing authority, surrendered while under suspension, discipline, or investigation by a licensing authority or surrendered following an arrest . . . .”

To be covered by the protections of the PREP Act, the Fifth Amendment requires these qualified individuals to complete the CDC’s COVID-19 Vaccine Training and, for healthcare providers who are not currently practicing or whose license or certification is expired, to undergo a period of on-site observation by a currently practicing healthcare professional.

The language of the Fifth Amendment can be found here. The press release issued by HHS is available here.