DRAFT FOR DISCUSSION Pneumococcal Vaccine SDF AVI version 3.0 Lauren Franzel AVI Strategic Vaccine Supply Sub Team March 10, 2011
Pneumococcal Vaccine SDF version 3.0 Executive summary No financial or supply constraints Policy revisions and changes in country adoption decisions result in 54 introductions by 2015, all but 1 expected applying in 2011-2012 Up to 20 NVS applications for PCV expected in May 2011, 26 including the 5 conditionally approved and 1 resubmission AMC demand exceeds 134m doses in 2016 per SDF v3.0 base case scenario 15-Mar-11 2 AVI Pneumococcal SDF version 3.0
Graduating countries and % NVS threshold represent important demand opportunities Evolution of Pneumo SDF from ADIP to V3 (2009-2030) Detail 2009-2016 15-Mar-11 AVI Pneumococcal SDF version 3.0 3
Since AVI in place very limited changes in countries interest in PCV 15-Mar-11 AVI Pneumococcal SDF version 3.0 4
Forecasting process designed to ensure multiple input and verification points Feedback Assumption owners provide input SVS benchmarks assumption GAVI PD confirms input into AF SVS runs SDF and AF Feedback SVS Sub team & GAVI Focal Point review draft SDF and AF SVS incorporates feedback from subteam AVI AMT / GAVI reviews and endorses SDF & AF Feedback SVS incorporates feedback from AMT/GAVI Feedback Director of AVI Approves SDF & AF and submits to GAVI F&O GAVI Finance develops financial forecasts GAVI Forecast Review Board convenes Expenditure Review Board Approves Forecasts 15-Mar-11 AVI Pneumococcal SDF version 3.0 5
SDF version 3.0 base case assumptions (1/3) Finance & support* No global financial and supply constraints included into the base case strategic demand forecast; GAVI support based on revised eligibility approved by November 2009 Board and pilot prioritization policy approved by June 2010 Board Applications round to re-start as per May 2011 with graduating countries grandfathered for the first round and NVS threshold at % DTP3 NVS applications evaluated on national metrics (no separate state / sub-national applications) After graduation from GAVI support countries assumed to be in condition to fully finance purchase of PCV Co-financing policy revision (December 2010) fully incorporated, effective from 2012 GNI projections based on 2009 IRBD actual and CGD projections PAHO single price clause not impacting negatively manufacturers intention to supply Target Population Surviving Infants based on 2008 UN population prospect, medium variant for population, birth & infant mortality rates India population at state level based on Indian census (projected with UN growth rate) 15-Mar-11 AVI Pneumococcal SDF version 3.0 6
SDF version 3.0 base case assumptions (2/3) Products Logistics All products WHO pre-qualified, meet or exceed AMC profile and have suitable presentation Mix of international and developing countries suppliers ensures no capacity constraint: Synflorix available since end Q1 2010 1, Phase IV study in Kenya and Ethiopia assumed successful, Prevnar13 available since Q3 2010 2 First DCMVN products to be available by 2016 3 and acceptable from countries with their serotype coverage India preference for introduction with local manufacturer can be derogated in the first years Schedule = 6, 10 and 14 weeks of age with DTP or Pentavalent / No Booster some countries as India may consider different schedule Presentation = 1-dose and 2-dose liquid vials (future DCVMN manufacturers may provide higher number of doses per vial) Supply availability sufficient assuming successful call-for-offer in 2011 Wastage = 10% based on WHO guidance (to reflect an unknown mix of presentations ranging from 1 to >2 doses per vial) for countries introducing Prevnar13 5% wastage assumed Buffer stocks = 25% of between forecast years Cold chain up scaling and financing available at central & local level in all countries 1 Synflorix: PQ subject to special conditions accompanying 2 dose vial presentation in March 2010; Kenya and other special cases only for post-introduction surveillance of 2-dose vial presentation 2 Prevnar13: WHO PQ in August 2010, first shipments commenced in Q4 2010 3 Based on standard development timelines (see backup) of 5 years from phase 1 to pre-registration 15-Mar-11 7 AVI Pneumococcal SDF version 3.0
