IVB Director's Report to SAGE

Transcription

1 IVB Director's Report to SAGE Achievement of previous recommendations & Progress highlights SAGE Meeting, 5-7 April 2011 J.M. Okwo-Bele, WHO 1

2 Outline Follow-up of previous meetings' recommendations Feasibility of measles eradication Meningococcal A Conjugate Vaccine campaigns LMIC: sustainable adoption and financing of new vaccines China's National Regulatory Authority RTS,S malaria vaccine update Update on Regional Vaccination Weeks The Decade of Vaccines Future agenda items for SAGE 2

3 Feasibility of Measles Eradication Executive Board (Jan 2011) Endorsed the SAGE recommendations Did not request a resolution on measles eradication at 2011 WHA Next steps discussed at the Global Measles Management Meeting (15-17 March) New Measles Strategic Plan for to be developed Aligned with MDG targets for 2015 and supporting existing regional elimination goals Periodic updates on progress towards existing goals will be provided to SAGE 3

4 Men A conjugate vaccine - MenAfriVac Progress to date and next steps Sept 2010: Pilot introduction Dec 2010: Burkina Faso: nationwide Mali : 22/59 districts Niger : 11/42 districts Q Finalize Mali and Niger Northern Nigeria & Cameroon Chad nationwide 4

5 Use of vaccine in pregnant and lactating women GACVS (after review of clinical data) : No concern with respect to the safety of the vaccine Need of postmarketing surveillance, including studies to assess vaccine safety in pregnancy WHO recommends immunizing pregnant and lactating women with MenAfriVac vaccine during any stage of pregnancy or lactation advise governments to implement pregnancy exposure registries to collect health information from women who are given the vaccine when they are pregnant 5

6 Preliminary results from 2010 MenAfriVac introduction Countries N districts Vaccinated pop Vaccine coverage Burkina Faso 63/ % Mali 22/ % Niger 11/ % TOTAL 96/ % 6

7 Meningitis Surveillance in Burkina Faso Number of confirmed cases, Weeks 1-11, Year N of cases N CSF NmA Nm W135 NmX S pn Hib Others Negative Source: MoH BF Hi : Haemophilus influenzae S pn : Streptococcus pneumoniae 7

8 Lower middle income countries : Sustainable adoption and financing of new vaccines November 2010 SAGE: WHO to facilitate the establishment of a partnership to consider: pooled procurement; tiered pricing; greater transparency of pricing 16 countries that were eligible for GAVI support will no longer have access to this support beyond From 2011 to 2015 they will be required to annually increase their co-financing portion of the vaccine procurement costs in order to achieve 100% funding by How to maintain and improve the gain reached with GAVI investment? 8

9 NUVI & LMIC: In response to SAGE and WHA Study on LMIC & NUVI completed & report available Vaccine pricing and pricing policies January 2010 brainstorming meeting : full project is under development on price information & pricing transparency UNICEF is now releasing prices per vaccine and per producer. EMRO: pooled vaccine procurement initiative discussed during the March 2011 meeting of the Arab League MOH - Some countries have already expressed official commitments to join EURO: Initial analysis of financial sustainability of immunization programmes examined by ETAGE 9

10 NRA strengthening in China Progress as of Feb 2011 NRA declared officially functional on 28th February 2011 New code of GMP issued to implement the highest GMP in all vaccine manufacturers as of 1st March with a grace period of 24 months Major organisational changes in several regulatory functions including amendments of legal basis and processes to meet international standards of quality, safety and efficacy Institutional Development Plan endorsed supported by the 11th and 12th Government Strategic Plan Prequalification road map discussed to allow vaccine prequalification within months 10

11 Vaccines from China are eligible for WHO PQ Orientation workshop held in Beijing on 22 March attended by more than 30 vaccine manufacturers from China Strong interest in supply to global market through WHO PQ and UN procurement Priorities being established for submissions from China 11

