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Seth Berkley, MD President, CEO, and Founder

Realizing the Potential of Global Vaccines. Seth Berkley, MD President, CEO, and Founder. Tuesday, 2 May, 2011 Global Vaccines 202X: Access, Equity, Ethics University of Pennsylvania. Disparity in Global Immunization Rates 1980-1990. Immunization Coverage

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Seth Berkley, MD President, CEO, and Founder

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  1. Realizing the Potential of Global Vaccines Seth Berkley, MD President, CEO, and Founder Tuesday, 2 May, 2011 Global Vaccines 202X: Access, Equity, Ethics University of Pennsylvania

  2. Disparity in Global Immunization Rates 1980-1990 Immunization Coverage Low- and High-income countries, 1980-1990 GAVI Alliance 2010, global immunization rates based on DTP3 coverage

  3. New Commitments, New Mechanisms 1970-1990 • “Preventable childhood diseases. . . against which there are effective vaccines. . . are currently responsible for the great majority of the world's 14 million deaths of children under 5 years and disability of millions more every year.” • “Effective action can and must be taken to combat these diseases. . .” • -UNICEF 1990 World Summit for Children Task Force for Child Survival Declaration of Manhattan, CVI UNICEF Child Survival Resolution WHO Standardized Immunization Schedules WHO Expanded Program on Immunization PAHO revolving fund established 1970 1975 1980 1985 1990

  4. Unprecedented Results: 1980-1990 WHO Global and regional immunization profile; 2010

  5. Proliferation of efforts; continued fragmentation – 1980-1990 Nat’l Research Agencies World Bank WHO Academia Rotary Industry UNICEF WHO I Biotechs LMICs UNICEF R&D DELIVERY ERADICATION

  6. Closing the gap: an unfinished project Source: GAVI, WHO, Vaccine introduction database

  7. Hib Disease: Global Child Mortality, 2000 Hib and Pneumococcal Global Burden of Disease Study Team 2009, http://www.who.int/nuvi/hib/GBD_Hib.pdf

  8. Increasing coverage: GAVI Alliance 2000 - Present Nat’l Research Agencies GAVI Academia BMGF WHO Rotary Industry Biotechs BMGF UNICEF R&D DELIVERY ERADICATION WHO LMICs Original EPI New Vaccines I World Bank UNICEF

  9. Accelerating vaccine introduction and scale-up Strategies Partnerships Financing GAVI Alliance, 2010, based on WHO data from 2008

  10. Increased competition reduces vaccine price Number of manufacturers and price decline of pentavalent vaccine (DPT, Hib, Hep B) Source: UNICEF Supply Division, 2010

  11. Tiered Pricing Source: UNICEF Supply Division; CDC

  12. R&D for Global Health Prior to PDPs 1975-1997 Of 1,123 drugs on the global market between 1975-1997, only 13 targeted tropical diseases, representing 1.1% of all drugs developed. Drugs on the Global Market 1975-1997 Drugs for neglected tropical diseases, 1.1% 2009 PDPs had nearly 150 biopharmaceutical, diagnostic and vector control candidates for neglected diseases in various stages of development, including 32 in late-stage clinical trials. Drugs targeting all other disease types, 98.9% Source: Access to Essential Medicines in Poor Countries: A Lost Battle? Bernard Pécoul, MD, MPH; Pierre Chirac, PharmD; Patrice Trouiller, PharmD; Jacques Pinel, PharmD JAMA. 1999;281:361-367.

  13. Strengthening the Pipeline: Product Development Partnerships (PDPs) 1977 1986 ’87 ’88 ’89 1990 ’91 ’92 ’93 ’94 ’95 ’96 ’97 ’98 ’99 2000 ’01 ’02 ’03 ’04 ’05 ’06 ’07 ’08 ’09 Selected otherpublic-private partnerships Working on health issues 1999 2005 2003 2000 2001 1998 2002 1990 1986 1989 1996

  14. The need for an HIV vaccine • In 2009, 33.3 million people living with HIV worldwide • 7,100 new HIV infections daily; 2.6 million per year • For every 1 person put on treatment, 2 people become infected • 30 million AIDS-related deaths to date • 260,000 children die of AIDS every year 2009 2005 33.3 million 32 million 2000 28.5 million We need to fully scale-up current strategies and develop new prevention technologies 1984 1996 HIV discovered as the causal agent • Introduction of anti-retroviral therapy • 20 million people living with HIV 1990 7.5 million people living with HIV 1981 First cases of AIDS Source: Joint United Nations Programme on HIV/AIDS

  15. Unprecedented momentumin the HIV vaccine field • VACCINES • AIDS vaccine shows first efficacy in clinical trials • Replicating viral vector effective in controlling SIV in animal studies • More than 15 new broadly neutralizing antibodies and their targets on HIV discovered

