GAVI Role in IPV Introductions Melissa Malhame 12 th WHO/UNICEF Consultation with OPV/IPV Manufacturers and National Regulatory Authorities Geneva, Switzerland, 10
GAVI vaccine support Currently supported vaccines: Routine: pentavalent, pneumococcal, rotavirus, human papillomavirus (HPV), yellow fever, measles second dose Campaign: yellow fever, meningococcal A conjugate, measles, rubella Stockpile: meningitis and yellow fever vaccines for outbreak response Prioritised for future support: Japanese encephalitis and typhoid conjugate vaccines
GAVI supports the world s poorest countries Type and value of support, 2000 2012 Source: GAVI Alliance, 2013
How GAVI works
Polio Eradication and Endgame Strategic Plan (2013-2018) Oral polio vaccines (OPV) causing a growing percentage of cases Inactivated polio vaccine (IPV) in routine immunisation could help Prevent polio cases caused by oral polio vaccine Eradication and Endgame Strategic Plan Mitigate against risk of outbreaks Countries prioritised into tiers for introduction Last wild polio case Begin Last phasing OPV2 out use OPV Global certification Certification bopv Stop cessation OPV 2013 2014 2015 2016 2017 2018 2019 Objective 1: Poliovirus Detection and Interruption Objective 2: Routine immunisation, IPV, & OPV phasing out Objective 2: RI Strengthening & OPV Withdrawal Wild poliovirus interruption Strengthen Routine Immunization Address pre-reqs for OPV2 cess. Strengthen routine immunisation Begin phasing in IPV Complete IPV Outbreak response (especially cvdpvs) Complete IPV introduction & OPV 2 withdrawal Prepare to phase out OPV 4 IPV in routine immunisation Phasing out OPV IPV & OPV in Routine immunization
Clear prioritisation of countries for IPV introduction most Tier 1 and Tier 2 are GAVI countries 3. Implementation
GAVI Board Decision June 2013 6
Response to GAVI Board requests Developed long term approach Defined accountability and oversight structures relative to Global Polio Eradication Initiative (GPEI) Initiated country dialogue Inactivated polio vaccine Analysed policy implications of IPV support Developed supply and procurement roadmap Estimated costs (refinements continue) Analysed risks for GAVI s vaccine programmes 7
Aligned coordination and accountability mechanisms GAVI GAVI Alliance Board CEO and GAVI ET Strategic Goal Mgt Groups Leadership alignment GAVI CEO WHO ADG Operational integration IMG Sub-groups: - Communications - Implementation - Financing - Regulatory - Routine immunization GPEI Polio Oversight Board Polio Steering Committee Management Groups Key: Oversight Executive Management Program Management 8
GAVI-GPEI collaboration on IPV introduction processes Joint view: Both organisations working through a single process Coordinated: Aligned work but not joint accountability Topic GAVI Countries Non-GAVI Countries Demand forecasts Joint* Joint Supply Joint Coordinated Procurement Joint Coordinated Regulatory Joint Separate Implementation / TA Joint Coordinated Communications & programmatic reporting Coordinated, often joint Coordinated Financial projections Coordinated Coordinated Financial flow Coordinated Separate Financial reporting Separate Separate * Forecast to date developed to match Endgame timelines
Implementation work stream Lead* : WHO/EPI and GAVI secretariat Objective: Ensure all OPV using countries have access to information, technical and financial support to introduce IPV and switch from topv to bopv. Status: Countries tiered according to level of risk Initial demand forecast developed Readiness assessment (product registration, supply chain, procurement preferences) Policy dialogue with countries (e.g. Regional Committees, Technical Advisory Groups, Key countries) Communication materials Introduction strategies for GAVI and Non GAVI countries *This group operates as a joint subgroup of the IMG and the Vaccine Implementation Management Team, which helps coordinate new vaccine introduction through the GAVI Alliance
Recommended policy exceptions Unique challenges of Endgame Very rapid uptake IPV use time-limited Limited health impact for any single country, BUT broader global benefit Therefore, we recommend exceptions to several GAVI policies Eligibility and Graduation Co-financing Prioritisation 11
