§ 1110 — System For Tracking And Recording Vaccine Information; Anthrax Vaccine Immunization Program

(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. (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). (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.