Prioritising vaccine support the GAVI perspective

Transcription

1 Prioritising vaccine support the GAVI perspective Seth Berkley, M.D. CEO GAVI Alliance Fondation Mérieux November, 2012

2 Mission and strategic goals To save children s lives and protect people s health by increasing access to immunisation in poor countries 1 2 The vaccine goal Accelerate the uptake and use of underused and new vaccines 3 4 The financing goal Increase the predictability of global financing and improve the sustainability of national financing for immunisation The health systems goal Contribute to strengthening the capacity of integrated health systems to deliver immunisation The market-shaping goal Shape vaccine markets to provide appropriate and affordable vaccines

3 GAVI supports the world s poorest countries Type and value of support, Source: GAVI Alliance, 2012

4 Global burden of pneumococcal disease Source: WHO, Estimated Hib and pneumococcal deaths for children under 5 years of age, 2000

5 Global burden of rotavirus diarrhoeal disease Source: WHO, Estimated rotavirus deaths for children under 5 years of age, 2008

6 Vaccine support the GAVI portfolio Currently supported: pentavalent, pneumococcal, rotavirus, meningitis A, human papillomavirus (HPV), rubella, yellow fever and measles (second dose) vaccines Also: meningitis and yellow fever vaccine stockpiles Prioritised for future support: Japanese encephalitis and typhoid vaccines Monitoring development: IPV, malaria, dengue

7 What developing countries have achieved with GAVI support Immunised 370 million children Prevented more than 5.5 million future deaths Accelerated vaccine introductions in over 70 countries Strengthened health systems to deliver immunisation Helped shape the market for vaccines Additional children immunised Sources: WHO-UNICEF coverage estimates for , as of July Coverage projections for 2012, as of September World Population Prospects, the 2010 revision. New York, United Nations, 2010; (surviving infants)

8 More than saving lives: reduced disability and morbidity (millions) Future deaths averted DALYs averted % % Hepatitis B % % Hib % % Pneumococcal % % Rotavirus % % Rubella % % HPV % % Other % % 4.1% Total % %

9 A strong platform Source: WHO/UNICEF vaccine coverage estimates (July 2012) Country income categories (World Bank) as of July 2012 (2011 GNI per capita)

10 Taking stock: the immunisation gap 136 million surviving newborns in 2010: Source: Johns Hopkins Bloomberg School of Public Health; UN,DESA, Population Division; WHO/UNICEF

11 Infectious causes of child deaths 1 59 months GAVI-eligible countries 2010 estimates Source: CHERG, WHO and UNICEF 2012

12 Source: WHO/UNICEF estimates for (Published July 2012) Over 23 million children still unimmunised Global number of under-five children unimmunised with 3 doses of DTP, 2011

13 Driving equity in vaccine access Hepatitis B Hib Source: WHO, Vaccine introduction database. Country income categories (World Bank) as of July 2012 (2011 GNI per capita)

14 Number of children immunised with pneumococcal and rotavirus vaccines Sources: WHO-UNICEF coverage estimates for , as of July Coverage projections for 2012, as of September World Population Prospects, the 2010 revision. New York, United Nations, 2010; (surviving infants)

15 GAVI s funding model

16 GAVI co-financing policy: country ownership and steps to sustainability Country groupings: Low-income countries (<US$ 1,005 per capita GNI) pay US$ 0.20 per dose Intermediate countries (US$ 1,005 US$1,520) increase copayments by 15% per year Graduating countries (>US$ 1,520) increase payments steadily to reach sustainability after five years

17 How the co-financing policy works Source: GAVI Alliance 2012

18 Market shaping key objectives Balance supply & demand Ensure sufficient, uninterrupted supply Vaccine prices Minimise cost to GAVI and countries Appropriate products Ensure appropriate, quality vaccines & foster innovation Information Communicate timely, transparent and accurate market information

19 Co-financing performance and indicators Total number of countries expected to co-finance and co-financing amount paid by countries* Source: GAVI Alliance, 2012