GAVI policy exceptions to align with the Endgame Some important recommended policy exceptions to support Endgame plans Eligibility: GAVI 73 countries Application window: Until June 2015 with introduction targeted within 1 year of approval. Window to remain open if need arises Duration of support: Full support until 2024, possible review in 2018 for graduating countries Immunisation cover filter: 70% DTP coverage filter does not apply Co-financing: Exception to co-financing 12
Policies not impacted Country-by-country approach Gender Supply and procurement strategy Performance based financing Self-procurement Donation TAP 13
Supply & Procurement Roadmap In support of the Polio Eradication Endgame Strategy Reviews the market landscape Informs the supply and procurement strategy Defines/prioritizes objectives and desired target outcomes Details a joint stakeholders action plan Close collaboration: GAVI Secretariat, GPEI, WHO, the Bill & Melinda Gates Foundation, UNICEF-SD 14
Initial IPV demand forecast Line: Scenario 1* Bars: Scenario 2* *Scenario 1 = Ideal ; Scenario 2 = Endgame timelines 15
IPV demand forecast Scenarios represent an initial view into demand: Scenario 1*: 523M doses needed by 2018. First intro: Q1/2014 and last intro: Q3/2015 Scenario 2*: 454M doses needed by 2018. First intro: Q3/2014 and last intro: Q4/2015 Forecasts generated through global-level discussions with partners and preliminary discussions with some large countries; Dose calculated based on assumption that coverage will match DTP3 within 12 months after introduction, except for large countries where introduction spans over two years 16
Supply is expected to meet demand in almost all scenarios Global bulk capacity grows from 220 million doses in 2013 to 300-400 million in 2016 and to 300-600 million in 2018 Current IPV vaccines: 4 prequalified IPV Salk: SP, GSK, SII/Bbio, SSI and 2 locally registered IPV Salk in India: Panacea, BioE One manufacturer is expected to represent over 80% of capacity available to GAVI73 during the initial uptake period 2014-2016 and 50% of world bulk capacity 2014-24 New IPV vaccines will enter the market 2014-2020 but the major capacity increase is expected from manufacturers with currently available pre-qualified vaccines Future developments & new entrants Full-dose Salk IPV One new entrant expected in the longer-term Full-dose Sabin IPV Future Sabin-based IPV local vaccine manufacturers are expected to satisfy local demand in China (in the near-term) and Indonesia (in the medium-term) Dose-sparing IPV ID data for two currently available IPV Salk vaccines expected to be available 2014/15 Adjuvanted dose-sparing new vaccines may become available from 2017 and may moderately increase global supply capacity by 10 to 20% wp-hexavalents One or two wp-hexavalent vaccines may become available between 2018 and 2024 Hexavalent: GAVI support would require a new decision by the GAVI Alliance s Board 17
Roles in procurement processes GAVI Countries (Joint) Donors Non-GAVI Countries (Coordinated) Donors GAVI UNICEF UNICEF SD/PAHO UNICEF SD or PAHO - for IPV procurement (then onto IPV suppliers) Countries if procure directly per GAVI policy IPV suppliers for procurement through UNICEF SD/PAHO Countries for those that procure directly* *Final funding flows for directly (self) procuring countries, if applicable, to be determined 18
Risk & mitigation Unclear country demand Country dialogue beginning IPV impact on other vaccine programmes County by country analysis & strategies GAVI s systems delay introduction Tailor systems to IPV Perceptions of polio campaigns Support IPV in routine immunisation 19
Country-by-country analyses of the impact of IPV introduction Forecasted acceleration from approximately 10 vaccine introductions per year from 2000-2012: 47 introductions in 2013 79 in 2014 (14% IPV) 123 in 2015 (43% IPV) Number of forecasted vaccine introductions in a year Number of countries (2014) Number of countries (2015) 1 25 30 2 16 25 3 6 13 4 1 1 20
GAVI-supported vaccine introductions and campaigns, 2012 Source: GAVI Alliance, 2012
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