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Vaccines for Children Program Stockpile Status

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. Topics. VFC Stockpile strategic plan

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Vaccines for Children Program Stockpile Status

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  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

  3. 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

  4. 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

  5. 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

  6. 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

  7. Stockpile Status and Target Amounts: February 2010

  8. 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

  9. 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

  10. 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

  11. 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

  12. discussion

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

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