The GVS blueprint and its implementation Dr Madhava

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

Unsafe vaccine can have serious consequences Safety crises derail immunization programs l Real incidents: – Intussusception following Rotavirus vaccine. – Polio following IPV. – Narcolepsy and H 1 N 1 vaccination. l Real safety issues: – – Programme errors. Anaphylaxis. VAPP/ VDPV. Disseminated BCG disease. l Rumours, poor science and over-reaction: – – – 2| 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. WHO Technical Briefing Seminar | 1 November 2013

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. 3| WHO Technical Briefing Seminar | 1 November 2013

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

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 5| WHO Technical Briefing Seminar | 1 November 2013

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

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

Situation analysis 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 8| WHO Technical Briefing Seminar | 1 November 2013

Blueprint development l Blueprint strategy designed as framework for collaborative support to national strengthening of vaccine safety systems. l 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). 9| WHO Technical Briefing Seminar | 1 November 2013

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

The Global Vaccine Safety Initiative (GVSI) for implementing the Blueprint l Serve as a forum for vaccine safety stakeholders. l Guided by a General Meeting and steered by a Planning Group. l Proposals and recommendations constitute a reference for participating organizations' or institutions' guidelines, official policy or other action. l WHO provides the institutional base for Blueprint implementation and serves as secretariat to the Initiative. 11 | WHO Technical Briefing Seminar | 1 November 2013

• Established in March 2012. • Chair: Dodoo. • Meet at Alex least once a year. Global Vaccine Safety Initiative structure • Members: Jan Bonhoeffer, Sandra Deotti, Ajit Palreports Singh, Ananda Amarasinghe and • Review of activities Sten Olsson. of/that result from the Initiative Planning group: • Reviews the Initiative's work plan and budget. Chair General meeting: guides the Initiative Observers 12 | coordinates work of General • Puts forward proposals and • Reviews activity reports of the Initiative. Meeting make non-binding to Initiative 5 – recommendations 9 participants. • Reviews proposals and recommendations of the Planning Group, and where Two-years Term of office appropriate, recommend all or part of their content for endorsement by respective GVSI participants. WHO Secretariat support WHO Technical Briefing Seminar | 1 November 2013 • Endorses the Initiative work plan.

GVSI collaborating parties PARTICIPANTS • Intergovernmental organizations • International non-governmental organizations OBSERVERS • Organizations, agencies or institutions involved in activities which are relevant to all or part of the mandate of the Initiative • Academic institutions • Governmental institutions & agencies involved in regulatory activities • International industry associations/ umbrella organizations • WHO Collaborating Centres 13 | WHO Technical Briefing Seminar | 1 November 2013 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

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

GVSI portfolio of activities l Public version available online 16 April 2013. l Includes activities that are: – Planned, on-going or completed. – Funded, partially funded, unfunded. – Prioritized according to need and feasibility. l Public version reviewed twice yearly by planning group. l Working version includes new proposals on a rolling basis - "under review". 15 | WHO Technical Briefing Seminar | 1 November 2013

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

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

Selected ongoing GVSI priority projects l Web-based national AEFI data system (on- and off-line data processing application). l Active surveillance for new vaccines (rotavirus, Men. A conjugate in pregnancy). l Hypothesis testing for rare AEFI through multi-country collaboration of sentinel sites. l Expansion of national vaccine PV systems assessments. l Vaccine safety training through UMC course. l Translation of training and other reference materials. l Vaccine pharmacovigilance toolkit. 18 | WHO Technical Briefing Seminar | 1 November 2013

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

The way forward l Global Vaccine Safety Initiative supports Member States as a forum to coordinate – and where possible synergize – existing efforts. l 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. l Diversify funding sources: – Direct support for contributing partners. – Seek predictable and sustainable resources. 20 | WHO Technical Briefing Seminar | 1 November 2013

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

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

Blueprint objectives l 1. Strengthen vaccine safety l 5. Establish a legal, regulatory and administrative framework at all levels l 2. Strengthen ability to evaluate vaccine safety signals l 6. Strengthen regional and global technical support platforms for vaccine pharmacovigilance monitoring systems l 3. Develop vaccine safety communication plans, understand perceptions of risk, and prepare for managing any AEFI and crises promptly l 4. Develop internationally harmonized tools and methods for vaccine pharmacovigilance 23 | l 7. Make expert scientific advice on vaccine safety issues available l 8. Put in place systems for appropriate interaction between national governments, multilateral agencies, and manufacturers WHO Technical Briefing Seminar | 1 November 2013

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

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

Minimal capacity: Managerial requirements to strengthen vaccine safety Minimal Capacity includes: National pharmacovigilance resources Minimal capacity Regulatory framework Clear lines of accountability Institutional development plan to define provisions for monitoring and management of AEFI for the conduct of vaccine safety work For implementation of activities and development of performance indicators Managerial principles 26 | WHO Technical Briefing Seminar | 1 November 2013 Commitment to sharing information on vaccine safety with other countries.

Enhanced capacity – an increased level of vaccine safety activity • 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 27 | WHO Technical Briefing Seminar | 1 November 2013

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