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

DISCUSSIONDISCUSSION

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