the pneumococcal pilot tania cernuschi · the entire $1.5 billion aggregate amc contribution is on...
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Advance Market Commitment Advance Market Commitment The Pneumococcal Pilot The Pneumococcal Pilot
Tania CernuschiAMC Manager
4th Annual Global Immunization MeetingNew York City, 19 February, 2009
Objectives of the presentationObjectives of the presentation
Photo: UNICEF
Advance Market Commitment Advance Market Commitment 19 February, 2009
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• The AMC concept
• The Pneumococcal Pilot
• How does it work
• Implications for countries
• Next steps
What is an AMC?What is an AMC?
• An AMC creates the market conditions to stimulate private investment in vaccine R&D and manufacturing capacity for future vaccines.
• An AMC requires donors to make legally binding financial commitments to support a market of a pre-agreed value.
• Companies participating in an AMC commit to supply certain quantities of a successful vaccine.
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What is an AMC? (cont.) What is an AMC? (cont.)
• As demand from GAVI eligible countries materializes, the companies can receive a relatively higher price for the first few doses of vaccine (AMC price).
• Once the AMC is exhausted, companies are required to ensure the supply of the vaccine at a long term price below a pre-set cap (tail price cap).
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Pneumococcal AMCPneumococcal AMC
Overarching goal: reduce morbidity and mortality from pneumococcal disease.
o Accelerate development of vaccines that meet developing country needs.
o Bring forward the availability of effective pneumo vaccines - scale up of production capacity.
o Accelerate vaccine uptake - predictable vaccine pricing for countries and manufacturers.
o Test AMC concept
• Financial commitment: US$ 1.5 billion from Italy, UK, Canada, Norway, Russia, Bill & Melinda Gates Foundation.
• In addition, GAVI endorsed a budget of up to US$ 1.3 billion (2010-2015) Advance Market Commitment Advance Market Commitment
19 February, 20095
Attribute Minimal Acceptable Profile
Vaccines serotypes• Must cover at least 60% of invasive disease isolates in target region• Must include serotypes 1,5,14
Target population Prevent disease among children < 5, in particular < 2
Dosage and scheduleCompatible with national infant immunisation programmes and no more than 3 doses in first year of life
Routes of administration Intramuscular or subcutaneous
Product presentation Mono-dose or low multi-dose
Product formulation Liquid formulation
Storage and cold chain Stable at 2-8 °C with minimum shelf life of 24 months
Product registration and pre-qualification
WHO pre-qualified
Target Product ProfileTarget Product Profile
Vaccine: pneumococcal vaccine – Technical Product Profile (TPP)
http://www.vaccineamc.org/updatedec_08.html
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How does it work? Supply CommitmentsHow does it work? Supply Commitments
$ 750M
AMC Funds Available
US$ 1.5 billion
• Suppliers make 10-year commitment to supply a share of the total demand forecast of 200 million doses annually.
• The AMC provides a directly proportional share of the US$1.5 billion.
Example:
•Firm A makes an offer to supply 100M doses
(50% of 200M)
•Firm A is entitled to US$ 750M
(50% of the total US$ 1.5B AMC)
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FIRM A gets $ 750M
How does it work? Prices & FundingHow does it work? Prices & Funding
AM
C
Pri
ce
TailPriceCAP
AMC Period Tail Period
AMC Envelope
GAVICountry Co-pay
$7
$3.50
10 yrs
FIRM A US$ 750 M
Matching capacity with demandMatching capacity with demandT
housands
Doses
The entire $1.5 billion aggregate AMC contribution is on offer at the launch of the pneumo-AMC.
UNICEF will issue calls for offers based on the long term demand forecast .
Offers cannot be higher than the forecasted demand for the start date proposed by the supplier.
Offers must have a start date no more than 5 years into the future.
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Stakeholders and activities overviewStakeholders and activities overview
Donors Offer2009
Donors Offer2009
DonorsFinancial Support
DonorsFinancial Support
Entry into a Supply
Agreement
Entry into a Supply
Agreement
Application for vaccines
Application for vaccines
IAC assesses if the vaccine
meets the Target Product Profile
IAC assesses if the vaccine
meets the Target Product Profile
WHO prequalifies
pneumococcal vaccine
WHO prequalifies
pneumococcal vaccine
Application for pre-qualification
Application for pre-qualification
AMC Manufacturers Registration
AMC Manufacturers Registration
GAVI Strategic Demand forecast
updated biannually
GAVI Strategic Demand forecast
updated biannually
UNICEF Call for Supply Offers
UNICEF Call for Supply Offers
CountriesDecide to adopt vaccine and co-
finance
CountriesDecide to adopt vaccine and co-
finance
GAVIFinancial,
Administrative, Programmatic
support
GAVIFinancial,
Administrative, Programmatic
support
WHOTechnical support
Defines TPPsPre-qualification
WHOTechnical support
Defines TPPsPre-qualification
ManufacturersDevelop and
produce vaccines
ManufacturersDevelop and
produce vaccines
UNICEFProcurement
Agency
UNICEFProcurement
Agency
Manufacturer supply offerManufacturer supply offer
World BankFinancial
Management for Donor Funds
World BankFinancial
Management for Donor Funds
What does this mean for GAVI countries?What does this mean for GAVI countries?
• Countries express their preference on pneumo vaccines
• GAVI co-financing and default policies will apply to the AMC without modifications
• Vaccines are procured through UNICEF
But different:
Same:
• Vaccines will be available in the right quantities to cover demand
• Availability of support funding is known years in advance
• The price of these vaccines for developing countries is known years before procurement starts
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First possible call for offers
Mid Q2
First Supply
Agreement
potentially signed
Q3/Q4
2010
Vaccines could be delivered to countries Q1
First potential vaccine
AvailableMid Q2
2009
Next stepsNext steps
Signature of
Legal agreements
Q1/Q2
ImplementationDesign
Pneumo Demand Forecast GAVI Eligible Countries
Pneumo Demand Forecast GAVI Eligible Countries
Source: PneumoADIP, Dec 2007
Potential to save 7m lives by 2030
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Thank you!Thank you!
Source: GAVI
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