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

Army Seal Air Force Seal Navy Seal Marine Corp Seal DOD Seal
Q111589
FROM
QUAD SERVICE MMQC FT DETRICK MD//USAMMA/AFMLO/NMLC//
 
***PRIORITY***MESSAGE RELEASED:
09/01/2011
 
****************UNCLASSIFIED****************
 
SUBJ: MMQC-11-1589
IMPLEMENTATION GUIDANCE FOR THE ADENOVIRUS TYPE 4 AND TYPE 7 VACCINE LIVE, ORAL
REFERENCES:

A. DEPARTMENT OF DEFENSE (DOD) JOINT REGULATION (ARMY REGULATION 40-562,
BUMEDINST 
6230.15A, AFJI480110, CG COMDTINST M6230.4F), IMMUNIZATION AND CHEMOPROPHYLAXIS,
29 SEPTEMBER 2006.
	
B. 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.

C. DEPARTMENT OF DEFENSE, ARMED FORCES EPIDEMIOLOGICAL BOARD,
PREVENTION/MINIMIZATION 
OF ADENOVIRUS INFECTION, NUMBER 02-01, NOVEMBER 23, 2001.
	
D. FOOD
AND DRUG ADMINISTRATION (FDA), CENTER FOR BIOLOGICS EVALUATION AND 
RESEARCH (CBER),
ADENOVIRUS TYPE 4 AND TYPE 7 VACCINE, LIVE ORAL - PRODUCT 
APPROVAL INFORMATION, 16 MARCH
2011.  

E. FOOD AND DRUG ADMINISTRATION (FDA), CENTER FOR BIOLOGICS EVALUATION AND
RESEARCH (CBER), PACKAGE INSERT, ADENOVIRUS TYPE 4 AND TYPE 7 VACCINE, LIVE 
AND ORAL.

1.
SITUATION: ON 16 MAR 11, FOOD AND DRUG ADMINISTRATION (FDA) LICENSED THE 
ADENOVIRUS TYPES 4
AND 7, LIVE, ORAL VACCINE, MANUFACTURED BY TEVA PHARMACEUTICALS 
USA/BARR LABORATORIES, FOR
USE IN MILITARY POPULATIONS 17 TO 50 YEARS OF AGE. 
THIS MESSAGE PROVIDES GUIDANCE ON SAFE
GUARDING AND HANDLING OF ADENOVIRUS 
TYPE 4 AND TYPE 7 LIVE ORAL VACCINE AMONG INITIAL ENTRY
TRAINING (IET) SERVICE 
MEMBERS AT ARMY BASIC COMBAT TRAINING CENTERS.  
  
2. TIMELINE: THE
SERVICES WILL BEGIN VACCINATING THEIR MILITARY ENLISTED BASIC 
TRAINEES UPON RECEIVING THE
INITIAL SHIPMENT OF THE ADENOVIRUS VACCINE TYPE 
4 AND TYPE 7, LIVE, ORAL, ON OR ABOUT 4TH
OCTOBER 2011. 

3. POLICY: THE SERVICES MUST ADMINISTER ADENOVIRUS VACCINE TO ALL ENLISTED
MILITARY RECRUITS IN ACCORDANCE WITH THE DOD JOINT REGULATION (ARMY REGULATION 
40-562,
BUMEDINST 6230.15A, AFJI480110, CG COMDTINST M6230.4F), IMMUNIZATION 
AND CHEMOPROPHYLAXIS, 29
SEPTEMBER 2006.
			
4. CLINICAL REQUIREMENTS: ADENOVIRUS VACCINE TYPE 4 AND TYPE 7 ARE
TABLETS 
ADMINISTERED ORALLY TO ENLISTED MILITARY RECRUITS 17 TO 50 YEARS OF AGE. 
EACH
TABLET MUST BE SWALLOWED WHOLE AND CANNOT BE CHEWED OR CRUSHED. POSTPONE 
ADMINISTRATION TO
INDIVIDUALS WITH VOMITING AND/OR DIARRHEA AND THOSE WITH 
MODERATE TO SEVERE ACUTE ILLNESS.
A. A SINGLE DOSE CONSISTS OF TWO LIVE, ORAL ENTERIC-COATED TABLETS (TYPE 4 
WHITE TABLET, TYPE
7 LIGHT PEACH TABLET). ADENOVIRUS VACCINE TYPE 4 AND TYPE 
7 IS ADMINISTERED ONLY ONCE AND NO
BOOSTER IS REQUIRED.

B. THE ADENOVIRUS VACCINE CAN BE ADMINISTERED SIMULTANEOUSLY OR AT ANY
INTERVAL 
BEFORE OR AFTER OTHER VACCINES, INCLUDING LIVE VACCINES.