12 RTS,S Malaria Vaccine Update One experimental malaria vaccine (RTS,S/AS01) in Phase 3 trials. Enrolment of 15,461 children completed in Feb 2011 in 2 age groups children aged 6-14 weeks in co-administration children 5-17 months old. Standing WHO malaria vaccine expert (JTEG) Acts as joint IVB and Malaria Programmes technical expert group JTEG has advised that data may be available to support policy recommendation in 2015 with the full Phase 3 trial report Interim data package to become available in Q in older, non-target population media interest at this time likely this data will not support policy recommendation (It is not in the target population). JTEG will review each data package as it becomes available with SAGE liaison member attending 12

13 Update on Regional Vaccination Weeks 2011* African Vaccination Week - 35/46 countries participating Slogan "Vaccinated communities, Healthy Community" Vaccination Week in the Americas - All 44 member states Theme: Vaccinate your family, protect your community Vaccination Week in the Eastern Mediterranean - 17/22 countries Theme: Partnership for immunization European Immunization Week - 47/53 countries Theme: Shared solutions to common threats Vaccination Week in the Western Pacific - 31/37 countries 13 *between 23 April to 1 May

14 Updates on the Decade of Vaccines (DoV) Collaboration & DoV/Delivery workstream 14

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16 The DoV Collaboration Leadership Council (LC) Dr. Margaret Chan Director General World Health Organization Mr. Anthony Lake Executive Director UNICEF Dr. Anthony Fauci Director, National Institute of Allergy and Infectious Diseases Dr. Tachi Yamada President of Global Health Bill & Melinda Gates Foundation Ms. Joy Phumaphi Executive Secretary African Leaders Malaria Alliance 16

17 DoV/LC videoconference held on 3 Feb 2011 Summary of key points/decisions International Advisory Committee (IAC) ToRs modified to include 'ambassadorial' role while retaining some technical expertise Membership being proposed World Health Assembly (WHA) May 2011: Present the DoV concept + request engagement in developing its content May 2012: Present the Global Vaccine Action Plan (GVAP) and a resolution on the DoV Opportunities to sustain DoV momentum: Recent activities highlighted (WEC, Men A & PCV launches) Next LC meeting: 23 June at Pacific Health Summit, Seattle 17

18 DOV Collaboration Steering Committee Working Group Co-chairs Delivery R & D Steering Committee Dr. Jean Marie Okwo-Bele Dr. Jos Vandelaer Dr. Seth Berkley Dr. David Salisbury Prof. Pedro Alonso Dr. Christopher Elias Public Support Global Access Dr. Nicole Bates Dr. Peter Singer Ms. Sandy Wrobel Dr. Orin Levine 18

19 Steering Committee: Members at Large Dr. Zulfiqar Bhutta Dr. Lola Dare Ms. Helen Evans Dr. Lee Hall Dr. Lucky Slamet Dr. Anne Schucat Dr. Ciro de Quadros Dr. Gina Tambini 19

20 The DoV Vision (draft) "We envision a world where children, families and communities enjoy life protected from the threat of disease". Recognizing that immunization is one of the most cost-effective means to achieve this vision, the purpose of the Decade of Vaccines is to extend the full benefits of immunization to all people, regardless of where they live. Access to safe and effective vaccines is a human right that is currently not enjoyed by everyone, particularly in low and middleincome countries. 20

21 DoV goals (being formulated) 1. Achieve global eradication and elimination goals agreed by the WHA for VPDs Targets: PEI, measles elimination, MNTE, Rubella elimination 2. In every country, reduce the incidence of VPDs such that they are no longer public health problems Targets: list of other 13 VPDs: DTC, Hep B, Hib, etc 3. Maximize the contribution of immunization programmes to broader disease control and health efforts Targets: Cervical cancer, ARI, malaria, diarrhoeal diseases, TB, seasonal flu 4. Encouraging a robust scientific enterprise to produce innovation in the discovery and development of new and improved vaccines for high priority disease targets and ensuring a culture of innovation and continuous improvement in immunization strategies and programmes Targets: short term op research priorities; mid-term translational research priorities and long term vaccinology and immunology research priorities 5. Ensure adequate and sustained support for vaccines and immunization Targets: financial and human resources, infrastructure, political commitment, supply chain/ logistics 21