20 Projected vaccine costs as a share of projected public spending on health, 2015 Vaccines < 1 percent of government spending on health New Cofinancing Categories Per capita government spending on health Government spending on health as % of government spending Government spending as % of GDP Vaccines as % of government spending on health Low income $ % 25.0% 4.2% 6.3% Intermediate $ % 31.2% 1.5% 2.2% Graduating $ % 37.0% 0.5% 0.6% Data Sources: World Bank/ WHO National Health Accounts/ GAVI Demand Forecast Note: Eritrea, India, Korea D.R., Somalia and Zimbabwe excluded from analysis

21 Ramsay pricing Source: GAVI Alliance, 2012

22 Tiered pricing Source: UNICEF Supply Division; CDC

23 The GAVI Vaccine investment strategy Individual investment cases until 2008 Penta, Yellow fever, Meningococcal A, measles, rotavirus, pneumococcal vaccines First comprehensive vaccine investment strategy in 2008, prioritised: HPV, rubella -> first applications in 2012 Japanese encephalitis, typhoid conjugate -> when suitable vaccines become pre-qualified

24 Disease & Vaccine Landscape Analysis (2008) DISEASE CHARACTERIZATION JE JE Disease Overview DISEASE PATHOGEN, TRANSMISSION & TARGET POPULATION 1 Disease Pathogen Japanese Encephalitis (JE) virus is in the Flavivirus genus Transmission Transmitted by Culex mosquitoes (Cx. tritaeniorhynchus) Aquatic birds, pigs and other animals serve as a reservoir, and as an amplifying host Disease Overview NON-VACCINE PREVENTION & TREATMENT INTERVENTIONS 8 Non-Vaccine Prevention Geographic Distribution Reduction in cultivation, use of pesticides and centralized pig production may help to prevent Rural populations the spread in of Asia JE, and but Western there is no Pacific proof Region to support these prevention efforts Disease Target Population Treatment Interventions Infants and children up to the age of 15 years old are most susceptible to infection No specific antiviral treatment exists Supportive therapy can reduce morbidity and mortality 3 0 = Mannitol and other medications to reduce intracerebral pressure = Trihexyphenidyl Disease hydrochloride Overview and central dopamine agonists are used to treat acute extrapyramidal symptoms DISEASE BURDEN IN GAVI-ELIGIBLE COUNTRIES MORBIDITY 3-6 Neutralizing murine monoclonal antibodies are reported to improve clinical outcomes as well WHO Morbidity Morbidity Rate WHO Country Country Region (Annual Cases) (Cases/100,000) Region Bangladesh SEARO 15, Guinea AFRO Bhutan SEARO Guinea-Bissau AFRO India SEARO 115, Guyana AMRO Indonesia SEARO 23, Haiti AMRO Korea, DPR SEARO 2, Honduras AMRO Myanmar SEARO 4, Kenya AFRO Nepal SEARO 2, Kiribati WPRO Sri Lanka SEARO 1, Kyrgyzstan EURO Timor-Leste SEARO Lesotho AFRO Pakistan EMRO 7,967 5 Liberia AFRO Lao PDR WPRO Madagascar AFRO Viet Nam WPRO 2,979 4 Malawi AFRO 8 Cambodia WPRO Mali AFRO Papua New Guinea WPRO Mauritania AFRO Afghanistan EMRO Moldova, Rep. of EURO Angola AFRO Mongolia WPRO Armenia EURO Mozambique AFRO Azerbaijan EURO Nicaragua AMRO Benin AFRO Niger AFRO Bolivia AMRO Nigeria AFRO Burkina Faso AFRO Rwanda AFRO Burundi AFRO São Tomé and Principe AFRO Cameroon AFRO Senegal AFRO Central African Republic AFRO Sierra Leone AFRO Chad AFRO Solomon Islands WPRO Comoros AFRO Somalia EMRO Congo, Dem. Rep. AFRO Sudan