C. THE ADENOVIRUS
VACCINE SHOULD NOT BE ADMINISTERED TO INDIVIDUALS WITH KNOWN 
SEVERE ALLERGIC REACTIONS TO ANY
COMPONENTS OF THE VACCINE; PREGNANT FEMALES, 
NURSING MOTHERS, FEMALES CONSIDERING PREGNANCY
WITHIN 6 WEEKS OF RECEIVING 
THE VACCINE; INDIVIDUALS INCAPABLE OF SWALLOWING AN ENTIRE
TABLET, WHOLE, WITHOUT 
CHEWING.  

5. EDUCATION: PRIOR TO VACCINATION PROVIDE ALL VACCINEES
A COPY OF THE 
VACCINE INFORMATION STATEMENT (VIS) FOR ADENOVIRUS TYPE 4 AND TYPE 7, PUBLISHED
14 JULY 2011 BY THE CENTERS FOR DISEASE CONTROL AND PREVENTION. DISPLAY 
THE VIS AT THE
RECRUIT IMMUNIZATION SITE AND URGE EACH VACCINEE TO READ THE 
VIS PRIOR TO IMMUNIZATION.  THE
ADENOVIRUS VIS IS AVAILABLE FOR DOWNLOAD AT 
WWW.CDC.GOV/VACCINES/PUBS/VIS/DEFAULT.HTM OR
WWW.VACCINE.MIL/ADENOVIRUS.
THE MANUFACTURER WILL PROVIDE A BROCHURE WHICH CONTAINS ADDITIONAL
INFORMATION 
ABOUT THE ADENOVIRUS VACCINE. A COPY OF THE BROCHURE IS AVAILABLE FOR DOWNLOAD
AT WWW.VACCINE.MIL/ADENOVIRUS.  

A. THE VACCINE CONTAINS LIVE ADENOVIRUS THAT IS SHED IN THE
STOOL FOR UP TO 
28 DAYS FOLLOWING VACCINATION, INSTRUCT ALL VACCINEES IN THE PROPER
PROCEDURES 
FOR HAND WASHING AND UTILIZATION OF HAND SANITIZER TO PREVENT THE SPREAD OF 
THE
VIRUS.  

B. VACCINEES SHOULD EXERCISE CAUTION WHEN IN CLOSE CONTACT WITH CHILDREN LESS
THAN 7 YEARS OF AGE, IMMUNE COMPROMISED INDIVIDUALS AND PREGNANT WOMEN DURING 
THE 28 DAYS
PERIOD OF VIRAL SHEDDING FOLLOWING VACCINATION. 

C. FEMALE PERSONNEL WHO RECEIVED THE
ADENOVIRUS VACCINE DURING PREGNANCY OR 
BECOME PREGNANT WITHIN 6 WEEKS OF VACCINATION SHOULD
RECEIVE INFORMATION ABOUT 
THE ADENOVIRUS PREGNANCY REGISTRY FOR SELF-REFERRAL. PER THE
PACKAGE INSERT, 
ALL CASES IN WHICH A WOMEN RECEIVES ADENOVIRUS VACCINE DURING PREGNANCY OR
BECOMES PREGNANT (CONCEPTION OCCURS) WITHIN 6 WEEKS FOLLOWING VACCINATION SHOULD 
BE REPORTED
TO THE ADENOVIRUS PREGNANCY REGISTRY BY CALLING 1-866-790-4549 
OR TEXT OR EMAIL:
ADENOVIRUS@KENDLE.COM.

6. VACCINE ORDERING, STORAGE, AND HANDLING PROCEDURES:

A. THE U.S.
ARMY MEDICAL MATERIEL AGENCY(USAMMA) DISTRIBUTION OPERATIONS CENTER 
(DOC) WILL COORDINATE THE
DISTRIBUTION OF THE ADENOVIRUS VACCINE TO SUPPORTING 
MEDICAL SUPPLY ACTIVITIES FOR ALL
SERVICES. ADENOVIRUS VACCINE IS CENTRALLY 
FUNDED AND THEREFORE WILL BE ISSUED AT NO COST TO
ALL SITES. EACH RECEIVING 
ACTIVITY WILL CONVEY TO USAMMA DOC THEIR MONTH'S ADENOVIRUS VACCINE
REQUIREMENT. 
EACH RECEIVING ACTIVITY WILL ALSO (A) VALIDATE THEIR POINT(S) OF CONTACT FOR
ISSUES REGARDING THE ADENOVIRUS VACCINE, AND (B) RECONFIRM THAT THERE IS ADEQUATE 
AND
ACCEPTABLE STORAGE TO ACCOMMODATE THE ADENOVIRUS VACCINE. THE MANUFACTURER 
WILL SHIP THE
VACCINE DIRECTLY TO THE RECRUIT TRAINING SITES WITH COORDINATION 
FROM USAMMA DOC.

