Army Regulation 40-562
Medical Services
Immunizations and Chemoprophylaxis
Distribution Restriction Statement.
Destruction Notice.
Department of the Army
Bureau of Medicine
Air Force
Coast Guard
This publication
supersedes Army Regulation 40-562/BUMEDINST 6230.15/Air Force Instruction
48-110(1)/CG COMDTINST M6230.4F dated 20 Jan 1995.
Unclassified
Summary of Change
This revision--
· Describes standards for military immunization delivery, including quality-improvement mechanisms (para 2-1 and app B).
· Describes roles for the Military
Vaccine Agency and the Vaccine Healthcare Centers Network (paras
2-6, 2-7, and 3-1).
· States that electronic immunization
tracking systems are the preferred record for immunization data (para 2-7).
· Provides guidance on managing
Service members who lose immunization records (para
2-7).
· Describes a procedure for dispersing
immunization during initial military training into two clusters, the first to
reduce imminent risk of contagious disease in settings of close contact and the
second for other vaccine-preventable diseases (para
3-1).
· Describes a procedure for giving
credit for immunizations documented before military Service (para 3-1).
· Describes procedures for abiding by
regulations for vaccines and other products administered in investigational new
drug status or under emergency use authorization (ch
7 and ch 8).
History. This issue publishes a major revision.
Summary. This publication provides the 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.
Applicability. This regulation applies to uniformed
departments of the Army, Marine Corps, Navy, Air Force, and Coast Guard
(including the Active and Reserve Components of each Service), nonmilitary
persons under military jurisdiction, selected Federal employees, selected
employees of Department of Defense contractors, and family members and other
healthcare beneficiaries eligible for care within the military health care
system. Each form affected by the
Privacy Act that is required by this regulation either contains a Privacy Act
Statement incorporated in the body of the document or is covered by DD Form
2005, Privacy Act Statement-Healthcare Records.
Army Management Control Process. This
regulation contains management control provisions and identifies key management
controls that must be evaluated.
Supplementation. Army:
Supplementing this publication is prohibited without prior approval from
The Surgeon General (DASG-HCA), 5111 Leesburg Pike,
Interim
Changes.
Suggested Improvements. Army:
Users are invited to send comments and suggested improvements on DA Form
2028 (Recommended Changes to Publications and Blank Forms) or similar format
directly to HQDA (DASG-HCA), 5111 Leesburg Pike,
Committee Continuance Approval.
Distribution. This publication is available in electronic
media only and can be accessed according to instructions from each Service.
Table of Contents (listed by
paragraph number)
Chapter 1
Introduction
Purpose - 1-1
References - 1-2
Abbreviations and terms - 1-3
Responsibilities - 1-4
Chapter 2
Program Elements and Clinical
Considerations
Standards - 2-1
Logistics - 2-2
Storage and handling - 2-3
Hypersensitivity or allergy - 2-4
Immunizing women of childbearing
potential - 2-5
Exemptions - 2-6
Immunization records - 2-7
Jet-injection immunization devices -
2-8
Emergency response requirements -
2-9
Adverse events - 2-10
Program evaluation - 2-11
Blood donation - 2-12
Chapter 3
Personnel Subject to Immunization
Military personnel - 3-1
Other populations - 3-2
Chapter 4
Specific Immunization Requirements
for DoD and USCG Personnel
Adenovirus types 4 and 7 - 4-1
Anthrax - 4-2
Cholera - 4-3
Haemophilus influenzae
type b (Hib) - 4-4
Hepatitis A - 4-5
Hepatitis B - 4-6
Influenza A and B - 4-7
Japanese encephalitis - 4-8
Measles, mumps, and rubella - 4-9
Meningococcal disease - 4-10
Pertussis - 4-11
Plague - 4-12
Pneumococcal disease - 4-13
Poliomyelitis - 4-14
Rabies - 4-15
Smallpox - 4-16
Tetanus and diphtheria - 4-17
Typhoid fever - 4-18
Varicella - 4-19
Yellow fever - 4-20
Chapter 5
Chemoprophylaxis
General - 5-1
Anthrax - 5-2
Group A
streptococcal disease - 5-3
Influenza A&B - 5-4
Leptospirosis - 5-5
Malaria - 5-6
Meningococcal disease - 5-7
Plague - 5-8
Scrub typhus - 5-9
Traveler’s diarrhea - 5-10
Tuberculosis - 5-11
Chapter 6
Biological Warfare Defense
Purpose - 6-1
Responsibilities - 6-2
Procedures - 6-3
Chapter 7
Vaccines and Other Products in
Investigational New Drug Status
Purpose - 7-1
General guidance on
Health record-keeping requirements
for
Informational requirements for
Chapter 8
Emergency Use Authorization
General - 8-1
Criteria - 8-2
Refusal options - 8-3
DoD requests for EUAs
- 8-4
Appendixes
A. References
B.
Standards
for Military Immunization
C.
Medical and
Administrative Exemption Codes
D. Immunizations for Military Personnel
Chapter 1
Introduction
1-1. Purpose
This publication provides the 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.
1-2. References
References are provided in appendix A.
1-3. Explanation of abbreviations and
terms.
Abbreviations and terms used in this publication are defined in the glossary.
1-4. Responsibilities.
a. The command medical authority will prescribe
specific immunization and chemoprophylactic
requirements for their units per requirements established by this publication
and additional guidance provided by the appropriate surgeon general or United
States (U.S.) Coast Guard (USCG) Director of Health and Safety (G-WK).
b. Combatant commanders, commanders,
commanding officers, and officers-in-charge will–
(1) Ensure military and nonmilitary
personnel under their jurisdiction receive required immunizations and
chemoprophylaxis.
(2) Maintain appropriate
international, Federal, State, and local records of all immunizations and
chemoprophylaxis.
(3) Ensure personnel transferred to
another command receive proper screening for and administration of appropriate
immunizations and chemoprophylaxis for the area assigned, timed to provide
immunity before deployment or exposure.
(4) Ensure deviations from specified
immunizations are cleared or authorized by the appropriate combatant commander;
surgeon general; or Commandant G-WK, USCG.
(5) Observe International Military
Standardization Agreements (STANAGs), including
STANAG 2037, STANAG 2491, and STANAG 3474.
c. Medical commanders, commanding officers,
and command surgeons will–
(1) Ensure individuals administering
immunizations are properly trained IAW Department of Defense (DoD), Service, USCG, and Centers for Disease Control and
Prevention (CDC) guidelines and act within their scope of practice as
determined by each Service. These training standards will include baseline and
annual refresher training.
(2) Appoint in writing a privileged
physician as officer-in-charge of any clinic or activity that administers
immunizations. It is not required that a physician be present for
administration of vaccines. However, a physician must be available to address
immunization issues. The responsible physician must approve all standard
operating procedures for immunization administration in clinics or locations
where immunizations are administered.
(3) Ensure current national
standards for adult and pediatric immunizations and chemoprophylactic
practices are followed and references listed appendix A of this publication are
reflected in local practice.
(4) Ensure patients are evaluated
for preexisting immunity or need for medical exemptions to immunization, and
granted exemptions are documented as discussed in paragraph 2-6.
(5) Ensure patients needing
evaluation of adverse events after immunization are referred to appropriate
medical providers, such as the clinical resources of the Vaccine Healthcare
Centers (VHC) Network (see para d (2) below), for
evaluation, consultation, or indicated intervention.
(6) Ensure compliance with policies
and procedures for creating and maintaining immunization records.
(7) Ensure emergency medical response is
available, that personnel who administer immunizations are trained at a minimum
in basic cardiopulmonary resuscitation and the administration of epinephrine,
that personnel practice emergency responses, and that healthcare providers are available
to respond to adverse events resulting from immunization.
d. Support elements. Inclusion of Section 1.4
is contingent on approval of revised DoDI 6205.2. If DoDI 6205.2 is not approved by the
time this regulation/instruction is approved, drop section 1.4.
(1) The Army, in cooperation with
the military Services, will operate a Military Vaccine Agency, to provide the
military Services with a single source for information, education, and
coordination of vaccine-related activities, to fulfill DoD Instruction 6205.2.
This agency will measure and analyze implementation of immunization policies as
indicators of readiness, safety, and effectiveness. This agency will also
support expansion and quality of standardized automated immunization tracking
systems.
(2) The Army, in cooperation with
the other military Services, will coordinate clinical centers of excellence for
vaccine health care. These centers of excellence shall be known as the VHC
Network. The VHC Network shall establish and update as necessary joint clinical
quality standards for vaccine administration and for the education and training
of personnel in vaccine health care.
Chapter 2
Program Elements and Clinical Considerations
2-1. Standards
a. DoD policy. It is the DoD policy to follow recommendations of the CDC and the Advisory Committee on Immunization Practices (ACIP) concerning immunizations, unless there is a militarily relevant reason to do otherwise. Immunizing agents used in the DoD will meet the requirements of the Department of Health and Human Services (DHHS) for the production and distribution of such materials and meet standards acceptable to the Food and Drug Administration (FDA) and any applicable DoD investigational drug review process. Privileged healthcare providers may make clinical decisions for individual beneficiaries to customize medical care or to respond to an individual clinical situation.
b. Standards for delivery of military
vaccines. Standards for delivery of military vaccines are provided in appendix
B. Military Services will abide by these standards in routine immunization
delivery.
c. Expiration date. Immunizing agents
are not used beyond the stated potency expiration date, unless the appropriate
surgeon general or Commandant (G-WK), USCG authorizes extension in exceptional
circumstances.
d. Immunization intervals.
(1) Immunizations given at an
interval shorter than the recommended interval may not provide adequate immune
response and should not be counted as part of a primary series, unless part of “catch-up”
schedules accepted by the CDC.
(2) Restarting an immunization
series or adding extra doses is not necessary when an initial series of a
vaccine or toxoid is interrupted, because increasing the interval between doses
in a series does not diminish the ultimate immunity obtained. Instead, give
delayed doses as soon as feasible.
e. Simultaneous immunizations. National
norms regarding simultaneous administration of vaccines will be observed.
(1) In general, to minimize
injection-site discomfort in Service members, not more than five vaccine
injections will be given on the same day.
(2) Additional vaccinations are then
given at an appropriate later date. A week will often suffice for inactivated
vaccines. Live-virus vaccinations typically are given simultaneously or at an
interval of 4 or more weeks.
(3) Priority of immunization is
based on relative likelihood of the various microbial threats and the existence
of any vaccine-vaccine, vaccine-antibody, or vaccine-drug interactions. A
starting point for prioritizing immunizations for an individual would take into
account microbes most likely to be encountered (for example, typhoid, hepatitis
A, influenza), of greatest severity if encountered (for example, anthrax,
smallpox, meningococcal, yellow fever, Japanese encephalitis, rabies), or of
long-standing risk (for example, hepatitis B, tetanus-diphtheria,
poliomyelitis, varicella, measles-mumps-rubella).
This sequence would not apply in military training centers, where contagious
diseases would typically represent the most imminent threats.
