HPV Update Aurelia Nguyen Lauren Franzel (Copenhagen, Denmark, 27 June 2012)
Background Vaccine Investment Strategy June: Board agrees to use reduced overall disease burden as portfolio objective 2007 2008 2009 2010 2011 2012 November: Board recognizes need for comprehensive vaccine investment strategy October: Board endorses the portfolio: HPV, Japanese encephalitis, rubella and typhoid November, GAVI Board opened funding window for HPV country proposals provided: Acceptable price for vaccine Countries have demonstrated ability to deliver vaccine Board also requested to develop HPV demonstration projects
Two Pathways for HPV vaccine intro Country applications Country applications Not approved Natnl Intro (Pathway 1) Demonstrated ability needed Demo Program (Pathway 2) Not approved Approved Approved National Intro Scale-up Go/No- Go? Go No Go Not Ready Applications from another pathway
Introduction timeline NVS window opens Deadline for country applications IRC review National Applications Countries approved for national intro Vaccine introduction Nationally Jun 12 Sep 12 Dec 12 2013 Jun 14 2015 HPV Demo Programme Windows opens Q3 tbd Country approved for demo projects Vaccine intro in demo area Ntnl intro Application opens Vaccine introduced Nationally Countries with demonstrated ability Countries without demonstrated ability
HPV National Introduction
Why GAVI opened a funding window : Status of vaccine introduction worldwide Status as of April 2012 National HPV Programs GAVI eligible countries Source: Courtesy of Progress in Cervical Cancer Prevention: The CCA Report Card, August 2011
Application Requirements for National Intro Demonstrate to have a DTP3 coverage of at least 70%. Identify a single year target vaccination cohort within the target population of 9-13 year old girls. Have demonstrated ability to deliver a complete multi-dose series of vaccines to at least 50% of the target vaccination cohort in an average size district (preferably comprising urban and rural areas) using a strategy similar to the one proposed for national HPV vaccine delivery. Provide a report on the costing analysis of the proposed delivery strategy. GAVI will not provide financial support for recurrent operational costs. HPV operational costs relatively high. Clarify plans for communication and social mobilisation reflecting unique needs of the programme. If possible, national roadmap or strategy for establishing or strengthening a national comprehensive approach to cervical cancer prevention and control.
Overview of HPV Strategic Demand Forecast v5.1 No supply or financial constraints assumed 40 GAVI supported introductions by 2020 Up to 21 countries are forecasted to run demonstration projects with GAVI support by 2015; up to 36 for 2020 GAVI supported demand to peak at 41m in 2026 Up to 32m girls immunized with HPV vaccines by 2020 with GAVI support
SDF version 5.1 base-case assumptions (1/2) Finance and support Target population No global financial or supply constraints included in the base-case strategic demand forecast. NVS applications evaluated on national metrics (no separate state / subnational applications). Co-financing policy revision (December 2010) fully incorporated. Eligibility for GAVI support based on GNI projections from 2010 World Bank actuals and GDP per capita growth rate (2011-2015, IMF). Girls aged 10 years, based on 2010 UN population prospect, medium variant. India population at state level based on 2011 Indian census (projected with UN growth rate). Introduction Introduction timing as per HPV sub-team inputs received in June 2012 Countries that have experience demonstration project assumed to be early adopters for HPV vaccination. From 2009 to 2011, both Gardasil and Cervarix have been used in pilot projects via donation in a number of countries.
SDF version 5.1 base-case assumptions (2/2) Products Coverage Uptake Logistics All products WHO pre-qualified and with suitable presentation. Mix of international and developing countries suppliers: Cervarix from GSK and Gardasil from Merck currently available; new vaccines from developing countries expected. Schedule = 3 doses at 10 years of age (female only) with no booster. Presentation = 1- and 2-dose liquid vials. Reference coverage: linear extrapolation of DTP2 from WHO/UNICEF estimate of DTP3/1 projected based on standard AVI WHO coverage forecasting rules. Girls enrolled in school to reach reference coverage. Girls not enrolled in school to reach 70% of reference coverage in BASE CASE SCENARIO Coverage: (Girls in school)*(ref. coverage) + (Girls out of school)*(ref. coverage)*0.7 Time to match reference coverage slower than HepB/penta analog (new vaccine with no overlap): 36 months for small countries / 48 for medium or large countries / 60 months for very large countries. Wastage = mixture of 5% and 10% based on product presentation, 1- and 2-dose vials. Buffer stocks = 25% of demand increase. Cold chain up-scaling and ongoing financing available at central and local levels in all countries. Scenario(s) Country request scenario assumes immediate uptake and uses DTP1 as analogue High scenario assumes acceleration of 1 year among early adopters (depending on experience with demonstration projects) and 2 years acceleration among medium and late adopters Low scenario applies 2 year delay across all countries that have not yet introduced HPV vaccines 10
