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U.S. Army Medical Materiel Agency
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1 message found.


Medical Material Quality Control Message

MMQC-19-1808


Message Number: MMQC-19-1808
Released On: 26-Apr-19
Message Class: Informational
Material Type: Vaccine
MMQC\MMI Reference: MMQC-19-1343
FDA Recall Reference:
ECRI Reference:
DLA Reference:
MFG Release Date:

Subject:

Yellow Fever Vaccine (YF-VAX) Ordering Restrictions & Inventory Requirements / Additional Guidance


Reason / Information:

High Priority / Informational / Vaccine / This message contains information previously published in MMQC-19-1343, updated to reflect new restrictions. Sanofi Pasture Inc (SP) has halted all YF-VAX distribution effective immediately. SP have placed all orders submitted after 16 April on hold.

REASON: SP, the sole manufacturer of this vaccine, identified a packaging deviation issue, resulting in halt of YF-VAX shipments. There are no product quality, safety or efficacy concerns with the product itself. An assessment by the manufacturer is underway and a path forward is being developed, with required guidance from the US Food and Drug Administration (FDA). The manufacturer will continue to accept orders and place them in a queue for shipment upon release of doses. The manufacturer anticipates resolution by the end of May.

Additional restrictions may be implemented as ongoing assessments of the DoD on-hand supply of YF-VAX are conducted.


Disposition / Instructions:

Actions Required:

(1) Due to limited supply, Medical Treatment Facilities (MTFs) and immunization activities shall not allow vaccine to expire.

(2) All activities must IMMEDIATELY report on-hand inventory of YF-VAX vaccine NLT Saturday 4 May. Expiring vaccine must be made available for use by all DoD facilities to support current deployments.

(a) All MTFs and immunizations activities shall submit a Yellow Fever Vaccine Inventory Report via the DHA IHB, CAC-enabled, on-line Vaccine Inventory Reporting portal at: http://www.vaccines.mil/yfreport . Locations unable to access the portal must send an email to dha.ncr.immunization.mbx.vaccinvent@mail.mil with the subject line ???Mandatory YF Reporting??? with the required information in line 2.b (below).

(b) Reports must include LOT number, expiration date and number of doses on-hand, to include zero on-hand balance.

(c) MTFs and immunization sites that do not comply with this requirement will be reported to their Service leadership.

(3) MTFs and immunization activities shall restrict on hand supply to Service members on official travel within 30 days to an endemic region, or have leisure travel scheduled to USAFRICOM or USSOUTHCOM within 30 days.

(a) DoD personnel on official or leisure travel within 30 days to USAFRICOM.

---DoD personnel on official travel or leisure travel to Morocco, Tunisia or Comoros are exempt from the above requirement per USAFRICOM FHP Guidance.

---DoD personnel traveling from CONUS to Ascension Island and directly back to CONUS are exempt from the above requirement. DoD personnel traveling to Ascension Island from any other locations outside of CONUS are required to have the vaccine.

(b) DoD personnel on official or leisure travel within 30 days to USSOUTHCOM.

(c) DoD personnel on official or leisure travel and beneficiaries on leisure travel within 30 days to or through a yellow fever endemic area as identified by WHO: http://www.who.int/ith/2016-ith-annex1.pdf.

(d) Refer, to Combatant Command (CCMD) Force Health Protection (FHP) Guidance for current requirements. https://health.mil/Military-Health-Topics/Health-Readiness/Immunization-Healthcare/Vaccine-Recommendations/Vaccine-Recommendations-by-AOR

(4) Per WHO and the CDC ACIP, a 10 year booster for yellow fever vaccine is no longer required. One lifetime dose provides long-lasting protection and is adequate for DoD personnel and leisure travelers. A small, specific group of travelers may be considered for an additional dose per ACIP recommendations. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6423a5.htm

(5) If customer(s) have any questions in regards to the reporting requirement or process contact your Defense Health Agency ??? IHS see link above in paragraph 2. For technical issues or other questions please call the DHA-IHB at 877-GET-VACC (877-438-8222) option 4 or email at DODvaccines@mail.mil.


Item Information:

NSN (FSC-NIIN): 6505 - 011715260
NDC: 49281-0915-01
Nomenclature: YELLOW FEVER VACCINE (YF-VAX); SINGLE DOSE VIAL PRESENTATION 5's
UI: PG
Manufacturer: SANOFI PASTEUR
Distributor:

LOT / SN:
All

Service/Additional Instructions:


Consignee:
Defense Health Agency (DHA): Inquiries regarding VF-VAX support can be made to: E-mail: dodvaccines@mail.mil. Phone (Comm): 877-GET-VACC (438-8222), (DSN): 312-
761-4245.

National Capital Region (NCR): Submit YF-VAX order authorization requests and inquiries to: Janice McCreary-Watson or LTC Casey Geaney. E-mail: Janice.e.mccrearywatson.civ@mail.mil. Phone (Comm): 301-295-5103. E-mail: casey.j.geaney.mil@mail.mil. Phone (Comm): 301-295-4511.

