ADA275188 : DoD Immunization Program for Biological Warfare Defense. DODD-6205.3

SORT: 6205.03
DOCI: DODD 6205.3
DATE: 19931126
TITL: DODD 6205.3 DoD Immunization Program for Biological Warfare Defense,
November 26, 1993, ASD(NS&CP)

Refs:(a) Title 10, United States Code
(b) DoD Instruction 6205.2, "Immunization Requirements," October 9, 1986
(c) AR 40-562/NAVMEDCOMINST 6230.3/AFR 161-13/CG COMDTINST M6230.4D,
"Immunizations and Chemoprophylaxis," November 7, 1988
(d) DoD Directive 5136.1, "Assistant Secretary of Defense for Health
Affairs," December 2, 1992
(e) through (g), see enclosure 1

A. PURPOSE

This Directive:

1. Establishes policy, assigns responsibilities, and prescribes procedures
for members of the Department of Defense against validated biological
warfare threats, and prioritization of research, development, testing,
acquisition, and stockpiling of biological defense vaccines under
reference (a).

2. Provides vaccination guidance that focuses exclusively on defense
against biological warfare threats and complements immunization
requirements for naturally occurring endemic disease threats outlined in
references (b) and (c).

3. Addresses peacetime and contingency requirements for immunization
against biological warfare threats against U.S. personnel.

4. Designates the Secretary of the Army as the "DoD Executive Agent" for
the DoD Immunization Program for Biological Warfare Defense.

5. Provides direction on levels of acquisition and stockpiling of
biological defense vaccines and prioritizes research and development
efforts in defending against current and emerging biological warfare
threats.

B. APPLICABILITY AND SCOPE

This Directive applies to:

1. The Office of the Secretary of Defense, the Military Departments
(including their National Guards), the Chairman of the Joint Chiefs of
Staff, the Unified Commands, and the Defense Agencies (hereafter referred
to collectively as "the DoD Components"). The term "Military Services," as
used herein, refers to the Army, the Navy, the Air Force, and the Marine
Corps.

2. Essential DoD civilian personnel, and personnel of other Federal
Departments, when assigned as part of the U.S. Armed Forces.

C. DEFINITIONS

Terms used in this Directive are defined in enclosure 2.

D. POLICY

It is DoD policy that:

1. For immunization, the following personnel, subject to special
exceptions approved by the Chairman of the Joint Chiefs of Staff, should
be immunized against validated biological warfare threat agents, for which
suitable vaccines are available, in sufficient time to develop immunity
before deployment to high-threat areas:

a.  Personnel assigned to high-threat areas.

b.  Personnel predesignated for immediate contingency deployment (crisis
response).

c.  Personnel identified and scheduled for deployment on an imminent or
ongoing contingency operation to a high-threat area.

2. For vaccine research, development, testing, evaluation, acquisition,
and stockpiling, efforts for the improvement of existing vaccines and the
development of new vaccines against all validated biological warfare
threat agents shall be integrated and prioritized.  The Department of
Defense shall develop a capability to acquire and stockpile adequate
quantities of vaccines to protect the programmed force against all
validated biological warfare threats.

E. RESPONSIBILITIES

1. The Under Secretary of Defense for Acquisition and Technology shall
ensure the coordination and integration of the DoD Immunization Program
for Biological Warfare Defense with all acquisition-related elements of
the DoD Biological Defense Program.

2. The Under Secretary of Defense for Policy shall review all facets of
the DoD Immunization Program for Biological Warfare Defense to ensure that
it is consistent with DoD policy and is adequately integrated into overall
DoD biological defense policies.

3. The Assistant Secretary of Defense for Health Affairs shall:

a.  Serve as the advisor to the Secretary of Defense as in DoD Directive
5136.1 (reference (d)) on the DoD Immunization Program for Biological
Warfare Defense.

b.  In consultation with the DoD Executive Agent, the Secretaries of the
Military Departments, and the Chair of the Armed Forces Epidemiological
Board, identify vaccines available to protect against biological threat
agents designated by the Chairman of the Joint Chiefs of Staff and
recommend appropriate immunization protocols.

c.  Issue instructions to the Military Departments and the other
appropriate DoD Components on the immunization of DoD personnel, under the
guidelines of this Directive, and monitor and evaluate the implementation
of those instructions.

