PEDIATRIC VACCINE STOCKPILES

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PEDIATRIC VACCINE STOCKPILES

• A Status Report on the Pediatric Vaccine
  Stockpiles
• January 24, 2005

Eddie Wilder Project Officer, Pediatric Vaccine
Stockpile Immunization Services Division
(ISD) National Immunization Program (NIP)
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Background

• 01/83 Began stockpiling pediatric vaccines
• 01/93 VFC legislation enacted established
  requirement for 6-month stockpile of all
  routinely recommended childhood vaccines
• 09/02 GAO issues report entitled Childhood
  Vaccines, Ensuring an Adequate Supply Poses
  Continuing Challenges
• 10/02 NVAC recommends enhancement of CDC
  vaccine stockpile

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ACCOMPLISHMENTS

• Logistics Management Institute (LMI) work begun
• High level strategic plan developed
• Booz Allen Hamilton (BAH) contract initialized
  Vaccine Management Business Improvement Project
  (VMBIP) ongoing
• Reached target quantities on MMR and Varicella
  partial target quantities of vaccine for Hep A,
  Hep B, Hib, and e-IPV

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Pediatric Vaccine Stockpile

• What is the Vaccine Management Business
  Improvement Project (VMBIP)
• Objective a complete redesign of the national
  distribution, ordering, inventory and funds
  management system for publicly purchased vaccine
• Site visits projects, distributors,
  manufacturers
• Vetting phase with design teams distribution,
  ordering, funds mgmt, stockpile, systems
• Plans for pilot, scale-up and national roll-out
• Standard operating procedures for stockpile
  build-up, management, reporting and draw down

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Pediatric Vaccine StockpileJanuary 2005
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Current Projected FundingFY 2001-2006
Projected funding.
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InFluenza Vaccine Stockpile

• 40M authorized by OMB for each of FY 2004 and FY
  2005
• Approximately 19M obligated in FY 2004 for the
  purchase of influenza vaccine for stockpile
• Aventis delivered 2.5M doses of influenza vaccine
  to stockpile on January 15, 2005 600,000 more
  doses to be delivered soon

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Pediatric Vaccine Stockpile

• NIP is working with BAH on VMBIP
• Stockpile Management
• Outstanding issues
• Revenue recognition
• Contract review and revision
• Target quantities
• Emergency non-emergency release protocols

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Pediatric Vaccine Stockpile

• Revenue recognition issues have delayed stockpile
  build-up progress
• SAB 101 requirements conflict with current
  stockpile contract
• All four (4) manufacturers are affected by
  revenue recognition
• Alternative models are being considered
• Annual fee
• CDC contracted off-site stockpile

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Pediatric Vaccine Stockpile

• Target Quantities
• Currently based on birth cohort
• Changing market share and risk issues
• Combination vaccines
• Shortages versus disease outbreaks
• Quarterly assessment and possible adjustment
• NVAC workgroup with ACIP representation to be
  established for external input

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Pediatric Vaccine Stockpile

• Emergency non-emergency release protocols
• Definition of emergency versus non-emergency
  release
• Need for formal language in contract

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Next Steps

• Resolve revenue recognition issue
• Review and revise contracts with two (2)
  manufacturers who have existing stockpile
  contracts
• Include new manufacturers in stockpile process
• Incorporate stockpile management into VMBIP

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Pediatric Vaccine Stockpile

• Questions ???