(4) Prioritization (see para (3) above) is best performed by an experienced
healthcare provider. The five-injection threshold should only be exceeded in
cases where the vaccine recipient is deploying beyond the reach of deployable
medical resources, where exceptional personal exposure to infectious diseases
exists, or when authorized by the physician responsible for the immunization
service.
f.
Screening for
immunity. For some vaccine-preventable diseases, serologic or other tests can
be used to identify preexisting immunity from infection or disease which may
remove the need for superfluous immunization. Such testing will be adopted where
it offers advantages in terms of improved care or medical economics.
2-2. Logistics
a. Immunizing agents are requisitioned IAW medical supply procedures.
b. Personnel involved with medical
supply will expend sufficient resources to maintain the cold chain in vaccine
delivery ensuring appropriate storage temperatures during shipment and avoiding
inappropriately low or elevated temperatures. Shipping advice is available from
Service medical logistics centers.
c. To minimize the shipment of vaccines
that must be stored at frozen temperatures, small stations and ships may
requisition these items from a military medical activity stocking the items.
Requisitioning procedures and reimbursement are prescribed by the supplying
activity.
2-3. Storage and handling
Immunizing agents are stored, shipped, and handled IAW the pharmaceutical manufacturers’ instructions as outlined in the product's package insert or other guidance.
2-4. Hypersensitivity or allergy
a. Before administration of any medication, including vaccines, determine if the individual has previously shown any unusual degree of adverse reaction or allergy to it or any specific component of it (for example, eggs, gelatin, preservatives) or latex packaging, if applicable. Review the manufacturers’ package inserts and reference materials for product-specific information.
b. Individuals with reported
hypersensitivity are deferred from immunization or chemoprophylaxis.
(1) Refer the patient to an
appropriate specialist for evaluation, unless the medical record documents
prior consultation or specialist’s recommendations.
See paragraph 2-6 for discussion of medical exemptions.
(2) Document hypersensitivity to any
vaccine, vaccine component, or medication on the Standard Form (SF) 600 (Health
Record-Chronological Record of Medical Care) and on the problem list.
Exemptions from further immunization are entered in DoD-
or USCG-approved electronic immunization tracking systems (ITSs), on the Public Health
Service (PHS) Form 731 (International Certificate of Vaccination), and in other
relevant paper-based immunization records.
2-5. Immunizing women of childbearing
potential
A pregnancy-screening test for women of childbearing potential is not routinely required before administering vaccines, including live-virus vaccines. Take the following precautions to avoid unintentional immunization with contraindicated products during pregnancy:
a. Display signs asking pregnant women
to identify themselves. Discretely ask the woman if
she is or might be pregnant. If the answer is a certain ‘no,’
document this in the healthcare record and immunize her. If the answer is ‘yes,’ defer her from immunization until her pregnancy ends,
unless benefits of immunization outweigh risks in pregnancy (see para d below and ACIP guidelines regarding immunizations
indicated during pregnancy). If pregnancy status is uncertain, defer
immunization until after a negative pregnancy evaluation (e.g., urine or
serologic test).
b. With regard to
smallpox (vaccinia) vaccine, a specific
pre-immunization screening form (available at www.smallpox.mil/resource/forms.asp)
that assesses the date of the last menstrual period is required. For women
whose last menstrual period was more than 28 days ago, a pregnancy test is recommended.
c. If a live virus vaccine is administered, counsel the woman to avoid becoming pregnant for an appropriate interval (for example, 1 month) and document that counseling in the health record.
d. If a woman is pregnant and immunization is indicated for her while
pregnant, immunize under direction of the woman’s
obstetric healthcare provider.
e. Breastfeeding women may be
vaccinated IAW current ACIP guidelines. At present, no immunization products
are medically contraindicated in breastfeeding women. Smallpox vaccine is
withheld from breastfeeding women, except in an outbreak, primarily due to the
potential for contact transmission of vaccinia virus
to the child.
f.
When a
contraindicated vaccine is inadvertently administered to a pregnant woman,
report the event upon discovery to local preventive medicine and obstetric
services and complete quality-assurance documents. In some cases, special
registries for such cases have been established, such as the National Smallpox
Vaccine in Pregnancy Registry.
2-6. Exemptions
There are two types of immunization exemptions: medical and administrative. Granting medical exemptions is a medical function that can only be validated by healthcare personnel. Granting administrative exemptions is a non-medical function, usually controlled by the individual’s unit commander.
a. Medical exemptions. A medical
exemption includes any medical contraindication relevant to a specific vaccine
or other medication. Medical exemptions will be customized to the health of the
vaccine candidate and the nature of the immunization planned. Medical
exemptions may be temporary (up to 365 days) or permanent. General examples of
medical exemptions include those in (1)-(3) below. Standard exemption codes
appear in appendix c.
(1) Underlying health condition of
the vaccine candidate (for example, based on immune competence, pharmacologic
or radiation therapy, pregnancy, previous response to immunization).
(2) Evidence of immunity based on
serologic tests, documented infection, or similar circumstances.
(3) An individual’s
clinical case is complex or not readily definable. In such cases, consult
appropriate medical specialist(s); additional clinical support is available
from the DoD VHC Network.
(4) The primary care provider or a
physician specialist may grant temporary or permanent medical exemptions. If
additional clinical consultation is needed to assess a patient’s
condition, the primary care provider will perform the initial clinical work-up
appropriate to the presenting symptoms and grant a temporary medical exemption
pending the results of a referral to a medical specialist appropriate to the individual’s clinical condition (for example, dermatology,
neurology, rheumatology, allergy-immunology). The VHC Network can facilitate
these referrals. Multidisciplinary consultations may be appropriate. Return of
the patient to his or her primary care provider is not required if the
referring specialist grants a permanent medical exemption. Cases warranting
permanent medical exemption due to a vaccine-related adverse event will be
reported to the Vaccine Adverse Events Reporting System (VAERS). Medical
records will be annotated regarding temporary and permanent medical exemptions.
When no longer clinically warranted, medical exemptions will
be revoked. For Air Force (AF) personnel, military members with permanent
medical exemptions will require a medical evaluation board and/or a flying
waiver IAW AF Instruction 48-123.
(5) Service members who disagree
with a given provider’s/consultant’s recommendations
regarding exemption may be referred for a second opinion to a provider
experienced in vaccine adverse-event management (e.g,
VHC Network).
(6) Personnel will appropriately
annotate electronic ITSs and paper-based medical
records with exemption codes denoting evidence of immunity, severe adverse
event after immunization, other temporary or permanent reasons for medical
exemption, and other appropriate categories.
b. Administrative exemptions. Standard
exemption codes appear in appendix C.
(1) Separation or retirement. Within
180 days before separation or retirement, Service members may be exempt from
deployment (mobility) immunizations (see app D) if the following conditions are
met:
(a) They are not currently assigned, deployed, or scheduled to perform
duties in a geographic area where an immunization is indicated.
(b) The commander has not directed immunization because of overriding
mission requirements.
Personnel meeting these requirements
and desiring an immunization exemption must identify themselves to their
commander. The member must have approved retirement or separation orders.
Active-duty personnel continuing duty in the Reserve Component (RC) are not
exempted on this basis.
(2) Thirty days or less of service
remaining.
Exemptions apply to civilian employees and contractor personnel who will leave
a position subject to immunization within 30 days or less.
(3) Religious. Immunization
exemptions for religious reasons may be granted according to Service-specific
policies to accommodate doctrinal religious beliefs of a Service member. This
is a command decision made with medical and chaplain input.
(a) Requests for religious exemption must include name, rank, social
security number (SSN), occupational specialty code or branch, name of
recognized religious group, date of applicant’s
affiliation, a description of the religious tenet or belief contrary to
immunization, and supporting certification signed by an authorized personal
religious counselor. The counselor attests that the applicant is an active
member in good standing of the espoused religious group, adheres to tenets
consistent with the espoused religious beliefs, and the religious group has a
tenet or belief opposing immunizations. AF: Permanent exemptions for religious
reasons will not be granted. The major command (MAJCOM)/ commander is the designated approval and revocation authority for
temporary immunization exemptions. USCG: G-WPM is the designated approval and
revocation authority for temporary immunization exemptions.
(b) A military chaplain must counsel the applicant and recommend approval or
denial of the exemption request, by endorsement. The chaplain should attempt to
ascertain the validity of the Service member’s
request. The chaplain’s endorsement should address
the above issues to the greatest extent possible, based on his/her counseling
and knowledge of the individual and the individual’s
religion.
(c) A military physician must counsel the applicant and recommend approval
or denial of the exemption request, by endorsement. The physician should ensure
that the Service member is making an informed decision, and should address, at
a minimum, the following:
1. Specific information about the
diseases concerned,
2. Specific vaccine information
including benefits and risks, and
3. Potential risk of infection
incurred by unvaccinated individuals.
(d) The commander must counsel the individual and recommend approval or
denial of the exemption request, by endorsement. The commander must counsel
that noncompliance with immunization requirements may adversely impact deployability, assignment, or international travel, and
that the exemption may be revoked under imminent risk conditions. The
commander, in making his/her recommendation, should consider the potential
impact on the individual, the unit, and the mission.
(e) Forward exemption requests through command channels to the respective
Service personnel command for decision. Individuals with active requests for
religious exemption are temporarily deferred from immunizations, pending
outcome of their request. USCG: Forward through appropriate chain to G-WPM, via
G-WKH-1.
(f) Religious exemptions may be revoked if the individual and/or
his or her unit’s mission are at imminent risk of
exposure to a disease for which an immunization is available. This is in
keeping with the authority concerning involuntary therapeutic care when
military mission accomplishment may be compromised.
(4) Civilian personnel affected
by this document who
are members of bargaining units will be considered for exemption consistent
with applicable personnel management policies.
(5) Administrative or medical personnel
will appropriately annotate electronic ITSs with
exemption codes denoting separation, permanent-change-of-station, emergency leave, missing/prisoner of war, deceased, and other
appropriate categories.
2-7. Immunization records
a. Electronic immunization tracking systems.
(1) For military personnel, civilian
employees, and other healthcare beneficiaries, DoD-approved electronic ITSs are the preferred record for immunization data.
Electronic immunization records and exemption information will be transmitted
to and received from a DoD-centralized immunization repository at least weekly.
Transcription of historical immunization data from official immunization
records will occur concurrently with the implementation of electronic
immunization tracking.
(2) Electronic ITSs
must–
(a) Comply with the requirements of the National Vaccine Injury Compensation
(NVIC) Program outlined in paragraph d below.
(b) Incorporate appropriate levels of security to preclude unauthorized
access to personal medical information.
(c) Incorporate appropriate redundancy characteristics to survive hardware
or software malfunction.
(d) Be capable of generating printed reports of immunization status and
exemption information on both an individual and unit basis.
(3) A printed report from an
electronic ITS, in PHS Form 731, SF 601, or DD Form 2766C (Vaccine
Administration Record (Continuation Sheet)) format, accompanied by an official
clinic stamp and the authorized signature and printed name of an authenticating
official, will qualify as an official paper immunization record.
