UNICEF/UN074388/LeMoyne MARKET UPDATE: ROUTINE VACCINE INTRODUCTIONS PCV HPV ROTA Vaccine Industry Consultation October 2018
Pneumococcal Conjugate Vaccine (PCV)
Background The AMC initiative has opened access to PCV in low and lowermiddle income countries, with 80% of countries introduced. Vaccinated, 64.1 million, 47% Unvaccinated, 71.2 million, 53% There remains a gap, over half of global surviving infants are unvaccinated with PCV. In support of UNICEF Strategic Plan goal that every child survives and thrives, UNICEF mandate and focus over the next period is to ensure every child has access to immunization regardless of geography and income. Key areas of focus over the next strategic period include: Availability of supply at affordable prices for MICs (e.g. PCV introductions in MICs to bridge the gap in PCV access). Source: IVAC 2018
PCV 10 PCV 13 Gavi-73, PCV market evolution 280 240 AMC-4, 9.5% AMC -Fund allocation Balance, 17.5% AMC-1, 30.0% AMC eligible countries need to apply for PCV intro. before 2020 200 AMC-3, 25.0% AMC-2, 18.0% 160 120 80 Introduced Pending Introduction The 59 th country introduction is expected in Q4 2018 40 Shortest period from pdt development to intro in LICs 0 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 Gavi-73 demand New Introduction AMC annual demand target Contracted Vol (2010-2017) Contracted Vol (2018-2027)
MICs introduction Gap and Interventions Percentage of countries with PCV immunization schedule Gavi post-2020 Strategy support to MICs in accelerating their vaccine agenda Market intelligence Demand generation through multi-year commitment Source: GVAP 2017 annual report There remains a gap in PCV introductions comparing with Gavi supported countries to the self-financing MICs, where approximately 45% have PCV. This gap in access to these life saving vaccines has implications on UNICEF s goal of ensuring every child survives and thrives. New PCV introductions is an outcome indicator for UNICEF s strategic period (2018-2021). VPPEF Exploring all contractual modalities with flexibility to improve and unlock affordable PCV access in MICs New financing mechanisms and expanding existing platforms to support countries overcome fiscal challenges to improve access to new vaccines
Summary and Next steps UNICEF and Gavi will continue to support Gavi eligible countries that are pending introductions to overcome the bottlenecks, including improving coverage UNICEF continues to assess contracting options and way forward for MICs, including engaging with suppliers UNICEF calls on industry to be responsive, supportive and continue collaboration to increase PCV introductions Milestones Timeline Continued dialogue on developing options for contracting for MICs 2018 /2019 AMC 5 Call for supply offers? 2019/2020 Non-AMC Tender (for Gavi countries) 2020 Market Note Q4 2018
Human Papillomavirus Vaccine (HPV)
Background HPV Global Introduction Status 2018 18 countries and 3 territories have genderneutral vaccinations schedules. Source: PATH August 2018 No decision 71 countries 36% Planning Introduction by end of 2021 34 countries 18% Introduced into National Program 90 countries 46% Initiatives that will impact global demand: WHO Cervical Cancer elimination goal Adoption of gender-neutral vaccination by High Income Countries (HICs) UNICEF Strategic Plan Young People s Agenda 24 countries have introduced HPV vaccines into their national immunization programme by 2021
Doses in Millions Market Update 40.0 35.0 30.0 25.0 20.0 Demo: 23 countries National: 3 countries 14 Gavi countries approved for routine and multi-age cohorts vaccination 15.0 10.0 5.0 Gavi opened funding window for HPV vaccine Tender launched LTAs for Gavi countries established WHO recommended 2-dose schedule Redesign of HPV programme approved by Gavi Board LTA established covering demand of 1 MIC Supply insufficient to meet demand in the short to medium term 0.0 2011 2012 2013 2014 2015 2016 2017 2018 GAVI funded Country Co-financing Procurement Services Projection RFP Forecast
Doses in Millions Doses in Thousands Demand Forecast 60 50 Gavi Market Shortfall in supply for Gavi-supported countries 450 400 350 MICs Market (Through UNICEF, currently) 40 300 250 30 200 20 150 100 10 50 0 2019 2020 2021 2022 2023 0 2019 2020 2021 2022 Total Supply Total for Routine Immunization Total Demand Total for Multi-age Cohorts Total for Routine Total for Multi-age Cohorts Available Supply
Challenges and Way Forward
Summary and next steps HPV vaccination is a key priority in elimination of cervical cancer Demand certainty for Gavi countries has improved with redesign of program and country approvals. Supply is constrained in the short to medium term; working with industry and partners to improve supply availability. Long-term demand forecast visibility for MICs, including pooling of demand by 2019. UNICEF is exploring options for securing sufficient supply of HPV vaccines for 2020 and beyond.