B.
ADENOVIRUS TYPE 4 AND TYPE 7 VACCINE, LIVE, ORAL MUST BE REFRIGERATED BETWEEN 
2� AND 8�C (35�
AND 46� F) AND NEVER FROZEN.  

C. ONCE THE RECEIVING ACTIVITY RECEIVES THE VACCINE SHIPMENT,
THEY MUST CONTACT 
USAMMA DOC PRIOR TO OPENING THE CONTAINER.  IF THE RECEIVING ACTIVITY FAILS
TO CONTACT USAMMA DOC, USAMMA DOC WILL CONTACT THE RECEIVING ACTIVITY AFTER 
VERIFICATION OF
DELIVERY THROUGH THE CARRIER.  

D. USAMMA DOC WILL THEN TELEPHONICALLY INSTRUCT THE
RECEIVING ACTIVITY REGARDING 
THE CORRECT PROCEDURES FOR OPENING THE CONTAINER, CHECKING ON
THE STATUS OF 
THE SHIPMENT, AND READING THE ACCOMPANYING TEMPERATURE MONITORING DEVICE.
THE RECEIVING ACTIVITY WILL FOLLOW ALL STEPS EXACTLY AS PRESCRIBED AND RELAYED 
BY USAMMA DOC
WITHIN MINUTES OF OPENING THE SHIPPING CONTAINER. BASED UPON 
THE READING OF THE TEMPERATURE
MONITORING DEVICE, USAMMA DOC WILL EITHER VERBALLY 
AUTHORIZE RELEASE OF THE PRODUCT FOR
IMMEDIATE USE OR WILL INSTRUCT THE RECEIVING 
ACTIVITY ON FURTHER ACTION AND DISPOSITION OF
THE SHIPMENT.

E. IN ACCORDANCE WITH USAMMA DOC INSTRUCTIONS THE RECEIVING ACTIVITY WILL
EXPRESS 
MAIL THE RETURN TEMPERATURE MONITORING DEVICE TO USAMMA DOC. UPON RECEIPT, 
USAMMA
DOC WILL DOWNLOAD THE TEMPERATURE DATA FROM THE MONITORING DEVICE AND 
BASED ON THE DATA FROM
THE MONITORING DEVICE, USAMMA DOC MAY ISSUE FURTHER 
INSTRUCTIONS TO THE RECEIVING ACTIVITY
REGARDING THE STATUS OF THE VACCINE 
SHIPMENT.  

F. ALL BOTTLES MUST BE PROTECTED FROM
MOISTURE AND REMAIN TIGHTLY CLOSED.  
THE DESICCANT CANISTER SHOULD NOT BE REMOVED FROM THE
BOTTLE.  

7. IMMUNIZATION RECORD KEEPING PROCEDURES: EVERY VACCINATION MUST BE ENTERED
INTO A DOD-APPROVED ELECTRONIC IMMUNIZATION TRACKING SYSTEM. THE ASSIGNED CVX 
CODE FOR
ADENOVIRUS VACCINE TYPE 4 AND TYPE 7 IS "143".  

 
08. 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. 

09.
POC FOR THIS MESSAGE IS USAMMA PHARMACY CONSULTANT AND DEPUTY DIRECTOR, 
DISTRIBUTION
OPERATIONS, MILVAX. TELEPHONE COM: 301-619-4347; DSN: 343, FAX: 4468, 
EMAIL:
USAMMADOC@AMEDD.ARMY.MIL

10. 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. 

11. 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:
HTTP://WWW.USAMMA.ARMY.MIL/ASSETS/APPS/NALA_QAWEB/NALA_INDEX.CFM 
CLICK ON "SUBSCRIBE TO MMQC
MESSAGES HERE."

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.SGALC@DETRICK.AF.MIL 

AIR FORCE MEMBERS MAY SUBSCRIBE TO THE DOD MMQC MESSAGES
AND RECEIVE EMAIL
NOTIFICATIONS DIRECTLY FROM USAMMA WHEN THEY ARE PUBLISHED AT THE FOLLOWING
WEBSITE: HTTPS://MEDLOG.DETRICK.AF.MIL/, GO TO "SITE SETTINGS" AND CHECK
"SUBSCRIBE TO MMQC
MESSAGES."

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: NMLC.VACCINES@MED.NAVY.MIL

NAVY MEMBERS MAY SUBSCRIBE TO RECEIVE DOD MMQC MESSAGES AT
HTTP://WWW.USAMMA.ARMY.MIL
CLICK ON "SUBSCRIBE TO MMQC MESSAGES."
Last Modified Date: 03/18/2014