4. The Secretary of the Army. as the DoD Executive Agent for the
Immunization Program for Biological Warfare Defense, shall:

a.  Besides those responsibilities in the Deputy Secretary of Defense
Memorandum and the Joint Service Agreement (references (e) and (f)), do
the following to enhance the DoD Immunization Program for Biological
Warfare Defense, and report annually through the Assistant Secretary of
Defense for Health Affairs (ASD(HA)) to the Secretary of Defense the
capability to carryout those policies:

(1) Vaccine Research and Development

Priorities developed in coordination with the ASD(HA), the Chairman of
the Joint Chiefs of Staff, and the Secretaries of the Military Departments
shall include the development of vaccines against validated biological
warfare threat agents for which none exist, improvement of vaccines that
are unacceptable in the time they take to produce immunity or in the level
of immunity they produce or are inadequate because of the number of doses
required to achieve immunity, assessment of the effectiveness of vaccines
against biological warfare threat agents in their likely modes of use
(e.g., aerosols), and development of multivalent vaccines that will
produce protective immunity after a single vaccination.  Vaccines must be
either licensed by the Food and Drug Administration (FDA) or have been
designated, under FDA requirements, "for use as investigational new drugs
(INDs)," as in 21 CFR 50 (reference (g)).

(2) Vaccine Acquisition and Stockpiling

b.  Develop and maintain a DoD capability to acquire and stockpile adequate
quantities of vaccines to protect the programmed force against all
validated biological warfare threat agents for which suitable vaccines
exist.

c.  On an annual basis, provide information and recommendations, in
coordination with the Secretaries of the Military Departments and the
Chair of the Armed Forces Epidemiological Board, to the ASD(HA) on
vaccines to acquire and appropriate immunization schedules that include
reimmunization required to develop and maintain protective immunity.  Those
recommendations should include, but not be limited to the following:

(1) All relevant data on the effectiveness of each vaccine against the
corresponding biological warfare threat agent.

(2) The expected type, frequency, and severity of vaccine-associated
adverse reactions.

d.  Serve as the focal point for the submission of information from the
Services, as specified by subsection E.5., below, and monitor the
Services' implementation of the DoD Immunization Program for Biological
Warfare Defense.  Recommend appropriate changes and improvements to the
Secretary of Defense through the ASD(HA), and the Secretaries of the
Military Departments.  Report to the Secretary of Defense annually on the
Immunization Program for Biological Warfare Defense.

e.  The Executive Agent Acquisition Executive (AE) shall plan, program, and
budget for biological defense.  The AE shall coordinate directly with the
ASD(HA), the Under Secretary of Defense for Policy, the Under Secretary of
Defense for Acquisition, the Secretaries of the Departments, and other
offices as required to ensure program integration.

5. The Secretaries of the Military Departments shall:

a.  Implement, monitor, evaluate, and document the DoD Immunization Program
for Biological Warfare Defense in their Department and establish
procedures for coordinating and reporting the following information to the
Executive Agent:

(1) The identification, reporting, and epidemiologic evaluation of vaccine
-associated adverse reactions, in accordance with FDA requirements.

(2) The collection and forwarding of data required by the Executive Agent
needed to meet requirements of the FDA for products that are the INDs.

b.  Transmit the instructions of the ASD(HA) about the immunization program
for biological warfare defense to subordinate units.

c.  Program and budget for the required vaccinations for members of their
Department and provide the DoD Executive Agent with projected program
requirements.

6. The Chairman of the Joint Chiefs of Staff, in consultation with the
Commanders of the Unified Commands; the Chiefs of the Military Services;
and the Director, Defense Intelligence Agency (DIA), annually and as
required, shall validate and prioritize the biological warfare threats to
DoD personnel and forward that list to the DoD Executive Agent through the
ASD(HA).

7. The Commanders of the Unified Commands, annually and as required, shall
provide the Chairman of the Joint Chiefs of Staff with their assessment of
the biological warfare threats to their theaters.

