December 18, 2020
Guidance for National Guard Personnel Regarding COVID-19 Vaccines and Immunity under the PREP Act
Today, the U.S. Department of Health and Human Services through the Assistant Secretary for Health, extended coverage under the Public Readiness and Emergency Preparedness Act (PREP Act) to qualified National Guardsmen administering COVID-19 vaccinations that have been authorized or licensed by the Food and Drug Administration (FDA). This will allow states and/or territories that wish to fully utilize National Guard health and medical personnel to increase access to COVID-19 vaccinations the flexibility to do so.
U.S. Department of Health & Human Services
Office of the Assistant Secretary for Health
December 18, 2020
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. As states continue to develop, refine, and implement their vaccination plans, there may be a desire to utilize National Guard personnel (“Guardsmen”) for the administration of COVID-19 vaccines.
The Army National Guard and Air National Guard, collectively known as the “National Guard” are reserve components of the Armed Forces. The National Guard provides “trained units and qualified persons available for active duty in the armed forces, in time of war or national emergency, and at such other times as the national security may require, to fill the needs of the armed forces whenever more units and persons are needed than are in the regular components.”1
The National Guard also has an important role under state authority, responding to various emergencies such as disasters and civil disorders. There are 54 separate National Guard organizations: one for each state, and one for Puerto Rico, Guam, the U.S. Virgin Islands, and the District of Columbia. With the exception of the District of Columbia National Guard, an exclusively federal organization operating under federal control, the other 53 National Guards operate as state or territorial organizations most of the time under the control of their respective governors.
National Guard health and medical personnel are well-positioned to increase access to COVID-19 vaccinations within their respective states. The National Guard has a range of providers authorized, such as physicians, nurse practitioners, physician assistants, nurses, emergency medical technicians, and medics, to administer vaccines to National Guard personnel. The National Guard is subject to Department of Defense (DoD) regulation that provides directive requirements for the Military Vaccination Program, establishes general principles, procedures, policies, and responsibilities for the immunization program, and implements 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), the Office of the Assistant Secretary for Health (OASH) issues this guidance. Subject to satisfaction of the requirements listed below, this guidance authorizes qualified Guardsmen to administer to persons ages three or older COVID-19 vaccinations that have been authorized or licensed by the Food and Drug Administration (FDA).
Such Guardsmen 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 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, Guardsmen must satisfy the following requirements:
- The vaccine must be FDA-authorized or FDA-licensed.
- The vaccination must be ordered and administered according to the Advisory Committee on Immunization Practices’ (ACIP’s) COVID-19 vaccine recommendation.
- The Guardsman must be authorized by his or her National Guard unit to administer vaccines.
- The Guardsman must have a current certificate in basic cardiopulmonary resuscitation. This requirement is satisfied by, among other things, a certification in basic cardiopulmonary resuscitation by an online program that has received accreditation from the American Nurses Credentialing Center, the Accreditation Council for Pharmacy Education, or the Accreditation Council for Continuing Medical Education.
- The Guardsman must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers vaccines, including informing the patient’s primary-care provider when available, submitting the required immunization information to the State or local immunization information system (vaccine registry), complying with requirements related 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.
- The Guardsman 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 program provider agreement and any other federal requirements that apply to the administration of COVID-19 vaccine(s).
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.3 But this authorization shall not preempt State and local laws that permit additional individuals to administer COVID-19 vaccines to additional persons.4
- 1. 10 U.S.C. § 10102
- 2. https://armypubs.army.mil/ProductMaps/PubForm/Details.aspx?PUB_ID=11
- 3. 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-guidance-documents/advisory-opinion-20-02-hhs-ogc-prep-act.pdf (last visited Dec. 15, 2020).
- 4. 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.