1. National Vaccine Advisory Committee A Status Report on the Pediatric Vaccine Stockpiles 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 History of Stockpiles Current Status of Pediatric Stockpiles Current Status of Pediatric Stockpiles Stockpile Challenges Stockpile Challenges Resolution Options Resolution Options Next Steps Next Steps

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

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

5. Pediatric Vaccine Stockpile Target Quantities January 2005

6. Pediatric Vaccine Stockpile Doses Purchased January 2005

7. Current Status of the Pediatric Vaccine Stockpile January 2005

8. Current Status of Stockpile Contracts Aventis Aventis Current Storage and Rotation Contract Current Storage and Rotation Contract Purchased product for stockpile Purchased product for stockpile Contract issues Contract issues Merck Merck Current Storage and Rotation Contract Current Storage and Rotation Contract Purchased product for stockpile Purchased product for stockpile Contract issues Contract issues GSK GSK No storage and rotation contract No storage and rotation contract No vaccines delivered to stockpile No vaccines delivered to stockpile Wyeth Wyeth No storage and rotation contract No storage and rotation contract No vaccines delivered to stockpile No vaccines delivered to stockpile

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

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

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

12. Next Steps Resolve revenue recognition issue Resolve revenue recognition issue Review and revise contracts with two (2) manufacturers who have existing stockpile contracts Review and revise contracts with two (2) manufacturers who have existing stockpile contracts Include new manufacturers in stockpile process Include new manufacturers in stockpile process NVAC’s particpation in target quantity workgroup NVAC’s particpation in target quantity workgroup