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DOD Medical Materiel Quality Control Messages (MMQC)/Medical Materiel Information Messages (MMI) & Images

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Q081629
FROM
QUAD SERVICE MMQC FT DETRICK MD//USAMMA/AFMLO/NMLC//
 
***PRIORITY***MESSAGE RELEASED:
12/29/2008
 
****************UNCLASSIFIED****************
 
SUBJ: MMQC-08-1629
IMPLEMENTATION INSTRUCTIONS FOR CHANGE IN ROUTE AND CHANGE IN DOSING SCHEDULE FOR THE ANTHRAX
VACCINE ADSORBED (AVA) IN THE DOD ANTHRAX VACCINE IMMUNIZATION PROGRAM (AVIP)
 
 
1.
REFERENCES:

A. DEPARTMENT OF DEFENSE DIRECTIVE (DODD) 6205.02E, POLICY AND PROGRAM FOR
IMMUNIZATIONS TO PROTECT THE HEALTH OF SERVICE MEMBERS AND MILITARY BENEFICIARIES, 
19
SEPTEMBER 2006. AVAILABLE AT:
HTTP://WWW.VACCINES.MIL/DOCUMENTS/973POLICY620502P.PDF.

B.
UNDER SECRETARY OF DEFENSE FOR PERSONNEL AND READINESS, IMPLEMENTATION OF 
THE ANTHRAX VACCINE
IMMUNIZATION PROGRAM (AVIP), 6 DECEMBER 2006. AVAILABLE 
AT:
HTTP://WWW.VACCINES.MIL/DOCUMENTS/979AVIP%20IMPLEMENTATION%20GUIDANCE%206%2
0DEC%2006.PDF.
C. ASSISTANT SECRETARY OF DEFENSE FOR HEALTH AFFAIRS, POLICY ON CLINICAL
ISSUES RELATED TO
ANTHRAX VACCINATION, 6 AUGUST 2002. AVAILABLE AT:
HTTP://WWW.ANTHRAX.MIL/DOCUMENTS/141CLINICALISSUES.PDF.

D. DEPARTMENT OF DEFENSE JOINT
REGULATION (ARMY REGULATION 40�562, 
BUMEDINST 6230.15A, AFJI 48�110, CG COMDTINST M6230.4F),
IMMUNIZATIONS AND
CHEMOPROPHYLAXIS, 29 SEPTEMBER 2006. AVAILABLE AT:
HTTP://WWW.VACCINES.MIL/DOCUMENTS/969R40_562.PDF.

E. FOOD AND DRUG ADMINISTRATION (FDA),
CENTER FOR BIOLOGICS EVALUATION AND
RESEARCH (CBER), ANTHRAX VACCINE ADSORBED- PRODUCT
APPROVAL LETTER, 
15 DECEMBE4 2008. AVAILABLE AT:
HTTP://WWW.FDA.GOV/CBER/APPROVLTR/BIOTHRAX121108L.HTM.

F. EMERGENT BIOSOLUTIONS, BIOTHRAX�
(ANTHRAX VACCINE ADSORBED) PACKAGE
INSERT. AVAILABLE AT:
HTTP://WWW.FDA.GOV/CBER/LABEL/BIOTHRAXLB.PDF.

G. DEPARTMENT OF DEFENSE, COMMUNICATION PLAN -
ANTHRAX VACCINE ADSORBED - ROUTE 
CHANGE AND DOSE REDUCTION, 15 DECEMBER 2008.

H.
DEPARTMENT OF DEFENSE EDUCATIONAL BROCHURE, WHAT YOU NEED TO KNOW ABOUT
ANTHRAX VACCINE,
PENDING UPDATE. AVAILABLE AT:
HTTP://WWW.ANTHRAX.MIL/AVIP2008.

2. PURPOSE: TO PROVIDE
INSTRUCTIONS TO SERVICE REPRESENTATIVES ON THE CHANGE 
IN THE ROUTE OF ADMINISTRATION AND THE
CHANGE IN THE DOSING SCHEDULE OF ANTHRAX 
VACCINE ADSORBED (AVA) AS PART OF THE DEPARTMENT OF
DEFENSE (DOD) ANTHRAX VACCINE 
IMMUNIZATION PROGRAM (AVIP).