  16. The AIDS Vaccine Pipeline; where are we today? • Efficacy Trials Completed • 2003 VaxGen: gp 120: No efficacy • 2007 Merck: Ad 5-gag-pol-nef: No efficacy • 2009 Sanofi + VaxGen: ALVAC + gp120: ~30% efficacy • Efficacy Trials Underway • NIH-VRC: DNA + Ad-5: • started 2009, results 2013++ Efficacy Trials Planned • IAVI/NIH/BIDMC/HVTN/Crucell: AD26 + AD35: planned 2013 • MHRP/NIH/BMGF: RV-144 F/U: Poxvirus + Protein Boost: planned 2014 • Other Candidates Currently in Clinical Trials • Phase II: Range of Cellular immunity candidates • Phase I: Range of Cellular immunity candidates www.iavi.org

  17. Early positioningin AIDS vaccine R&D A well-established continuum of players moves new drugs to market Clinicaldevelopment Basic research Applied research Preclinical development Advanced development Large-scale Efficacy trials Public sector, academia Biotech companies Pharmaceutical companies IAVI initially worked to ensure a vaccine for the developing world by focusing on product development Clinical development Basic research Applied research Preclinicaldevelopment Advanced development Large-scale Efficacy trials Public sector, academia Biotech companies, pharmaceutical companies Advocacy Clinical trial network in developing world Gap-filling science

  18. Filling the gapin AIDS vaccine R&D But as product failures forced big players out or moved them downstream,a development gap grew … Basic research Applied research Preclinicaldevelopment Clinical development Advanced development Large-scale Efficacy trials Public sector, academia Pharmaceutical companies, product-development partnerships Human Immunology Lab (2001) … and IAVI moved to fill the void, creating new programs as needs arose Neutralizing Antibody Consortium (2002) Live Attenuated Consortium (2006) Vectors Consortium (2007) AIDS Vaccine Design and Development Lab (2008) IAVI Neutralizing Antibody Center at The Scripps Research Institute (2009)

  19. IAVI Today Integrated organization that links our … Industry-style labs and diverse research portfolio Academic, government and private-sector partnerships Network of clinical trial centers in Africa and India Advocacy and outreach from community to international level

  20. IAVI partnersaround the globe IAVI facilities Neutralizing Antibody Consortium Vectors Consortium Live Attenuated Consortium Innovation Fund grant recipients IAVI-supported clinical research centers Other scientific and civil-society partners

  21. From HIV Antibodies……. to HIV Vaccine The purpose: find antibodies that can fight a broad range of HIV strains How it was done: • 49 research partners in 12 countries • 1800 HIV-positive volunteers • IAVI’s Innovation fund: new technology • 3 state-of-the-art laboratories • 3 biotech companies • The result: Two new antibodies isolated from an African volunteer, more potent than previously seen, that target a new site found on a broad range of HIV strains, including strains from Africa • Additional 15 antibodies isolated with new targets • Combination of 2 of the antibodies block 99/100 viruses

  22. With new antibodies,new targets Mabs from new donors 17, 36 & 39 Conserved determinants in the V1/V2 andV3 loops PG9, PG16 Glycanshield 2G12 CD4 binding site b12, VRC01,VRC03, HJ16,PGV04 MPER 2F5, 4E10, Z13e1 Source: Schief, W.R. et al.. CurrOpin HIV AIDS. 2009 Sep; 4(5):431-40.

  23. Total Global Funding for HIV Vaccine Research Relative to the projected cost of the epidemic in LMICs US$ Billions Resources required to respond to the AIDS epidemic in low- and middle-income countries (US$ Billions)1 If current spending trends continued, the annual cost of the AIDS response in LMIC in 2031 would be ~$30billion Total global investment in AIDS vaccine R&D (US$ Billions)2 1AIDS 2031 Modeling Working Group, 2010 2Advancing the Science in a Time of Fiscal Constraint, HIV Vaccines and Microbicides Resource Tracking Working Group, 2010

  24. Investment in preventive HIV vaccine R&D, 2000–2009 $961 $933 WORLD TOTAL, 2009: US$ 868 million $868 $759 US$ 800 million $683 United States 600 $550 $548 $367 400 $327 Philanthropic 200 Europe Other public sector Pharmaceutical, biotech Multilaterals 2000 ’01 ’02 ’03 ’04 ’05 ’06 ’07 ’08 ’09 HIV Vaccines and Microbicides Resource Tracking Working Group. Advancing the Science in a Time of Fiscal Constraint: Funding For HIV Prevention Technologies in 2009. New York, 2010

