PEDIATRIC VACCINE PEDIATRIC VACCINE STOCKPILESSTOCKPILES

A Status Report on the A Status Report on the Pediatric Vaccine StockpilesPediatric Vaccine Stockpiles

November 2005November 2005

Gregory S. Wallace, M.D., M.S., M.P.H.Chief, Program Support Branch (PSB)Immunization Services Division (ISD)National Immunization Program (NIP)

HistoryHistory 19831983 Began stockpiling pediatric vaccinesBegan stockpiling pediatric vaccines 19931993 VFC legislation enacted; established VFC legislation enacted; established

requirement for 6-month stockpile of requirement for 6-month stockpile of all routinely recommended childhood all routinely recommended childhood

vaccinesvaccines 19931993 Began purchasing vaccines for Began purchasing vaccines for

stockpilestockpile 20022002 Revenue recognition issues arise Revenue recognition issues arise 20052005 All vaccine manufacturers agree to sell All vaccine manufacturers agree to sell

vaccines to CDC for stockpilevaccines to CDC for stockpile

Pediatric Vaccine Pediatric Vaccine StockpilesStockpiles

What happened?What happened? May 2005 - CDC met with SECMay 2005 - CDC met with SEC June-July 2005 - SEC met with the corporate HQ’s June-July 2005 - SEC met with the corporate HQ’s

of all four vaccine manufacturersof all four vaccine manufacturers August 2005 - All of the vaccine manufacturers August 2005 - All of the vaccine manufacturers

agreed to participate in the CDC Pediatric Vaccine agreed to participate in the CDC Pediatric Vaccine Stockpile ProgramStockpile Program Regardless of the revenue recognition issuesRegardless of the revenue recognition issues Based on their capacity to sell CDC vaccines for the Based on their capacity to sell CDC vaccines for the

stockpile stockpile

Pediatric Vaccine Pediatric Vaccine StockpilesStockpiles

Fiscal Year (FY) 2005 activityFiscal Year (FY) 2005 activity All four manufacturers agreed in FY All four manufacturers agreed in FY

2005 to sell vaccine to CDC for the 2005 to sell vaccine to CDC for the Pediatric Vaccine StockpilesPediatric Vaccine Stockpiles

$158.8M obligated to purchase 5,500 doses$158.8M obligated to purchase 5,500 doses CDC established new target quantities CDC established new target quantities

for stockpiled vaccinefor stockpiled vaccine CDC established revised plans for CDC established revised plans for

future vaccine purchases for the future vaccine purchases for the stockpilestockpile

Pediatric Vaccine StockpilesPediatric Vaccine StockpilesCurrent StatusCurrent Status

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Millions

of D

ose

s

Target quantityDoses purchasedDoses delivered

Purchased/Undelivered DosesPurchased/Undelivered Doses FY 2003FY 2003

− 2.4 million doses IPV (sanofi)2.4 million doses IPV (sanofi)− 2 million doses HepB (GSK)2 million doses HepB (GSK)− 1 million doses HepA (GSK)1 million doses HepA (GSK)− 0.8 million doses PCV7 (Wyeth)0.8 million doses PCV7 (Wyeth)

FY 2005FY 2005− 0.5 million doses Hib (sanofi)0.5 million doses Hib (sanofi)− 1.5 million doses DTaP (sanofi & GSK)1.5 million doses DTaP (sanofi & GSK)− 2 million doses PCV7 (Wyeth)2 million doses PCV7 (Wyeth)− 0.5 million doses DTaP/HepB/IPV0.5 million doses DTaP/HepB/IPV

Pediatric Vaccine Pediatric Vaccine StockpileStockpiless

Stockpile managementStockpile managementTarget quantities workgroupTarget quantities workgroupNVAC & ACIP participationNVAC & ACIP participation

Contract review and revisionContract review and revisionPurchase vs. delivery pricePurchase vs. delivery priceThird-party distributorThird-party distributor

Next StepsNext Steps

Review and revise contracts with Review and revise contracts with two (2) manufacturers who have two (2) manufacturers who have existingexisting stockpile contracts stockpile contracts

Establish Establish newnew stockpile contracts stockpile contracts with two(2) vaccine with two(2) vaccine manufacturersmanufacturers

Incorporate stockpile Incorporate stockpile management into VMBIPmanagement into VMBIP