(4) A printed report as identified
in paragraph (3) above will suffice as a valid certificate of vaccination for
international travel for active duty members of the Armed Forces as outlined in
Article 80 (Part VI) of the World Health Organization (WHO) international
health regulations.
b. Non-electronic immunization records.
(1) PHS Form 731. Prepared
upon request for each member of the Armed Forces and for nonmilitary personnel
receiving immunizations. The form contains valid certificates of
immunization for international travel and quarantine purposes IAW WHO
international health regulations. PHS Form 731 remains in the custody of the
individual who is responsible for its safekeeping and for keeping it in his/her
possession when traveling internationally. Data is entered by hand, rubber
stamp, typewriter, or by printout from a DoD-approved electronic ITS.
(a) Abbreviations. Use only abbreviations for vaccines and their
manufacturers conforming to the nomenclature adopted by the CDC Vaccine
Identification Standards Initiative (VISI) (www.cdc.gov/nip/visi/prototypes.htm#abbreviations).
When writing, the day, month, and year are listed in that
order. The day is expressed in Arabic numerals, the month spelled out or
abbreviated using the first three letters of the word, and the year expressed
in Arabic numerals either by four digits or by the last two digits (for
example, 14 June 1994 or 14 Jun 94).
(b) Transcribed records. Entries based on prior official records will
include the following statement: "Transcribed from official records."
Alternately, the statement may cite the specific source (for example, “Transcribed
from SF 601”). When entries are transcribed onto paper records, the initials of
the transcriber will be included on each entry.
(c) Supply. PHS Form 731 is obtained through normal publication supply
channels. The DoD immunization stamp (rubber stamp,
fixed type, immunization certification, DoD seal, national stock number: 7520-00-823-8162)
is available through medical supply channels.
(d) Stamps. IAW instructions received from the Foreign Quarantine Division
of the CDC; the appropriate surgeon general; Chief, Bureau of Medicine and
Surgery; or Commandant (G-WK), USCG authorizes the use of a standard address
for military members which may be stamped on the face of the PHS Form 731.
Stamps are procured by local purchase as necessary.
1.
2.
3.
4.
5. USCG. Commandant (G-WK), USCG
Headquarters, 2100 Second Street SW, Washington, DC 20593-0001.
(e) Written signatures. In all cases, written signatures must appear in
appropriate spaces on each certificate; signature stamps are not valid.
(2) SF 601 (Marine Corps, Navy, and
USCG). Prepare SF 601 IAW Chapter 16, NAVMED P-107, U.S. Navy, or CG COMDTINST
M6000.1 series. When prepared, SF 601 and PHS Form 731 contain the SSN as
identifying data.
(3) AF. Initiate DD Form 2766C for
all personnel at the time of entry into military service.
(4) Paper-based immunization
records. Individuals preparing paper-based immunization records will ensure
that paper records match the electronic ITS.
(5) Deployment records. Transfer
information regarding immunizations, including date, immunization given, dose,
and initials of person administering to the deployable medical record (that is,
DD Form 2766 (Adult Preventive and Chronic Care Flowsheet)),
or comparable approved form, either by computer-generated report or by hand.
c. Lost immunization records. If an individual’s immunization records are lost, assume the
individual received standard vaccinations administered at entry into military
service by the individual’s accession source (for
example, enlisted, Service academy, direct commission), unless there is an
objective reason to believe otherwise. Do not repeat such vaccinations. Base
decisions for future immunizations on assumed date of last vaccination (for
example, Service member assumed to have received tetanus-diphtheria toxoid in
July 1995 would next be vaccinated in July 2005).
d. National Vaccine Injury Compensation
Program.
(1) The National Childhood Vaccine
Injury Act (NCVIA) of 1986 and other regulations set standards for certain
immunizations. These requirements apply to U.S. vaccines containing diphtheria,
tetanus, pertussis, measles, mumps, rubella, poliovirus, hepatitis B, Haemophilus influenzae
type b, varicella, rotavirus, pneumococcal-conjugate
antigens, and any new vaccine recommended by the CDC for routine administration
to children after the Secretary DHHS publishes a notice of coverage. For these
vaccines, the patient’s
name; identifying number (for example, sponsor’s
SSN); type of vaccine; date of administration; manufacturer; lot number; and
the name, address, and title of person administering the vaccine must be
recorded in a permanent medical record or permanent office log or file, in
either paper or electronic format. The electronic ITS is
the primary method of immunization documentation. Other records and management
reports may be generated from the electronic immunization database, as
described above. Until electronic systems are fully implemented, continue to
record the information on the paper immunization record and in a permanent
clinic immunization log.
(2) Personnel who administer
any vaccine covered
under the NVIC Program, to either children or adults, will provide the vaccinee an opportunity to read the most recent relevant
Vaccine Information Statements (VISs) provided by the
DHHS and an opportunity to ask questions about the vaccine. Single camera-ready
copies of VISs are available from State health
departments or through the CDC website (www.cdc.gov/nip/). Translations of VISs into languages other than English are available from
nongovernmental organizations (for example, Immunization Action Coalition).
(3) Personnel who
administer vaccines are not
required to obtain the signature of the military member, patient, or legal
representative acknowledging receipt of the VISs.
However, to ensure the existence of a record that the materials were provided,
healthcare personnel who administer vaccines will make a notation in each
patient's health record (for example, SF 600, SF 601, DD Form 2766C) that the VISs
were provided at the time of immunization.
(4) To comply with the NCVIA of 1986
and other regulations, current versions of the VISs
published by the CDC will be posted on readily accessible bulletin boards near
immunization clinics and mass immunization sites. Printed copies will be
provided to any Service member or beneficiary who requests one. Further, the
Military Vaccine Agency website (www.vaccines.mil) will link to the current
versions of VISs.
(5) The NCVIA requires that the
following events be reported to VAERS:
(a) Any event listed in the NVIC Program’s Vaccine
Injury Table (www.hrsa.gov/osp/vicp/table.htm) that occurs within the time period
specified or within 7 days, if that is longer.
(b) Any contraindicating event listed in a vaccine’s
package insert (that is, product labeling).
(6) In addition, VAERS accepts all
reports by any interested party of real or suspected adverse events occurring
after the administration of any vaccine.
(7) All DoD
and USCG healthcare beneficiaries are eligible to file claims with the NVIC
Program, according to the Program’s procedures.
2-8. Jet-Injection immunization devices
a. Needle-free multi-use-nozzle jet injectors (MUNJIs) capable of 600 or more injections per hour, formerly identified within DoD supply systems as "hypodermic injection apparatus jet automatic: 115 volt or foot operated," were withdrawn from DoD and USCG use in 1997 on grounds of safety. Their use of the same unsterile nozzle and fluid pathway to inject consecutive patients could allow transmission of blood-borne pathogens. MUNJIs are known by the trade names Ped-O-Jet®, Med-E-Jet®, Hypospray®, and DermoJet®, among other brands, and were usually refilled quickly from attached multi-dose vaccine vials. These devices remain unapproved and will not be used.
b. A new generation of needle-free disposable-cartridge jet injectors
(DCJIs) avoid the safety
concerns of MUNJIs by their use of a new, disposable,
sterile fluid pathway for each patient. Several are FDA-cleared for sale in the
2-9. Emergency-response requirements
a. Written plan. Clinics or activities administering immunizations will develop and maintain a written plan for emergency response, including management of anaphylaxis and fainting.
b. Training. Whenever vaccines are
administered, at least one person present must be trained and current in basic
cardiopulmonary resuscitation, oro-pharyngeal airway
management, and recognition and initial treatment of anaphylaxis with
epinephrine.
c. Anaphylaxis management. Supplies
necessary for emergency medical management of anaphylaxis (that is,
epinephrine, oral airway) and equipment and ability to activate an emergency
medical system must be immediately accessible on scene during administration of
any vaccine.
d. Observation. ACIP general
recommendations suggest that people be observed for 15 to 20 minutes after
being vaccinated.
e.
Temporary flying restrictions. Aviation personnel
typically will be grounded for 12 hours after immunization, or as specified by
their flight surgeon. No formal grounding documents are required for
uncomplicated immunization. Personnel who previously experienced urticaria, hypersensitivity phenomena, or other unusual
phenomena after an immunization will be exempt from flying duties for an
appropriate interval (for example, 72 hours) as determined by the flight
surgeon. Further temporary grounding may be necessary until significant side
effects resolve.
f.
Personnel experiencing adverse events that could
compromise their performance will remove themselves from flying duties and
notify their flight surgeon.
2-10. Adverse events
Describe in the individual’s health record a detailed account of severe adverse events after administering immunizing agents and other medications.
a. Mandatory information consists of
identification, lot number, and manufacturer of the biological agent; date of
administration; name and location of the medical facility; the type and
severity of the event; treatment provided, and any exemption from additional
doses.
b. The NVIC Program requires healthcare
providers to report adverse events to VAERS. They may use the VAERS reporting
form (Form VAERS-1) or submit electronic reports via the www.vaers.org website.
VAERS forms and information can be obtained by calling 1-800-822-7967 or by
accessing the VAERS website.
c. Reporting requirements.
(1) Healthcare personnel must report
adverse events resulting in hospitalization, a life-threatening event (for
example, anaphylaxis), time lost from duty more than 24 hours (more than 1 duty
shift), or an event related to suspected contamination of a vaccine vial.
Reports are also required for the following events: anaphylaxis, brachial
neuritis, encephalopathy, encephalitis, rubella-associated chronic arthritis,
thrombocytopenic purpura, vaccine-strain measles infection in an immunodeficient recipient, paralytic poliomyelitis, and any
other entry in the Vaccine Injury Table maintained by the NVIC Program
(www.hrsa.gov/osp/vicp/table.htm). These are minimum requirements.
(2) Further, healthcare
providers are encouraged to report other adverse events that the provider considers unexpected in
nature or severity.
d. Patients may also submit a VAERS
report directly. If a patient wishes to submit a VAERS report, healthcare
personnel will assist the patient in completing the form, regardless of
professional judgment about causal association to immunization.
(1) Reports of expected reactions
are not required (for example, low-grade, self-limited fever of less than 24
hours duration, temporary local soreness, redness, or minor swelling at the
site of immunization), because they are already expected, but may be submitted.
e. Attach pertinent information from
the vaccine recipient’s medical record to the VAERS
report. Submit copies of the VAERS report within 7 days of adverse event
recognition as follows:
(1) Send the original report form
and any appropriate supporting documents to the VAERS.
(2) Retain one copy for the Clinical
Quality Management Program at the reporting medical unit.
(3) Either file
a copy of the VAERS report in the patient’s individual
medical record or record the relevant information on the VAERS report within
the medical record.
(4) Submit one copy to the
appropriate disease-control authority according to current contact instructions–
(a) Army. Army Medical Surveillance Activity.
(b) Marine Corps and Navy. Navy Environmental
(c) AF. Air Force Institute for Operational Health.
(d) USCG. Commandant (G-WKH-1), USCG Headquarters.
f.