  25. Countries’ public contributions to HIV vaccine R&D compared to their economic size (2007-2009 average, selected countries ) % of country’s public sector contribution to total global HIV vaccine funding effort % of country’s portion of global GDP International Monetary Fund, 2010; HIV Vaccines and Microbicides Resource Tracking Working Group, 2010

  26. A revitalized vaccine pipeline HIV, TB (~?) HPV (2006) Malaria (~2014) Shigella (~2015) Rota (2004) Typhoid (~2012) DTP-HepB+Hib Pentavalent Vaccine (1998) MenA (2009) Dengue (~2016) Cholera (2009) Hib (1988) rBCG (~2018) Pneumo (2000) HepB (1981) JE (2009) ETEC (~2015) 1980 – 1999: 3 vaccines 2000 – 2019: >12 vaccines Applied Strategies - Project Optimize Vision Workshop, Landscape Overview, June 2010

  27. Not just new, but better vaccines • Reducing the number of total vaccinations against DTP3, Hib, and HepB • Introduction of pentavalent vaccine – 5 vaccines over 3 doses • Lower shipping, injection costs • Partnership model – country MoHs with WHO, UNICEF, and other GAVI partners • Making vaccines more durable • Thermostable formulations of a hep B vaccine and a meningitis A vaccine produced by a spray-drying method • Cold-chain, storage improvements Nothing better illustrates the benefits of secure, long-term funding than the pentavalent vaccine, which immunises children against diphtheria, tetanus and pertussis, hepatitis B and Hib. Kristensen, “Stabilization of vaccines: Lessons learned” Human Vaccines, 2010

  28. A vast improvement overall: 1990-2008 Immunization Coverage Low- and High-income countries, 1990-2008 GAVI Alliance 2010, global immunization rates based on DTP3 coverage

  29. Unprecedented Results: 1990-2009 WHO Global and regional immunization profile; 2010

  30. But over 23 million children still unimmunised Global number of under-five children unimmunised with 3 doses of DTP Source/credits: WHO/UNICEF coverage estimates 1980-2009, July 2010

  31. India: Reaching universal coverage Vaccine coverage disparities between regions: • Average for India for 2005-2006: 44% of children fully immunized by 24 months • Range for all Indian states in that year: 21%-81% National Family Health Survey, India, 2007 (most recent available figures)

  32. Progress in Global Polio Eradication; Still Endemic in India… 1988 2009 • Today, India is one of four remaining Polio endemic countries • As of April 19th, 2011, there has only been one reported case of Polio in India this year http://www.polioeradication.org/Dataandmonitoring/Poliothisweek.aspx

  33. India: From producer to innovator • Shantha Biotech – focusing on inexpensive HepB vaccine • Leveraging local leadership and talent, with cross sectoral partnerships (pharma, WHO, NIH) • Balance between local health impact and financial returns • Health success – Shanvac-B (Hep B vaccine) • Lowered price, increased uptake • Scientific success • WHO Prequalification • Quality validation • Financial success • US$ 340 million contract with UNICEF for pentavalent vaccine • Acquired in 2009 by Sanofi-Aventis for ~US$800 million Chakma et al, “India’s billion dollar biotech” - Nature Biotechnology 2010

  34. THSTI-IAVI HIV Vaccine Laboratory • A partnership set up to accelerate and advance HIV vaccine research and development expand the NAC program and facilitate development of new generation vaccine candidates • Vision: Identify candidate immunogens that elicit broadly neutralizing antibody responses against HIV-1 by establishing an innovative discovery program employing high throughput technology Broadly neutralizing antibodies Assays to rapidly screen immunogens High-throughput immunogen design Determining structure of novel antigens Characterize sera and identify broadly neutralizing monoclonal antibodies Immunogen design Immunogen screening Clinical development Structuralbiology • NAC Center, TSRI • Innovation fund • Design Lab, NY • DBT-IAVI • Indian Medicinal Chem. • THSTI-IAVI HIV Vaccine Lab Protocol G High-throughput robot

  35. A Call for the Decade of Vaccines • Call to governments, private sector to partner • Committed $10 billion over 10 years • Efforts for vaccine discovery, development, delivery • Potential to save 8 million child lives by 2020 with existing vaccines • Significant, but not sufficient investment April 11, 2011

  36. Decade of Vaccines Collaboration Organizational Structure April 11, 2011

  37. From ‘Call’ to ‘Action’: everyone has a role • Commitment to increasing uptake and access • Sustainable funding • Policymaker attention • Funding FaithCommunity Physicians Vaccine uptake and lives saved • Advocacy • Demand creation • Evidence base • R&D, manufacturingcapacity • Technical expertise • Affordable pricing Engaged Public • Technical consensus • Policy roadmap • Delivery • Evidence base • Financing mechanisms • Development of vx candidates • Technical expertise Decade of Vaccines slide, April 11, 2011