22 DoV-Delivery Timeline To date: 12 Nov 2010: Partners meetings DoV/Delivery Nov Jan 2011: DoV/Delivery Sub-Groups develop ideas and strategies in each area of work 31Jan-2Feb 2011: DoV/Delivery meeting to consolidate the work of each of the Subgroups. 17 Feb 2011: DoV/Delivery meeting on draft consolidated document 4 March 2011: Submission of WHA document Next Steps May 2011: WHA discussion on DoV May-Dec 2011: Consultations with partners and countries on DoV/Delivery June 2011: Pacific Health Summit Nov 2011: SAGE Dec 2011: Final Draft of the DoV/Delivery document March 2012: 'zenith' week (contribute to DoV Global Action Plan) May 2012: WHA on GVAP 22

23 Proposed Delivery Themes and Priorities Working Group meeting (17 Feb 2011) 1. Coverage Equity Eradication - Reaching More; Improving equity; Accelerated Disease Control; Eradication 2. Protection Synergies - Completing the unfinished agenda of underutilized and regionally important vaccines; - Accelerated introduction of new vaccines; - Preparing for pipeline vaccines and next generation of existing new vaccines; - Integration vaccine delivery with other interventions; and - Synergies with other disease control initiatives 3. Measurement Commitment Self-reliance - Financing - Addressing system components; - Information and data for decision making and impact monitoring; - Supply & Logistics; Norms and standards; Operational research; - Country commitment, self-reliance and accountability - Finance mapping and tracking 4. Costing - Estimating the resources required to achieve Delivery Goals in LI and LMICs - Estimating existing financing - Deriving the financing gap for Delivery 1. Achieving Equity in the use of vaccines 2. Uphold Immunization as a human right 3. Seek Synergies: Immunization as a key component of primary health care 4. Develop immunization systems able to meet the challenge 5. Bolster national self reliance and partnerships 23

24 Comments on 17 Feb 2011 (not a consensus building meeting) General feeling: document not bold, excitement-generating enough Over-all agreement with the 5 objectives but some objectives could be merged Equity needs clarification better use universal immunization? Immunization as a human right - important concept, but unsure about implications Document was seen as too extensive and demanding at country level Goal should be quantifiable and measurable, or that targets should be set. The demand side was generally felt as being too weak, and little on research Relationship between the DoV/Delivery document and the GIVS remains a major point of confusion. Clarify the shape of the final DoV Global Action Plan 24

25 Post-17 Feb Thinking Guiding Principles: Immunization as Human Right National ownership and accountability Desired Outcomes: Immunization is demanded by all communities All target groups reached Critical Success Factors / Recommendations: All Relevant stakeholders at all levels mobilized: political commitment, civil society, financing Immunization expanded into broader health care system: life-time approach, underserved, new vaccines in comprehensive preventive health Accountable management and decision-making: tracking resources, data for monitoring, human resources, infrastructure, outbreaks, accelerated disease control. 25

26 Costing of Delivery Estimate of the resource requirements to achieve the goals of DoV/Delivery" in low and lower-middle income countries for the period and derive the unfunded mandate Deliverables by Dec 2011: Headline figure on needs, financing and gaps in L&LMIC Analysis of estimates and report on findings Documented methodology Established process to review and validate methodology and results Estimates presented at various global and regional forums as needed 26