Immediately notify
the Joint Readiness Clinical Advisory Board (www.jrcab.army.mil), via email
message, if contamination or other serious problem with a vaccine vial or lot
is suspected. Suspend usage, but quarantine and retain all such opened or
unopened vials or lots under appropriate storage conditions pending further
investigation and disposition instructions.
g. An
adverse reaction to a DoD-directed immunization is a line-of-duty condition.
Military treatment facility (MTF) commanders will provide full access to RC members
for evaluation and treatment of adverse events potentially related to
DoD-directed immunizations. RC unit commanders will inform their members that
they may seek medical care for such adverse events, with the unit providing
assistance and information related to pay status and compensation issues. Any
necessary documentation, including line-of-duty determinations, will be
completed after the Guardsman or Reservist is evaluated and, if required,
treated. In no case will such evaluation or treatment be denied or delayed
pending line-of-duty determination. If additional health care is required after
the initial visit and a line-of-duty determination has established a Service
connection, a notice of eligibility must be completed IAW DoD
Directive 1241.1.
2-11. Program evaluation
a.
General
requirements. Each Service will develop appropriate quality-improvement
mechanisms to ensure immunizations are being administered IAW this publication.
b. Program assessment. MTFs and commands holding medical records will conduct
periodic reviews of immunization practices to ensure compliance with current
standards of care and documentation and as a measure of medical readiness and
health promotion. This will include self-assessment of the vaccine coverage level
of supported populations (for example, military units, preschool children,
influenza immunization of beneficiaries 50 years or older, pneumococcal
immunization of patients with diabetes). Commands will track performance over
time to progressively improve vaccine coverage.
c. Measure of coverage. MTFs and commands will, on at least an annual basis,
conduct a review of the adequacy of immunization coverage among supported
populations.
2-12. Blood donation
For timing of immunization with
regard to blood donation, clinicians will take into account the policies of the
Armed Services Blood Program Office (www.tricare.osd.mil/asbpo).
Chapter 3
Personnel Subject to Immunization
3-1. Military personnel
a. Accessions. Service accessions
include Service members in recruit training, Reserve Officer Training Corps
(ROTC),
(1) First cluster. The first cluster
of immunizations are administered before or at the beginning of collective
training (initial entry training, basic military training) to protect against
pathogens that represent an imminent risk of contagious disease in settings of
close contact: adenovirus (when licensed); influenza (once per season);
meningococcal; measles, mumps, rubella; and varicella
(if susceptible). Pneumococcal vaccine may be
administered if warranted epidemiologically.
(2) Second cluster. The second
cluster of immunizations may be administered in the first or second half of
basic military training, during advanced individual training, or upon arriving
at the first duty station to protect against travel and other military risks.
These immunizations include: hepatitis A, hepatitis B, influenza (once per
season), poliovirus, and tetanus-diphtheria. For Marine Corps, Navy, and USCG:
yellow fever. Live-virus vaccinations during the second cluster must follow at
least 28 days after any earlier live-virus vaccinations.
(3) Earlier immunizations. When
determining the immunization needs of accessions, give credit for immunizations
appropriately documented earlier in life (for example, data from electronic
immunization registries maintained by State health departments). Immunize if
the primary series is incomplete, if a booster immunization is needed, or if the
Service member has no serologic or historic evidence of immunity. Complete
multiple-dose immunization series according to the recommended schedule as soon
as possible. Except in an outbreak setting or for individual clinical purposes,
immunization records will not normally be screened after completion of initial
training with regard to measles, mumps, rubella, or poliovirus.
(4) ROTC cadets who are ordered or
called to active duty or active duty for training in the U.S. for a period of
30 days or more (and not in recruit training). Unless documentation of
immunization or immunity can be transferred into military records, ROTC cadets
attending training camps in the
(5) Service academy cadets and
midshipmen. Cadets and midshipmen receive vaccines to prevent meningococcal
disease, measles, mumps, rubella, varicella,
hepatitis A, and hepatitis B, tetanus-diphtheria, influenza (seasonal), and
poliomyelitis. These immunizations may be split into two clusters, as described
above. Cadets and midshipmen who travel overseas as part of
their training will receive immunizations according to geographic risk
analysis.
(6) Initial officer training.
Commissioned and warrant officers attending military training programs (for
example, Officer Basic Course) are screened for immunization status. If needed,
they receive vaccines to prevent measles, mumps, rubella, varicella,
hepatitis A, hepatitis B, tetanus-diphtheria, influenza (seasonal), and
poliomyelitis. These immunizations may be split into two clusters, as described
above.
b. Active duty personnel. Active-duty
personnel are immunized IAW appendix D or as supplemented in official notices
posted at the Military Vaccine Agency website, www.vaccines.mil. During
military service, active-duty personnel shall receive or be up-to-date on
immunizations for hepatitis A, influenza, and tetanus-diphtheria. For Marine
Corps and Navy: additionally, yellow fever. For USCG: additionally, hepatitis
B.
c. Reserve Components. RC personnel are
immunized IAW appendix D or as supplemented in notices posted at
www.vaccines.mil and shall receive the same immunizations as active-duty
personnel. RC members must be in a duty status to receive required
immunizations. For Marine Corps and Navy: Additionally, yellow fever.
d. Occupational risk. Military members
at occupational risk will receive appropriate vaccines per appendix D or as
supplemented in notices posted at www.vaccines.mil. Special populations at
occupational risk for vaccine-preventable diseases not listed in appendix D
shall be immunized per Federal, Service, or local occupational medicine
guidance.
e. Service-specific requirements.
(1) Army. Typhoid and yellow-fever
immunization required for alert forces, defined as: members of units, both
active and RC, designated to be in a state of readiness for
deployment to any area outside of the
(2) Marine Corps and Navy. Typhoid
immunization required for alert forces, defined as: fleet units deployed on a
scheduled or situational basis to any foreign country (except
(3) Air Force. Only operational
units specifically identified by the MAJCOM surgeon require initial and
subsequent immunization against meningococcal disease, typhoid fever, and
yellow fever.
(4) Coast Guard. Yellow-fever
immunization is required for all personnel assigned or attached to the
following operational units (alert forces): WHEC, WMEC, WPB, WAGB, WLB, USCG
Air Stations, National Strike Force, Port Security Units, Marine Safety and
Security Teams, Special Response Teams, Tactical Law Enforcement Teams, Law
Enforcement Detachments, Homeland Defense Contingency Units, and members of the
Coast Guard Reserve
designated by the district commander, individuals or special teams available
for immediate deployment outside the U.S., and members of a unit whose
commanding officer chooses to protect and preserve operational effectiveness.
Typhoid vaccine is required for all alert forces whose operational mission
requires deployment to typhoid-endemic areas (for example, Central and
f.
Geographic (travel)
immunization requirements.
(1) Each Service preventive medicine
authority maintains current health threat assessments based on disease
prevalence in specific geographic regions using Federal, DoD,
USCG, and other relevant sources of information. These assessments are
disseminated to units within their respective jurisdictions.
(2) Installations and deployed units
report disease occurrence through appropriate unit and/or medical lines of
communication.
(3) Combatant commanders, in
coordination with the appropriate surgeons general or Commandant (G-WK), Coast
Guard, establish specific immunization requirements based on a disease threat
assessment. These requirements may differ from standard Service immunization
policies for personnel entering their area of responsibility to participate in
exercises or operational missions. Personnel on official deployment or travel
orders will be immunized by local medical support IAW the specific guidance
established by the combatant commander before departure.
(4) For short-notice travel or
deployments requiring vaccines given in a multidose
series, administer the first dose of the basic series. Administer as many of
the subsequent doses as time permits. If the series
cannot be completed before departure, complete it upon arrival. Completion
before departure is the goal. Inform the patient that in order to obtain
optimal immunity, the series must completed by
receiving additional doses.
(5) Quarantine, entry, and reentry
requirements. Follow the provisions of U.S. Foreign Quarantine regulations
concerning entry or reentry of military and nonmilitary personnel into the
g. Other Uniformed Service personnel.
Members of other Uniformed Services are authorized immunizations according to
their occupation, official duties, travel plans, health status, or other
relevant factors.
3-2. Other populations
a. Family members of military personnel. Family members should receive immunizations according to current ACIP recommendations. ACIP recommendations are available at the CDC website (www.cdc.gov/nip) or the Military Vaccine website (www.vaccines.mil). In addition, family members may be subject to Service-specific requirements/recommendations for immunizations applicable to the country in which they will reside while accompanying military members under military sponsorship.
b. Emergency-essential civilian
employees and Federal civilian employees subject to rapid deployment. Civilian
employees and other groups having status equivalent to deployable forces
serving under the auspices of the military Services are provided the same
immunizations as military personnel. These immunizations shall be provided
without charge at military activities. Emergency-essential employees will be
notified that they may be required to take immunizations as a condition of
employment. A record of notification will be filed with a signed DD Form 2365
(DoD Civilian Employee Overseas Emergency-Essential Position Agreement).
Applicable vacancy announcements and position descriptions shall note obligations
to receive immunizations. Emergency-essential employees have the same access as
military personnel to treatment and necessary medical care related to adverse
events after immunization, consistent with applicable occupational health
program requirements.
c. Other Federal civilian employees,
contracted workers, and their family members.
(1) Other employees and their family
members engaged in foreign duty under military sponsorship. Federal civilian
employees and their family members shall receive country-specific immunizations
without charge at military activities upon presentation of official orders or
authorization. Area preventive medicine authorities are consulted for
recommendations applicable to specific areas. Persons declining immunizations required
for entry into foreign countries are referred to the appropriate authority for
counseling. Document counseling in the medical record and note that omission of
certain immunizations may subject them to compulsory immunizations, detention
and quarantine, or denial of entry by host country authorities. Where military
personnel are collocated with Department of State personnel, the two staffs
shall work together in the interest of disease prevention and health promotion.
(2) Civilian employees at occupational
risk for vaccine-preventable disease. Federal civilian employees at risk of
exposure to an infectious disease associated with their occupation shall
receive appropriate immunizations without charge at military activities.
Immunizations will be administered upon recommendation of the responsible
occupational medicine authority.
(3) Civilian healthcare employees.
Susceptible or occupationally exposed healthcare employees (including
volunteers) who have direct contact with patients shall receive appropriate
immunization against influenza, measles, mumps, rubella, and varicella unless a current immunization, a protective
titer, or a medical exemption is documented. This policy applies to all
healthcare settings, regardless of age or sex of the healthcare employee.
Employees, including volunteers, who have contact with or potential exposure to
human blood or blood products (whether from patient care, laboratory, or other
healthcare settings) are provided hepatitis B virus vaccine IAW the local bloodborne-pathogen exposure-control plan.
