On January 28, 2021, the U.S. Department of Health and Human Services (“HHS”) issued its fifth amendment[1] 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”).[2] 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.[3] 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, [4] will be afforded liability protections in accordance with the PREP Act and the terms of the amended Declaration.
Most notably, the Fifth Amendment:
- Authorizes any healthcare provider who holds an active licensed or certification in a state to prescribe, dispense, and/or administer COVID-19 vaccines in any other state or U.S. territory;
- Authorizes 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;
- Requires any healthcare professional described above to complete Centers for Disease Control and Prevention (CDC) COVID-19 Vaccine Training and, for healthcare providers who are not currently practicing or whose license or certification is expired, requires an on-site observation period by a currently-practicing healthcare professional; and
- Preempts any State law that would otherwise prohibit a member of any of the classes of “qualified persons” specified in the Declaration from administering a covered countermeasure.[5]
This latest amendment is effective as of January 28, 2021.
[2] We’ve also published several pieces since then highlighting subsequent developments for the application of the PREP Act, and you can read our prior publications providing key background on the Declaration here.
[4] See 42 U.S.C. §§ 247d-6d(a)(3)(C), 247d-6d(a)(4)(B) (identifying a “qualified person” as a “covered person” subject to PREP Act immunity).
[5] For example, the Fifth Amendment makes clear that it preempts any State law that would otherwise prohibit the above healthcare professionals who are “qualified persons” from prescribing, dispensing, or administering COVID-19 vaccines.
See Fifth Amendment, Description of This Amendment by Section at Section V. Covered Persons.
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