DLA-Troop Support: Inquiries regarding VF-VAX support can be made to: Customer Pharmacy Operations Center (CPOC) E-mail: cpoc@dla.mil.

Sanofi-Pasteur Customer Service: Communicate YF-VAX orders and inquiries to: E-mail: CAMMil-YFsanofipasteur@sanofipasteur.com. Phone (Comm) 800-822-2463

ARMY:
Submit YF-VAX order authorization requests and inquiries to: E-mail: usarmy.detrick.medcom-usamma.mbx.vaccines@mail.mil. Phone (Comm): 301-619-
4318/3017/4128/4198; (DSN): 343-4318/3017/4128/4198; Fax: 301-619-4468.

USAMMC-E: Submit YF-VAX order authorization requests and inquiries to: E-mail: usarmy.rheinland-pfalz.medcom-usammce.list.pharmacy-consultant@mail.mil Phone (DSN):
314-495-7118.

ARMY Unit Assemblages containing YF-VAX, NSN 6505-012036289

UA NIIN NOMENCLATURE

C383 013249294 MEDICAL MATERIEL SET,
M306 013301867 MMS PHARMACY M
M383 013464823 MMS MEDSUP CBT MF2K/M

AIR FORCE:
Submit YF-VAX order authorization requests and inquiries to: E-mail: AFMOA.SGALC.YellowFever@us.af.mil. Phone (Comm): 301- 619-4170; (DSN): 343-4170; Fax: 301-619-2557.

NAVY:
Submit YF-VAX order authorization requests and inquiries to: Public Health, Emergency Preparedness and Response BUMED ; CDR Carolyn A. Reimann, MD, MSPH at E-Mail: carolyn.a.reimann.mil@mail.mil / phone (703) 681-9120 and CDR Tai Do, MD, MPH at E-Mail: tai.a.do.mil@mail.mil / phone (703) 681-5467.

When submitting your request please attach the DMLSS or TEWLS drop shipment order for review and approval.

NAVY Assemblages containing YF-VAX, NSN 6505-011715260:

0230 PREVENTIVE MEDICINE - LSD 41
0330 PREVENTIVE MEDICINE - MCM
0430 PREVENTIVE MEDICINE - FFG
0530 PREVENTIVE MEDICINE - LCS
0630 PREVENTIVE MEDICINE - DDG
0730 PREVENTIVE MEDICINE - CG
0930 PREVENTIVE MEDICINE - EXPEDITIONARY MOBILE BASE (ESB)
1030 PREVENTIVE MEDICINE - LPD 17
1130 PREVENTIVE MEDICINE - LCC 1230 PREVENTIVE MEDICINE - LHA
1330 PREVENTIVE MEDICINE - LHD
1530 PREVENTIVE MEDICINE - LHA-6
1630 PREVENTIVE MEDICINE - DDG-1000

1800 MEDICAL AID STATION ASHORE
3030 PREVENTIVE MEDIC

COAST GUARD:
Submit YF-VAX order authorization requests and inquiries to: E-mail: aaron.p.middlekauff@uscg.mil. Phone (Comm): 202-475-5181; Fax: 202-475-5911.


POC Contact Information:

US AIR FORCE
Email: usaf.detrick.afmoa.mbx.sgmp-scs-alerts@mail.mil
Phone (COMM): 301-619-4183
Phone (DSN): 343-4183
Fax: 301-619-2557

US ARMY
Email: usarmy.detrick.medcom-usamma.mbx.doc@mail.mil
Phone (COMM): 301-619-4198
Phone (DSN): 343-4198
Fax: 301-619-4468

US NAVY
Email: usn.detrick.navmedlogcomftdmd.list.mmqc@mail.mil
Phone (COMM): 301-619-3085
Phone (DSN): 343-3085
Fax: 301-619-2473

USAMMC-E Pharmacy
Email: usarmy.rheinland-pfalz.medcom-usammce.list.pharmacy-consultant@mail.mil
Phone (COMM): 49-6331-86-7230
Phone (DSN): 495-7230
Fax:

USCG
Email: paul.t.michaud@uscg.mil or daniel.l.hasenfang@uscg
Phone (COMM): 202-475-5171 or 757-628-4
Phone (DSN):
Fax:

Additional Message Recipients:

Please ensure dissemination of this information to the following:

Command Channels
Immunization Clinics
Medical Log Officers
Medical Staff
Pharmacy Officers
Supply Officers
Supported Activities/Centers
Vaccince Shot Teams

Message Dissemination Authorization

AF Activities will take action as prescribed in AFMAN41-209, Medical Logistics Support, Chapter 7. For MAJCOMS & NGB ??? This Msg has been transmitted to all designated subordinate medical activities

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.

DODD 5105.22 and DODD 6025.13


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