(4) DoD schoolteachers, day care center
workers, and children attending DoD-sponsored schools and day care centers or
similar facilities on military installations. As a condition of employment or
attendance at these facilities, schoolteachers, child care center workers,
volunteers, and children attending DoD-sponsored primary and secondary schools,
child care centers, or similar facilities are administered appropriate vaccines
against communicable diseases: measles, mumps, rubella, diphtheria, influenza,
poliovirus, pertussis (once adult vaccine licensed), and varicella
unless already immune (based on documented receipt of vaccine series or
physician-diagnosed illness) or medically/administratively exempt. For rubella,
immunity is based only on documentation of receipt of vaccine or laboratory
evidence of immunity. Administer influenza vaccine annually to schoolteachers,
day care workers, and volunteers. In addition, all other age-appropriate
ACIP-recommended vaccines for children are required unless there is
documentation of previous immunization, religious exemption, or medical
contraindication. Installation medical staff will collaborate with DoD school and day care center authorities to ensure
effective immunization screening procedures. Local MTFs
will appoint liaisons to these facilities to ensure understanding and
compliance.
(5) Employees with potential
occupational exposure to wastewater or sewage. Employees at occupational risk
shall receive tetanus-diphtheria per ACIP recommendations. Other vaccines are
not routinely required based solely on occupational risk for wastewater
treatment system workers.
d. Provision of vaccine to civilian
workers. The installation or activity commander, upon the recommendation of the
appropriate medical authority, will provide immunizations against diseases that
may be a significant cause of lost work hours in the civilian work force (for
example, influenza). Such immunizations are voluntary and are administered
without charge to the employee.
e. Foreign nationals. Foreign nationals
who come to the
f.
Sponsored
individuals. Other individuals who travel from, or reside outside, the
g. Overseas commander authority. The
overseas commander, commanding officer, or officer-in-charge, upon the
recommendation of the appropriate medical authority, will provide immunizations
against communicable diseases judged to be a potential hazard to the health of
the command; such vaccines are administered without charge.
(1) Contracted workers. For civilian personnel working under contract to any component of the DoD or USCG, immunizations may be provided according to terms of the contract, and
are provided as stated in the contract agreement. Otherwise, contractors provide appropriate immunizations to their
employees. When immunization is a condition of employment under the contract,
contracted employees will be notified as far in advance as practical. For
vaccines with limited distribution (for example, anthrax, smallpox), DoD or USCG may provide the immunizations to these workers.
The contractor is responsible for work-related illnesses, injuries, or
disabilities under worker-compensation programs, supplemented by existing Secretarial
designee authority.
Contracted healthcare workers are eligible for immunizations required or
offered to healthcare employees. These immunizations are provided as stated in
the contract agreement. These contracts will include specifications describing
immunizations required of contracted healthcare workers.
Chapter 4
Specific Immunization Requirements for DoD and USCG Personnel
(Also see appendix D for Service implementation.)
4-1. Adenovirus types 4 and 7
Military indication. When FDA-licensed adenovirus vaccines are available, administer to military recruits arriving at initial training to prevent febrile respiratory disease and its complications and disease outbreaks resulting from person-to-person transmission.
4-2. Anthrax
a. Military indication. For prevention of anthrax infection by any route of exposure due to spores or the bacteria Bacillus anthracis. Inhalational anthrax is almost uniformly fatal once symptoms develop.
b. Military and civilian personnel.
Administer anthrax vaccine to military personnel and applicable civilians
according to DoD or USCG policy for the Anthrax
Vaccine Immunization Program and Service-specific implementation plans. Anthrax
vaccination will be conducted for personnel in geographic areas or in
occupational roles designated by the Services, Chairman of the Joint Chiefs, or
the Office of the Secretary of Defense as being at higher threat for release of
anthrax as a weapon.
c. Occupational risk. Administer
anthrax vaccine to at-risk veterinary and laboratory workers and others at
occupational risk of exposure.
4-3. Cholera
Military indication. When an FDA-licensed cholera vaccine to counter Vibrio cholerae is available, administer according to DoD policy in appropriate deployed or deploying populations. Cholera immunization is no longer required to meet international travel requirements by any nation.
4-4. Haemophilus influenzae type b (Hib)
a. Military
indication. For the prevention of invasive Haemophilus
disease in people who have anatomic or functional asplenia.
b. Military and civilian personnel. Administer one dose of Hib vaccine to people who do not have spleens.
4-5. Hepatitis A
a. Military indication. For prevention of hepatitis A, an acute infection of the liver, acquired by consuming food or water contaminated with hepatitis A virus during deployment or travel to areas with poor food, water, and sewage sanitation. Hepatitis A is endemic worldwide.
b. Military personnel. Administer
hepatitis A vaccine to all military personnel. Whenever possible, the first
dose should be administered during accession training (for example, with the
second cluster of immunizations).
c. Occupational risk. Hepatitis A
vaccine is indicated for day care workers, food handlers, healthcare workers
having contact with active cases, and laboratory workers who are at risk of
exposure.
d. Product selection. Immunization may
be accomplished with single-agent hepatitis A vaccine or combined hepatitis
A-hepatitis B vaccine.
4-6. Hepatitis B.
a. Military indication. For prevention of hepatitis B, an acute or potentially chronic infection of the liver, that is acquired through percutaneous, sexual, and other permucosal exposure to blood and body fluids from persons infected with hepatitis B virus. Hepatitis B infections occur worldwide, and some infected persons maintain a chronic carrier state.
b. Military personnel. Unless already
immune, administer hepatitis B vaccine to susceptible military personnel with
the second cluster of immunizations during accession training, as well as
military personnel susceptible based on occupation or behavior, or deploying
for more than 30 days to areas of high hepatitis B endemicity
(for example, portions of Asia).
c. Occupational risk. Administer
hepatitis B vaccine to susceptible personnel who are at risk of exposure to
blood-borne pathogens per Occupational Safety and Health Administration
standards (29 CFR 1910.1030, www.osha.gov/SLTC/bloodbornepathogens/index.html).
For military purposes, this includes occupational specialties involving
healthcare workers, emergency medical technicians, mortuary-affairs personnel,
search and rescue specialists, correctional-facility staff, and designated
special-operations forces. Post-immunization serologic testing may be warranted
for selected personnel, according to CDC and ACIP recommendations. Document results of serologic testing in a DoD-approved electronic
immunization tracking system on the DD Form 2766. Follow CDC
recommendations for post-exposure management related to blood-borne pathogens.
d. At-risk adults. Administer hepatitis
B vaccine to susceptible beneficiaries with multiple sexual partners who are
treated for a sexually transmitted disease.
e. Army only. For
personnel on permanent-change-of-station orders or assigned to the Korean
peninsula, complete the primary series of hepatitis B immunizations.
Administer at least two doses according to the licensed schedule before
arriving in
f.
Healthcare workers.
Post-immunization serologic testing may be warranted for selected healthcare workers and mortuary-affairs personnel to identify
non-responders to hepatitis B vaccine, according to CDC and ACIP recommendations. Document results of serologic testing in a DoD-approved
electronic immunization tracking system and on the deployable medical record.
g. Product selection. Immunization may
be accomplished with single-agent hepatitis B vaccine or combined hepatitis A—hepatitis B vaccine.
4-7. Influenza A and B
a. Military indication. For prevention of influenza A and B, which are acute febrile respiratory viral infections that can cause epidemics within military populations, especially under conditions of crowding, such as recruit training, aboard ship, extended air transport, or deployment settings. Influenza A has the potential for pandemic spread.
b. Military personnel. Administer
influenza vaccine annually to all active duty and selected Reserve military
personnel.
c. Occupational risk. Offer influenza
vaccine to all other workers annually.
4-8. Japanese encephalitis
a. Military indication. For prevention of Japanese encephalitis, a mosquito-borne viral
disease, during deployments and travel to endemic areas in Eastern Asia and the
western
b. Military personnel. Administer
Japanese-encephalitis vaccine to military personnel and other beneficiaries who
are or will be stationed at least 30 days in rural areas of
c. Alert personnel. Administer Japanese
encephalitis vaccine to alert personnel at risk of deployment within 10 days of
notification to rural areas of
d. Temporary flying restrictions.
Aviation personnel will be grounded for 12 hours after immunization (the
standard procedure after any immunization) or according to the instructions of
their flight surgeon. Personnel who previously experienced urticaria
or hypersensitivity phenomena of any type after Japanese-encephalitis vaccine
will be exempt from flying duties for at least 72 hours after dose one, five
days after dose two, and 72 hours after dose three.
4-9. Measles, mumps, and rubella
a. Military indication. For prevention of measles, mumps, and rubella, primarily by boosting immunity acquired from childhood immunization. These three acute viral infections are spread by the respiratory route or person-to-person contact. In military recruit populations, each can cause disease outbreaks. Rubella usually causes a mild infection, but infection during the first trimester of pregnancy puts the fetus at high risk of congenital rubella syndrome and birth defects. Young adults may experience more severe complications from mumps infection. All three diseases occur worldwide, primarily among children.
b. Recruits and other accessions.
Administer measles, mumps, rubella (MMR) vaccine to susceptible recruits and
accessions within the first two weeks of training.
c. Military personnel. People born in
1957 or earlier are presumed to be immune through infection. Ensure military
personnel born after 1957 have received two lifetime doses of MMR vaccine or
have positive serologic test results. Unless there is reason to suspect
otherwise (for example, childhood spent in a developing country, childhood
immunizations not administered), a childhood dose of MMR vaccine may be
assumed. Document results of serologic testing in a
DoD-approved electronic immunization tracking system and on DD Form 2766.
Because of the high level of childhood immunization against these diseases,
after completion of initial training immunization records will not normally be
screened with regard to measles, mumps, or rubella immunity, except in an
outbreak setting or for individual clinical purposes.
d. Occupational risk. Ensure healthcare
workers have received two lifetime doses of MMR vaccine or have positive
serologic test results. Unless there is reason to suspect otherwise (for
example, childhood in a developing country, childhood immunizations not
administered), a childhood dose of MMR vaccine may be assumed. Document results of serologic testing in a DoD-approved electronic
immunization tracking system and on DD Form 2766.
e. Bivalent measles-rubella vaccine.
For personnel whose records show receipt of bivalent measles-rubella vaccine,
administration of MMR vaccine to achieve immunity against mumps is not
necessary as a military requirement, but may be appropriate in exceptional
clinical circumstances.
4-10. Meningococcal disease
a. Military indication. For the
prevention of meningitis and other systemic infection caused by the bacteria Neisseria meningitidis,
serogroups A, C, W-135, and Y. No vaccine against serogroup B meningococci, another
common pathogen, is currently licensed in the
b. Recruits and other accessions.
Administer meningococcal vaccine to recruits, cadets at Service academies, and
other accessions within the first two weeks of training.
c. Military personnel. Administer
meningococcal vaccine to military personnel traveling for more than 15 days to
regions subject to meningococcal outbreaks, if not administered within the last
5 years. Consult combatant command surgeons for current recommendations based
on disease distribution.
d. Alert personnel. Administer
meningococcal vaccine to personnel at risk of deployment within 10 days of
notification, if not administered within an appropriate booster interval. Air
Force: Only units specifically identified by the MAJCOM surgeon require initial
and subsequent immunization against meningococcal disease.
e. Other personnel. Administer
meningococcal vaccine to personnel traveling to sub-Saharan
4-11. Pertussis
When an FDA-licensed pertussis vaccine for adolescents and adults to counter Bordetella pertussis is available, administer to appropriate beneficiary populations according to ACIP recommendations.