EMRO Congo, Rep. AFRO Tajikistan EURO Côte d'ivoire AFRO Tanzania, United Rep. of AFRO Cuba AMRO Togo AFRO Djibouti EMRO Uganda AFRO Eritrea AFRO Ukraine EURO 4 Ethiopia AFRO Uzbekistan EURO Gambia, The AFRO Yemen EMRO GAVI Vaccine Investment Strategy 6 Georgia EURO Zambia AFRO Vaccine Landscape Analysis_Cholera_Apr08 Ghana AFRO Zimbabwe AFRO JE None Reported Data Not Available or Non-Endemic Morbidity (Annual Cases) JE Morbidity Rate (Cases/100,000) Disease Overview DISEASE IMPACT 1 Total Morbidity At least 50,000 cases of JE are reported annually (~12 million asymptomatic cases) This is an underestimation of disease incidence since incidence rates during outbreaks can reach >100 cases per 100,000 population Surveillance data in developing countries is limited and under reported Total Mortality Disease Overview Case Fatality Rates are high (30-35%) resulting in ~15,000 deaths annually INEQUITIES Epidemic Potential Large outbreaks in the summer in parts of China, South-East Russian Federation, South and South-East Asia (outbreaks can reach >100 cases per 100,000 population) Inequity of Poor Disease Sequelae Japanese Encephalitis mainly strikes poor rural communities in 14 poor countries of Southeast About Asia 50% and of the cases Western result in Pacific permanent neuropsychiatric sequelae ~30% of survivors have persistent motor deficits and ~20% have severe cognitive and language impairment Gender Inequities Disease Overview None Reported Gender Based Criteria Applies 0 4 = Data Rationale Not Available = or Non-Endemic Do men or women suffer from the disease differently? - Not applicable DISEASE BURDEN IN GAVI-ELIGIBLE COUNTRIES MORTALITY 4-7 WHO Mortality Mortality Rate WHO Mortality Mortality Rate Country Is disease prevalence greater Country Region (Annual Deaths) (Deaths/1,000,000) - Region (Annual Deaths) Not applicable (Deaths/1,000,000) Bangladesh SEARO 4,682 in men or women? 31 Guinea AFRO Bhutan SEARO Guinea-Bissau AFRO India SEARO Does 34,648 the disease adversely 31 affect Guyana AMRO Indonesia SEARO 6, Haiti - AMRO Not applicable Korea, DPR SEARO women 721 during pregnancy? 31 Honduras AMRO Myanmar SEARO 1, Kenya AFRO Nepal SEARO Kiribati WPRO Sri Lanka SEARO Kyrgyzstan EURO Timor-Leste SEARO Lesotho AFRO Pakistan EMRO 2, Liberia AFRO Cambodia WPRO Madagascar AFRO Lao PDR WPRO Malawi AFRO 9 Papua New Guinea WPRO Mali AFRO Viet Nam WPRO Mauritania AFRO Afghanistan EMRO Moldova, Rep. of EURO Angola AFRO Mongolia WPRO Armenia EURO Mozambique AFRO Azerbaijan EURO Nicaragua AMRO Benin AFRO Niger AFRO Bolivia AMRO Nigeria AFRO Burkina Faso AFRO Rwanda AFRO Burundi AFRO São Tomé and Principe AFRO Cameroon AFRO Senegal AFRO Central African Republic AFRO Sierra Leone AFRO Chad AFRO Solomon Islands WPRO Comoros AFRO Somalia EMRO Congo, Dem. Rep. AFRO Sudan EMRO Congo, Rep. AFRO Tajikistan EURO Côte d'ivoire AFRO Tanzania, United Rep. of AFRO Cuba AMRO Togo AFRO Djibouti EMRO Uganda AFRO Eritrea AFRO Ukraine EURO Ethiopia AFRO Uzbekistan EURO Gambia, The AFRO Yemen EMRO Georgia GAVI Vaccine Investment EURO Strategy 7 Zambia AFRO Ghana Vaccine Landscape AFRO Analysis_JE_Apr08 Zimbabwe AFRO JE JE * WHO, expert, PDP, PPP reviewed Disease-specific summaries can be found in the disease analysis presentations posted on GAVI s website

