National Vaccine Advisory Committee

1
National Vaccine Advisory Committee

• A Status Report on the
• Pediatric Vaccine Stockpiles
• February 8, 2005

Eddie Wilder Project Officer, Pediatric Vaccine
Stockpile Immunization Services Division
(ISD) National Immunization Program (NIP)
2
Agenda

• History of Stockpiles
• Current Status of Pediatric Stockpiles
• Stockpile Challenges
• Resolution Options
• Next Steps

3
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

4
Accomplishments

• Logistics Management Institute (LMI) work begun
• Broad 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

5
Pediatric Vaccine StockpileTarget
QuantitiesJanuary 2005
6
Pediatric Vaccine StockpileDoses
PurchasedJanuary 2005
7
Current Status of the Pediatric Vaccine
StockpileJanuary 2005
8
Current Status of Stockpile Contracts

• Aventis
• Current Storage and Rotation Contract
• Purchased product for stockpile
• Contract issues
• Merck
• Current Storage and Rotation Contract
• Purchased product for stockpile
• Contract issues
• GSK
• No storage and rotation contract
• No vaccines delivered to stockpile
• Wyeth
• No storage and rotation contract
• No vaccines delivered to stockpile

9
Pediatric Vaccine Stockpile

• Revenue recognition issues have delayed stockpile
  build-up progress
• SAB 101 has 7 requirements
• All four (4) manufacturers are affected by
  revenue recognition
• HHS has 90-days to develop plan to resolve

10
Pediatric Vaccine Stockpile

• CDC has developed alternate models
• Annual fee model
• Pros
• Resolves revenue recognition issue with no major
  operational changes
• Easier to manage expiration risk
• Cons
• May result in unreasonable cost to CDC
• May result in accounting constraints at the
  manufacturer
• Requires significant negotiation on value for
  operating fee

11
Pediatric Vaccine Stockpile

• CDC has developed alternate models
• Off-site storage model
• Pros
• Resolves revenue recognition issue
• Provides greater assurance of stockpile
  availability
• Cons
• Requires consolidated distribution approach
  impacts implementation timing
• Dramatically increases CDC liability and risks of
  vaccine expiration

12
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
• NVACs particpation in target quantity workgroup