Further Amendments to the PREP Act to Meet Vaccine Administration Needs | Morgan Lewis – Health Law Analysis


Given the significant push to vaccinate the public since early 2021, the increasing availability of vaccines, and the need to recruit additional staff to administer vaccinations, the Secretary of the US Department of Health and Human Services (HHS ) again changed his return. under the Public Preparedness and Civil Protection Act (PREP Act) to accommodate certain workforce barriers that were not previously considered.

Repeatedly since the start of 2021, the secretary cited an “urgent need to expand the pool of COVID-19 vaccinators to respond effectively to the pandemic” as a rationale for releasing several amendments to the PREP law statement focused exclusively on staff growth. in the fight against the pandemic.

The PREP Act authorizes the Secretary of HHS to issue a declaration guaranteeing immunity from liability against claims for losses resulting from a “covered countermeasure”. We have previously reported on the release of the initial PREP statement and the multiple changes released since the initial PREP statement by the HHS with respect to COVID-19; see The PREP Law: Considerations for Healthcare Providers and HHS extends PREP immunity from liability. The statement, as amended, provides broad immunity from liability to Covered Persons engaged in activities such as the manufacture, distribution or administration of a COVID-19 vaccine that has received emergency use authorization ( EUA) or US Food and Drug Administration approval. (FDA).

The last Fifth, Sixth and Seventh Amendments added subsections (g) and (h) to the initial statement of the Prep Act, with the express purpose of reducing personnel or manpower barriers to faster vaccine delivery across the United States.

Released on February 2, 2021, the Fifth Amendment ensures that healthcare professionals can cross state borders to administer vaccines without fear of violating a state license or other ban. This amendment allows “any health care professional or other person who holds an active license or certification allowing the person to prescribe, dispense or administer vaccines under the law of any state” to administer COVID vaccines- 19 in any other state in association with an effort by a government authority to administer vaccines. As long as the individual’s license or certification is not otherwise suspended or restricted by a state licensing authority or otherwise abandoned, the liability protection of the law PREP will apply. Any contrary state law is preempted.

To accommodate the protection offered by the Fifth Amendment, individuals must show that they have completed COVID-19 vaccine training modules from the Centers for Disease Control and Prevention (CDC). For healthcare professionals who are not actively practicing, documentation of an observation period by a practicing healthcare professional with sufficient immunization experience that confirms the competence of the healthcare professional is required.

The sixth amendment to the declaration adds additional qualified personnel to the category of qualified persons covered by the PREP law. This amendment extends the protection of the PREP Act to any federal government employee, contractor or volunteer who distributes or dispenses COVID-19 vaccines. This expansion appears to ensure that persons who would otherwise not be covered receive the liability protection afforded by the PREP Act, “even though such authorized duties or responsibilities would not normally extend to members of the public or would otherwise be over. limited than the activities ”that such persons would normally be permitted to carry out. Again, any contrary state law is preempted.

Finally, the seventh amendment to the declaration of the PREP law, published on March 16, 2021, aims to further extend vaccinations by extending the protection of the PREP law to midwives, paramedics, emergency medical technicians (EMT ) advanced or intermediate, medical assistants, respiratory therapists, dentists. , podiatrists, optometrists and veterinarians administering COVID-19 vaccines.

In all cases, additional staff should administer a vaccine approved for use by the FDA and should administer the vaccination in accordance with the recommended guidelines produced by the Advisory Committee on Immunization Practices (ACIP). In addition, documentation should be available showing that an observation period has occurred during which a practicing healthcare professional experienced in the administration of intramuscular injections has confirmed the healthcare provider’s competence to. health or student. All personnel must be duly certified or licensed in their home state.

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