8. The Chair of the Armed Forces Epidemiological Board, in consultation
with the DoD Executive Agent and the Secretaries of the Military
Departments, annually and as required, shall identify to the ASD(HA)
vaccines available to protect against validated biological warfare threat
agents, and recommend appropriate immunization protocols.

F. PROCEDURES

The DoD Immunization Program for Biological Warfare Defense shall be
conducted, as follows:

1. The Commanders of the Unified Commands, annually and as required, shall
provide the Chairman of the Joint Chiefs of Staff with their assessment of
the biological warfare threats to their theater.

2. The Chairman of the Joint Chiefs of Staff, in consultation with the
Commanders of the Unified Commands; the Chiefs of the Military Services;
and the Director, DIA, annually, shall validate and prioritize the
biological warfare threats to DoD personnel and forward them to the DoD
Executive Agent through the ASD(HA).

3. Within 30 days of receiving the validated and prioritized biological
warfare threat list from the Chairman of the Joint Chiefs of Staff, the
DoD Executive Agent shall, in consultation with the Secretaries of the
Military Departments and the Chair of the Armed Forces Epidemiology Board,
provide recommendations to the ASD(HA) on vaccines and immunization
protocols necessary to enhance protection against validated biological
warfare threat agents.

4. Within 30 days of receiving the coordinated recommendations of the DoD
Executive Agent, the ASD(HA) shall direct the Secretaries of the Military
Departments to begin immunization of the specified DoD personnel against
specific biological warfare threat agents.

5. For biological threats for which the only available vaccine is an ND,
it shall be administered under 21 CFR 50 and 312 (reference (g)) and the
established ND protocol and/or other applicable legal procedures.

G. INFORMATION REQUIREMENTS

The annual reporting requirements in section E., above, have been assigned
Report Control Symbol DD-POL(A) 1921.

H. EFFECTIVE DATE AND IMPLEMENTATION

This Directive is effective immediately.  The Secretaries of the Military
Departments shall forward one copy of implementing documents to the
Assistant Secretary of Defense for Health Affairs within 120 days.

William J. Perry Deputy Secretary of Defense

Enclosures - 2 1. References 2. Definitions

REFERENCES, continued

(e) Deputy Secretary of Defense Memorandum, "Biological Warfare Defense
Program," August 26, 1991
(f) Joint Service Agreement, "Joint Service Coordination of Chemical
Warfare and Chemical-Biological Defense Requirements, Research,
Development, and Acquisition," July 5, 1984
(g) Title 21, Code of Federal Regulations, Parts 50, "Informed Consent of
Human Subjects," and 312, "Investigational New Drug Application," current
edition

DEFINITIONS

1. Biological Warfare Agent.  A microorganism or biological toxin intended
to cause disease, injury, or death in humans.

2. Biological Warfare Threat.  A biological materiel planned to be deployed
to produce casualties in humans.

3. High-Threat Area.  A geographic area in the proximity of a nation or
nations considered to pose a potential biological threat to DoD personnel
by the Chairman of the Joint Chiefs of Staff in consultation with the
Commanders in Chief of the Unified Commands and the Director, DIA.

4. Immunity.  The capacity to resist the effects of exposure to a specific
biological agent or toxin.

5. Immunization.  The process of rendering an individual immune.
Immunization refers to "the administration of a vaccine to stimulate the
immune system to produce an immune response (active immunization)." That
process may require weeks to months and administration of multiple doses
of vaccine.

6. Programmed Force.  The DoD active and Reserve force approved by the
Secretary of Defense in the Future Years Defense Program.

7. Vaccination.  The administration of a vaccine to an individual for
inducing immunity.

8. Vaccine.  A preparation that contains one or more components of a
biological agent or toxin, and induces an immune response against that
agent when administered to an individual.

9. Validated Biological Warfare Threat Agent.  A biological warfare agent
that is validated as a threat to DoD personnel by the Chairman of the
Joint Chiefs of Staff, in consultation with the Commanders of the Unified
and Specified Commands; the Chiefs of the Military Services; and the
Director, DIA.

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