Inaugural Keynote Lecture: Contributions of Gavi and DCVMN to the global vaccine markets DCVMN 18th AGM Seth Berkley M.D, CEO 26 September 2017, Seoul www.gavi.org Gavi’s mission, model and 1 achievements to date Gavi’s mission Saving by increasing and protecting in lower-income children’s equitable use of people’s health countries lives vaccines DCVMN 18th AGM 26 September 2017 Gavi’s partnership model IMPLEMENTING COUNTRY DONOR COUNTRY GOVERNMENTS GOVERNMENTS CIVIL SOCIETY RESEARCH & ORGANISATIONS TECHNICAL AGENCIES VACCINE PRIVATE MANUFACTURERS SECTOR PARTNERS DCVMN 18th AGM 26 September 2017 Increasing immunisation coverage Launch of Gavi Post-Gavi 20% increase points 2000-2016 1980 1985 1990 1995 2000 2005 2010 2016 2020 Expanded Programme Stall in immunisation Support from Gavi to world’s on Immunization takes off coverage lowest-income countries * Based on data officially reported to WHO and UNICEF by current member states. Note: Includes DTP-containing vaccines, such as pentavalent vaccine. th Source: WHO/UNICEF Estimates of National Immunization Coverage, 2017 DCVMN 18 AGM 26 September 2017 Accelerating access to new vaccines in poorest countries 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. DCVMN 18th AGM Source: The International Vaccine Access Center (IVAC) VIMS database. Data as of 31 December 2016. 26 September 2017 Gavi vaccine introductions and campaigns Year of first introduction/use of stockpile Introductions by September 2017 2001 YELLOW FEVER HEPATITIS B HIB Pentavalent* 73 PENTA 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 DCVMN 18th AGM vaccine independently of Gavi support. ** Measles routine = measles 2nd dose 26 September 2017 As of 20 September 2017 Gavi partnerships with countries: the India example Pentavalent vaccine Measles-rubella vaccine • India’s introduction with Gavi support and • Campaign completed in five states and transition to full scale self-financing increased started in 6 additional states the Penta market by ~80m doses per year • Increased and steady demand helped secure lower prices Pneumococcal vaccine Rotavirus vaccine • Launch started in three states • Launched in nine states, self-financed Aug-2017: Intensified Mission Indradhanush: Aim to reach 90% immunisation coverage by 2018 DCVMN 18th AGM 26 September 2017 GAVI’S RESOURCE MOBILISATION MODEL Market- shaping 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 Growing country co-financing contribution $180 100 71 $160 90 $20 $140 80 67 68 70 70 62 70 $120 57 52 60 $100 50 $80 32 $137 40 $60 $125 $113 30 Number ofNumber countries $40 $91 $64 20 financing financing amount in $US (millions) - $20 $31 $32 $36 10 Co $21 $0 0 2008 2009 2010 2011 2012 2013 2014 2015 2016* Co-financing Self-financing Countries * In 2016, 67countries were co-financing and 4 countries fully self-financing DCVMN 18th AGM 26 September 2017 One third of initial 73 Gavi countries in or completed transition Initially 73 Gavi-supported countries 17 in accelerated transition 9 fully self-financing all vaccines th DCVMN 18 AGM Note: Gavi’s support to the Ukraine ended before the Source: Gavi, the Vaccine Alliance, 2017 co-financing and transition policies were 26 September 2017 implemented. Innovative finance key to Gavi’s funding model International Advance Market Advance Purchase The Gavi Matching Finance Facility for Commitment (AMC) Commitment (APC) Fund Immunisation for pneumococcal for Ebola vaccine (IFFIm) vaccine > US$ 5 billion US$1.5 billion DCVMN 18th AGM 26 September 2017 Affordable and sustainable vaccine prices Cost to immunise a child with full course of: BCG Gavi HEPATITIS B Approx. price: PENTAVALENT DTP USA price: HIB US$ 35 US$ 950 ROTAVIRUS PNEUMOCOCCAL INACTIVATED POLIO MEASLES RUBELLA HPV (CERVICAL CANCER) DCVMN 18th AGM 26 September 2017 Market shaping and the role of 2 industry in the Vaccine Alliance Vaccine markets, how partners achieve impact UPSTREAM PLANNING INCENTIVES PROCUREMENT OPERATIONS BMGF GAVI UNICEF TACTICS Product Programmatically Negotiating Tender process Supply chain innovation