How to Ensure Financial Sustainability for Graduating Countries?

TODAY’S VACCINATION ECOSYSTEM STATUS – MARKET-SHAPING PRINCIPLES, PRACTICE, IMPACT AND LESSONS LEARNT

GAVI PERSPECTIVE

Aurélia Nguyen Tuesday 20 January 2015, Veyrier-du-Lac, France

www.gavi.org AGENDA

• Market shaping in the Gavi context • Objectives • Practice • Results so far • Challenges GAVI, THE VACCINE ALLIANCE Gavi, the Vaccine Alliance, is a public-private partnership focused on saving children's lives and protecting people's health by increasing access to immunisation in poor countries

CURRENTLY SUPPORTED GAVI

VACCINATION PROGRAMMES

GAVI/Olivier GAVI/Olivier

Routine Campaign Stockpile For Board (for outbreak response) review • Pentavalent • Yellow fever • Yellow fever • Malaria Lewis, Gavi/2012/Sala Brooks, Gavi/2013/Adrian • Pneumococcal • Meningococcal A • Meningitis

• Rotavirus • Measles-rubella • Cholera , Gavi/2012/Adrian Brooks Gavi/2012/Adrian ,

• Human • Japanese • (Ebola) Asselin papillomavirus encephalitis right): to left (from • Yellow fever • Measles second dose • Inactivated polio vaccine GAVI ADOPTED AN EXPLICIT STRATEGIC GOAL TO SHAPE VACCINE MARKETS…

4 Strategic goals guide Gavi’s mission, 2011-2015

Health Vaccine Financing Market systems goal shaping goal goal goal

Accelerate the Contribute to Increase the Shape vaccine uptake and use strengthening predictability of markets to ensure of underused and the capacity of global financing adequate supply of new vaccines integrated health and improve the appropriate, quality systems to deliver sustainability of vaccines at low and immunisation national financing sustainable prices for immunisation AGENDA

• Market shaping in the Gavi context • Objectives • Practice • Results so far • Challenges …WHICH IS UNDERPINNED BY SUPPLY & PROCUREMENT OBJECTIVES

These objectives aim to meet Gavi’s market shaping goal by balancing supply and demand, ensuring security of supply, minimising the cost of vaccines, and fostering development of appropriate and quality vaccines AGENDA

• Market shaping in the Gavi context • Objectives • Practice • Results so far • Challenges DEMAND FORECASTING IS A CORE ACTIVITY

Demand forecasting Provides early recognition and estimates future needs

Gain better understanding Allows Gavi Alliance and of Gavi’s vaccine markets manufacturers to effectively plan for the long term

GAVI Alliance Strategic Goal 4 EXAMPLE SDF: HPV DEMAND 2014-2034 Base Unconstrained*: Total Required Supply for 94 Countries by Financing

100

80 Doses Doses (Millions) 70 Other 60 281 283 284 277 278 280 Nigeria 269 274 276 260 12 12 Graduated 50 234 12 12 12 194 12 12 12 10 12 Eligible 182 8 6 6 6 40 7 5 5 6 6 178 5 5 5 2014 SDFv9 Base Uncon (3 dose) 172 5 5 3 4 5 30 4 4 9 11 15 15 15 17 2014 SDFv9 Base Uncon (2 dose) 170 4 1 3 4 14 14 15 167 1- 3- 20 3- 155 30 25 27 28 28 29 26 1- 23 25 23 23 22 23 23 24 22 10 141 18 103 130 2- 11 1 5 - 01- 2- 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033 2034

* Scenario: National base unconstrained. Gavi eligible demand is forecasted to peak at 30 million doses in 2026

Categories: - Eligible: Includes doses that Gavi directly finances and doses that are co-financed by the country. - Graduated: Doses related to countries that have introduced HPV with Gavi support and have graduated during the forecasting time period. - Other: Doses from Gavi73 countries that introduce HPV without Gavi and non-Gavi eligible LMICs. SUPPLY AND PROCUREMENT ROADMAPS SET TARGETS & ENSURE COORDINATION

Vaccine-specific documents: Short to long term view of how the market should evolve for particular vaccines and identification of mechanisms to influence the supply and price environment and achieve set targets

Roadmap structure

Alliance Market intelligence coordination

Objectives prioritized Target outcomes Action plan Interventions Objective 1 Accountable, Responsible, Supporting  Target outcome TO 1 Measured Output GAVI Strategy  Target outcome TO 2 Due Date / Status Objective 2  For TO 1  Target outcome TO 8  For TO 2  Etc.

