1. Vaccines for Children Program Stockpile Status National Vaccine Advisory Committee February 4, 2010 Washington, DC Lance E Rodewald, MD Director, Immunization Services Division National Center for Immunization and Respiratory Diseases, CDC

2. Topics  VFC Stockpile strategic plan  Next steps toward fulfilling the strategic plan  Additional planning: influenza vaccine

4. VFC Stockpile Strategic Plan (1)  History of VFC stockpile plan – Pre-2002 plan  Only monopoly VFC vaccines  Targets at full VFC authority – Post-2002 plan  All VFC vaccines  Targets at full VFC authority  Rationale for strategic planning – Stockpile cost was increasing rapidly with new vaccines  Characteristics of vaccines and their diseases vary and smaller target amounts may be appropriate for some vaccines  Burden of disease impact was not systematically considered in the Post-2002 plan – Development and management of stockpile was becoming more challenging due to changes in vaccines in VFC – Centralized distribution adds previously unavailable capabilities – Post-2002 plan not fully implemented, providing an opportunity to change plan prior to costly and risky build-up – Manufacturer participation is voluntary – need a plan that makes sense for all stakeholders

5. VFC Stockpile Strategic Plan (2)  Inputs – VFC statute – Disease / vaccine considerations  Outbreak management potential and needs  Impact of shortages on burden of disease – Vaccine use in public and private sectors  Objectives of plan – Identify the minimum target sizes of stockpile vaccines to  Meet VFC statute requirements  Meet outbreak management needs  Withstand a 1-year disruption in supply without an increase in burden of disease – Develop strategy to build to the targets over 5 years

6. Elements of Strategic Plan  Stockpile is a national resource – Implies loaning doses for private sector for supply maintenance  For most vaccines, a 3-month national supply (6-month federal contract supply) is the target – Smaller than previous targets  smaller “insurance policy” – MMR is exception – IPV target amount not finalized  Target amounts mirror public sector vaccine use, which is similar to private sector vaccine use  Build to new targets over 5 years and re-evaluate

7. Advantages of Smaller Targets  Public health benefit achievable with smaller targets is similar to that achievable with larger targets – Morbidity and mortality similar – Outbreaks able to be managed – Difference is duration of maintenance of supply in disruption  Experience managing full stockpiles will be helpful – Target amount adjustment – Physical location of stockpiled vaccine – Managing under different shortage situations  Less vaccine is at risk – ~37 M doses vs ~77 M doses – ~$1.6 B vs ~$3.5 B

8. Stockpile Status and Target Amounts: February 2010

9. Stockpile Maintenance Challenges  Introduction of new vaccines  Shelf life versus throughput balance constrains target size  Mirroring the market  Outmoded vaccines  Role of loaning doses to maintain private sector in shortage situation

10. Vetting and Funding Status  CDC approval January 2009  HHS vetting 2009  OMB presentation 2009 – Most funding approved for 5-year build-up – Discussions of maintenance mechanics ongoing – Further presentation to OMB policy makers 2010  Next steps – Discussions with manufacturers on key provisions – Filling to new targets over 5 years

11. Influenza Stockpile  Initiated after 2003-04 influenza season – Initially $40 M / year, all VFC funded  Contract for last doses of season – Cannot build stockpile when vaccine demand is > than supply  Use of stockpile variable, but very low – Even during sever shortage years – Funding reduced at CDC request to $7 M / year  CDC position on influenza stockpile in 2010

12. Conclusions  VFC enables the nation to have a public/private stockpile to maintain supply and fight outbreaks of VPDs  Prudent stockpile plan developed and now able to be implemented  Next planning step is influenza stockpile

13. DISCUSSION

15. GAO 2002; Childhood vaccines: Ensuring an adequate supply poses continuing challenges