4-12. Plague
The
causative agent of plague, Yersinia pestis, has been identified as a potential biological
warfare agent. When an FDA-licensed vaccine is available, administer according
to DoD policy in appropriate populations.
4-13. Pneumococcal
disease
a. Military indication. For prevention of pneumococcal disease due to Streptococcus pneumoniae in personnel who fall into a high-risk category due to age or underlying health conditions (for example, people without spleens) or who are in high-risk situations, such as certain recruit populations.
b. Recruits and other accessions. If
warranted, based on disease incidence, administer pneumococcal
vaccine to high-risk recruits and accessions within the first 2 weeks of
training based on preventive medicine guidance.
c. Military personnel. Administer pneumococcal vaccine to military personnel who are in a
high-risk category per ACIP recommendations. Administer a second dose to people
without spleens 5 years after the initial dose.
4-14. Poliomyelitis
a. Military indication. For prevention of poliomyelitis, primarily by boosting immunity
acquired from childhood immunization. Poliomyelitis is acquired by
person-to-person transmission through the fecal-oral route. Persons deploying
or traveling to areas with poor sanitation are at increased risk, although
international immunization efforts have decreased poliomyelitis incidence
worldwide. Only inactivated poliovirus vaccine (IPV) is available in the
b. Recruits and other accessions.
Administer a single booster dose of IPV to recruits and accessions. Personnel
who have not received primary series must complete the series using IPV. Unless
there is reason to suspect otherwise (for example, childhood spent in a
developing country, childhood immunizations not administered), receipt of the
basic immunizing series of IPV may be assumed.
c. Military personnel. Because of the
high level of childhood immunization against these diseases, cease screening
immunization records with regard to poliovirus immunity after completion of
initial training, except in an outbreak setting or for individual clinical
purposes.
4-15. Rabies
a. Military indication. For prevention of rabies after the bite of an animal suspected to be infected with rabies virus. Vaccine is given in conjunction with wound care and the administration of human rabies immune globulin. For pre-exposure immunization of persons occupationally at risk of exposure to rabid animals (for example, animal handlers and certain laboratory, wildlife management, and security personnel) and persons assigned long-term to regions with endemic rabies, especially in dogs and cats.
b. Military personnel. Administer
pre-exposure rabies vaccine series to special operations personnel. Give
booster doses every 2 years or when antibody concentrations indicate.
c. Occupational risk. Administer
pre-exposure rabies vaccine series to veterinary workers, animal handlers, and
security personnel who have animal control duties. Give booster doses every 2
years or when antibody concentrations indicate.
4-16. Smallpox
Military indication. In 1980, the WHO declared the global eradication of naturally occurring smallpox. Nonetheless, stocks of variola virus, the causative agent of smallpox, could be used as a biological warfare agent. Vaccinate designated military and civilian personnel according to DoD or USCG policy and Service-specific implementation plans. These include military personnel and applicable civilians who are smallpox epidemic response team members, assigned to medical teams at hospitals and clinics, or assigned to designated forces that constitute mission-critical capabilities. Vaccination will be conducted for personnel based on geographic location or occupational role designated by the Services, Chairman of the Joint Chiefs, or the Office of the Secretary of Defense as being at higher threat for exposure to smallpox. These roles will include laboratory workers and designated special-mission units.
a. Training and education. Military and
civilian personnel eligible to receive smallpox vaccine will be educated before
immunization regarding criteria for exemption from immunization, expected
response at the vaccination site, vaccination-site care, risks of spreading vaccinia to close contacts, and other relevant topics.
b. Screening. A specific screening form
posted at www.smallpox.mil will be used to identify people with personal or
household contraindications to smallpox vaccination. Screening will include
assessing pregnancy status and recency of test for
human immunodeficiency virus infection. In the event of a smallpox outbreak, “permanent”
exemptions may be rescinded according to individual risk of exposure to variola virus.
c. Vaccination. Internal MTFs and command clinical quality management programs will
have mechanisms to confirm that vaccinators demonstrate proper vaccination
technique.
d. Post-vaccination site care.
Appropriate care will be taken to prevent the spread of vaccinia
virus from the vaccination site. MTFs will operate
site-care stations to monitor the vaccination sites of vaccinated healthcare
workers, promote effective bandaging, and encourage scrupulous hand washing.
e. Post-vaccination evaluation (“take check”).
Assessment and documentation of response to vaccination is required for
healthcare workers and members of smallpox response teams who would travel into
a smallpox outbreak area. Others receiving smallpox vaccine also should have
their vaccination response evaluated and recorded. Documentation will include
electronic immunization tracking systems.
4-17. Tetanus and diphtheria
a. Military indication. For prevention of tetanus and diphtheria (Td) primarily by boosting immunity acquired from childhood immunization. Tetanus is an acute illness caused by an exotoxin of Clostridium tetani, a bacteria that grows at the site of wounds contaminated with its spores. C. tetani spores are ubiquitous in the environment worldwide. Diphtheria is an acute disease caused by a cytotoxin of the bacteria Corynebacterium diphtheriae. Diphtheria occurs worldwide.
b. Recruits and other accessions.
Individuals with previous history of Td immunization receive a booster dose
upon accession. For those individuals lacking a reliable history of prior
immunization, initiate a primary series of Td toxoid IAW ACIP guidelines.
Unless there is reason to suspect otherwise (for example, childhood spent in a
developing country, childhood immunizations not administered), receipt of the
basic immunizing series may be assumed.
c. Military personnel. Administer
booster doses of Td toxoid to all personnel every 10 years.
d. Occupational risk. Administer
booster doses of Td toxoid to all workers every 10 years.
e. All personnel. Following ACIP wound-management
guidelines, in the treatment of contaminated wounds, administer a booster of Td
toxoid if more than 5 years have elapsed since the last dose of Td. Tetanus
immune globulin is warranted in treating contaminated wounds if the patient
received fewer than three doses of a vaccine containing tetanus toxoid at any
time, or if receipt of a prior basic immunizing series is unlikely.
4-18. Typhoid fever
a. Military indication. For prevention of typhoid fever, a systemic bacterial disease, acquired by consuming food or water contaminated with Salmonella typhi during deployment or travel to typhoid-endemic areas and other areas with poor sanitation.
b. Recruits and other accessions. Not
routinely administered, except for personnel with overseas assignment orders.
c. Military personnel. Administer
typhoid vaccine to military personnel before overseas deployment to
typhoid-endemic areas.
d. Alert personnel. Administer typhoid
vaccine to alert personnel prepared for deployment to typhoid-endemic areas or
personnel who would be exposed to potentially contaminated
local food and drink. Administer booster doses per vaccination schedule. Air
Force: Only units specifically identified by the MAJCOM surgeon require initial
and subsequent immunization against typhoid fever.
4-19. Varicella
a. Military indication. For prevention of varicella (chickenpox) among susceptible military members, especially recruits, cadets at Service academies, other trainees, and special operations personnel, living in military environments conducive to person-to-person spread of respiratory diseases (for example, barracks, ships). Although varicella is a common childhood disease, adults may experience more severe illness and have higher complication and case-fatality rates.
b. Recruits and other accessions.
Administer varicella vaccine to susceptible recruits
and other accessions within the first two weeks of training. Serologic
screening of recruits is the preferred means of determining those susceptible
to varicella infection and in need of immunization.
If serologic screening is not feasible, persons may be questioned for
indicators of pre-existing immunity. Identify those persons who do not have a
personal history of varicella disease, documentation
of prior varicella immunization, or documentation of
immunity based on serologic testing as susceptible. Document
results of serologic testing in a DoD-approved electronic ITS and on DD Form 2766.
Adults and adolescents require two doses of varicella
vaccine given 4 to 8 weeks apart.
c. Healthcare workers. Administer varicella vaccine to susceptible healthcare workers.
Determine susceptibility as noted above for recruits. Routine post-immunization
testing for antibodies to varicella is not
recommended.
d. Other susceptible adults. Offer varicella vaccine to other susceptible people, especially nonpregnant women of childbearing age and men living in
households with young children.
4-20. Yellow fever
a. Military indication. For prevention of yellow fever, a mosquito-borne viral disease, and to meet international health requirements during deployment or travel to yellow fever-endemic areas.
b. Military personnel. Administer yellow
fever vaccine to military personnel traveling to or transiting through
yellow-fever endemic areas.
c. Alert personnel. Administer yellow
fever vaccine to alert personnel prepared for deployment to yellow
fever-endemic areas. Administer booster doses per vaccination schedule. Air
Force: Only units specifically identified by the MAJCOM surgeon require initial
and subsequent immunization against yellow fever.
d. Other personnel. Administer yellow
fever vaccine to personnel traveling to or transiting through yellow fever
endemic areas.
Chapter 5
Chemoprophylaxis.
5-1. General.
This section reviews military-relevant diseases and associated chemoprophylaxis guidelines. Chemoprophylaxis is defined here as the administration of medication before or during possible exposure to an infectious agent, to prevent either infection or disease. Command medical officers will review indications for use and potential adverse effects of specific chemoprophylactic medications before use. Consult current authoritative recommendations (for example, CDC, ACIP, Armed Forces Medical Intelligence Center, Control of Communicable Diseases Manual) and observe instructions from the relevant preventive medicine authority, in particular relevant combatant command surgeons, for the use of chemoprophylactic agents. The following classes of chemoprophylaxis are not addressed in this document:
a. Chemical warfare-related
chemoprophylaxis (see the current version of Medical Management of Chemical
Casualties, published by the U.S. Army Medical Research Institute of
Chemical Defense).
b. Medical therapy for tuberculosis
infection (see publications from CDC, the American Thoracic Society, the
Advisory Council for the Elimination of Tuberculosis, and similar authorities).
c. Radiation-related chemoprophylaxis
(for example, potassium iodide, granisetron, or
Prussian blue).
d. Other forms of prevention involving nonbiological medications (for example, calcium, aspirin, vitamins).
5-2. Anthrax.
a. Military indication. Antibiotics have been shown to increase survival when used after exposure to anthrax and before onset of symptoms. The respective combatant commander will direct prophylactic use.
Chemoprophylaxis. Consider doxycycline
or ciprofloxacin. For children, consider amoxicillin suspension. Adapt
according to current authoritative recommendations.
5-3. Group A Streptococcal Disease.
a. Military indication. Outbreaks of group A streptococci can spread rapidly in groups having especially close contact, such as military populations during contingency operations and during certain types of training. It may be required to administer penicillin prophylactically to the entire group to terminate disease transmission.
b. Chemoprophylaxis. Consider
penicillin G benzathine (IM) or penicillin VK (oral).
Administration prophylactically to an entire group
may be needed to terminate disease transmission.
c. Customized approach. Because of localized
epidemiologic factors, each Service will develop policies for surveillance and
prophylaxis of streptococcal disease at recruit centers.
