Vaccines for Children Program Stockpile Status
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Transcript of Vaccines for Children Program Stockpile Status
Vaccines for Children Program Stockpile Status
Vaccines for Children Program Stockpile Status
National Vaccine Advisory CommitteeNational Vaccine Advisory CommitteeFebruary 4, 2010February 4, 2010Washington, DCWashington, DC
Lance E Rodewald, MDLance E Rodewald, MD
Director, Immunization Services DivisionDirector, Immunization Services DivisionNational Center for Immunization and Respiratory Diseases, CDCNational Center for Immunization and Respiratory Diseases, CDC
TopicsTopics
VFC Stockpile strategic planVFC Stockpile strategic plan
Next steps toward fulfilling the strategic planNext steps toward fulfilling the strategic plan
Additional planning: influenza vaccineAdditional planning: influenza vaccine
VFC Stockpile Strategic Plan (1)VFC Stockpile Strategic Plan (1)
History of VFC stockpile planHistory of VFC stockpile plan– Pre-2002 planPre-2002 plan
Only monopoly VFC vaccinesOnly monopoly VFC vaccines Targets at full VFC authorityTargets at full VFC authority
– Post-2002 planPost-2002 plan All VFC vaccinesAll VFC vaccines Targets at full VFC authorityTargets at full VFC authority
Rationale for strategic planningRationale for strategic planning– Stockpile cost was increasing rapidly with new vaccinesStockpile cost was increasing rapidly with new vaccines
Characteristics of vaccines and their diseases vary and smaller target amounts may be appropriate for Characteristics of vaccines and their diseases vary and smaller target amounts may be appropriate for some vaccinessome vaccines
Burden of disease impact was not systematically considered in the Post-2002 planBurden of disease impact was not systematically considered in the Post-2002 plan
– Development and management of stockpile was becoming more challenging due Development and management of stockpile was becoming more challenging due to changes in vaccines in VFCto changes in vaccines in VFC
– Centralized distribution adds previously unavailable capabilitiesCentralized distribution adds previously unavailable capabilities– Post-2002 plan not fully implemented, providing an opportunity to change plan Post-2002 plan not fully implemented, providing an opportunity to change plan
prior to costly and risky build-upprior to costly and risky build-up– Manufacturer participation is voluntary – need a plan that makes sense for all Manufacturer participation is voluntary – need a plan that makes sense for all
stakeholdersstakeholders
VFC Stockpile Strategic Plan (2)VFC Stockpile Strategic Plan (2)
InputsInputs– VFC statuteVFC statute
– Disease / vaccine considerationsDisease / vaccine considerations Outbreak management potential and needsOutbreak management potential and needs Impact of shortages on burden of diseaseImpact of shortages on burden of disease
– Vaccine use in public and private sectorsVaccine use in public and private sectors
Objectives of planObjectives of plan– Identify the minimum target sizes of stockpile vaccines toIdentify the minimum target sizes of stockpile vaccines to
Meet VFC statute requirementsMeet VFC statute requirements Meet outbreak management needsMeet outbreak management needs Withstand a 1-year disruption in supply without an increase in burden Withstand a 1-year disruption in supply without an increase in burden
of diseaseof disease
– Develop strategy to build to the targets over 5 yearsDevelop strategy to build to the targets over 5 years
Elements of Strategic PlanElements of Strategic Plan
Stockpile is a national resourceStockpile is a national resource– Implies loaning doses for private sector for supply maintenanceImplies loaning doses for private sector for supply maintenance
For most vaccines, a 3-month national supply (6-month federal For most vaccines, a 3-month national supply (6-month federal contract supply) is the targetcontract supply) is the target– Smaller than previous targets Smaller than previous targets smaller “insurance policy” smaller “insurance policy”
– MMR is exceptionMMR is exception
– IPV target amount not finalizedIPV target amount not finalized
Target amounts mirror public sector vaccine use, which is Target amounts mirror public sector vaccine use, which is similar to private sector vaccine usesimilar to private sector vaccine use
Build to new targets over 5 years and re-evaluateBuild to new targets over 5 years and re-evaluate
Advantages of Smaller TargetsAdvantages of Smaller Targets
Public health benefit achievable with smaller targets is similar Public health benefit achievable with smaller targets is similar to that achievable with larger targetsto that achievable with larger targets– Morbidity and mortality similarMorbidity and mortality similar
– Outbreaks able to be managedOutbreaks able to be managed
– Difference is duration of maintenance of supply in disruptionDifference is duration of maintenance of supply in disruption
Experience managing full stockpiles will be helpfulExperience managing full stockpiles will be helpful– Target amount adjustmentTarget amount adjustment
– Physical location of stockpiled vaccinePhysical location of stockpiled vaccine
– Managing under different shortage situationsManaging under different shortage situations
Less vaccine is at riskLess vaccine is at risk
– ~37 M doses vs ~77 M doses~37 M doses vs ~77 M doses
– ~$1.6 B vs ~$3.5 B~$1.6 B vs ~$3.5 B
Stockpile Status and Target Stockpile Status and Target Amounts: February 2010Amounts: February 2010
Stockpile Maintenance Stockpile Maintenance ChallengesChallenges
Introduction of new vaccinesIntroduction of new vaccines
Shelf life versus throughput balance constrains Shelf life versus throughput balance constrains target sizetarget size
Mirroring the marketMirroring the market
Outmoded vaccinesOutmoded vaccines
Role of loaning doses to maintain private sector in Role of loaning doses to maintain private sector in shortage situationshortage situation
Vetting and Funding StatusVetting and Funding Status
CDC approval January 2009CDC approval January 2009
HHS vetting 2009HHS vetting 2009
OMB presentation 2009OMB presentation 2009– Most funding approved for 5-year build-upMost funding approved for 5-year build-up
– Discussions of maintenance mechanics ongoingDiscussions of maintenance mechanics ongoing
– Further presentation to OMB policy makers 2010Further presentation to OMB policy makers 2010
Next stepsNext steps– Discussions with manufacturers on key provisionsDiscussions with manufacturers on key provisions
– Filling to new targets over 5 yearsFilling to new targets over 5 years
Influenza StockpileInfluenza Stockpile
Initiated after 2003-04 influenza seasonInitiated after 2003-04 influenza season– Initially $40 M / year, all VFC fundedInitially $40 M / year, all VFC funded
Contract for last doses of seasonContract for last doses of season– Cannot build stockpile when vaccine demand is > than Cannot build stockpile when vaccine demand is > than
supplysupply
Use of stockpile variable, but very lowUse of stockpile variable, but very low– Even during sever shortage yearsEven during sever shortage years
– Funding reduced at CDC request to $7 M / yearFunding reduced at CDC request to $7 M / year
CDC position on influenza stockpile in 2010CDC position on influenza stockpile in 2010
ConclusionsConclusions
VFC enables the nation to have a VFC enables the nation to have a public/private stockpile to maintain public/private stockpile to maintain supply and fight outbreaks of VPDssupply and fight outbreaks of VPDs
Prudent stockpile plan developed and Prudent stockpile plan developed and now able to be implementednow able to be implemented
Next planning step is influenza Next planning step is influenza stockpilestockpile