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The GVS blueprint and its implementation

The GVS blueprint and its implementation . Dr Madhava Ram Medical Officer EMP/ SAV. Unsafe vaccine can have serious consequences Safety crises derail immunization programs. Real incidents: Intussusception following Rotavirus vaccine. Polio following IPV. Narcolepsy and H1N1 vaccination.

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The GVS blueprint and its implementation

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  1. The GVS blueprint and its implementation Dr Madhava Ram Medical Officer EMP/ SAV

  2. Unsafe vaccine can have serious consequencesSafety crises derail immunization programs • Real incidents: • Intussusception following Rotavirus vaccine. • Polio following IPV. • Narcolepsy and H1N1 vaccination. • Real safety issues: • Programme errors. • Anaphylaxis. • VAPP/ VDPV. • Disseminated BCG disease. • Rumours, poor science and over-reaction: • Pertussis vaccine coverage in the UK. • Multiple Sclerosis and hepatitis B vaccine in France. • OPV and chronic diseases in Nigeria. • Thiomersal and neuro-developmental disorders. • Pentavalent vaccine in Asian countries.

  3. Global Vaccine Safety Blueprint Developed with and for low- and middle-countries: • A capacity-building model towards, at least, a minimal capacity for vaccine pharmacovigilance. • Solutions for enhancing vaccine pharmacovigilance capacity to adequately monitor newly available vaccine products. • Access to technical support from institutions with adequate expertise, cultural and geographical proximity through an integrated network. • Pharmacovigilance business models aligned with those for drugs and other medicinal products.

  4. Global Vaccine Safety Blueprint

  5. Blueprint’s 3 strategic goals

  6. 8 strategic objectives support 3 goals of the Blueprint Supporting elementsensuring effectiveness of VPV Directly related to vaccine PV Obj. 3 Obj. 5 Obj. 4 Obj. 6 Obj. 7 Obj. 1 Obj. 2 Obj. 8 Minimal Capacity Enhanced Capacity Public private information exchange AEFI Detection Regulatory framework Global analysis & response Technical support & trainings Vaccine Safety Communication Tools & methods AEFI investigation International Collaboration

  7. Blueprint Development and Implementation The Global Vaccine Safety Initiative 2012… Sep-Dec 2011 Jan-Sep 2011 Feb-Dec 2010

  8. Situation analysis Experts perception of gaps and needs SWOT of existing international activities Regulators perception Industry perception Descriptive analysis of 11 countries NRA assessment data Financial analysis http://whqlibdoc.who.int/hq/2012/WHO_IVB_12.04_eng.pdf

  9. Blueprint development • Blueprint strategy designed as framework for collaborative support to national strengthening of vaccine safety systems. • Many stakeholders contributed to Blueprint development: • Collaborative Group. • Consultative Committee (vaccine safety experts, regulators, industry, national and WHO HQ/regional staff). • Individual briefings (CIOMS/WHO work group, IABS, international vaccine safety meetings, manufacturers organizations, GACVS, IPAC).

  10. Blueprint endorsement • Strategic Advisory Group of Experts- Nov 11 • Global Advisory Committee on Vaccine Safety- Dec 11 Global Vaccine Action Plan 65th World Health Assembly-May 12 http://extranet.who.int/iris/restricted/bitstream/10665/70919/1/WHO_IVB_12.07_eng.pdf

  11. The Global Vaccine Safety Initiative (GVSI) for implementing the Blueprint • Serve as a forum for vaccine safety stakeholders. • Guided by a General Meeting and steered by a Planning Group. • Proposals and recommendations constitute a reference for participating organizations' or institutions' guidelines, official policy or other action. • WHO provides the institutional base for Blueprint implementation and serves as secretariat to the Initiative.

