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Immunization Systems Management Group (IMG)

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  1. Polio Eradication & Endgame Strategic PlanPlanning for the introduction of the Inactivated Polio Vaccine (IPV) Immunization Systems Management Group (IMG) December 4, 2013 Webinar

  2. Presenters of the Webinar IPV introduction

  3. Objectives • Overview of GPEI: The Polio Eradication & Endgame Strategic Plan • Review Objective 2 of The Plan: introduction of IPV and withdrawal of OPV • SAGE recommendation • Policies and Partners Activities for IPV introduction • Immunization Systems Management Group (IMG) • Financing IPV • Supply & Price • Country readiness • GAVI Policies and Processes • Communication & Advocacy Strategy IPV introduction

  4. Significant Decline in Polio-paralyzed Children, 1988-2013* Last case of Wild Type 2 polio *as of 5 November 2013 IPV introduction

  5. Circulating vaccine-derived poliovirus outbreaks (cVDPVs), 2000-2013 Type 1 (79 cases) Type 2 (478 cases) Type 3 (9 cases) Type 1 Type 2 Type 3

  6. The Polio Eradication & Endgame Strategic Plan 2013-2018 The Plan differs from previous eradication plans “complete the eradication and containment of all wild, vaccine-related, andSabin poliovirusessuch that no child ever again suffers paralytic poliomyelitis.” IPV introduction

  7. The Plan has Four Objectives • 1 • Detect and interrupt all poliovirus transmission • 2 • Strengthen immunization systems and withdraw oral polio vaccines • 3 • Contain poliovirus and certify interruption of transmission • 4 • Plan polio’s legacy IPV introduction

  8. Objective 2 of The Plan addresses the Endgame • Introduce at least one dose of IPV • Withdrawal OPV in phases • Into routine immunization schedule • Prior to OPV withdrawal • Strengthen routine immunization systems • Phase 1: remove type 2 component of OPV Switch from trivalent OPV (tOPV) to bivalent OPV (bOPV) • Phase 2: withdraw bOPV IPV introduction

  9. Why withdraw OPV? ? A hypothetical scenario of estimated VAPP/cVDPV cases As wild polioviruses are eradicated, number of cases related to polio vaccine (VAPP plus cVDPVs) exceeds number of cases related to wild poliovirus (as of 5 Nov. 2013) IPV introduction

  10. Rationale for introducing at least one dose of IPVprior to the tOPV-bOPV switch IPV • Reduce risks associated with OPV2 cessation • Lower risk of re-emergence of type 2 polioviruses • Facilitate interruption of transmission with the use of monovalent OPV2 if type 2 outbreaks occur • Boost immunity against types 1 & 3 thus hastening polio eradication IPV introduction

  11. Timeline for implementation of Objective 2 Last wild polio case tOPV-bOPV switch Global certification Stop bOPV Anticipated timeline 2013 2014 2015 2016 2017 2018 2019-2020 Phase in IPV IPV in routine immunization • By end-2015: introduce one dose of IPV in immunization programs of all countries, prior to tOPV-bOPV switch • 2016:tOPV-bOPV switch globally • 2019-2020: withdrawal of bOPVafter the world is certified polio-free by 2018 IPV introduction

  12. Planned use of IPV: SAGE Recommendations • Single dose of IPV at 14 weeks of agewith DTP3, in addition to OPV3 or OPV4. • Countries have flexibility to consider alternative schedules • All endemic and other high risk countries should develop a plan for IPV introduction by mid-2014 and all OPV-only using countries by end-2014 Summary of SAGE Meeting at http://www.who.int/immunization/sage/report_summary_november_2013/en/index.html IPV introduction

  13. Policy Aspects Related to IPV Partners’ Activities to Achieve Objective 2 IPV introduction

  14. All countries should introduce IPV by end 2015 • Criteria established to identify countries at highest risk following OPV type 2 withdrawal • cVDPV2 outbreak • Importations • Countries divided into ‘Tiers’ by risk level A word of caution: • Tiering of countries is not an ‘introduction schedule’ or ‘introduction prioritization list’. • The tiering reflects the level of risk faced by the countries if IPV is not introduced prior to OPV type 2 withdrawal IPV introduction

  15. Tiers groups countries according to the level of risk of cVDPV2 outbreak following OPV type 2 withdrawal IPV introduction

  16. OPV-only using countries: Tiers 100% % of birth cohort 38% 83% 61% 72% 24% India China Tier 1 Tier 2 Tier 3 Tier 4 19 countries 14 countries 77 countries 12 countries # of countries IPV introduction