3. SUMMARY: THE FDA HAS
APPROVED A CHANGE IN ROUTE OF ADMINISTRATION FOR
THE ANTHRAX VACCINE ADSORBED (AVA) FROM A
SUBCUTANEOUS (SC) INJECTION TO
INTRAMUSCULAR (IM). THE FDA HAS ALSO APPROVED A CHANGE IN THE
VACCINATION SERIES 
BY REMOVING THE 2-WEEK DOSE POST-VACCINATION AND ASSERTING THE SAFETY AND
EFFECTIVENESS OF THE NEW 5-DOSE REGIMEN.

4. TIMELINE:

A. EFFECTIVE 11 DECEMBER 2008: DOD
HEALTHCARE PROVIDERS WILL BEGIN
ADMINISTERING AVA VIA THE INTRAMUSCULAR (IM) ROUTE PER THE FDA
APPROVED
MANUFACTURER�S RECOMMENDATION.

B. EFFECTIVE 11 DECEMBER 2008: DOD HEALTHCARE
PROVIDERS WILL BEGIN ADHERING 
TO THE NEW FDA APPROVED MANUFACTURER RECOMMENDED 5 DOSE
VACCINATION SERIES 
AS DESCRIBED IN THE VACCINE PRESCRIBING INFORMATION.

5. ANTHRAX VACCINE
IMMUNIZATION PROGRAM (AVIP) POLICY: THE DOD POLICY FOR
AVIP REMAINS THE SAME. THIS NEW ROUTE
AND SCHEDULE IS A CLINICAL CHANGE AND 
DOES NOT ALTER THE POPULATION BEING VACCINATED OR THE
PREVIOUS REQUIREMENTS 
OF AVIP.

6. CLINICAL REQUIREMENTS: ANTHRAX VACCINATION WILL BE GIVEN
AS A SERIES OF
FIVE 0.5-ML INTRAMUSCULAR DOSES AT 0, 4 WEEKS, 6 MONTHS, 12 MONTHS, AND 18
MONTHS, WITH BOOSTERS GIVEN ANNUALLY TO MAINTAIN IMMUNITY. INJECTIONS ARE GIVEN 
IN THE
DELTOID REGION OF THE UPPER ARM. THE SIGNIFICANT CHANGES ARE:

A. AS STATED IN PRIOR
POLICIES, DOSES OF THE VACCINE SHOULD NOT BE ADMINISTERED 
ON A COMPRESSED OR ACCELERATED
SCHEDULE. THE DOSES WILL BE ADMINISTERED
INTRAMUSCULARLY AT 0, 4 WEEKS, 6 MONTHS, 12 MONTHS,
AND 18 MONTHS FOR THE PRIMARY 
SERIES AND YEARLY BOOSTERS THEREAFTER. FOR AN INDIVIDUAL WHO IS
LATE OR HAS 
MISSED A DOSE IN THE STANDARD IMMUNIZATION SCHEDULE, THE FOLLOWING PROCEDURES
SHALL BE FOLLOWED:

  1) RESUME THE PRIMARY SERIES WITH ADMINISTRATION OF THE NEXT DOSE IN
THE
SERIES. ADMINISTER SUBSEQUENT DOSES OF VACCINE AT INTERVALS BASED ON THE DATE 
THE LAST
DOSE WAS GIVEN, NOT WHEN IT WAS ORIGINALLY SCHEDULED.

  2) PER THE ADVISORY COMMITTEE ON
IMMUNIZATION PRACTICES (ACIP)
RECOMMENDATIONS, THE PRIMARY AVA SERIES DOES NOT NEED TO BE
RESTARTED REGARDLESS 
OF TIME ELAPSED SINCE LAST DOSE. ONCE THE PRIMARY SERIES OF FIVE DOSES
IS COMPLETE, 
THE PRIMARY SERIES IS NEVER REPEATED. AVAILABLE AVA SPECIFIC DATA SUGGESTS
THAT SIGNIFICANTLY INCREASING THE INTERVAL BETWEEN DOSES DOES NOT ADVERSELY 
AFFECT
IMMUNOGENICITY OR SAFETY. THEREFORE, AS WITH OTHER VACCINES, INTERRUPTION 
OF THE VACCINATION
SCHEDULE DOES NOT REQUIRE RESTARTING THE ENTIRE SERIES OR 
THE ADDITION OF EXTRA DOSES.
3) IF AN ANNUAL BOOSTER HAS NOT BEEN ADMINISTERED ON TIME, ADMINISTER THE
BOOSTER DOSE AT THE
EARLIEST POSSIBLE DATE, ADJUSTING THE SUBSEQUENT BOOSTER 
SCHEDULE ACCORDINGLY.

