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An Assessment of the CDC Anthrax Vaccine Safety and Efficacy Research Program (2003)

Chapter: Appendix E Department of Defense Memorandum: Reintroduction of the Anthrax Vaccine Immunization Program

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Suggested Citation:"Appendix E Department of Defense Memorandum: Reintroduction of the Anthrax Vaccine Immunization Program." Institute of Medicine. 2003. An Assessment of the CDC Anthrax Vaccine Safety and Efficacy Research Program. Washington, DC: The National Academies Press. doi: 10.17226/10527.
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Appendix E
Department of Defense Memorandum: Reintroduction of the Anthrax Vaccine Immunization Program

Suggested Citation:"Appendix E Department of Defense Memorandum: Reintroduction of the Anthrax Vaccine Immunization Program." Institute of Medicine. 2003. An Assessment of the CDC Anthrax Vaccine Safety and Efficacy Research Program. Washington, DC: The National Academies Press. doi: 10.17226/10527.
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DEPUTY SECRETARY OF DEFENSE

1010 DEFENSE PENTAGON WASHINGTON, DC20301–1010

JUN 28 2002

MEMORANDUM FOR SECRETARIES OF THE MILITARY DEPARTMENTS CHAIRMAN OF THE JOINT CHIEFS OF STAFF UNDER SECRETARIES OF DEFENSE ASSISTANT SECRETARIES OF DEFENSE GENERAL COUNSEL, DEPARTMENT OF DEFENSE INSPECTOR GENERAL, DEPARTMENT OF DEFENSE DIRECTORS OF DEFENSE AGENCIES COMMANDANT OF THE US COAST GUARD

SUBJECT: Reintroduction of the Anthrax Vaccine Immunization Program (AVIP)

Food and Drug Administration (FDA) approval of the manufacturer’s renovated facility restores the availability of anthrax vaccine. FDA has determined that the current anthrax vaccine is safe and effective in protecting against all forms of anthrax infection, a scientific conclusion recently supported by the Institute of Medicine.

Current intelligence assessments indicate that the anthrax threat to Department of Defense (DoD) forces is real. The Department’s goal is to protect all forces against anthrax as a part of the Department’s Force Health Protection program. Steps are being taken by the Department to ensure protection of U.S. servicemembers and DoD pexsonnel against the threat of anthrax and other potential bioweapon agents, including improved intelligence, detection, and surveillance capabilities, protective clothing and equipment, and new generafon vaccines and other medical countermeasures.

At this time, the DoD will resume an Anthrax Vaccine Immunization Program (AVIP) consistent with FDA guidelines and the best practice of medicine, beginning with military personnel, and Emergency-Essential DoD civilians and contractors, at higher risk whose performance is essential for certain mission critical capabilities. Vaccination is mandatory for these personnel, except as provided under applicable medical and administrative exemption policies.

The scope of the AVIP shall encompass personnel assigned to or deployed for more than 15 days in higher threat areas whose performance is essential for certain mission critical capabilities. Near-term AVIP implementation may also include other personnel determined by the Assistant Secretary of Defense for Health Affairs, in consultation with the Chairman of the Joint Chiefs of Staff, to be at higher

U1 0535 /02

Suggested Citation:"Appendix E Department of Defense Memorandum: Reintroduction of the Anthrax Vaccine Immunization Program." Institute of Medicine. 2003. An Assessment of the CDC Anthrax Vaccine Safety and Efficacy Research Program. Washington, DC: The National Academies Press. doi: 10.17226/10527.
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risk of exposure to anthrax as conditions change. Vaccinations shall begin, to the extent feasible, 45 days prior to deployment or arrival in higher threat areas.

For personnel who are covered under this new policy, who had previously begun the six shot series but had not completed it, resumption of their vaccination series will begin immediately. For personnel whose six shot series was interrupted, but who are not covered under the new policy, completion of their vaccination series will be deferred until further notice; resumption will begin when feasible, subject to availability of vaccine. Personnel currently being immunized—designated special mission units, manufacturing and DoD research personnel, and Congressionally mandated anthrax vaccine researchers—will continue with their scheduled vaccinations and annual booster shots.

The Under Secretary of Defense for Personnel and Readiness shall issue policy guidance on the medical and administrative aspects of the AVIP. Effective program implementation continues to be the responsibility of the Secretary of the Army as the Executive Agent for the AVIP and the designated senior military officers of the Services.

Suggested Citation:"Appendix E Department of Defense Memorandum: Reintroduction of the Anthrax Vaccine Immunization Program." Institute of Medicine. 2003. An Assessment of the CDC Anthrax Vaccine Safety and Efficacy Research Program. Washington, DC: The National Academies Press. doi: 10.17226/10527.
×
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Suggested Citation:"Appendix E Department of Defense Memorandum: Reintroduction of the Anthrax Vaccine Immunization Program." Institute of Medicine. 2003. An Assessment of the CDC Anthrax Vaccine Safety and Efficacy Research Program. Washington, DC: The National Academies Press. doi: 10.17226/10527.
×
Page 149
Suggested Citation:"Appendix E Department of Defense Memorandum: Reintroduction of the Anthrax Vaccine Immunization Program." Institute of Medicine. 2003. An Assessment of the CDC Anthrax Vaccine Safety and Efficacy Research Program. Washington, DC: The National Academies Press. doi: 10.17226/10527.
×
Page 150
Suggested Citation:"Appendix E Department of Defense Memorandum: Reintroduction of the Anthrax Vaccine Immunization Program." Institute of Medicine. 2003. An Assessment of the CDC Anthrax Vaccine Safety and Efficacy Research Program. Washington, DC: The National Academies Press. doi: 10.17226/10527.
×
Page 151
Suggested Citation:"Appendix E Department of Defense Memorandum: Reintroduction of the Anthrax Vaccine Immunization Program." Institute of Medicine. 2003. An Assessment of the CDC Anthrax Vaccine Safety and Efficacy Research Program. Washington, DC: The National Academies Press. doi: 10.17226/10527.
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Page 152
Next: Appendix F Institute of Medicine: CDC Anthrax Vaccine Safety & Efficacy Research Program. Interim Report Findings and Recommendations1 »
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In 1998, the Department of Defense (DoD) began a program of mandatory immunization against anthrax for all military personnel. As the program proceeded, however, some military personnel and their families raised concerns about the safety and efficacy of the anthrax vaccine. Acknowledging both the need to protect military personnel and the concerns about the anthrax vaccine, congress directed the Centers for Disease Control and Prevention (CDC) to carry out a research program on its safety and efficacy. To assist in the development of this program, CDC requested the Institute of Medicine (IOM) to convene a committee to review the completeness and appropriateness of the research program. In An Assessment of the CDC Anthrax Vaccine Safety and Efficacy Research Program, the committee makes an overall assessment of the CDD research plan and reviews the specific studies proposed by CDC in the three areas of efficacy, safety and acceptability. The committee also notes additional research needs that became evident following the bioterrorist events of 2001 and makes recommendations about the leadership of the research program.

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