CVD 103HgR TRIAL IN MALI

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GLOBAL ALLIANCE FOR VACCINES AND IMMUNIZATION

• This seminar will cover
• What GAVI is and how it works
• TF on RD selects 3 vaccine projects
• Accelerated Development and
• Introduction Plans (ADIPs)
• 3 vaccine technology projects
• Request for your help

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VACCINE ADVANCES, LAST QUARTER OF THE 20TH
CENTURY

• The power of focused partnerships
• Smallpox Eradication Program
• Expanded Program on Immunization
• Polio Eradication Initiative
• Harvest of modern biotechnology
• Conjugate vaccines Recombinant strains
• Live vector vaccines DNA vaccines
• New adjuvants Transgenic plants
• Genome-based proteomic vaccines

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THE IMMUNIZATION GAPS, 1998

• ACCESS- Low immunization coverage in certain
  countries, and regional discrepancies
• EQUITY- Lack of introduction into the poorer
  developing countries of newly-developed vaccines
  against major child killers (Hib, HBV)
• INVESTMENT- Insufficient investment into vaccine
  research for diseases with high burdens largely
  confined to developing countries (e.g., TB,
  malaria, AIDS, Shigella)
• AGENCY ALIGNMENT- Sub-optimal coordination among
  critical immunization agencies

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STEP-WISE PROCESS LEADING TO GAVI

• March 1998 -- World Bank Meeting
• June 1998-- Interagency Working Group formed

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THE GAVI PARTNERS

• Countries (Developing and industrialized)
• International Agencies (UNICEF, WHO)
• Development Banks (e.g., World Bank, ADB)
• Industry (Industrialized developing country)
• Technical Agencies (e.g., CDC, NIBS, IVI)
• Research Institutes (e.g., Pasteur, NIH)
• Bilateral Agencies (e.g., AID, DFID)
• Foundations (e.g., Bill and Melinda Gates,
  Rockefeller, Sabin)
• NGOs (e.g., Path/CVP, AMP)
• Academia
• BROAD PARTNERS, CORE FOCAL PARTNERS

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GAVI STRATEGIC OBJECTIVES

• Improve access to sustainable immunization
  services
• Expand use of existing cost-effective vaccines
  where they address a public health problem
• Accelerate the development and introduction of
  new vaccines
• Accelerate research and development of vaccines
  needed primarily by developing countries
• Assist countries to meet Accelerated Disease
  Control targets (polio, measles, etc.)
• Make immunization a centerpiece in international
  development efforts

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FORMALIZED INTERNATIONAL COALITIONS ON VACCINES
AND IMMUNIZATIONS

• The Task Force for Child Survival -- 1980s
• The Childrens Vaccine Initiative -- 1990s
• The Global Alliance for Vaccines and Immunization
  (GAVI) -- 2000

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WHY GAVI MAY BE SPECIAL

• Maintains focus
• High level commitment by partners (GAVI Board)
• Coordination among critical partners
• at the international level (GAVI Working Group)
• at the country level (Interagency Coordinating
  Committees, ICCs)
• Close cooperation between industry and public
  sector partners
• New resources (e.g., the Vaccine Fund)

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HOW DOES GAVI WORK?

• GAVI Board 15 members. Highest forum.
  Decision-making on objectives and strategies 3
  meetings annually monthly teleconferences
• Working Group 10 members. Translates Board
  decisions into agency work plans joint policy.
  Creative solutions to problems. Bi-weekly
  teleconferences 6 meetings per year
• Secretariat Small team. Funded by partners.
  Provides coordination. Housed in UNICEF, Geneva
• Task Forces (Advocacy, Financing,
  Implementation, Research Development)
• Partners Meeting (every two years) Brings
  together the broader immunization community.
• The Vaccine Fund Underutilized and new vaccines,
  infrastructure and focused RD

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HOW GAVI WORKS

• Each partner chooses how to contribute according
  to its strengths, agenda, etc.
• A partner may strengthen itself to address a GAVI
  objective
• Coordination and synergy allow goals to be
  achieved that no partner can accomplish alone
• Rarely, partners agree to establish a new entity,
  e.g., the Vaccine Fund

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THE VACCINE FUND A financial instrument of the
Global Alliance for Vaccines and Immunization
(GAVI)
Immunization services
Vaccines (e.g., HBV Hib) Safe injection
materials
RD 3 vaccines 3 technologies
Current capitalization 1.2 billion (Initiated
with a donation of 750 million by the Bill
Melinda Gates Foundation)
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GAVI TASK FORCE ON RD, 6/02

• Co-Chairs Myron Levine (Academia), Marie-Paule
  Kieny (WHO-IVR), Rino Rappuoli (Industry)
• Members
• Fred Binka Navrongo Center, Ghana
• Gordon Dougan Imperial College, UK
• Elaine Esber Merck Vaccines, USA
• Michael Free PATH, USA
• Reinhard Gluck Berna Biotech, Switzerland
• Jan Holmgren Goteborg University, Sweden
• Rosanna Lagos CVD-Chile, Chile
• Margaret Liu Transgene Gates Foundation, USA
• Sir Gustav Nossal U. of Melbourne, Australia
• Punnee Pitisuttithum Mahidol U., Thailand
• Replaced Yasuhiro Suzuki, WHO 11-01
  replaced Barry Bloom, Harvard U. 1/02

