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

2. WHO Technical Briefing Seminar | 1 November 2013 2 |2 | Unsafe vaccine can have serious consequences Safety 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. WHO Technical Briefing Seminar | 1 November 2013 3 |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. WHO Technical Briefing Seminar | 1 November 2013 4 |4 | Global Vaccine Safety Blueprint To optimize the safety of vaccines through effective use of pharmacovigilance principles and methods MISSION Effective vaccine pharmacovigilance systems are established in all countries VISION

5. WHO Technical Briefing Seminar | 1 November 2013 5 |5 | Blueprint’s 3 strategic goals To assist low and middle income countries (LMIC) to have at least minimal capacity for vaccine safety activities To enhance capacity for vaccine safety assessment in countries that introduce newly-developed vaccines, that introduce vaccines in settings with novel characteristics, or that both manufacture and use prequalified vaccines to establish a global vaccine safety support structure

6. WHO Technical Briefing Seminar | 1 November 2013 6 |6 | 8 strategic objectives support 3 goals of the Blueprint International Collaboration Minimal Capacity Obj. 1Obj. 2 Obj. 3 Obj. 4 AEFI investigation AEFI Detection Tools & methods Vaccine Safety Communication Directly related to vaccine PV Obj. 5 Obj. 6 Obj. 7 Obj. 8 Technical support & trainings Regulatory framework Public private information exchange Global analysis & response Supporting elements ensuring effectiveness of VPV Enhanced Capacity

7. WHO Technical Briefing Seminar | 1 November 2013 7 |7 | Situation analysis Blueprint development Blueprint endorsement The Global Vaccine Safety Initiative Feb-Dec 2010 Jan-Sep 2011 Sep-Dec 2011 2012… Blueprint Development and Implementation

8. WHO Technical Briefing Seminar | 1 November 2013 8 |8 | 1.Experts perception of gaps and needs 2.SWOT of existing international activities 3.Regulators perception 4.Industry perception 5.Descriptive analysis of 11 countries 6.NRA assessment data 7.Financial analysis http://whqlibdoc.who.int/hq/2012/WHO_IVB_12.04_eng.pdf Situation analysis

9. WHO Technical Briefing Seminar | 1 November 2013 9 |9 | 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). Blueprint development

10. WHO Technical Briefing Seminar | 1 November 2013 10 | Global Vaccine Action Plan 65th World Health Assembly-May 12 Global Vaccine Action Plan 65th World Health Assembly-May 12 Blueprint endorsement Strategic Advisory Group of Experts- Nov 11 Global Advisory Committee on Vaccine Safety- Dec 11 http://extranet.who.int/iris/restricted/bitstream/10665/70919/1/WHO_IVB_12.07_eng.pdf

11. WHO Technical Briefing Seminar | 1 November 2013 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. WHO Technical Briefing Seminar | 1 November 2013 12 | Global Vaccine Safety Initiative - structure Planning group: coordinates work of General Meeting WHO Secretariat support Observers General meeting: guides the Initiative Chair 5 – 9 participants Two-years Term of office 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.

13. WHO Technical Briefing Seminar | 1 November 2013 13 | 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 GVSI collaborating parties

14. WHO Technical Briefing Seminar | 1 November 2013 14 | National capacity Regional office Pool of experts IDP Harmoniz ed tools Training resources Training for industry Implementation mechanism

15. WHO Technical Briefing Seminar | 1 November 2013 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. WHO Technical Briefing Seminar | 1 November 2013 16 | Portfolio snapshot

17. WHO Technical Briefing Seminar | 1 November 2013 17 | AEFI standard reporting form …in one year, GVSI …

18. WHO Technical Briefing Seminar | 1 November 2013 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. WHO Technical Briefing Seminar | 1 November 2013 19 | GVSI GACVS Training resources, etc… Global Vaccine Safety website http://www.who.int/vaccine_safety/en/

20. WHO Technical Briefing Seminar | 1 November 2013 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. WHO Technical Briefing Seminar | 1 November 2013 21 | Questions ???

22. WHO Technical Briefing Seminar | 1 November 2013 22 | Additional Slides

23. WHO Technical Briefing Seminar | 1 November 2013 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. WHO Technical Briefing Seminar | 1 November 2013 24 | Minimal capacity includes  National dedicated pharmacovigilance resources.  Managerial principles.

25. WHO Technical Briefing Seminar | 1 November 2013 25 | Minimal Capacity includes: Minimal capacity: National Pharmacovigilance capacity clear strategy for risk communication National pharmacovigilance resources national database or system for collating, managing & retrieving AEFI reports national reporting form for AEFI health-care workers & others encouraged to report vaccine safety issues national AEFI expert review committee harmonized set of standards implemented

26. WHO Technical Briefing Seminar | 1 November 2013 26 | Minimal Capacity includes: Minimal capacity: Managerial requirements to strengthen vaccine safety Managerial principles 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 safety with other countries. Regulatory framework to define provisions for monitoring and management of AEFI National pharmacovigilance resources Minimal capacity

27. WHO Technical Briefing Seminar | 1 November 2013 27 | Enhanced capacity – an increased level of vaccine safety activity Managerial principles National pharmacovigilance resources 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.

28. WHO Technical Briefing Seminar | 1 November 2013 28 | International collaboration in support of countries Benefits from establishing a global support structure sufficient and effective pharmacovigilance if new vaccine is introduced regional and international sharing of vaccine safety data global and regional expert advisory bodies (GACVS, SAGE, regional TAGs) networks of experts investigational capacity at regional & international levels & information sharing centres of excellence to support capacity-building initiatives and crisis responses