5-4. Influenza A&B
a. Military indication. Influenza can be a significant cause of morbidity in a susceptible population and can degrade mission capability. Oseltamivir is effective in the chemoprophylaxis of both influenza type A and type B. Amantadine and rimantadine are effective in the chemoprophylaxis of influenza A, but not influenza B. Consider antiviral therapy in the event of vaccine failure or if an outbreak occurs early in the season before widespread immunization. Zanamavir has been shown to be effective in treatment, but not prophylaxis, of both influenza type A and type B.
b. Chemoprophylaxis. Consider amantadine, rimantidine, or oseltamivir. Adapt according to current authoritative
recommendations.
5-5. Leptospirosis
a. Military indication. Leptospirosis can cause morbidity in personnel exposed to contaminated water sources. Doxycycline is effective in preventing leptospirosis in exposed military personnel during periods of high exposure.
b. Chemoprophylaxis. Consider doxycycline.
5-6. Malaria
a. Military indication. Malaria has caused morbidity and mortality in military populations for centuries. Military operations often occur in areas of the world where malaria is endemic. Medical commanders will designate trained staff to provide comprehensive malaria prevention counseling regarding mosquito avoidance, personal protective measures (for example, clothing, repellents, bed nets) and chemoprophylaxis to military and civilian personnel considered to be at risk of contracting malaria. Counseling will include instruction on how to take the prescribed anti-malarial medication, the importance of compliance with the prescribed medication schedule, information about potential adverse effects, and the need to seek medical care if these adverse effects occur. Detailed resources are available at www.cdc.gov/travel.
b. Chemoprophylaxis. The Services or
the combatant command surgeon determine specific chemoprophylactic
regimens, typically with input from the Armed Forces Medical Intelligence
Center, for the area of operations based on degree and length of exposure and
the prevalence of drug resistant strains of Plasmodia
in the area(s) of travel. These regimens take into consideration reports of
malaria activity reported by CDC and WHO. Anti-malarials
are prescription medications to be individually dispensed in labeled,
child-resistant containers. Healthcare providers must document malaria
chemoprophylaxis prescriptions in the Service member's medical record whenever
these medications are prescribed. This record keeping should include the member’s electronic medication profile (for example,
Composite Health Care System), whenever possible.
c. Pre-primaquine
testing. Obtain glucose-6-phosphate dehydrogenase
(G6PD) testing for individuals requiring primaquine
chemoprophylaxis. Permanently record G6PD test results in the medical record
and on DD Form 2766.
5-7. Meningococcal disease
a. Military indication. Meningococcal disease can result in morbidity and potential mortality in populations with crowded conditions. Chemoprophylaxis has been shown to prevent disease when administered post-exposure to susceptible persons.
b. Chemoprophylaxis. For close contacts
of cases of meningococcal disease, consider rifampin,
ceftriaxone, ciprofloxacin, or sulfadiazine.
5-8. Plague
a. Military indication. Plague has been identified as a potential biological warfare agent, especially with regard to inducing pneumonic plague. There is no approved vaccine that is effective against pneumonic plague. Provide people potentially exposed to cases of pneumonic plague with chemoprophylaxis.
b. Chemoprophylaxis. Consider
tetracycline, doxycycline, or chloramphenicol.
5-9. Scrub typhus
a. Military indication. Spread by the bite of infective larval mites. May be a source of morbidity in populations encountering primitive field conditions.
b. Chemoprophylaxis. Consider doxycycline.
5-10. Traveler's diarrhea
a. Military indication. Diarrhea can have a significant impact on military operations when deploying to various locations around the world. Strict food and water discipline is the preferred means of prevention. However, for persons going to high-risk areas where food and water discipline is unreasonable or impossible, consider chemoprophylaxis.
b. Chemoprophylaxis. Consider ciprofloxacin
or other quinolones. An alternative to
chemoprophylaxis is to prescribe medication for very early treatment,
withholding administration of the first dose until the onset of diarrhea.
5-11. Tuberculosis
See Service-specific policies and
regulations for tuberculosis surveillance, chemoprophylaxis, and treatment
guidelines.
Chapter 6
Biological Warfare Defense
6-1. Purpose
DoD Directive 6205.3 establishes policy; assigns responsibilities; prescribes procedures for members of the DoD to defend against validated biological warfare threats; and outlines criteria to prioritize research, development, testing, acquisition, and stockpiling of biological defense vaccines under Title 10 of the United States Code.
6-2. Responsibilities
a. The combatant commanders, annually and as required, provide the Chairman of the Joint Chiefs of Staff with their assessment of the biological warfare threats to their theaters.
b. 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, identifies
to the Assistant Secretary of Defense (Health Affairs) (ASD(HA))
vaccines available to protect against validated biological warfare threat
agents and recommends appropriate immunization protocols and/or
chemoprophylaxis.
6-3. Procedures
The DoD Immunization Program for Biological Warfare Defense is conducted as follows:
a. The combatant commanders, annually
and as required, provide the Chairman of the Joint Chiefs of Staff with their
assessment of the biological warfare threats to their theater.
b. The Chairman of the Joint Chiefs of
Staff, in consultation with the combatant commanders; the chiefs of the
military Services; and the Director, Defense Intelligence Agency, annually
validates and prioritizes the biological warfare threats to DoD personnel and
forwards the threat list to the DoD Executive Agent through the ASD(HA).
c. 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, in consultation with the
Secretaries of the Military Departments and the Chairman of the Armed Forces
Epidemiological Board, provides recommendations to the ASD(HA)
on vaccines and immunization protocols necessary to enhance protection against
validated biological warfare threat agents.
d. Within 30 days of receiving the
coordinated recommendations of the DoD Executive Agent, the ASD(HA)
directs the Secretaries of the Military Departments to begin immunization of
the specified DoD personnel against specific biological warfare threat agents.
The ASD(HA) will coordinate with and obtain approval
from the Secretary or Deputy Secretary of Defense before issuing the
appropriate direction.
Chapter 7
Vaccines and Other Products
in Investigational New Drug Status.
7-1. Purpose
For infectious disease threats for which the only available vaccine or chemoprophylaxis product is in an investigational new drug (IND) status, the IND product must be administered in full accordance with FDA regulations at 21 CFR Parts 50 and 312. DoD may need to use products that have not been approved for commercial marketing as force health protection measures in combat settings, other military operations, peacekeeping, or humanitarian missions.
7-2. General guidance on
Combatant commanders must request
approval from the Secretary of Defense to use INDs for force health protection.
If the member’s use of an
7-3. Health record-keeping requirements for
All IND vaccines or chemoprophylaxis
products that are administered to a military member, whether with the member’s informed consent or with an approved waiver of
informed consent, must be recorded in the individual’s
permanent health record and/or other paper or DoD-approved electronic
immunization tracking systems. For vaccines, the documentation shall be that required
for other vaccines with an annotation “IND” with the vaccine name. This
record-keeping requirement is in addition to any record-keeping requirements of
the FDA-approved
7-4. Information requirements for
Any recipient of an
Chapter 8
Emergency Use Authorization
8-1. General
Under section 564 of the Food Drug
and Cosmetic Act (21 U.S.C. 360bbb-3), some drugs that have not been approved
by the FDA through the regular drug approval process (or not approved for an
intended use) may be used as medical countermeasures to chemical, biological,
radiological, or nuclear (CBRN) agents or threats if the FDA grants an
Emergency Use Authorization (EUA). This EUA authority is an alternative to the
otherwise applicable requirement to file an
8-2. Criteria
In general, the FDA may grant an EUA, for up to 12 months with and potential renewal, based on the following steps:
a. The Secretary of Defense has
determined that there is a military emergency or significant potential for a
military emergency relating to a particular CBRN agent or threat.
b. The Secretary of DHHS declares an emergency
based on the Secretary of Defense’s determination.
c. The commissioner of the FDA determines–
(1) The vaccine or drug may be
effective in diagnosing, treating, or preventing that disease or condition.
(2) The known and potential benefits
of the vaccine or drug outweigh the known and potential risks; and
(3) There is no adequate, approved,
and available alternative medical countermeasure.
d. The duration of authorization
corresponds to the duration of the emergency or significant potential for an
emergency.
8-3. Refusal options
The FDA may decide that potential recipients of a drug under an EUA should have the option to refuse it. The President may waive this option for military personnel.
8-4. DoD requests for EUAs
Requests for possible EUAs for military purposes must be submitted for consideration to the ASD(HA).
Appendix A
References
Section I
Required Publications
There are no required publications.
Section II
Related Publications
AF Instruction 48-123
Medical Examinations and Standards (www.e-publishing.af.mil/pubfiles/af/48/afi48-123/afi48-123.pdf).
CG COMDTINST M6000.1 Series
Medical Manual
DoD Directive 1241.1
Reserve Component Medical Care and Incapacitation Pay and Line of Duty Conditions (www.dtic.mil/whs/directives/corres/pdf/d12411 022804/d12411p.pdf).
DoD Directive 6205.3
DoD Immunization Program for Biological Warfare Defense, 26 November 1993 (www.dtic.mil/whs/directives/corres/html/62053.htm).
DoD Directive 62??
Force Health Protection (publication pending).
DoD Instruction 6205.2
Immunization Requirements, 9 October 1986 (www.dtic.mil/whs/directives/corres/html.62052.htm)
NATO STANAG 2037
Vaccination of NATO Forces, 5 March 2004
NATO STANAG 2491
NBC/MED Policy for the Immunization of NATO Personnel Against Biological Warfare Agents, 22 May 2003.
NATO STANAG 3474
Temporary Flying Restrictions Due to Exogenous Factors Affecting Aircrew Efficiency, 18 October 1996.
NAVMED P-107
Manual of the Medical Department
Section III
Prescribed Forms
There are no forms prescribed by this regulation.
Section IV
Referenced Forms
DD Form 2365
DoD Civilian Employee Overseas Emergency-Essential Position Agreement
DD Form 2766
Adult Preventive and Chronic Care Flowsheet.
DD Form 2766C
Vaccine Administration Record (Continuation Sheet).
Form VAERS-1
Vaccine Adverse Event Reporting System. Available at www.vaers.org.
PHS Form 731
International Certificate of Vaccination.(Marine Corps and Navy--S/N 0108-LF-400-0706. Available from the Navy Supply System and may be requisitioned per NAVSUP P-2002D.)
SF 600
Health Record--Chronological Record of Medical Care.
SF 601
Health Record-Immunization Record
Appendix
B
Standards for Military Immunization
B-1.
Standard 1.
Immunization availability
a. Immunizations are available with minimum
disruption of deployment or training schedules.
b. Immunizations are available at
convenient times, without unnecessary barriers.
c. Immunization services are responsive
to the needs of beneficiaries. Providers incorporate immunization screening and
services as a routine part of clinical care for all beneficiaries. Immunization
services are available on a walk-in basis, as staffing permits. Physical
examinations and temperature measurements before immunization are not routinely
required if it would delay or impede the timely receipt of immunizations.
Immunization does not depend on individual written orders or referral from a
primary care provider. Rather, standing orders with quality-assurance
procedures are implemented. As clinically appropriate, beneficiaries receive
simultaneously the vaccine doses that they need.
