Public Health Emergency - Leading a Nation Prepared
U.S. Department of Health & Human Services Office of the Assistant Secretary for Health February 2, 2021
On January 31, 2020, the Secretary of Health and Human Services declared that, effective January 27, 2020, the 2019 novel coronavirus (COVID-19) is a public-health emergency for the United States. The United States Department of Health and Human Services (HHS) is the lead agency for the federal government’s response to the COVID-19 pandemic.
A key component of that response is access to COVID-19 vaccines across the United States. The United States anticipates deploying federal personnel, including members of the armed forces, contractors, and volunteers to assist states in their vaccination campaigns.
The Department of Defense (DOD) includes the Military Health System,1 composed of hundreds of hospitals and clinics and thousands of trained and qualified medical personnel. Over the past year, the DOD has provided many military medical personnel in support of prior Federal Emergency Management Agency mission assignments for COVID-19 response.
DOD health and medical personnel, contractors, and volunteers are well-positioned to increase access to COVID-19 vaccinations across the country. DOD has a range of providers that it has authorized to administer such vaccines. Examples include, but are not limited to, physicians, nurse practitioners, physician assistants, nurses, emergency medical technicians, corpsmen, and medics, to administer vaccines. DOD regulations provide directive requirements for the DOD Immunization Program, establish general principles, procedures, policies, and responsibilities for the immunization program, and implement military and international health regulations and requirements.2
Therefore, as an Authority Having Jurisdiction under the Secretary’s March 10, 2020 declaration under the Public Readiness and Emergency Preparedness Act (PREP Act), as amended, the Office of the Assistant Secretary for Preparedness and Response issues this guidance. Subject to satisfaction of the requirements listed below, this guidance authorizes qualified DOD personnel, contractors, and volunteers as “covered persons” to administer COVID-19 vaccinations that have been authorized or licensed by the Food and Drug Administration (FDA).
Such DOD personnel, contractors or volunteers will qualify as “covered persons” under the PREP Act, subject to other applicable requirements of the Act and the requirements discussed below. They may also receive immunity under the PREP Act with respect to all claims for loss caused by, arising out of, relating to, or resulting from, the administration or use of HHS Food and Drug Administration (FDA)-authorized or FDA-licensed COVID-19 vaccines. 42 U.S.C. § 247d-6d(a)(1).
To qualify as “covered persons” under 42 U.S.C. § 247d-6d((i)(8)(B) when administering FDA authorized or licensed COVID-19 vaccines, DOD personnel, contractors, and volunteers must satisfy the following requirements:
This authorization preempts any State and local law that prohibits or effectively prohibits those who satisfy these requirements from ordering or administering COVID-19 vaccines as set forth above.4 But this authorization shall not preempt State and local laws that permit additional individuals to administer COVID-19 vaccines to additional persons.5
2 E.g., Department of Defense Instruction 6205.02, “DoD Immunization Program,” July 23, 2019, available at: https://www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodi/620502p.pdf?ver=2019-07-23-085404-617
3 See, e.g.,
Advisory Opinion 21-02 on the Public Readiness and Emergency Preparedness Act and the Secretary’s Declaration under the Act, available at: https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/AO-21-02-PREP-Act_1-12-2021_FINAL_SIGNED.pdf (last visited Feb. 2, 2121)
4 See, e.g.,
Advisory Opinion 20-02 on the Public Readiness and Emergency Preparedness Act and the Secretary’s Declaration under the Act, available at https://www.hhs.gov/guidance/sites/default/files/hhs-guidancedocuments/advisory-opinion-20-02-hhs-ogc-prep-act.pdf (last visited Feb. 2, 2121). 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, 2020, available at: https://www.justice.gov/sites/default/files/opinions/attachments/2021/01/19/2021-01-19-prep-act-preemption.pdf (last visited Feb. 2, 2121)
5 Moreover, nothing herein shall affect federal-law requirements in 42 C.F.R. Part 455, subpart E regarding screening and enrollment of Medicare and Medicaid providers.
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