  17. GPEI Oversight & Management • Management & Coordination of partners’ activities to achieve Objective 2 • WHO*, UNICEF*, CDC, BMGF, Rotary and GAVI • * Co-chairs IPV introduction

  18. Policy Aspects Related to IPV Formulation, Demand Forecast, Supply, Price IPV introduction

  19. IPV Presentations and Formulations • Stand-alone IPV • Only WHO prequalified formulation • 1-dose, 2-dose, and 10-dose available now • 5-dose expected in 2014 • Preservative : 2PE does not allow for Multi dose vial Policy application • Combination product • Combination with whole-cell pertussis not currently available • Tetravalent, pentavalent, hexavalent available • Substantially higher cost than stand-alone IPV IPV introduction

  20. Vaccine Demand Forecast & Supply • GPEI has ensured sufficient production capacity for current IPV stand-alone products to meet the needs of all OPV using countries to introduce one dose of IPV into their routine immunization programme • Initial global demand forecast: 580-624 million doses needed by 2018 • However, to ensure sufficient IPV is available when countries are ready to introduce, it is essential that all countries define target introduction dates as soon as possible, no later than mid-end 2014 • Four manufacturers currently produce stand-alone IPV • Sanofi- Pasteur, France (SP) • Serum Institute of India (SII) • GlaxoSmithKline, Belgium (GSK) • Statens Serum Institut, Denmark (SSI) IPV introduction

  21. IPV Price – Current & Future http://www.cdc.gov/vaccines/programs/vfc/awardees/vaccine-management/price-list/index.html http://www.paho.org/hq/index.php?option=com_content&view=article&id=1864&Itemid=2234&lang=en http://www.unicef.org/supply/index_66260.html • GPEI aims at following pricing levels for low & middle income countries • Low-income countries: ~US$ 1.00 per dose • Lower-middle income countries : ~$1.50 per dose IPV introduction

  22. Programmatic Implications of IPV Introduction IPV introduction

  23. Immunization schedule uptakeOverview 1991-2013 of introduction status and 2014-2016 projections Source: WHO/IVB Database as at 18 October 2013 Date of slide: 18 October 2013 IPV introduction

  24. Considerations for Planning and Logistics • Coordination with other introductions • Many countries have planned introductions for other new vaccines (eg., rotavirus, PCV) • Multi Dose Vial Policy (MDVP) • IPV can only be kept for 6 hours or until the end of the vaccination session once the vial is opened • High Wastage Rates • 50% for 10-dose vial and 30% for 5-dose vial • Licensing • IPV must be licensed in country/ accept WHO PQ’ed product • Cold chain • Limited impact on cold chain due to addition of IPV, but may be challenging in context of other introductions IPV introduction

  25. Pilot introductions, training materials, and deployable consultants • Discussions with all WHO & UNICEF regional offices on plans to engage countries • Shortlist of potential early introducers (2014) • Planning for possible “Pilot Countries" (early 2014) • Objective would be early identification of operational issues associated with IPV introduction and its impact on the existing immunization system in the countries, so that they can be corrected and shared with other countries • Development of training materials underway • Planning training of cadre of deployable training consultants IPV introduction

  26. NextSteps Supply UNICEF Tender closed Negotiations with industry Procurement reference group convened by UNICEF, GAVI and WHO UNICEF awards contracts (early 2014) Demand & Country Readiness Engaging immunization partners & stakeholders Country decision making Country input on introduction dates & revised forecasts Technical assistance to ensure readiness Countries develop introduction plans IPV introduction

  27. Policy Aspects Related to IPV GAVI-GPEI Partnership on Introduction of IPV IPV introduction

  28. GAVI – GPEI Partnership • GPEI and the GAVI Alliance recognise the importance of strong partnership and complementarity; partners are now working together to improve coordination and strengthen routine immunisation services • In June 2013, the GAVI Alliance Board supported GAVI playing a lead role in the introduction of IPV into the routine immunisation programs in all 73 eligible and graduating GAVI countries. • The Board requested the GAVI Secretariat present a long-term strategyon how GAVI will support the introduction of IPV in its partner countries by November 2013. This will consider possible adjustments to GAVI policies and processes. IPV introduction

  29. Actions taken by the GAVI Board on 21-22 November 2013 • Eligibility • 73 GAVI eligible & graduating countries. • As per phase II eligibility criteria • Application window • Until June 2015 with introduction targeted by end of 2015 • Window to remain open if need arises • Duration of support • Full support until 2024 (subject to funding beyond 2018) • Immunisation cover filter • 70% DTP3 coverage filter does not apply • Co-financing • all countries exempted even if country is in default; Exempt ALL co-financing but recommended • Introduction grant • GAVI 73 countries eligible for routine vaccine introduction grant • *All policy exceptions to be reviewed in 2018 IPV introduction