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GAVI TASK FORCE ON RDA tool to achieve the
GAVI research objectives

• Oslo, June 2000. The GAVI BOARD requested the
  GAVI Task Force on RD to identify
• 3 specific vaccine RD projects
• 3 vaccine technology projects
• Allow public sector and industry to set
  functional terms of engagement
• Precedents for more complex public/private
  partnership projects in the future

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GAVI TASK FORCE ON R D

• 3 vaccine development projects selected at the
  RD TF meeting, Boston, September 2000
• Can diminish young child mortality in developing
  countries
• Technologically-feasible (low hanging fruit)
• Proof-of-principle already demonstrated
• Licensure introduction achievable in 7 years
• Expedite research agenda including clinical
  trials of safety, efficacy, practicality in
  developing countries
• Coordinate effort with TFs on Financing, Country
  Coordination Advocacy
• WHO IVR agrees to serve as TF Secretariat

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SELECTING VACCINES TO ACCELERATE

• Disease burden
• mortality morbidity
• DALYs
• Public health issues
• public perception other control measures
• epidemic potential elimination possible
• Development evaluation issues (feasibility)
• maturity of the science antigenic complexity
• candidates already exist known impedances
• ease of Phase III trials vaccine characteristics
• Implementation issues
• ease of manufacture combinable
• no. of doses, route temperature stability
• Likelihood of return on private investment

GAVI MISSION To save childrens lives and
protect peoples health through the widespread
use of vaccines, with a particular emphasis on
developing countries
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TARGETS FOR DIMINISHING MORTALITY

• Children lt 5 years
• Respiratory infections (PNEUMOCOCCUS, Hib, RSV)
• Diarrheal diseases (ROTAVIRUS, Shigella, ETEC)
• Measles
• Malaria
• Adults
• AIDS
• Acute respiratory infections
• Tuberculosis
• Other
• typhoid fever (Salmonella Typhi)
• GROUP A MENINGOCOCCUS

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VACCINES SELECTED FOR ACCELERATED DEVELOPMENT
INTRODUCTION

• Pneumococcal conjugates
• Live oral rotavirus
• Group A meningococcal conjugate (as either
  monovalent A, bivalent A/C or quadrivalent
  A/C/W135/Y)

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GAVI RD PROJECTS

• Under auspices of the GAVI Task Force on RD,
  pneumococcal and rotavirus vaccine Research
  Agendas were drafted.
• Priorities were set timelines budgets prepared
  
• Research Agendas were combined (12/01) with
  advocacy, financing and implementation agendas to
  create preliminary Business Plans.
• Since 1/02, McKinsey Consultants (contracted by
  World Bank, Gates Foundation Vaccine Fund) have
  worked with GAVI partners to convert the Business
  Plans into target-driven
• Accelerated Development Introduction Plans
  (ADIPs)

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ADIP STRATEGIES FOR INTRODUCING FUTURE
PNEUMOCOCCAL VACCINES

• Time Some
• Strategy Frame Caveats
• 23-valent PS 2003 ? immune response
• 9- 11- valent conjugate 2006-7 supply finance
• Make late stage conj. locally 2009? IPR
  production
• Local mfrs from start 2012? major tech transfer
• Public sector Greenfield gt 2012
• Future Vaccines
• Common proteins 2012
• Other (e.g., WCV, live vectors) gt2012

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GAVI STRATEGY AN ADIP TO REDUCE DEMAND
UNCERTAINTY AND ACHIEVE AN AFFORDABLE PRICE
Predictable(and growing) production capacity
Predictable (and lower) price
GAVIs ADIP
Predictable (and growing) demand
Desired end product A lower price as a result
of the increased demand predictability
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ROLES FOR THE RD COMMUNITY IN THE ADIP
Communicate value
Establish value
Deliver value
RD community is the key player in showing
disease burden and vaccine impact.
A role that we play but can do better. Data
should reach decision-makers, not just journals.
Research can help here too. We can design
studies to address key operational issues.

• Assure long-term supply
• Secure sustainable funding
• Assure delivery system

• Disease burden studies, efficacy trials, etc.
• Make first assessment of national demand
• Establish price estimate

• Develop communication strategy
• Education, meetings, lobbying
• Continuously refine demand forecast

Key activities
Disease burden and vaccine impact are well
understood at country level
Reliable supply of affordable vaccine and
assured financing
Messages that generate political will to
prioritize introduction of vaccine in the country

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RD VACCINE TECHNOLOGIES TO ADDRESS THE ACCESS GAP

• Current realities for immunization services in
  developing countries

• Most vaccines
• require 3 doses
• are administered parenterally
• are sensitive to excessive heat or freezing
• come in multi-dose vials

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3 PRIORITY VACCINE TECHNOLOGY AGENDAS

• Decreased dependency upon and ultimate
  elimination of the cold chain
• Refined tools to measure progress in improving
  immunization services
• Reducing infectious wastes and ultimately
  eliminating the use of sharps (needles syringes)