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Federal Register / Vol. 86, No. 147 / Wednesday, August 4, 2021 / Notices complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a vaccine must review the vaccine registry or other vaccination records prior to administering a vaccine;
xi. The licensed pharmacist must inform his or her childhood-vaccination patients and the adult caregiver accompanying the child of the importance of a well-child visit with a pediatrician or other licensed primary care provider and refer patients as appropriate; and xii. The licensed pharmacist, the licensed or registered pharmacy intern and the qualified pharmacy technician must comply with any applicable requirements or conditions of use as set forth in the Centers for Disease Control and Prevention CDC COVID
19 vaccination provider agreement and any other federal requirements that apply to the administration of COVID
19 vaccines.
Further, the initial phrase of subsection Vf is revised to state authorize Any healthcare professional or other individual who holds an active license or certification permitting the person to prescribe, dispense, or administer vaccines under the law of any State as of the effective date of this amendment, or a pharmacist or pharmacy intern as authorized under the section Vd of this Declaration. . . .
Description of This Amendment by Section
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Section V. Covered Persons Under the PREP Act and the Declaration, a qualified person is a covered person. Subject to certain limitations, a covered person is immune from suit and liability under Federal and State law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration or use of a covered countermeasure if a declaration under the PREP Act has been issued with respect to such countermeasure.
Qualified person includes A a licensed health professional or other individual who is authorized to prescribe, administer, or dispense such countermeasures under the law of the State in which the countermeasure was prescribed, administered, or dispensed;
or B a person within a category of persons so identified in a declaration by the Secretary under subsection b of the PREP Act. 42 U.S.C. 247d6di8
By this amendment to the Declaration, the Secretary clarifies and expands the authorization for a category of persons
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who are qualified persons under section 247d6di8B. First, the amendment clarifies that qualified pharmacy technicians are authorized to administer Childhood vaccinations and COVID19
vaccinations that are Covered Countermeasures under section VI of this Declaration. The Department has authorized qualified pharmacy technicians to administer these vaccines under section Va of the Declaration through Guidance issued by the Assistant Secretary for Health.3 This amendment adds qualified pharmacy technicians to section Vd of the Declaration, to clarify that these healthcare professionals are authorized subject to the conditions stated in that subsection. In addition, the amendment expands the authorization for qualified pharmacy technicians and interns to administer seasonal influenza vaccines under the supervision of a pharmacist to persons aged 19 and older consistent with ACIP recommendations. The Secretary anticipates that there will be a need for the adult population to receive both COVID19 and seasonal influenza vaccines throughout the 20212022 influenza season. Health risks may increase for individuals who contract seasonal influenza concurrently with COVID19, thus expanding the scope of authorized vaccinators for seasonal influenza lessens the harm otherwise caused by COVID19.
While influenza incidence was lower than anticipated last fall and winter, the same cannot be assumed for the 2021
2022 flu season, as states have largely lifted the community mitigation measures previously in place at the height of the COVID19 pandemic.
Seasonal influenza has the potential to inflict significant burden and strain on the U.S. healthcare system in its own right; and in conjunction with the ongoing COVID19 pandemic, a spike in influenza cases could overwhelm healthcare providers. Like the vaccination against COVID19, the vaccination against influenza requires many people to be vaccinated within a short period of time, potentially creating a surge on the system. Concern also remains regarding the emergence of SARS-CoV2 variants and their potential to cause disease both among vaccinated and unvaccinated populations. It is yet to be determined if COVID19 vaccine boosters will be 3 Guidance for PREP Act Coverage for Qualified Pharmacy Technicians and State-Authorized Pharmacy Interns for Childhood Vaccines, COVID
19 Vaccines, and COVID19 Testing, OASH, Oct.
20, 2020, available at https www.hhs.gov/
guidance/sites/default/files/hhs-guidancedocuments//prep-act-guidance.pdf last visited June 17, 2021.

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recommended; however, if boosters become necessary, allowing pharmacy interns and technicians to administer both COVID19 vaccines and influenza vaccines would allow states maximum flexibility in limiting potential impacts of both illnesses. ACIP also recently voted unanimously in favor of COVID
19 and influenza vaccine coadministration.4 5 Like COVID19
vaccines, influenza vaccines are administered as intramuscular IM
injections, and would require minimal, if any, additional training to administer, and would not place any undue training burden on providers.
As qualified persons, these qualified pharmacy technicians and interns will be afforded liability protections in accordance with the PREP Act and the terms of this amended Declaration.
Second, to the extent that any State law that would otherwise prohibit these healthcare professionals who are a qualified person from prescribing, dispensing, or administering COVID19
vaccines or other Covered Countermeasures, such law is preempted. On May 19, 2020, the Office of the General Counsel issued an advisory opinion concluding that, because licensed pharmacists are qualified persons under this declaration, the PREP Act preempts state law that would otherwise prohibit such pharmacists from ordering and administering authorized COVID19
diagnostic tests.6 The opinion relied in part on the fact that the Congressional delegation of authority to the Secretary under the PREP Act to specify a class of persons, beyond those who are authorized to administer a covered countermeasure under State law, as qualified persons would be rendered a nullity in the absence of such preemption. This opinion is incorporated by reference into this declaration. Based on the reasoning set forth in the May 19, 2020 advisory opinion, any State law that would otherwise prohibit a member of any of the classes of qualified persons 4 https www.medpagetoday.com/
meetingcoverage/acip/93283.
5 https www.aappublications.org/news/2021/06/
24/acip-flu-rabies-dengue-062421.
6 Department of Health and Human Services General Counsel Advisory Opinion on the Public Readiness and Emergency Preparedness Act, May 19, 2020, available at: https www.hhs.gov/
guidance/sites/default/files/hhs-guidancedocuments/prep-act-advisory-opinion-hhs-ogc.pdf/
last visited Jan. 24, 2021. See also, Department of Justice Office of Legal Counsel Advisory Opinion for Robert P. Charrow, General Counsel of the Department of Health and Human Services, January 12, 2021, available at: https www.justice.gov/sites/
default/files/opinions/attachments/2021/01/19/
2021-01-19-prep-act-preemption.pdf last visited Jan. 24, 2021.

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