The Pneumococcal Pilot Tania Cernuschi · 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

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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Documents

The Pneumococcal Pilot Tania Cernuschi · 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