  30. Letters to countries • Letters to GAVI countries sent mid-October with response form • objective to understand status of country planning and TA requirements • 50% response rate from GAVI countries – most with introductions planned in 2015 • non-GAVI countries to be sent by the end of the month • Upcoming information for countries: • Joint WHO/UNICEF/GAVI letter on SAGE recommendations and GAVI Board decision to support IPV • GAVI letter to countries to inform of all Board decisions with details on IPV support and how to apply IPV introduction

  31. GAVI Secretariat-led Processes • Voluntary Expression of Interest by country • Streamlined application • Applications reviewed by IRC – Alliance Partners input allowed through open sessions • Additional IRC scheduled as necessary. Application deadlines for countries in 2014: • 6 February – IPV only • 30 March – IPV only • 1 May – all GAVI support, IPV, NVS and HSS • 15 September – all GAVI support, IPV, NVS and HSS • Reviewed by IRC, then CEO approves applications based on financial envelope • Regular procurement process • VIG transfer – countries encouraged to channel $ through UN agencies • Regular TA provision process IPV introduction

  32. Polio Endgame: Strengthen Routine Immunization (RI) using Polio Assets in 10 Focus Countries Focus Country, large WHO and UNICEF polio teams Focus country, large WHO polio teams

  33. Key GPEI RI Indicators for focus countries • Develop annual national immunization coverage improvement plans in at least 5 priority countries by 2013 (indicator per Polio Endgame Strategy) • Dedicate >50% of WHO/UNICEF polio funded field staff time to immunization strengthening tasks by 2014 • Increase DPT3 coverage by 10% per year in high risk districts in at least 5 priority countries with coverage improvement plans by 2014 • Monitor immunization session conducted versus planned (proposed ADDITIONAL indicator)

  34. IPV Introduction Communication and Advocacy:Update Glen Nowak, PhD. Senior Communication Strategist Task Force for Global Health IPV introduction

  35. Communication/Advocacy Objectives and Efforts • Awareness and understanding of IPV introduction in the 124 OPV vaccine-using countries– particularly the 31 countries in Tier 1 and Tier 2. • Support and commitment among the 124 OPV vaccine-using countries, particularly Tier 1 and Tier 2 countries to: • Adopt by mid- or late 2014 (depending on tier status) a plan to introduce at least one dose of IPV into their routine immunization program; • Implement that plan so that by the end of 2015, at least one dose of IPV is being administered in routine immunization programs in line with SAGE recommendations. • Systematically inform and engage stakeholders, partners and key audiences of progress and available resources/technical support for IPV introduction. • Help foster global consensus and commitment for IPV introduction. • Assist implementing partners and in-country immunization programs with communication plans and efforts, including those for health workers and parents/caregivers. IPV introduction

  36. Guiding Framework for IPV and Objective 2Communications and Advocacy Provide strong, compelling scientific and public health reasons and benefits for introducing IPV Foster awareness and understanding that IPV introduction reflects the success of polio eradication efforts – and IPV is needed to achieve complete victory over polio Foster awareness that financial, resource and/or technical assistance support is readily and easily available Positive recognition/acknowledgement for having a plan and adding IPV to routine schedule Assist in-country and other efforts to educate media, health care providers, communities, and parents/caregivers about IPV vaccine and immunization recommendations IPV introduction

  37. Efforts to Date can be found on www.who.int http://www.who.int/immunization/diseases/poliomyelitis/inactivated_polio_vaccine/en/ orhttp://tinyurl.com/ipv-intro IPV introduction

  38. Website provides updates and information in five areas IPV introduction

  39. Communications and Advocacy materials include. . . IPV introduction

  40. Achieving Communication and Advocacy Success • Messages and information need to foster country decisions to add IPV to routine immunization programs as well as initiate IPV introduction by end of 2015. • Feedback and input from implementing partners, stakeholders and people working with or in countries is needed to inform and tailor communication efforts • “IPV” needs to represent more than “inactivated polio vaccine” – it needs to represent “Important, Progress, and Vital for Victory” in eradicating polio and further opening the door to protecting children from other serious diseases IPV introduction

  41. Next Steps include. . . Finalizing a comprehensive communication and advocacy plan to guide efforts, help set priorities, achieve consistency in communications and messages Updating and adding communication and advocacy materials – key messages, FAQs, case studies Increasing access, visibility and distribution of IPV introduction communication and advocacy materials – including creation of a core “resource kit” “Map out” the in-country IPV introduction decision making process in order to more clearly and effectively guide communication and advocacy activities IPV introduction