27 Costing DoV/Delivery: Recipe (building blocks) & Ingredients (data sources & methods) $$$ ADC, ELIMINATION & ERADICATION 1 Global forecasts 1 VACCINES, INJ. SUPPLIES & COLD CHAIN 2 Global forecast tool 2 Driven by COVERAGE SERVICE DELIVERY (HR, TRANSPORT ) 3 cmyp unit costing & typologies 3 Projection methods COST COMPONENTS: 1. Campaigns: Vaccines; injection supplies and operational costs for Polio, Measles and MNT 2. Routine: Vaccines (traditional, underused and new vaccines (Hib, Rota, Pneumo, Mening A and HPV)); injections supplies and cold chain equipment/maintenance 3. Routine: Human resources; vehicles/transport, training, IEC/social mobilization, programme management and disease surveillance DATA SOURCES: 1. Global forecasts produced by the Polio, Measles and MNT initiatives 2. Global forecast produced by WHO for the GAVI AVI but supplemented with the 30+ non-gavi LLMICs 3. cmyp costing and financing tools from 60+ countries and extrapolated to other countries and over time using a unit costing and typology methodology (see related methods document) 4. WHO-UNICEF coverage projection algorithm (see related methods document) 27

28 DoV-Delivery Timeline To date: 12 Nov 2010: Partners meetings DoV/Delivery Nov Jan 2011: DoV/Delivery Sub-Groups develop ideas and strategies in each area of work 31Jan-2Feb 2011: DoV/Delivery meeting to consolidate the work of each of the Subgroups. 17 Feb 2011: DoV/Delivery meeting on draft consolidated document 4 March 2011: Submission of WHA document Next Steps May 2011: WHA discussion on DoV May-Dec 2011: Consultations with partners and countries on DoV/Delivery June 2011: Pacific Health Summit Nov 2011: SAGE Dec 2011: Final Draft of the DoV/Delivery document March 2012: 'zenith' week (contribute to DoV Global Action Plan) May 2012: WHA on GVAP 28

29 DoV/Delivery Consultations Confirmed 16 May : World Health Assembly 26 July: SEARO High Level Advocacy Meeting with Health Ministers July: SEARO EPI Managers Meeting 9-11Aug: WPRO TAG DoV Consultation Sept: EURO Regional Committee Meeting Planned (dates tbc) June/Oct/Dec: Next meetings of the Delivery WG Sept: AFRO DoV/D Forum-?Nigeria, Cameroun, Ghana, Ethiopia EMRO DoV/D Forum PAHO /EUR DoV/D Forum 29

30 SAGE Meetings: Topics on the Horizon Cross-cutting and strategic issues " Decade of Vaccine/Delivery Framework " Highest priorities " 1. Use of vaccine in humanitarian emergencies " 2. Reinforcing surveillance networks " 5. Validation of coverage figures " 6. Use of vaccines in immunocompromised populations " 7. Optimizing immunization schedules " 8. Impact of introduction of new vaccines on strengthening of immunization and health systems " 8. Maternal immunization to " 3.Accessibility to affordable enhance the protection of mothers vaccines and WHO's role and infants " 3. Communication methods for" 10. Involvement of the private vaccine-hesitant populations sector " 11.Strengthening of NITAGs 30

31 SAGE Meetings: Topics on the Horizon Vaccine specific recommendations and updates " Pneumo conjugate strain replacement (Nov 2011) " Rotavirus vaccines " TB vaccines " Measles eradication " Optimizing immunization schedules (rotavirus, pneumo, Hib) " Polio " bopv " Post eradication " Hepatitis A (Nov 2011) " Seasonal and pandemic influenza " Yellow Fever " Varicella & herpes zoster " JE " HPV " Malaria " Dengue 31

32 SAGE Meetings: Focus & format (initial thoughts) Over the last five years : despite twice more meetings, less topics discussed by SAGE due to more in depth discussions preponderance of discussions focusing on new vaccines In future : Equal high priorities between strategic and vaccine specific topics Need to focus more holistically on post introduction implementation Future SAGE meetings format/preparation: Propose integration of regional reports implementation with specific topics Regional focus on operational issues Need equal review of evidence for cross cutting topics 32

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