SDF version 3.0 base case assumptions (3/3) Introduction Uptake Introduction timing as per WHO Regional calls and other input received from WHO and UNICEF; introductions separated by 24 months unless documented input Applying countries are assumed to introduce the year following application in absence of national cold chain or other infrastructure limitations Delay applied if countries required multiple applications for GAVI support for other vaccines Countries applying for 2 vaccines are assumed to introduce within of 2 years of approval as not to lose GAVI support Twelve months average preparation time required after Board/EC approval (based on Penta analogue) preparation time required is expected to decrease to 11 months in 2012 and to 10 months from 2013 onwards. India phased introduction financed locally beyond GAVI cap 11 states (same 10 states Introducing Penta + Orissa pilot) to introduce in 2016, remaining states after 2 yrs; graduation as country in 2020 Chad and Somalia cannot apply for NVS because of low DTP coverage Ethiopia to introduce Q3 2011; Pakistan introduce in Q4 2011 Nigeria to introduce in 2014 after taking advantage of % DTP3 NVS threshold for Penta and Pneumo Indonesia loses eligibility in 2011 and is not expected to apply before graduating; locally financed introduction from 2018 Time to match reference coverage aligned with HepB/Penta analogue (Pneumo introduced with same schedule as Penta): 24 months for small countries / 36 for medium/large countries (>1 mln SI) / 48 months for very large countries (>3.5 mln SI) Coverage Reference coverage: DTP2 linear extrapolation based on DTP3/1 WHO/UNICEF 2010 estimates; 15-Mar-11 Nigeria assumption for reference coverage is 63% in 2010 8 Projected coverage: based AVI on Pneumococcal standard AVI coverage SDF version projections 3.0 rules
Millions of Doses Demand from GAVI 72 to peak at 207m doses in 2021 2 AVI SDF v3.0 BASE CASE - Total required supply from GAVI 72 including graduating countries 200 1 100 Call for offer reference year 71 96 112 134 2 16 151 21 26 184 5 7 47 198 205 207 206 207 207 207 207 206 206 205 205 11 12 14 13 13 13 13 13 13 13 13 13 5 8 8 21 26 29 30 31 48 48 57 61 61 60 59 59 58 57 56 55 54 54 112 116 122 125 125 124 124 40 112 108 96 107 105 106 89 90 88 88 71 14 1 1 40 14 1 1 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 2028 2029 2030 Eligible India India graduated* Other countries graduated* Graduating before introduction AVI SDF v2.0 2009 2010 2011 2012 2013 2014 2015 2009-2015 Introductions 2 1 15 12 18 4 2 54 Countries that introduced prior to graduation assumed to continue purchasing vaccines with their own funds when commitment ends AVI Pneumococcal SDF version 3.0 15-Mar-11 9
Millions From 2019, 4 large countries constitute almost % of demand Pneumococcal Vaccine - AMC Required Supply (72 GAVI eligible countries) by large country 200 1 100 71 96 14 2-112 15 7-134 15 10 16 151 15 12 26 184 15 13 5 47 205 207 206 207 207 207 207 206 206 205 205 198 15 15 15 15 15 15 15 15 15 15 15 15 13 13 13 13 13 14 14 14 14 14 15 13 9 11 11 11 11 11 11 11 11 8 11 11 57 61 61 60 59 59 58 57 56 55 54 54-11 - 87 91 96 102 104 105 105 106 106 107 107 108 108 108 108 108 40 77 7-57 14 2-30 1 1 12 1-1 - 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 2028 2029 2030 Other Countries India Indonesia Nigeria Pakistan PAHO 15-Mar-11 AVI Pneumococcal SDF version 3.0 10