  12. Meet at least once a year. • Review reports of activities of/that result from the Initiative • Puts forward proposals and make non-binding recommendations to Initiative participants. • Reviews proposals and recommendations of the Planning Group, and where appropriate, recommend all or part of their content for endorsement by respective GVSI participants. • Endorses the Initiative work plan. • Established in March 2012. • Chair: Alex Dodoo. • Members: Jan Bonhoeffer, Sandra Deotti, Ajit Pal Singh, Ananda Amarasinghe and Sten Olsson. • Reviews the Initiative's work plan and budget. • Reviews activity reports of the Initiative. Global Vaccine Safety Initiative - structure Planning group: coordinates work of General Meeting Chair 5 – 9 participants General meeting:guides the Initiative Two-years Term of office Observers WHO Secretariat support

  13. GVSI collaborating parties • PARTICIPANTS • Intergovernmental organizations • International non-governmental organizations • Academic institutions • Governmental institutions & agencies involved in regulatory activities • International industry associations/ umbrella organizations • WHO Collaborating Centres • OBSERVERS • Organizations, agencies or institutions involved in activities which are relevant to all or part of the mandate of the Initiative • Observers may • make a statement to present their views or position on the issue under consideration (upon invitation of Chair). • Observers may not • participate in discussions and deliberations of the Initiative, • have a role in decision making process

  14. Implementation mechanism

  15. GVSI portfolio of activities • Public version available online 16 April 2013. • Includes activities that are: • Planned, on-going or completed. • Funded, partially funded, unfunded. • Prioritized according to need and feasibility. • Public version reviewed twice yearly by planning group. • Working version includes new proposals on a rolling basis - "under review".

  16. Portfolio snapshot

  17. …in one year, GVSI … AEFI standard reporting form

  18. Selected ongoing GVSI priority projects • Web-based national AEFI data system (on- and off-line data processing application). • Active surveillance for new vaccines (rotavirus, MenA conjugate in pregnancy). • Hypothesis testing for rare AEFI through multi-country collaboration of sentinel sites. • Expansion of national vaccine PV systems assessments. • Vaccine safety training through UMC course. • Translation of training and other reference materials. • Vaccine pharmacovigilance toolkit.

  19. Global Vaccine Safety website http://www.who.int/vaccine_safety/en/

  20. The way forward • Global Vaccine Safety Initiative supports Member States as a forum to coordinate – and where possible synergize – existing efforts. • Initial implementation through existing mechanisms: • Vaccine pharmacovigilance network. • Decentralized support (regional office and partner organizations). • WHO collaborating centres and other partners. • Work with CIOMS on industry. • Progress monitored through SAGE and GACVS. • Diversify funding sources: • Direct support for contributing partners. • Seek predictable and sustainable resources.

  21. Questions ???

  22. Additional Slides

  23. Blueprint objectives 1. Strengthen vaccine safety monitoring systems 2. Strengthen ability to evaluate vaccine safety signals 3. Develop vaccine safety communication plans, understand perceptions of risk, and prepare for managing any AEFI and crises promptly 4. Develop internationally harmonized tools and methods for vaccine pharmacovigilance 5. Establish a legal, regulatory and administrative framework at all levels 6. Strengthen regional and global technical support platforms for vaccine pharmacovigilance 7. Make expert scientific advice on vaccine safety issues available 8. Put in place systems for appropriate interaction between national governments, multilateral agencies, and manufacturers

  24. Minimal capacity includes • National dedicated pharmacovigilance resources. • Managerial principles.

  25. Minimal capacity: National Pharmacovigilance capacity national reporting form for AEFI clear strategy for risk communication national database or system for collating, managing & retrieving AEFI reports National pharmacovigilance resources health-care workers & others encouraged to report vaccine safety issues national AEFI expert review committee harmonized set of standards implemented Minimal Capacity includes:

  26. Minimal capacity: Managerial requirements to strengthen vaccine safety National pharmacovigilance resources Regulatory framework to define provisions for monitoring and management of AEFI Clear lines of accountability for the conduct of vaccine safety work • Institutional development plan • For implementation of activities and development of performance indicators Commitment to sharing information on vaccine safetywith other countries. Managerial principles Minimal Capacity includes: Minimal capacity

  27. Is judged to be necessary in countries: • Introducing newly developed vaccines. • Manufacturing vaccines. • Includes: • Ability to carry out active surveillance rather than relying solely on spontaneous reporting of AEFI for the purpose of signal detection. • When necessary, ability to carry out epidemiological studies. National pharmacovigilance resources Managerial principles Enhanced capacity – an increased level of vaccine safety activity

  28. global and regional expert advisory bodies (GACVS, SAGE, regional TAGs) Benefits from establishing a global support structure centres of excellence to support capacity-building initiatives and crisis responses sufficient and effective pharmacovigilance if new vaccine is introduced investigational capacity at regional & international levels & information sharing regional and international sharing of vaccine safety data networks of experts International collaboration in support of countries

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