B-2.
Standard 2.
Information and education before immunization
a. Current versions of CDC VISs are provided before vaccination and posted in waiting areas of immunization clinics.
b. Immunization personnel know how to readily
obtain answers to patients’ immunization questions.
c. Before immunization, the vaccinee (individually or collectively) is given
information about benefits and risks associated with immunization. For
complicated topics (for example, anthrax, smallpox),
detailed educational programs and brochures are provided. This information is
culturally appropriate and at an appropriate reading level. Personnel are
available to accurately address questions and concerns posed by the vaccinee.
B-3.
Standard 3.
Vaccine storage and handling
a. Staff members adhere to cold-chain management principles, including both transportation and storage. A temperature-monitoring process will be used.
b. Vaccine inventories exceeding
$25,000 are connected to temperature-recording devices and alarm systems.
c. Adherence to vaccine handling
recommendations is critical, because mishandling can render vaccines ineffective.
People who handle vaccines ensure appropriate storage of vaccines.
B-4.
Standard 4.
Indications and contraindications to immunization
a. Each patient is asked about allergies, health status, and previous adverse events before immunization. Each patient is provided an opportunity to ask questions and obtain answers about vaccination, including potential contraindications. Patients are referred for appropriate medical evaluation as needed.
b. During screening, the patient
receives a comprehensive screening for all vaccine needs.
c. The patient’s
personal situation and needs are understood before immunization. If a
contraindication to immunization exists, this information is documented in the
medical record and immunization tracking system. Women are screened with regard
to pregnancy (see section 2-5). People who administer vaccines are able to
distinguish valid and invalid contraindications. Accepting conditions that are
not true contraindications may result in needless deferment of important
immunizations.
B-5.
Standard 5.
Immunization record keeping
a. Immunizations are recorded accurately in a DoD-approved electronic database according to Service-specific policy. Immunization records are updated on the day of immunization.
b. The immunization clinic or military
unit has one or more mechanisms for notifying patients when the next dose of an
immunization series is needed (that is, a reminder system).
c. The immunization clinic or military
unit has one or more mechanisms for notifying patients when they are overdue
for immunization (that is, a recall system).
d. Electronic ITSs
are the preferred immunization record for DoD and USCG
personnel. All Services will record military immunization data into an electronic
database that communicates with a centralized DOD registry. Reminder and recall
systems may be automated or manual and may include mailed, emailed, or
telephone messages.
B-6.
Standard 6.
Training
a. Medical personnel administer
vaccines after training to a standard acceptable to the MTF commander, command
surgeon, or other appropriate medical authority. Training will include vaccine
storage and handling, vaccine characteristics, interviewing techniques,
educational requirements, injection-technique, management and reporting of
adverse events, and anaphylaxis.
b. Training resources include resident
courses, the self-paced Project Immune Readiness (www.vhcinfo.org), and video training
from CDC. For immunization personnel, this will typically involve at least 8
hours of training, including specific training in the vaccines they administer
personally.
c. People who administer vaccines
complete at least 8 hours of annual continuing education and training on
current immunization recommendations, schedules, and techniques.
d. People who administer vaccines have
ready access to information resources regarding current recommendations for
childhood, general adult, travel, and military-specific immunizations.
e. People who administer vaccines must
be appropriately trained.
B-7.
Standard 7.
Adverse events after immunization
a. Epinephrine (preferably auto-injectable), properly stored, is readily available, along with other supplies determined locally.
b. Staff have
ready access to reporting options for the VAERS.
c. A quality-improvement process
assures adverse events are reported to VAERS promptly.
d. People who
administer vaccines are
trained and equipped to recognize and treat acute adverse events. People who
administer vaccines are
close to a telephone or radio, so emergency medical personnel can be summoned.
Medical providers document adverse events in the medical record at the time of
the event or as soon as possible thereafter.
B-8.
Standard 8.
Vaccine advocacy to protect the military family
a. The medical facility knows the extent of influenza and pneumococcal immunization coverage among its high-risk patients and has a plan to optimize that level.
b. The medical facility is implementing
a plan to optimize immunization rates among cardiac, pulmonary, diabetic, asplenic, and other patient groups at elevated risk of
complications from vaccine-preventable infectious diseases.
c. The medical facility conducts a
quality-improvement program to optimize its performance in immunizing children,
adolescents, and adults against the preventable infections that most threaten
them.
d. Commanders use immunization
databases to minimize the vulnerabilities of their units.
e. MTFs have plans to help their
beneficiaries optimize their personal protection against preventable infectious
diseases and meet national goals for optimal delivery of influenza and pneumococcal vaccines. All healthcare providers (not just
those in immunization clinics) routinely determine the immunization status of
their patients, offer vaccines to those for whom they are indicated, and
maintain complete immunization records.
Appendix
C
Medical and Administrative Exemption
Codes
Medical Exemption Codes
Section I
|
Code |
Meaning |
Explanation or Example |
Duration |
|
MA |
Medical, Assumed |
Prior vaccination reasonably inferred from individual’s past experiences (e.g., basic military
training), but documentation missing. Code used to avoid superfluous
vaccination. Code can be reversed upon further review. |
Indefinite |
|
MD |
Medical, Declined |
Declination of optional vaccines (not applicable to many
military vaccinations), religious waivers |
Indefinite |
|
MI |
Medical, Immune |
Evidence of immunity (e.g., by serologic antibody test, “take”
after smallpox vaccination); documented previous infection (e.g., chickenpox
infection); natural infection presumed (e.g., measles, if born before 1957) |
Indefinite |
|
MP |
Medical, Permanent |
HIV infection, prolonged or permanent immune suppression,
other contraindication determined by physician. Can be reversed if the
condition changes. For tuberculosis, positive tuberculosis test. |
Indefinite |
|
MR |
Medical, Reactive |
Permanent restriction from receiving additional doses of
a specific vaccine. Use only after severe reaction after vaccination (e.g., anaphylaxis).
Report such reactions to VAERS. Code can be reversed if an alternate form of
prophylaxis is available. Do not code mild, transient reactions as MR.
Code events referred for medical consultation as MT. |
Indefinite |
|
MS |
Medical, Supply |
Exempt due to lack of vaccine
supply |
Indefinite |
|
MT |
Medical, Temporary |
Pregnancy, hospitalization, events referred for medical
consultation, temporary immune suppression, convalescent leave, pending
medical evaluation board, any temporary contraindication to immunization |
Up to 365 days |
Administrative Exemption Codes:
Section II
|
Code |
Meaning |
Explanation or Example |
Duration |
|
AD |
Administrative, Deceased |
Service member is deceased |
Indefinite |
|
|
Administrative, Emergency Leave |
Service member is on emergency leave |
Up to 30 days |
|
AM |
Administrative, Missing |
Missing in action, prisoner of war |
Indefinite |
|
AP |
Administrative, PCS |
Permanent change of station |
Up to 90 days |
|
AR |
Administrative, Refusal |
Personnel involved in actions under the Uniformed Code of
Military Justice |
Until resolution |
|
AS |
Administrative, Separation |
Pending discharge, separation (typically within 60 days),
retirement (typically within 180 days) |
|
|
AT |
Administrative, Temporary |
Absent without leave, legal action pending (other than
code AR) |
Up to 90 days |
|
NR |
Not Required |
Military personnel who received immunization while eligible,
subsequently left military service, and now serve as
civilian employees or contract workers not otherwise required to be
immunized. |
Indefinite |
Appendix
D
Immunizations for Military Personnel (see text for specific
requirements)
Immunizing Agent Army Navy Air Marine Coast Force Corps Guard
____________________________________________________________________________
Anthrax S S S S S
____________________________________________________________________________
Hepatitis
A All All All All All
___________________________________________________________________________
Hepatitis
B Acc,Occ,S,T Acc,Occ,S,T Acc,Occ,S,T Acc,Occ,S,T All
____________________________________________________________________________
Influenza All All All All All
____________________________________________________________________________
Japanese
encephalitis S,T S,T S,T S,T S,T
____________________________________________________________________________
Measles All All All All All
____________________________________________________________________________
Meningococcal Acc,S,T Acc,S,T Acc,S,T Acc,S,T Acc,S,T
____________________________________________________________________________
Mumps All All All All All
____________________________________________________________________________
Poliovirus All All All All All
____________________________________________________________________________
Rabies Occ,S Occ,S Occ,S Occ,
____________________________________________________________________________
Rubella All All All All All
____________________________________________________________________________
Smallpox
(vaccinia) S S S S S
____________________________________________________________________________
Tetanus-diphtheria All All All All All
___________________________________________________________________________
Typhoid S,T S,T S,T S,T S,T
____________________________________________________________________________
Varicella Acc,Occ,S Acc,Occ,S Acc,Occ,S Acc,Occ,S Acc,Occ,S
____________________________________________________________________________
Yellow
fever S,T All S,T All Acc,S,T
Note.
|
Acc—Accessions in recruit training, academies, and other officer training. See text for
discussion of two clusters of immunization. |
|
AD—Active Duty personnel |
|
All—All personnel, including accessions,
active duty, Reserve Component personnel, and all others |
|
Occ—High-Risk Occupational Groups |
|
S—Specified by DoD, USCG, Service or
Combatant Command policy for identified subpopulations (for example, early deployers, special operations, alert forces). See text for expanded discussion. |
|
T—Traveling or deploying to high-risk areas
based on threat assessment or host country requirement |
Glossary
Section I
Abbreviations
ACIP
Advisory Committee on Immunization Practices
AF
Air Force
ASD(HA)
Assistant Secretary of Defense (Health Affairs)
CBRN
chemical, biological, radiological, or nuclear
CDC
Centers for Disease Control and Prevention
DCJI
disposable-cartridge jet injectors
DD
Department of Defense (form)
DHHS
Department of Health and Human Services
DOD
Department of Defense
DODI
Department of Defense Instruction
EUA
emergency use authorization
FDA
Food and Drug Administration
G6PD
glucose 6-phosphate dehydrogenase
G-WK
Coast Guard Director of Health and Safety
Hib
Haemophilus influenzae type b
investigational new drug
IPV
inactivated poliovirus vaccine
ITS
immunization tracking systems
MAJCOM
major command
MMR
measles, mumps, rubella
MTF
military treatment facility
MUNJI
multi-use nozzle jet injectors
NCVIA
National Childhood Vaccine Injury Act
ND
new drug
NVIC
National Vaccine Injury Compensation
PHS
Public Health Service
RC
reserve component
ROTC
Reserve Officers Training Corps
SF
standard form
SSN
Social Security number
Td
Tetanus and diphtheria
USCG
VAERS
Vaccine Adverse Events Reporting System
VHC
Vaccine Healthcare Centers
vaccine information statement
VISI
Vaccine Identification Standards Initiative
WHO
World Health Organization
Section II
Terms
Command medical authority
The senior medical officer who advises a unit commander or who commands a military medical unit.
Section III
Special Abbreviations and Terms
There are no entries in this section.