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:
(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 firstname.lastname@example.org 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.