PRIA, Government Policy, Made Personal

Summary

The Secretary of Defense must set up a system to track and record vaccine information for service members. It must log each vaccine given by DoD health care, any vaccine-related bad reactions, and any refusals. Refusals include those for FDA-licensed vaccines (section 351), vaccines given under an emergency use authorization (section 564), and investigational or unapproved drugs given under a presidential waiver (section 1107(f)(1)). The system must update each member’s electronic health record, use cyber protections to keep personal data safe, and work with the MHS GENESIS electronic health record (or its successor). The Secretary must also make uniform rules for medical and administrative exemptions from the anthrax vaccine program and tell all service members about those rules. The Secretary must run an anthrax vaccine safety program that includes outside review of reports, surveys of vaccinated personnel, a long-term study of a set group, and active monitoring of a sample group to spot patterns early. The Secretary can expand studies if needed. If an independent expert panel finds a member has an unexplained vaccine reaction, that person must be able to get fast care and follow-up at a DoD Center of Excellence.

Title 10, §1110

Armed Forces, Source: USLM XML via OLRC

(a)Overall System to Track and Record Vaccine Information.—

(1)The Secretary of Defense, in consultation with the Director of the Defense Health Agency and in coordination with the Secretaries of the military departments, shall establish a system to track and record the following information:

(A)Each vaccine administered by a health care provider of the Department of Defense to a member of an armed force under the jurisdiction of the Secretary of a military department.

(B)Any adverse reaction of the member related to such vaccine.

(C)Each refusal by such a member of any vaccine that is being so administered, including vaccines licensed by the Food and Drug Administration under section 351 of the Public Health Service Act (42 U.S.C. 262) and vaccines otherwise approved or authorized.

(D)Each refusal by such a member of a vaccine on the basis that the vaccine is being administered by a health care provider of the Department pursuant to an emergency use authorization granted by the Commissioner of Food and Drugs under section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–3).

(E)Each refusal by such a member of an investigational new drug or a drug unapproved for its applied use that is being administered pursuant to a request or requirement of the Secretary of Defense and with respect to which the President has granted a waiver of the prior consent requirement pursuant to section 1107(f)(1) of this title.

(2)In carrying out paragraph (1), the Secretary of Defense shall ensure that—

(A)any electronic health record maintained by the Secretary for a member of an armed force under the jurisdiction of the Secretary of a military department is updated with the information specified in such paragraph with respect to the member;

(B)any collection, storage, or use of such information is conducted through means involving such cyber protections as the Secretary determines necessary to safeguard the personal information of the member; and

(C)the system established under such paragraph is interoperable and compatible with the electronic health record system known as “MHS GENESIS”, or such successor system.

(b)Procedures for Medical and Administrative Exemptions From Anthrax Vaccine Immunization Program.—

(1)The Secretary shall establish uniform procedures under which members of the armed forces may be exempted from participating in the anthrax vaccine immunization program for either administrative or medical reasons.

(2)The Secretaries of the military departments shall provide for notification of all members of the armed forces of the procedures established pursuant to paragraph (1).

(c)System for Monitoring Adverse Reactions to Anthrax Vaccine.—

(1)The Secretary shall establish a system for monitoring adverse reactions of members of the armed forces to the anthrax vaccine. That system shall include the following:

(A)Independent review of Vaccine Adverse Event Reporting System reports.

(B)Periodic surveys of personnel to whom the vaccine is administered.

(C)A continuing longitudinal study of a pre-identified group of members of the armed forces (including men and women and members from all services).

(D)Active surveillance of a sample of members to whom the anthrax vaccine has been administered that is sufficient to identify, at the earliest opportunity, any patterns of adverse reactions, the discovery of which might be delayed by reliance solely on the Vaccine Adverse Event Reporting System.

(2)The Secretary may extend or expand any ongoing or planned study or analysis of trends in adverse reactions of members of the armed forces to the anthrax vaccine in order to meet any of the requirements in paragraph (1).

(3)The Secretary shall establish guidelines under which members of the armed forces who are determined by an independent expert panel to be experiencing unexplained adverse reactions may obtain access to a Department of Defense Center of Excellence treatment facility for expedited treatment and follow up.

Notes & Related Subsidiaries

Editorial Notes

Amendments

2021—Pub. L. 117–81, § 716(b)(1), substituted “System for tracking and recording vaccine information; anthrax vaccine immunization program” for “Anthrax vaccine immunization program; procedures for exemptions and monitoring reactions” in section catchline. Subsec. (a). Pub. L. 117–81, § 716(a)(2), added subsec. (a). Former subsec. (a) redesignated (b). Subsec. (b). Pub. L. 117–81, § 716(a)(1), (b)(2), redesignated subsec. (a) as (b), inserted “From Anthrax Vaccine Immunization Program” after “Exemptions” in heading, and substituted “Secretary” for “Secretary of Defense” in par. (1). Former subsec. (b) redesignated (c). Subsec. (c). Pub. L. 117–81, § 716(a)(1), (b)(3), redesignated subsec. (b) as (c) and inserted “to Anthrax Vaccine” after “Reactions” in heading.

Statutory Notes and Related Subsidiaries

Deadline for Establishment of System Pub. L. 117–81, div. A, title VII, § 716(d), Dec. 27, 2021, 135 Stat. 1789, provided that: “The Secretary of Defense shall establish the system under section 1110 of title 10, United States Code, as added by subsection (a), by not later than

January 1, 2023.” Department of Defense Standards for Exemptions From Mandatory COVID–19 Vaccines Pub. L. 117–81, div. A, title VII, § 720, Dec. 27, 2021, 135 Stat. 1791, provided that: “(a) Standards.—The Secretary of Defense shall establish uniform standards under which covered members may be exempted from receiving an otherwise mandated COVID–19 vaccine for administrative, medical, or religious reasons. “(b) Definitions.—In this section:“(1) The term ‘covered member’ means a member of an Armed Force under the jurisdiction of the Secretary of a military department. “(2) The term ‘COVID–19 vaccine’ means any vaccine for the coronavirus disease 2019 (COVID–19), including any subsequent booster shot for COVID–19.” Deadlines for Establishment and Implementation Pub. L. 106–398, § 1 [[div. A], title VII, § 751(e)], Oct. 30, 2000, 114 Stat. 1654, 1654A–195, provided that: “The Secretary of Defense shall— “(1) not later than

April 1, 2001, establish the uniform procedures for exemption from participation in the anthrax vaccine immunization program of the Department of Defense required under subsection (a) [now (b)] of section 1110 of title 10, United States Code (as added by subsection (b)); “(2) not later than

July 1, 2001, establish the system for monitoring adverse reactions of members of the Armed Forces to the anthrax vaccine required under subsection (b)(1) [now (c)(1)] of such section; “(3) not later than

April 1, 2001, establish the guidelines under which members of the Armed Forces may obtain access to a Department of Defense Center of Excellence treatment facility for expedited treatment and follow up required under subsection (b)(3) [now (c)(3)] of such section; and “(4) not later than

July 1, 2001, prescribe the

Regulations

regarding emergency essential employees of the Department of Defense required under subsection (a) of section 1580a of such title (as added by subsection (c)).”

§1110 System for Tracking and Recording Vaccine Information; Anthrax Vaccine Immunization Program