driven demand affordable pricing execution operations Providing financial forecasts Innovative Manufacturer Technical support resources Market analytics financing award for country-led Technical support Strategic vaccine mechanisms or programs, roadmaps market incentives introductions, packaging and Information cold chain transparency capacity DCVMN 18th AGM 26 September 2017 Gavi started at a time of limited supply 2001: 5 suppliers from 5 countries of production Belgium 1 France 1 Switzerland 1 Republic of Korea 1 Senegal 1 2001 Source: UNICEF Supply Division DCVMN 18th AGM 26 September 2017 Gavi has helped create a viable market with more secure supply 2016: 17 manufacturers from 11 countries of production Netherlands 1 Russian Belgium 1 Federation 1 France 1 Republic United States 2* of Korea 13 China 1 Senegal 1 India 4 Brazil 1 * One US manufacturer Indonesia 1 also produces in the Netherlands. Note: Country of production represents country of national regulatory agency responsible for vaccine lot release. 2016 DCVMN 18th AGM Source: UNICEF Supply Division and WHO list of pre-qualified vaccines, 2016 26 September 2017 DCVMN contribution to Gavi market 16 15 % of Gavi supplied doses 2012-2016 14 13 13 2% 12 12 10 8 10 6 6 5 40% 8 4 6 58% 5 5 5 5 4 5 Number of Gavi suppliers Gavi of Number 2 2 2 2 2 0 1 DCVMN supplied Gavi with 1.5bn 2012 2013 2014 2015 2016 doses over 2012-2016 Other suppliers* IFPMA suppliers DCVMN suppliers Total 19 DCVMN 18th AGM * Non-member suppliers: FSUE of Chumakov IPV and Institut Pasteur de Dakar 26 September 2017 Critical role of DCVMN in ensuring greater vaccine supply availability Vaccines for Other Vaccines for endemic diseases epidemics vaccines 18 16 14 12 10 8 6 4 2 0 DCVMN Manufacturers Non-DCVMN Manufacturers PQ Locally licenced In development PQ Locally licenced In development DCVMN 18th AGM 26 September 2017 Gavi collaboration with industry: the example of SII SII / Gavi collaboration since 2010 Measles MenA Penta MR IPV Start of SII supply 2007 2010 2011 2013 2014 • Over 2012-2016, SII supplied 1,193 million doses of vaccines and contributed to immunizing 923 million children DCVMN 18th AGM Source: UNICEF shipment data, 2017 26 September 2017 SII contribution to improving vaccine supply security: MenAfriVac success story Meningitis A vaccine The Challenge: The Solution: No affordable vaccine against meningitis A Partnership between WHO, PATH, US$ 90 Vaccine manufacturers reluctant to invest Bill & Melinda Gates Foundation US$ 0.64 SII vaccine development commitment 450 million people Initial investment to develop affordable Live in Africa’s vaccine “meningitis belt” across 26 countries Prevention vs Treatment Cost per person Gavi funds campaigns and routine introductions 450 million More than 235 million Severe consequences: people threatened people vaccinated since 2010 10% of people infected die 25% of survivors suffer permanent disabilities DCVMN 18th AGM 26 September 2017 Yellow Fever vaccine: example of an increasingly healthy market Start of YF Between 2013 and 2017, Gavi and Gavi support partners identified opportunities to improve supply security for YFV: Encouraging manufacturers to invest in securing and increasing supply Providing technical and financial support to manufacturers Strengthening National Regulatory Agencies responsible for ensuring vaccine quality and safety DCVMN 18th AGM 26 September 2017 Gavi is committed to supporting product innovation Accelerating product innovation to better meet country programmatic needs and improve coverage and equity Innovation Align product innovation priorities Delivery options and definitions across market- • Transdermal micro-array patch shaping partners • Needle free jet injectors • Blow-filled seal technology • Solar Direct Drive refrigerators Weigh benefits of long-term product innovations to support Product Presentations investment decisions 2013Shape cold chain equipment markets DCVMN 18th AGM 26 September 2017 Comparison of production processes: traditional, mRNA and DNA vaccines DCVMN 18th