Market analysis AGENDA

• Market shaping in the Gavi context • Objectives • Practice • Results so far • Challenges SINCE 2001, GAVI HAS INCREASED THE VACCINE MARKET SUPPLIER BASE 5 suppliers from 5 countries of production 2001

Source: UNICEF Supply Division SINCE 2001, GAVI HAS INCREASED THE VACCINE MARKET SUPPLIER BASE

15 manufacturers* from 11 countries of production 2014

China 1

* Includes 13 Gavi suppliers and manufacturer of select pre-qualified Gavi vaccines Source: UNICEF Supply Division and WHO list of pre-qualified vaccines, 2014 HOWEVER, SOME GAVI VACCINE MARKETS ARE MORE MATURE THAN OTHERS

Manufacturers with pre-qualified vaccines (as of Dec 2014) Supply = Demand

Yes (2013 is Pentavalent first year)

Yellow fever No

No (product Rotavirus preference imbalance)

Yes (needs careful PCV management)

Men A Yes

MR Yes

HPV Yes

Yes (needs careful IPV management)

JE Yes

Cholera GAVI IS SET TO ACHIEVE ITS 2015 PRICE TARGET, BUT MORE NEEDS TO BE DONE

Cost to fully immunise a child with pentavalent, pneumococcal and rotavirus vaccines reached a new low in mid 2014

* Future targets are not publicised to avoid setting a minimum price. Source: UNICEF Supply Division, 2014. AGENDA

• Market shaping in the Gavi context • Objectives • Practice • Results so far • Challenges PENTA/PCV/ROTA PROJECTED TO ACCOUNT FOR >75% OF 2016-2020 VACCINE COSTS HOW TO ENSURE FINANCIAL SUSTAINABILITY FOR GRADUATING COUNTRIES?

19 MANUFACTURER PRICE COMMITMENTS FOR GRADUATED COUNTRIES

Manufacturer Commitment to graduated countries Crucell • Access to Gavi price through 2020 Sanofi Pasteur / Shantha • 3 years access to Gavi price post-graduation** Biological E • No commitment Pentavalent* LG Life Sciences • No commitment Panacea • No commitment Serum Institute • No commitment • Access to AMC “tail price” (AMC supply GSK significantly diminishes from ~2023) Pneumococcal • 5 years price “freeze” post-graduation • Access to AMC “tail price” (AMC supply Pfizer significantly diminishes from ~2023) GSK • 5 years price “freeze” post-graduation Rotavirus Merck • No commitment GSK • 5 years price “freeze” post-graduation HPV Merck • No commitment

Notes: Gavi is currently engaging with manufacturers to try to extend the scope of some of these commitments and to secure commitments from additional manufacturers. Sanofi Pasteur / Shantha agreement also covers YF and Measles. * GSK is not expected to supply pentavalent vaccine to Gavi countries after 2014 ** For first 16 countries only

20 WHAT INNOVATIONS WILL MAKE A DIFFERENCE?

Thermostability Reduction of vaccine damage from exposure to high or low temperatures

Presentation & Packaging Size and doses per vial Vaccine labelling and tracking

Devices Vaccine preparation/delivery technologies

Combinations & Schedules Multiple antigens in one vaccine Number or timing of doses

Appropriate, effective, safe Improving protection/safety conferred in GAVI countries VACCINE DELIVERY INNOVATION: UNIJECT

• Product gained prequalification in December 2014

• Developed to meet needs of low/lower-middle income countries

• New delivery model • Simplifies vaccine administration - Reduction of average time per injection

• Could facilitate outreach - Greater official lay vaccinator integration into immunization activities - Reduces missed opportunities by ensuring syringe and vial always available together - Decreased weight and volume (versus 1 dose vials only)

• Availability to Gavi-supported countries under review • Initial use (limited to the current capacity) • Evaluate EBOLA VACCINE INNOVATION: A MARKET FAILURE & HUMAN SECURITY CHALLENGE

Affects the entire region, >17,000 continent… cases

• WB: Ebola could > 6,000 cost West Africa deaths US$ 32 billion by 2015

• IMF: sub-Saharan Africa growth forecast >17,000down cases from 5.5% to 5% Surrounding and high-risk (largely Ebola) countries > 6,000 deaths • Morbidity and mortality from other diseases on the rise

… with risk of further spread to other parts of the world 4 RECOMMENDED AREAS FOR GAVI ACTION

# cases (illustrative) Potential future outbreak Future (magnitude outbreak with unknown) Current stockpile outbreak present

1 Production & Time Procurement funding 2 2 Funding vaccine roll-out Funding vaccine roll-out

3 Future outbreak preparedness

4 Recovery of health and immunisation systems CHALLENGES WITH MEASURING RESULTS

Can Gavi’s existing SG4 indicators be improved?  The aim is to have meaningful, transparent and measurable indicators of progress in shaping vaccine markets

SG4 indicators Security of supply -> Change in vaccine price-> Appropriate Products Move to measuring Move to measuring a more ??? healthy markets holistic view of costs

Gavi/2012/Olivier Asselin *Future targets are not publicised to avoid setting a minimum price

Source: UNICEF Supply Division, 2014 THANK YOU