Fifth Amendment to PREP Act Declaration Expands the Ranks of Health Care Providers Authorized to Administer COVID-19 Vaccines

On January 28, 2021, the U.S. Department of Health and Human Services (“HHS”) issued a Fifth Amendment to the Declaration under the Public Readiness and Emergency Preparedness Act (“PREP Act”), which expands the categories of qualified individuals authorized to administer FDA-approved COVID-19 vaccines in response to the ongoing public health emergency brought on by the pandemic. Under the Fifth Amendment, doctors and nurses whose licenses expired within the past five years can now administer COVID-19 vaccines subject to certain training and observation requirements.

Although this amendment represents the fifth time the PREP Act Declaration has been amended, it’s the first such amendment issued by the Biden Administration. Given the further expansion of the PREP Act that the Fifth Amendment provides, it suggests the new administration is not inclined to scale back PREP Act coverage—at least not in its first few weeks on the job.

To the contrary, in a press release announcing the Fifth Amendment, HHS Acting Secretary Norris Cochran remarked, “the Biden Administration is broadening use of the PREP Act to expand the vaccination workforce quickly with additional qualified healthcare professionals,” adding that “[a]s vaccine supply is made more widely available over the coming months, having additional vaccinators at the ready will help providers and state health departments meet the demand for vaccine and protect their communities more quickly.”

As we have reported, the PREP Act[1] provides sweeping federal immunity to a “covered person” for claims relating to the authorized administration or use of a “covered countermeasure.” In general, if all elements of the Act are met, a covered person is protected from suit and liability under both federal and state law with respect to “all claims for loss caused by, arising out of, relating to, or resulting from the administration to or the use by an individual of a covered countermeasure.”^[2] This wide-ranging immunity applies to claims arising out of contract and tort, and it also covers personal injury, property damage, as well as business-interruption loss.

The goal of the Fifth Amendment is to expand the available health care providers authorized to administer a COVID-19 vaccine beyond those licensed in each state. The Fifth Amendment seeks to accomplish this goal by, among other things:

• Authorizing any health care 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.
• Permitting 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.
• And requiring any health care professional described above to complete Centers for Disease Control and Prevention COVID-19 Vaccine Training and, for health care providers who are not currently practicing or whose license or certification is expired, requires an on-site observation period by a currently practicing health care professional.

The upshot of this amendment is that if a person is authorized under the Declaration to administer covered countermeasures like a COVID-19 vaccine—including recently retired physicians and nurses—any state law that prohibits or effectively prohibits such a person from doing so is preempted.

[1] 42 U.S.C. § 247d-6d.

[2] Certain exceptions apply, including cases of wanton and willful harm that results in death or serious injury.