7. VACCINE
SAFETY:

A. RESEARCHERS AT THE CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) CONDUCTED 
A
RANDOMIZED DOUBLE-BLIND STUDY AND FOUND THAT PRIMARY SERIES DOSE REDUCTION 
FROM 6 DOSES TO 5
DOSES OVER AN 18 MONTH PERIOD, RECEIVE THE SAME BENEFIT OF 
PROTECTION FROM ANTHRAX VACCINE.
B. RESULTS DEMONSTRATED THAT 4 SUBCUTANEOUS (SC), 4 INTRAMUSCULAR (IM), AND
3 IM REGIMENS
PROVIDE EQUIVALENT IMMUNOLOGICAL PRIMING BY THE 7TH MONTH.
THE IM ADMINISTRATION SIGNIFICANTLY
REDUCED THE OCCURRENCE OF LOCAL ADVERSE 
EVENTS AT THE INJECTION SITE.

C. OUR SCIENTIFIC
UNDERSTANDING OF THE SAFETY PROFILE FOR ANTHRAX VACCINATION 
IS SHAPED BY OVER 30 HUMAN SAFETY
STUDIES CONDUCTED BY BOTH MILITARY AND
INDEPENDENT CIVILIAN EXPERT PANELS, INCLUDING A
COMPREHENSIVE EVALUATION BY 
THE NATIONAL ACADEMY OF SCIENCES AND ITS INSTITUTE OF MEDICINE
(IOM). AFTER 
A TWO-YEAR REVIEW, THE IOM CONCLUDED THAT SCIENTIFIC EVIDENCE FOR THE VACCINE�S
SAFETY AND EFFECTIVENESS IS SOUND.

8. EDUCATION REQUIREMENTS: PRIOR TO VACCINATION WITH
AVA, ALL VACCINEES MUST 
RECEIVE A COPY OF THE VACCINE INFORMATION STATEMENT (VIS) AND THE DOD
ANTHRAX 
INDIVIDUAL INFORMATION TRIFOLD BROCHURE. THESE ARE SHIPPED TO CLINICS AT NO 
COST IN
THE SAME QUANTITY AS THE ORDERED VACCINE. ADDITIONALLY, CLINICS MAY 
REQUEST ADDITIONAL COPIES
MILITARY VACCINE AGENCY THROUGH MILVAX BY PHONE AT 
877-GET-VACC OR EMAIL AT
VACCINES@AMEDD.ARMY.MIL. THESE PRODUCTS ARE ALSO AVAILABLE 
ON-LINE FOR DOWNLOADING AT:
HTTP://WWW.ANTHRAX.MIL/AVIP2008 OR HTTP://WWW.VACCINES.MIL/ANTHRAX.

9. VACCINE ORDERING,
STORAGE, AND HANDLING PROCEDURES:

A. THE ORDERING PROCESS WILL REMAIN THE SAME. CUSTOMERS
WILL ORDER FROM THE
USAMMA-DOC.

B. THE AVA VACCINE WILL BE DISTRIBUTED AND STORED AT 2-8� C
(36-46�F).

C. DOD USES THE SAME FDA APPROVED VACCINE THAT IS MAINTAINED IN THE
STRATEGIC
NATIONAL STOCKPILE. THIS VACCINE IS APPROVED FOR USE IN THE DOD.

10. IMMUNIZATION RECORD
KEEPING PROCEDURES: THERE IS NO CHANGE TO THE
IMMUNIZATION RECORD KEEPING REQUIREMENTS. EVERY
VACCINATION MUST BE ENTERED 
INTO A DOD-APPROVED ELECTRONIC IMMUNIZATION TRACKING SYSTEM.
11. QUESTIONS, CONTACT MILVAX AT 703-681-5101 OR DSN 761-5101.