  38. Realizing the promise of vaccines over the next decade... Develop financing mechanisms that span the entire continuum Create mechanisms that allow for rapid information flow between both ends of the vaccine continuum More robust involvement of low- and middle-income countries

  39. Factors Affecting Vaccine Availability VACCINE AVAILABILITY COUNTRY PROCUREMENT EXTERNAL RESOURCES PRICE

  40. Factors Affecting Vaccine Availability

  41. Examples of Innovative Financing Mechanisms Existing • International Financing Facility for Immunization (IFFIm) • Funds GAVI Alliance through sale of donor-backed bonds • Advanced Market Commitment • Incentivizes development, manufacturing of pneumococcal vaccine for the developing world by guaranteeing a market through donor commitments. Proposed • Currency Transaction Levy (Robin Hood Tax) • Would provide “billions” to unspecified global health and development activities through a small tax on currency transactions. • Health Impact Fund • Would offer firms the option to be rewarded according to a product’s health impact, if they agree to sell it at cost.

  42. The ideal vaccine continuum CSOs Rotary Foundations GAVI DELIVERY PDPs Industry Donor Countries Emerging Economies WHO R&D LMICs ERADICATION Achieving universal coverage Accelerating the pipeline Finishing the job I World Bank UNICEF

  43. EXTRA SLIDES

  44. A long-term investment:Vaccines take decades to develop INFECTIOUS AGENT(Disease) YEARSELAPSED AGENT LINKEDTO DISEASE IN … VACCINE LICENSEDIN U.S. IN … Measles Hepatitis B Human papilloma virus(cervical cancer) Rotavirus(diarrheal disease) Varicella zoster(chickenpox) Pertussis(whooping cough) Polio Haemophilus influenza Typhoid Malaria Human immunodeficiency virus(HIV/AIDS) 1963 1953 10 1965 1981 16 Early ’80sto mid-’90s 2006 12-25 1973 2006 33 1995 1953 42 1906 1948 42 47 1955 1908 1981 1889 92 105 1884 1989 — 1893 118 — 28 1983

  45. A vaccinewould give millions new hope 2.5 million 2.0 Vaccine effectiveness New infections prevented by 2030 1.5 LOW IMPACT Cuts infections 30%, available to 20% of population 2.1 million The world today:New adult HIV infections in low- and middle-income countries are projected to stabilize—but not decline The future:What would happen if a safe, effective, widely accessible vaccine were introduced? 1.0 MEDIUM IMPACT 50% effective, 30% coverage 5.6 million 70% effective, 40% coverage 9.8 million HIGH IMPACT 0.5 VERYHIGH IMPACT 90% effective, 40% coverage 12.0 million 2000 2005 2010 2015 2020 2025 2030 Source: IAVI calculations

  46. One infection averted by a vaccine means one person who will not need ART The potential cost-savings HPV (developed world) $360.00 HIV Vaccine (maximum price at which vaccine would still be cost-saving) $25 for 30% effective vaccine $800 for 70% effective vaccine Pneumo conjugate vaccination (under AMC) $3.50 Rotavirus vaccine (GAVI price) $0.30 Average lifetime cost of ART for one person $7,400 0 1000 2000 3000 4000 5000 6000 7000 IAVI/Futures Institute 2009. Estimating the Potential Impact of an AIDS Vaccine in Developing Countries, Marzetta et al 2010. “The potential global market size and public health value of an HIV-1 vaccine in a complex global market”

  47. IAVI’s role Mission To ensure the development of safe, effective, accessible, preventive HIV vaccines for use throughout the world Core principles • Focus • Speed • Flexibility • Willingness to take informed risk • Access is part of our mission Political willand finance Research& development Clinical trials Health and other systems Accessand uptake Production • Integrated model of R&D • Emphasis on applied research and product development • Targeting gaps • R&D partnerships with academia and industry • Conducted 25 human trials in 11 countries • Policy and advocacy for the global effort • Sustained commitment to developing countries • 200 staff, site workers in Africa, 5 regional offices, active in 25 countries; $100 M annual budget

  48. Evolution of the IAVI model Traditionally, a continuum of players moves new drugs to market Clinicaldevelopment Basic research Applied research Preclinical development Advanced development Large-scale Efficacy trials Public sector, academia Biotech companies Pharmaceutical companies From 1996-2000 IAVI focused on clinical development of vaccine candidates for the developing world Clinical development Basic research Applied research Preclinicaldevelopment Advanced development Large-scale Efficacy trials Public sector, academia Biotech companies, pharmaceutical companies Advocacy Clinical trial network in developing world Gap-filling science

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