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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

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
Topics

  • VFC Stockpile strategic plan

  • Next steps toward fulfilling the strategic plan

  • Additional planning: influenza vaccine


Vfc stockpile strategic plan 1
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


Vfc stockpile strategic plan 2
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


Elements of strategic plan
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


Advantages of smaller targets
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



Stockpile maintenance challenges
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


Vetting and funding status
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


Influenza stockpile
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


Conclusions
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




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