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The Challenge of Achieving Universal Access to Vaccines

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Keynote Address: The Challenge of Achieving Universal Access to Vaccines WIPO & AMF Seth Berkley M.D, CEO 8 November 2017 www.gavi.org 1 Vaccine landscape WIPO 8 November 2017 The world before vaccines Examples of major disease outbreaks Polio Cholera New York pandemic 1916 Europe 6,000 deaths 1829-1851 >200,000 deaths Yellow fever Philadelphia Smallpox 1793 epidemic >5,000 India deaths 1974 15,000 deaths Flu pandemic 1918-1920 > 50-100 million deaths worldwide WIPO 8 November 2017 History of vaccine development Source: Delaney et.al. 2014 WIPO 8 November 2017 Cumulative number of vaccines developed licensed 50+ vaccines Lyme OspA, protein (1998) Tuberculosis (Bacille Calmette-Guérin) Pneumococcal conjugate, heptavalent* (2000) 1927 Typhus Varicella (1995) Meningococcal quadrivalent conjugates* (2005) Japanese encephalitis (Vera-cell) (2009) 1938 Cholera (recombinant Toxin B) # (1993) Cholera (WC only) (2009) Tetanus toxoid Cholera (WC-rBC) (1991) Human papillomavirus recombinant bivalent (2009) Influenza H. influenzaeconjugate* (1987) Quadrivalent influenza vaccines (2012) Typhoid Cholera Pertussis 1936 Meningococcal C and Y and 1886 1896 1926 H. influenza type B polysaccharide (1985) Haemophilusinfluenza type b (2012) Adenovirus (1980) Meningococcal B (2013) Smallpox Diphtheria Yellow Rabies, cell culture (1980) Influenza vaccine (baculovirus) (2013) 1798 toxoid Fever Typhoid conjugate vaccine (2013) Rabies Plague Meningococcal polysaccharides (1974) 1923 1935 Human papillomavirus, 9-valent (2014) 1885 Rubella, live (1969) 1897 vaccines of number Cumulative Enterovirus(2015) Polio (oral live) (1963) Dengue (2015) Measles, live (1963) RTS,S (2015) 2017 13 valent pneumococcal conjugates (2010) Zoster, live (2006) Polio (injected inactivated) Rotavirus (attenuated and new reassortants (2006) (1955) Mumps, live Human papillomavirus recombinant quadrivalent(2006) (1967) Cold-Adapted Influenza (2003) Anthrax, secreted proteins (1970) Rotavirus reassortants(1999) Pneumococcus polysaccharides (1977) Meningococcal conjugate* (group C) (1999) Hepatitis B (plasma derived) (1981) Acellar pertussis, various (1996) Tick-borne encephalitis (1981) Hepatitis A, inactivated (1996) Sources: timeline as of the end of 2010: Plotkin SA, Plotkin SL. The development of vaccines: how the Hepatitis B surface antigen recombinant (1986) Cholera, live attenuated (1994) past led to the future. Nature Reviews Microbiology, AOP, 2011, 1–5. 2011-2015: US Food and Drug Typhoid (salmonella Ty21a), Live (1989) Typhoid (Vi) polysaccharide (1994) Administration (FDA) Japanese encephalitis, inactivated (1992) WIPO 8 November 2017 Growing market Vaccine market value in $bn Compound annual growth $49 rate of $32 7.5% $6 2000 2016 2022 Source: PATH (March 2016), Markets & Markets (2017) WIPO 8 November 2017 Vaccine industry dynamics Highly consolidated Four companies: ~80% global vaccine revenues Diverse business models Pipelines Portfolios Revenues and number of doses sold globally WIPO 8 November 2017 Vaccine suppliers to Gavi (volume) 700 15 16 13 13 14 600 12 12 500 10 306 323 10 400 331 361 8 300 6 200 178 4 268 301 100 191 123 153 2 suppliers Gavi of Number Doses supplied to Gavi (million) Gavi to supplied Doses 0 12 6 13 11 13 0 2012 2013 2014 2015 2016 Other suppliers IFPMA suppliers DCVMN suppliers # Suppliers * Non-member suppliers: FSUE of Chumakov IPV and Institut Pasteur de Dakar WIPO 8 November 2017 Innovation needed to address challenges across the value chain R&D Supply Delivery • Basic research • Manufacturing • Supply chain • Translational • Pricing • Data research • Product quality • Health systems • Clinical development WIPO 8 November 2017 Product development partnership (PDP) model critical to drive innovation and fill gaps Example: IAVI is an integrated organization that links its … Industry-style Academic, Network of Advocacy and labs and diverse government and clinical trial outreach from research private-sector centers in Africa community to portfolio partnerships and India international level WIPO 8 November 2017 Acceleration in number of PDPs BY YEAR STARTED Gates MRI 1977 1986 ’87 ’88 1989’89 1990 ’91 ’92 ’93 ’94 ’95 1996’96 ’97 1998’98 1999’99 2000 2001’01 2002’02 2003’03 ’04 2005’05 ’06 ’07 ’08 ’09 ’10 ’11 ’12 ’13 ’14 ’15 ’16 ’17 Selected other public-private partnerships Working on health issues WIPO 8 November 2017 Gavi’s mission, model and 2 achievements to date WIPO 8 November 2017 Gavi’s mission Saving by increasing and protecting in lower-income children’s equitable use of people’s health countries lives vaccines WIPO 8 November 2017 About Gavi Vaccine Alliance partners IMPLEMENTING COUNTRY DONOR COUNTRY GOVERNMENTS GOVERNMENTS CIVIL SOCIETY RESEARCH ORGANISATIONS