25 Disease & Vaccine Landscape Analysis (2008) VACCINE CHARACTERIZATION JE Vaccine Landscape LICENSED VACCINES Supplier (1 Partner) Chengdu (Wuhan, Lanzhour, Shanghai Instit for Biol Products) 9 Biken (GreenCross, NIPM, GPO, NIHE) 10 Beijing, Inst of Biological Products 9 Vaccine SA Attenuated JE-Vax Inactivated P3 Strain / Antigen SA strain Beijing strain P3 Strain Adjuvant / Platform Live, attenuated, primary hamster kidney cell culture derived Inactivated, mouse brain-derived Inactivated, primary hamster kidney cell culture derived Administration Route SQ SQ SQ Formulation Lyophilized Lyophilized Liquid Presentation 1 & 5-dose vials 1 dose vial 2, 5, 10-dose vials Dosing Schedule Target Population for Licensure Vaccine Landscape 1 dose at 9mo; boost 1 yr later (0, 12mo) 2 doses at 1-3 yrs (0, 1mo); boost after 1yo, then 3 yr intervals until age 10-15yo 2 doses at 12 mo (0, 1-4wks); JE boost at 2, 6, 10 yo > 9mo 12 mo 12 mo Safety No major safety concerns Poor; anaphylactic shock 1/10,000 No major safety concerns Efficacy % 80-91% 76-95% VACCINES IN CLINICAL DEVELOPMENT Supplier (1 Partner) Expected Duration of Protection Intercell Licensure AG (Biological Date E, (Location) WRAIR) 11 At least 5 years 2 years 1 year Acambis 1989 (Sanofi-Pasteur) (China) 12 Kaketsuken 1930s (Russia, Japan) Biken (As(Japan) of 2003, 9 Biken no longer exporting) (Japan) 9 Vaccine Estimated SA WHO Inactivated Chimerivax-JE 1Q11 KD-287 BK-VJE Assume will not seek WHO PQ Assume will not seek WHO PQ Prequalification Date Strain / Antigen (Assumes WHO PQ without boost) SA strain SA strain Beijing-1 strain Beijing-1 strain Inactivated, Vero cellderived Vero cell-derived-yf 11derived derived SA Inactivated (Intercell) Live, attenuated, chimeric Inactivated, Vero cell- Inactivated, Vero cell- Adjuvant / Platform Administration Route IM SQ SQ SQ Formulation Liquid Lyophilized Lyophilized Lyophilized SA Attenuated (Chengdu) multi-dose vials; pre-filled 1 dose vials or multi-dose 1 dose vials or multi-dose Presentation multi-dose vials syringe vials vials Dosing Schedule 2 doses (0, 1mo or 1yr) 1 dose 3 doses (0, 1, 6-24mo) 3 doses (0, 1, 6-24mo) Chimerivax-JE (Acambis) Target Population for Licensure > 9mo > 9mo > 6mo > 6mo Safety No major safety concerns No major safety concerns No major safety concerns No major safety concerns JE-Vax (Biken) Efficacy Comparable Immunogenicity Comparable Immunogenicity up to 100% up to 100% Expected Duration of Protection Stage of Development Estimated Licensure Date Estimated WHO Prequalification Date Ph 3 (adults) * ; Ph 2 (1-3 yo) 4Q08 (adults) 4Q09 (> 9mo) Ph 3 (adults); Ph 2 (age <15) 2009 (adults) 2010 (> 9mo) 4Q Phase 3 Phase 3 BK-VJE (Biken) 2009 (Japan) 2009 (Japan) Assume will not seek WHO PQ Vaccine Landscape Analysis COST EFFECTIVENESS LITERATURE SUMMARY (IV) Analysis of JE in Cambodia showed JE to cause 7,339 DALYs over 10 years, costing $28 (Range: $0-$347) (out of pocket only) per case treated. The costeffectiveness of SA vaccine in a 2009 population cohort (1-10 yo and 9-mo) over 10 years, demonstrated that the total cost per case treated was $1,660, and loss of earning related to long-term sequelae was $154, ,878. Vaccination prevented 3,099 cases and 403 deaths, saved $92,752 in out of pocket medical expenses, $42 per DALY averted, and $5,093 per death averted. 17 Cost-effectiveness analysis of JE vaccine in 14 GAVI eligible countries (out of pocket cost is excluded). Vaccination of a 2009 population First NRA Licensure cohort would prevent 322,131 cases and 71,161 deaths, $30,971,268 in direct medical cost WHO Pre-Qual Approval Vaccine 1967 Landscape savings (based on WHO CHOICE), $28 per DALY averted, and $3,562 per (Exclusively in China) death averted over 10-years. Without vaccination, JE infection resulted in ESTIMATED VACCINE AVAILABILITY 6,672,947 DALYs and treatment costs of $150 per case. 18 Inactivated P3 (Beijing Inst Biol Prod) Assume will not KD-287 (Kaketsuken) seek WHO PQ (adults) (> 9mo) (>9mo) (adults) (> 9mo) 17 (>9mo) (>9mo) JE JE Prior to * Supplier, expert, PDP reviewed Disease-specific summaries can be found in the disease analysis presentations posted on GAVI s website