40 GAVI supported introductions by 2020 1 2014 Rwanda Uganda* 2015 Kenya Kyrgyzstan Madagascar Mozambique Nicaragua Sao Tome e Principe Zambia* 2013-2015 2016 2017 2018 2019 2020 Total 2013-20 9 12 5 1 4 9 40 Forecast v5.1 6 7 6 4 5 5 33 Forecast v5.0 9 7 6 7 4 7 40 Forecast v4.0 * = Country with DTP issue = Country with qualified pilot project = Country with on-going pilot project 2 0 3 7 6 13 31 AVI Baseline v1.1 1 For countries that have introduced via donated product, introduction date indicates projected year of GAVI supported program 11
Million doses HPV demand from GAVI-eligible countries to peak at 41m doses in 2026 70% reach of out of school girls 70 AVI SDF v5.1: Total GAVI supply 60 50 40 30 20 10 1 3 1 2 9 3 17 4 22 5 29 6 6 7 6 6 6 8 8 8 9 8 9 9 35 32 35 36 36 39 41 11 12 13 12 18 19 19 19 33 34 34 35 Eligible Graduating before introduction AVI SDF v5.1 Low Other countries graduated AVI SDF v5.1 High AVI SDF v5.1 Country request assumptions 2013-2015 2016 2017 2018 2019 2020 Total 2013-20 9 12 5 1 4 9 40 Forecast v5.1
Immunized 10y old girls (Millions) Over 32m 10-yr-old girls to be vaccinated by 2020 with GAVI support 70% reach of out of school girls 25 HPV immunized 10y old girls 20 15 10 5 0 1 0 0 0 0 1 0 19 20 19 18 17 16 14 15 14 5 4 8 8 9 9 13 11 3 4 3 1 3 9 7 1 5 1 10 10 10 11 11 12 12 1 10 10 10 11 3 8 6 1 5 2 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 2028 2029 2030 Routine Immunized Girls (GAVI supported) Routine Immunized Girls (non GAVI supported) AVI SDF v5.1 High AVI SDF v5.1 Low AVI SDF v5.1 IRC assumptions
58% HPV coverage in GAVI73 by 2030 70% reach of out of school girls 60% 50% 40% 30% 24% Average coverage over time 45% 45% 43% 40% 37% 12% 12% 13% 6% 11% 30% 5% 57% 58% 56% 55% 52% 49% 14% 16% 25% 26% 27% 28% 20% 10% 0% 3% 0% 1% 1% 0% 0% 1% 2% 9% 2% 8% 17% 3% 14% 4% 20% 26% 31% 29% 31% 33% 33% 35% 36% 29% 30% 30% 30% 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 2028 2029 2030 Coverage (GAVI supported) Coverage (non GAVI supported) Coverage (GAVI73) AVI SDF v5.1 High Coverage (GAVI73) AVI SDF v5.1 Low Coverage (GAVI73) AVI SDF v5.1 IRC assumptions
HPV Demonstration Programme
GAVI eligible countries and experience with HPV vaccine with existing or past experience with HPV vaccine no past experience with HPV vaccine Source: Courtesy of PATH preliminary assessment of country readiness
General Framework At least one district (equivalent to an EPI administrative unit), with maximum of 15,000 eligible girls (tbc). A single year of age or a single school grade (with provisions for reaching out-of-school girls of similar age) cohort within the target population of 9-13 year old girls. Multi-disciplinary technical advisory group (leverage existing TAG, ICC, NiTAG, if applicable). Two year programme. Planning Vaccine Introduction Evaluation Testing of integrated adolescent health package Year 1: Demo project implementation Year 2: Bridging
Demonstration projects would take place two years before routine introduction in a small population Project details Target population Coverage Vaccine Start 2 years before routine introduction 2 years duration Average % of 10y old girls from previous successful demonstration projects (Merck, PATH) ~1-3%, which corresponds to one district 1,000 27,000 girls per country Reference coverage: linear extrapolation of DTP2 from WHO/UNICEF estimate of DTP3/1 projected based on standard AVI WHO coverage forecasting rules. Girls enrolled in school to reach reference coverage. Girls not enrolled in school to reach 70% of reference coverage. Coverage: (Girls in school)*(ref. coverage) + (Girls out of school)*(ref. coverage)*0.7 Schedule = 3 doses at 10 years of age (female only) with no booster. Presentation = 1- and 2-dose liquid vials Wastage = 5% and 10% based on product presentation. Buffer stocks = none
Up to 21 countries are forecasted to run demonstration projects with GAVI support by 2015; 36 for 2020 2013 Kyrgyzstan Madagascar Nicaragua Sao Tome e Principe Timor Leste 2014 Benin Burundi Cameroon Cote d'ivoire Ethiopia Gambia Malawi Nigeria PNG Senegal Uzbekistan Zimbabwe 2015 Bangladesh Central African Republic Comoros Togo 2013 2014 2015 2016 2017 2018 Total 2013-20 5 12(8) 4 1(0) 5 9 36 (31) Total 2013-2015 21(17) Country with some HPV experience
Doses (Thousands) Demand for demonstration projects to peak at 225k doses in 2015, reaching over 800K during period 250 DEMONSTRATION PROGRAMS: HPV demand (2012-2020) 200 150 100 50 0 2013 2014 2015 2016 2017 2018 Total 2013-20 5 12 (8) 4 1 (0) 5 9 36 (31)