Rotavirus Vaccine (Rota)
Background UNICEF presently procures on behalf of 40 Gavi-supported countries and for 2 self-financing MICs (Kiribati & State of Palestine) UNICEF has 3 LTAs for 3 WHO PQ vaccines valid for 2017-2021. RV coverage across Gavi is 28% as per WUENIC 2017 Manufacturer Vaccine Price per course Duration Schedule Cold chain/cm3 Storage Bharat Biotech (India) RV1-5 dose USD 2.85 * 3 years 3-doses 12.6-20C GlaxoSmithKline (Belgium) RV1-1dose EUR 3.76 5 years 2 doses 34.2 2-8C Merck (USA) RV5-1dose USD 9.6 5 years 3 doses 138.9 2-8C SII (India) RV5-1& 2 dose WHO PQ in Sep. 2018** 3 doses 32 & 53 2-8C * Price valid for Gov. of India only ** No award currently
Courses in millions Price per course in USD Historical procurement of Rota Vaccine through UNICEF RV has experienced rapid introduction in Gavi supported countries There was substantial decrease in overall WAP after innovative contracting mechanisms in 2012 Market imbalance, insufficient supply and technical manufacturing issues limiting introductions in larger countries. Lack of RV interchangeability has limited ability to supply alternatives 50 45 40 35 30 11.25 VVM Issue 12 Bharat & SII PQ 10 2 8 25 6 20 15 4 10 5 2-0 2011 2012 2013 2014 2015 2016 2017 2018 (as of August) RV5 Procured RV1 1 dose Procured RV1 5 dose Procured Demand Forecast 2012 Intial RV Forecast RV Supply Overall WAP
Projected Supply vs Demand Increase in supply from additional WHO prequalified products may allow further introductions Market imbalance and growth in global demand may create supply constraints: supply of RV5 beyond mid-2019 is unknown and countries are expected to switch to alternative products We will be encouraging increased diversification of supply, and RV interchangeability may additionally open up future opportunities +2 WHO PQ products coincides with national scale up in India Innovative RVs that are projected to ease supply constraints are expected ~ 2022/3
Planned introductions & product switches Due to supply constraints, 4 countries are switching products and there is delay in country introductions in 2018/2019 Partners are supporting countries to review alternative RV products Cost Effectiveness studies are on-going in over 21 MICs in Euro and in Asia, to inform introductions Introduced Gavi- Approved but not yet introduced Recommended for Gavi approval Forecasted Planned introductions prior to supply constraints India (1 +1* states) Benin Nepal *PICs *Bhutan Switch by 4 Gavi supported countries Note*: Bold = Gavi countries in late transition. *Self-financing PICs- Pacific Island Countries DRC CAR *Kiribati India (5 states*) Bangladesh Nigeria *SOP Lesotho Uganda Lao PDR India (4 states*) Cote d Ivoire Afghanistan Solomon Islands 34 Gavi supported countries 1 Gavi supported country Pakistan (6 districts*) Pakistan (national) Kyrgyzstan Myanmar 2 Gavi supported countries < = 2016 2017 2018 2019 2020 2021
Lessons learnt There has been mismatch between timing of demand and supply due to delayed introductions and low RV program uptake leading to challenges in contract management/ unutilised doses Rota coverage against DTP3 denotes room for improvement Rota working group expanded to include microplanning to support timely introduction & improve coverage (UNICEF PD, WHO, Gavi, RAVIN ) There is effort to match demand and supply: use of quarterly and ad hoc stock-take in countries to inform supply planning & replenishment, use of VIVA & SMT Scaling up rota production is challenging. Close collaboration with manufacturers to match program uptake and timing of supply is key. Legend: RotaC coverage rates in 2016 90% 80% 70% 60% 50% <50% Box indicates that country introduced in 2015 or later
Summary and next steps UNICEF and partners Additional awards to be made by UNICEF to support switches and country introductions- as demand materialize WHO is reviewing available data on interchangeability and will work with UNICEF to diversify supply Improve coverage Programmatic testing and country specific wastage rates required Issue Rota specific MICs solicitation during 2019 informed by on-going Cost Effectiveness studies, Market update, New tender for Gavi market in 2021 Industry Ask Additional supply required from existing and new manufacturers Interchangeability studies required for all products Review of product inserts with age restrictions impacting coverage Suitable products including acceleration of 2 nd generation products & presentations Affordable pricing to accelerate RV introduction in MICs
UNICEF/SUDA2014-XX228/Noorani Thank You UNICEF for every child