Millions of doses Importance of large countries can be seen now 140 120 100 80 60 40 20 0 Pneumo Strategic Demand Forecast Detail 2011-2016 54 55 52 134 48 10 112 10 96 11 7 15 30 9 2 15 8 71 14 9 11 9 8 8 18 40 7 8 78 7 5 58 6 14 36 31 2 20 8 2011 2012 2013 2014 2015 2016 40 30 20 10 0 All other countries DRC Ethiopia Pakistan Afghanistan Nigeria Bangladesh Total Introduce Countries (cumulative) 15-Mar-11 11 AVI Pneumococcal SDF version 3.0
Doses (Millions) GAVI commitments > SDF because of time to peak, coverage, and target population assumptions 200 1 AVI Version 3.0 Adjusted Demand vs. Strategic Demand Forecast GAVI-Eligible Supply Only 210 200 176 160 140 123 Drop in GAVI required supply due to India graduation 151 100 96 60 46 200 210 75 172 183 25 176 160 5 148 132 20 27 124 112 32 96 68 70 71 32 40 44 14 9 10 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 151 SDF - GAVI required supply Commitments Extensions New Requests Balance of Demand Adjusted GAVI demand Demand for approved countries based on GAVI commitments matching applications requested volumes Commitments cover only limited number of years (depending on cmyp), for outer years projections based on yearly growth rate from SDF applied to latest available committed volumes Year 1 of commitment assumed including 25% buffer stock. Projections for countries with only one year of demand based on year 1 values w/o buffer stocks and steady state growth rate. If a country has no approved supply, SVS SDF v3.0 forecast is used 15-Mar-11 12 AVI Pneumococcal SDF version 3.0
Millions of Doses If countries are able to reach reference coverage in year 1, reference year demand grows by 13% 2 AVI SDF v3.0 1 YEAR UPTAKE - Total required supply from GAVI 72 including graduating countries 200 1 100 Call for offer reference year 93 111 120 154 159 2 4 28 35 21 19 21 21 71 62 62 61 216 207 206 207 206 208 207 207 207 206 206 205 205 34 40 42 44 44 60 59 59 58 57 61 61 63 63 56 55 54 54 64 111 120 117 127 124 126 124 124 112 109 107 105 106 93 30 89 90 88 88 64 1 30 1 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 2028 2029 2030 Eligible India India graduated* Other countries graduated* AVI SDF v3.0 - BASE CASE 15-Mar-11 13 AVI Pneumococcal SDF version 3.0
Millions of Doses If cold chain and past application success delays are removed, demand materializes earlier 2 AVI SDF v3.0 AGGRESSIVE - Total required supply from GAVI 72 including graduating countries 200 1 100 83 102 115 134 2 16 151 5 26 184 12 47 198 205 207 206 207 207 206 206 205 205 205 204 16 20 22 34 39 41 43 43 60 60 62 62 57 61 61 60 59 59 58 57 56 55 54 54 49 102 115 116 120 125 125 124 124 112 108 107 105 106 83 89 90 88 89 15 49 1 15 1 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 2028 2029 2030 Eligible India India graduated* Other countries graduated* AVI SDF v3.0 - BASE CASE 2009 2010 2011 2012 2013 2014 2015 2009-2015 Introductions (BASE CASE) 2 1 15 12 18 4 2 54 Introductions (AGGRESIVE CASE) 2 1 15 26 6 4 0 54 15-Mar-11 14 AVI Pneumococcal SDF version 3.0
Millions of Doses Aggressive scenario and 1 year uptake assumption yield peak of 216 in 2018 for GAVI 72 2 AVI SDF v3.0 AGGRESSIVE & 1 YEAR UPTAKE - Total required supply from GAVI 72 including graduating countries 200 21 19 21 21 216 207 206 207 206 207 206 206 206 205 205 205 204 34 39 41 43 43 1 120 118 157 159 2 6 35 28 71 62 61 61 60 59 59 58 57 60 60 62 62 100 97 102 56 55 54 54 58 97 102 120 118 119 124 124 126 124 124 112 109 107 105 106 89 90 88 89 58 1 1 1 1 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 2028 2029 2030 Eligible India India graduated* Other countries graduated* AVI SDF v3.0 - BASE CASE Countries that introduced prior to graduation assumed to continue purchasing vaccines with their own funds when commitment ends AVI Pneumococcal SDF version 3.0 15-Mar-11 15
Thank you Courtesy of PATH 15-Mar-11 AVI Pneumococcal SDF version 3.0 16