 
12. PASS MESSAGE TO ALL
MEDICAL LOGISTICS OFFICERS, COMMAND CHANNELS, PHARMACY 
OFFICERS, MEDICAL STAFF SECTIONS,
SUPPLY OFFICERS, IMMUNIZATION CLINICS, VACCINE 
SHOT TEAMS, AND SUPPORTED ACTIVITIES/CENTERS.
13. POC FOR THIS MESSAGE IS USAMMA PHARMACY CONSULTANT AND DEPUTY DIRECTOR, 
DISTRIBUTION
OPERATIONS, MILVAX. TELEPHONE COM: 301-619-4307; DSN: 343, FAX: 4468, 
EMAIL:
USAMMADOC@AMEDD.ARMY.MIL

14. AUTHORITY: DODD 5105.22 AND DODD 6025.13. ADDITIONALLY:

A.
ARMY: SEE ARMY REGULATION (AR) 40-61, 28 JANUARY 2005, CHAPTER 4, AND THE 
DEPARTMENT OF THE
ARMY SUPPLY BULLETIN (SB 8-75-11) FOR APPLICABLE POLICIES 
AND PROCEDURES.

B. AIR FORCE: AF
ACTIVITIES WILL TAKE ACTION AS PRESCRIBED IN AFI 41-209, MEDICAL 
LOGISTICS SUPPORT, CHAPTERS
3 AND 9. FOR MAJCOMS & NGB--THIS MSG HAS BEEN 
TRANSMITTED TO ALL DESIGNATED SUBORDINATE
MEDICAL ACTIVITIES. 

15. SERVICE SPECIFIC POCS ARE:

ARMY: TELEPHONE COM: 301-619-4318,
DSN: 343, FAX: 4468, 
E-MAIL: USAMMADOC@AMEDD.ARMY.MIL

ARMY MEMBERS MAY SUBSCRIBE TO
DODMMQC MESSAGES AND MANY OTHER TOPICS AT THE 
FOLLOWING WEBSITE: WWW.USAMMA.ARMY.MIL CLICK ON
"SUBSCRIBE TO MMQC MESSAGES."

EUCOM AND CENTCOM CUSTOMERS CONTACT USAMMCE POC: USAMMCE
PHARMACY OFFICER, 
TELEPHONE COM: 011-49-6331-86-7230, DSN: 314-495-7230, 
E-MAIL:
USAMMCE_PHARMACY@AMEDD.ARMY.MIL

USFK CUSTOMERS CONTACT THE USAMMC-K (FORMERLY 16TH MEDLOG
BN) POC: 16TH MEDLOG
PHARMACY OFFICER, 
TELEPHONE COM: 011-82-54-970-8340, DSN: 315-765-8340,
E-MAIL: 16THMEDLOGCUSTSUPPORT@KOR.AMEDD.ARMY.MIL

AIR FORCE: TELEPHONE COM: 301-619-4170,
DSN: 343, E-MAIL: AFMOA.SG3SLC@DETRICK.AF.MIL

AIR FORCE MEMBERS MAY SUBSCRIBE TO THE DODMMQC
MESSAGES AND MANY OTHER 
TOPICS AT THE  FOLLOWING WEBSITE:
HTTPS://MEDLOG.DETRICK.AF.MIL/MLC/SITE_APPS/AFMLO/PRODUCT/CFM/LIST_DODMMQC.CFM. 
GO TO LIST
SERVER AND SELECT THE CATEGORY "DOD MEDICAL MATERIEL QUALITY CONTROL 
(DODMMQC)."

COAST
GUARD: TELEPHONE COM: 202-475-5172, E-MAIL: HQS-DG-LST-ANTHRAX@USCG.MIL OR
HQS-DG-LST-SMALLPOX@USCG.MIL

NAVY/MARINES: TELEPHONE COM: 301-619-8054 OR DSN: 343, 
EMAIL:
VACCINES@NMLC.MED.NAVY.MIL

NAVY MEMBERS MAY SUBSCRIBE TO RECEIVE DODMMQC MESSAGES AT
HTTP://WWW.USAMMA.ARMY.MIL
CLICK ON "SUBSCRIBE TO MMQC MESSAGES."
Last Modified Date: 08/01/2014