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 Next steps toward fulfilling the strategic plan Additional planning: influenza vaccine
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) 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 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 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 Status and Target Amounts: February 2010
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 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 Initiated after 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 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
DISCUSSION
GAO 2002; Childhood vaccines: Ensuring an adequate supply poses continuing challenges