AGENCIES VACCINE PRIVATE MANUFACTURERS SECTOR PARTNERS The Gavi business model: reinventing aid Pooling demand of Long-term Accelerating Shaping Strengthening vaccine Sustaining poorest countries funding access to vaccines markets delivery platforms immunisation Market shaping Transition Country out of Country support Donor base Supply Demand Country Country Country Co-financing Continued support Country As economies grow, countries transition out of Gavi support Initial self- Preparatory Accelerated Fully self- financing transition transition financing 100% Access to vaccine price commitments % of $0.20 per dose Co-financing for 5 or more years vaccine accelerates to cost As the country’s national reach 100% income grows, payments Country enters Gavi increase by 15% a year support, co-financing its vaccines years Variable duration Variable duration 5 years 5 years Low-income Eligibility End of Gavi country threshold threshold financing < US$ 1,025 per capita gross > US$ 1,580 per capita GNI national income (GNI) Note: the eligibility threshold is adjusted annually for inflation. Source: Gavi, the Vaccine Alliance, 2016 WIPO 8 November 2017 One third of initial 73 Gavi countries in or completed transition Initially 73 Gavi-supported countries 17 in accelerated transition 9 fully self-financing all vaccines Note: Gavi’s support to the Ukraine WIPO Map reflects 2017 eligibility ended before the co-financing and 8 November 2017 Source: Gavi, the Vaccine Alliance, 2017 transition policies were implemented. Immunisation coverage: closing the gap Launch of Gavi 100 96% High-income countries 86% 80 80% Post-Gavi 21% increase 60 points 2000-2016 Global average Lowest-income countries Gavi-supported countries 40 20 Immunisation coverage rate (%) rate coverage Immunisation 0 1980 1985 1990 1995 2000 2005 2010 2016 Expanded Programme Stall in immunisation Gavi support to world’s on Immunization takes off coverage poorest countries . Note: Includes DTP-containing vaccines, such as pentavalent vaccine. WIPO Source: WHO/UNICEF Estimates of National Immunization Coverage, 2016 8 November 2017 Achieving impact: India Launch of Intensified Mission Under-immunised children (million) Indradhanush 9.3 7.7 6.6 5.3 Gavi HSS 1 Gavi HSS 2 4.5 4.4 4.2 3.7 3.2 2.9 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 Under-immunised child: not received 3rd dose of DTP containing vaccine WIPO Source: WUENIC 2016 (July 2017 Release) 8 November 2017 Currently 7 of 10 countries with most under- immunised children receive Gavi support Top 10 countries, under-immunised, DTP3 3.44M 2.91M 1.43M 1.02M 0.72M 0.65M 0.44M 0.41M 0.41M 0.39M Nigeria India Pakistan Indonesia Ethiopia DRC Iraq Angola Brazil South Africa Other Transitioned Gavi WIPO 8 November 2017 Equitable access to life-saving vaccines Prior to Gavi support Now High-income countries Low-income countries High-income countries Low-income countries 100% 100% 100% 91% 86% 86% 77% 72% Hepatitis B 67% Hib Pneumococcal % of countries introduced vaccines nationally 3% 6% 6% 2000 2009 2000 2009 2016 Note: Only countries with universal national introduction are included. World Bank 2016 country classification has been applied to the whole time series. WIPO Source: The International Vaccine Access Center (IVAC) VIMS database. Data as of 31 December 2016. 8 November 2017 Gavi vaccine introductions and campaigns Year of first introduction/use of stockpile Introductions by September 2017 2001 PENTAVALENT HEPATITIS B YELLOW FEVER Pentavalent* 73 2002 HIB Pneumococcal 58 2007 MEASLES 2ND DOSE Rotavirus 41 2008 ROTAVIRUS Inactivated polio 54 2009 PNEUMOCOCCAL Meningitis A 6 25 >370 intros 2010 MENINGITIS A Yellow fever 17 14 in total 2013 MEASLES-RUBELLA HPV (CERVICAL CANCER) HPV 4 25 routine introduction 2014 ORAL CHOLERA INACTIVATED POLIO Measles 19 10 campaign or demonstration project 2015 JAPANESE ENCEPHALITIS Measles-rubella 5 24 2017 EBOLA Japanese encephalitis 1 3 * 5 of the 73 countries introduced pentavalent WIPO vaccine independently of Gavi support. ** Measles routine = measles 2nd dose 8 November 2017 As of 20 September 2017 Increased breadth of protection* delivered through routine immunisation 70% 60% 62% 50% 40% 37% 30% Breadth of of Breadth protection (%) protection 30% 23% 20% 20% 2013 2014 2015 2016 2017 2018 2019 2020 Year *Average coverage across all Gavi-supported vaccines in Gavi-supported countries WIPO 8 November 2017 Coverage rates for new vaccines Source: WHO/ UNICEF 2016 WIPO 8 November 2017 Innovative finance key to Gavi’s funding model International Advance Market Advance Purchase The Gavi Matching Finance Facility for Commitment (AMC) Commitment (APC) Fund Immunisation for pneumococcal for Ebola vaccine (IFFIm) vaccine > US$ 5 billion US$1.5 billion WIPO 8 November 2017 Gavi started at a time of limited supply 2001:
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