26 Objective of 2013 VIS: Identify new, priority investments in vaccines, licensed by 2019, for the GAVI Alliance to achieve its mission and goals in the most efficient and cost-efficient means while adhering to its operating principles Evidenced based portfolio approach Foundation for strategic planning and fundraising Inform country, partner and industry plans

27 Methodology Build upon 2008 process Consider diseases for which vaccines would be available by 2019 Prioritisation and analyses Three work streams: Analytic Stakeholder consultations Governance

28 Prioritization: Disease and Vaccine Landscape Analysis Disease characterization in our partner countries Vulnerable populations and epidemiology Gender inequity Long term sequellae Availability of alternate cost-effective interventions Vaccine characterization Estimated dates of availability Cost effectiveness data

29 Prioritization: Vaccine Policy and Strategies Decision analyses of how to use in our populations Preexisting use in other populations For our populations: Routine, catch-up, periodic campaigns, stockpiles, post-exposure (Rabies) Geographic distribution based upon prevalence high, medium, low risk

30 Prioritization: Vaccine Need, Adoption and Demand Forecasts Expert opinion (academics, PDPs, organizations) Country surveys Practicality of roll out; global supply and by country capacity Post-integrated forecast tested by GAVI teams with countries trying to control ambitions Priorititization of vaccine introductions by country (supply, need, practical issues)

31 Priortization: Financial Analysis and key inputs Demand: Function of estimated WHO pre-qualification date Country adoption forecast Coverage rate Doses and wastage Time to peak or campaign duration Cost: Price, country co-pay, vaccine equipment costs, shipping and insurance

32 Prioritization: Financial analysis and key inputs (cont.) Health impact Potential deaths averted; age distribution GAVI cost per death averted Potential cases averted Costs per cases averted Case savings per case averted GAVI cost per $$$ saved

33 Prioritization: Implementation Cost Analysis Expert, GAVI, and country consultations Incremental and sustained costs: Cold Chain, Waste management, transport, personnel training, social mobilization and communication, monitoring and evaluation surveillance (including AEFI surveillance) service delivery Effects on existing systems; impacts on partners Comparison of other antigens delivered; some novel deliveries Marginal system and delivery scale up costs

34 Analytic stream WHO factsheets Initial analyses In-depth analyses of shortlisted vaccines Stakeholder consultation stream Phase 1: Input on criteria and project objectives TCG Phase 2: Test and validate conclusions implied by analyses TCG TCG Phase 3: Targeted consultations with Board constituencies WHO landscape of current vaccines & those expected to be licensed by 2019 Narrow against criteria Initial analyses across all criteria Prioritisation by IRC/PPC/Board Refine, expand, more in-depth analyses Recommende d prioritisation Decisions on portfolio priorities or commitments Governance stream IRC /PPC/Board IRC PPC/Board

35 Key timelines Q4 2012: WHO defines disease/vaccines; analysis begins. Q1 2013: Country consultations and continued analysis Q2 2013: IRC review of analysis, PPC guidance; initial Board guidance/decisions Q3 2013: Final analyses; IRC review; PPC guidance Q4 2013: Board decision

36 Consultation at our Partners Forum in Tanzania next week Survey on criteria that GAVI should consider when evaluating potential priorities Can you pre-test? Please participate and give us your feedback! Eliane Furrer

37 What needs to happen after a Board decision SAGE recommendation / WHO position paper on vaccine use, if not yet available Vaccines need WHO pre-qualification Negotiations to secure adequate price, if necessary Development of country application guidelines Opening of GAVI funding window

38 Research and Monitoring

39 Thank you GAVI/2011/Ed Harris

40