Strengthening Global Capacity for Vaccine Pharmacovigilance The GVS Initiative Africa Pharmacovigilance Meeting 2012 20 April 2012 1
Vaccine pharmacovigilance for all Vaccine pharmacovigilance is defined as the science and activities relating to the detection, assessment, understanding and communication of adverse events following immunization ( ) and to the prevention of untoward effects of the vaccine or immunization. (CIOMS/WHO working group on vaccine pharmacovigilance 2012) Ensuring the safest possible use of vaccines should be the standard for all immunization programs. 2
nsafe vaccine can have serious consequences Safety crises derail immunization programs Real incidents: Tuberculosis following oral BCG. Polio following IPV. Swine flu campaign and GBS. Real safety issues: Programme errors. Anaphylaxis. VAPP. Disseminated BCG disease. Rumours, poor science and over-reaction: Pertussis vaccine coverage in the UK. MS and hepatitis B vaccine in France. OPV and chronic diseases in Nigeria. Thiomersal and neuro-developmental disorders. Pentavalent vaccine in Asian countries. 3
New vaccines Coming soon: malaria, dengue, Japanese encephalitis, typhoid conjugate, new TB vaccine, etc 4
country-driven model for capacity building in pharmacovigilance used for >15 years 5-step process: Benchmarking. Assessment against a published set of indicators. Elaboration of an institutional development plan. Implementation of the plan. Progress monitoring 5
Accomplishments since 1997 332 country visits - assessment & follow up 01 NRA assessments onducted NRA assessment completed including follow up Not yet conducted 6
Indicator PM06: Capacity to detect and investigate significant accine safety issues according to WB income status (end 2009) Group of countries Number of Countries Number of Countries with data available Number of Countries with Indicator Implemented % Implemented (of those with data available) % Implemented out of the total countries in the region A. Industrialized 48 48 45 94 94 B. Upper middle income 39 13 5 38 13 C1.Lower middle income 57 17 5 29 9 C2.Low income 49 17 2 12 4 7
Many resources already available for global vaccine pharmacovigilance 8
Global Vaccine Safety Blueprint Problem statement Develop 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 in order to adequately monitor newly available vaccine products. Access to coordinated 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. 9
Vision for the Global Vaccine Safety Blueprint Effective vaccine pharmacovigilance systems are established in all countries 10
hree main goals supporting the strategy of the Blueprint Minimal Capacity To assist low and middle income countries to have at least minimal capacity for vaccine safety activities. Enhanced Capacity To enhance capacity for vaccine safety assessment in countries that introduce newly developed vaccines, that introduce vaccines in settings wit novel characteristics or that both manufacture and use prequalified vaccine International Collaboration To establish a global vaccine safety support structure. 11
Minimal capacity includes National dedicated pharmacovigilance resources. Managerial principles. 12
Minimal Minimal capacity: National Capacity Pharmacovigilance includes: capacity clear strategy for risk communication health-care workers & others encouraged to report vaccine safety issues national reporting form for AEFI National pharmacovigilance resources harmonized set of standards implemented national database or system for collating, managing & retrieving AEFI reports national AEFI expert review committee 13
Minimal capacity: Managerial requirements to strengthen Minimal Capacity includes: vaccine safety National pharmacovigilance resources nimal pacity 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 safety with other countries. Managerial principles 14
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 15
8 strategic objectives support main goals of the Blueprint Directly relating to vaccine PV Supporting elements ensuring effectiveness of VPV Obj. 1 Obj. 2 Obj. 3 Obj. 4 Obj. 5 Obj. 6 Obj. 7 Obj. 8 inimal apacity nhanced apacity ternational ollaboration 16
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 international expert scientific advice on vaccine safety issues available 8. Put in place systems for appropriate interaction between national governments, multilateral agencies, and manufacturers 17
roposed Blueprint implementation throug a Global Vaccine Safety Initiative Participants in GVS Initiative: Government institutions and agencies, Intergovernmental organizations, including WHO, and international nongovernmental bodies, Academic and research institutions, International industry associations/umbrella organizations WHO collaborating centres (active in pharmacovigilance and vaccine pharmacovigilance). Interested parties may also participate as observers. WHO provides the institutional base for Blueprint implementation and serves as secretariat to the Initiative. 18
GVSI Initiative Planning Group Chair: Professor Alex Dodoo. Members: Professor Jan Bonhoeffer, Drs. Sandra Deotti, Christian Loucq, Ananda Amarasinghe and Sten Olsson. Initial short-term work plan: Covering all 8 objectives. Map ongoing activities (also beyond current GVSI). Convene all stakeholders. Seeks synergies, minimize duplications, increase circulation of information, mobilize financial resources. 19
Conclusions Broad support for the Blueprint goals and objectives. Initial implementation through existing mechanisms: Vaccine pharmacovigilance network. Decentralized support (regional office and partner organizations). WHO collaborating centres and other partners. Progress monitored through SAGE and GACVS. Diversify funding sources: Direct support for contributing partners. WHO increase country support. Seek predictable and sustainable resources. 20