Global Vaccine Safety Initiative Portfolio activities

Transcription

1 Global Vaccine Safety Initiative Portfolio activities Safety and Vigilance (SAV) Health Systems and Innovation (HIS) World Health Organization Geneva, Switzerland October 2013

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3 Table of Contents The Global Vaccine Safety Initiative activities portfolio... iv Portfolio background... iv Table 1: GVSI Blueprint main portfolio variables... v Table 2: Criteria for prioritization of GVSI portfolio activities to implement the global vaccine safety Blueprint.... v Figure 1: GVSI prioritization scheme... vi Overview of the GVSI portfolio activities... vi Activities Description... vii 1 - AEFI detection Page 1 of Investigation of Safety Signals Page 4 of Vaccine safety communication Page 7 of Tools and methods Page 9 of Regulatory framework Page 17 of Technical support and trainings Page 19 of Global analysis and response Page 27 of Public private interaction Page 28 of 28 iii

4 The Global Vaccine Safety Initiative activities portfolio Portfolio background The Global Vaccine Safety Initiative (GVSI) was launched under the auspices of the World Health Organization in March It is based on the Global Vaccine Safety Blueprint, the safety strategy of the Global Vaccine Safety Action Plan (GVAP). The GVSI vision is to establish effective vaccine pharmacovigilance systems in all countries by The GVSI is neither a legal entity, nor a partnership. It is a WHO mechanism for enhancing vaccine safety by providing a framework for WHO to convene its member states and partners (GVSI participants) for the implementation of the Global Vaccine Safety Blueprint. At the strategic level, a Planning Group (PG) that includes 5 to 9 external experts complementing WHO staff from headquarters and the six regional offices is appointed. At present, the PG members come from the Brighton Collaboration Foundation in Switzerland; the University of Ghana; the Ministry of Health of Sri Lanka; the International Vaccine Institute in Korea; the Ministry of Health from Brazil; the Uppsala Monitoring Centre in Sweden. At the operational level, activities and resources are coordinated by the WHO GVSI Secretariat to facilitate project-based collaborations. The core management tool is the GVSI portfolio. It is a dynamic listing, characterization and classification of activities proposed by GVSI participants and identified as priorities by the Planning Group for implementing the Blueprint. Each activity is listed with a summary of its purpose, relevance, description of work, deliverables, indicators for progress monitoring, budget, and level of priority (Table 1). Prioritization is based on the criteria listed in Table 2 and specifies priority 1 for key activities for which funding is immediately needed, priority 2 for important activities for which funding is recommended, and priority 3 for desirable activities that should be part of a full GSVI work plan (Figure 1). Activities submitted to the portfolio are not necessarily WHO activities but rather those that have been identified by the Planning Group as valuable contributions towards the shared mission of the Blueprint. Submission of activities to the GVSI portfolio is primarily for information purposes to assist WHO in coordinating global activities. WHO is neither responsible nor accountable for activities implemented by GVSI participants outside specific project agreements. WHO aims at bringing together donors and participants and coordinates interaction between them. iv

5 Table 1: GVSI Blueprint main portfolio variables Activity identification Activity title Activity description (s) Activity duration Contribution to the Blueprint Objectives Activity contact Progress monitoring Activity status Expected date of completion Milestone(s) Prioritization Impact Geographical relevance Feasibility Usefulness Sustainability Guidance Financial aspects Available funds Source of funding or funding sources approached Cost in the next phase Table 2: Criteria for prioritization of GVSI portfolio activities to implement the global vaccine safety Blueprint. Criterion Impact Geographic relevance Feasibility Usefulness Sustainability Guidance Description Activity s measurable improvement of vaccine pharmacovigilance and its tangible contribution to attaining the goal and objectives of the blueprint. National relevance: single country involvement. Regional relevance: more than one country in single WHO region involved. Global relevance: more than one WHO region involved. Reproducibility in another countries or regions increases geographic relevance of projects primarily implemented with geographically limited implementation. Ability to measure accomplishment of activity targets according pre-set parameters Practical worth or applicability evaluated by anticipated frequency, and scope of use. Capacity to endure according to metrics predicting the ability to maintain established infrastructures and processes with available local and global resources and efforts. Recommendations from advisory groups, governing bodies or national committees (e.g., GACVS, SAGE, ITAG). v

6 Figure 1: GVSI prioritization scheme Criteria for prioritization Impact Geographic relevance Feasibility Usefulness Sustainability Guidance Level 1 Key activity Funding is immediately needed Level 2 Important activity Funding is recommended Level 3 Desirable activity Funding as part of full work plan implementation Overview of the GVSI portfolio activities The current GVSI portfolio includes activities reviewed by the Planning Group at the June 2013 retreat. All GVSI projects are listed and monitored through the portfolio. Portfolio activities benefit from the visibility provided by the Initiative through its broad basis of stakeholders. GVSI participants and stakeholders may refer to the portfolio to assist in making funding decisions. Interested parties can request further details on the nature of the activities, outputs, outcomes and expected impact by contacting the responsible contact person or on request to GVSI@who.int vi

7 Activities Description vii

8 1 - AEFI detection PIN Promote harmonization through adoption of common post-marketing surveillance strategy in the 22 AVAREF countries. Trained NRAs and improved PMS. Completed akanmorib@who.int PIN Study on factors affecting AEFI detection in one SEARO country. Analysis of the factor that prevent AEFI reporting at each level of the immunization delivery system. Not Completion date guichards@who.int PIN Pilot project in one SEARO country to field test new notification forms including serious and mild AEFI and to update AEFI investigation template which meet requirement for new vaccine introduction. Notification forms, updated AEFI investigation forms are finalized. Completed guichards@who.int : Key activity for which funding is immediately needed. Page 1 of 28

9 PIN Build regulatory capacity of countries for evaluation of safety data from novel vaccines. Trained NRAs staff from AVAREF countries on reviewing safety data from novel vaccines. PIN Development of IT bridges among existing softwares to ensure regional data safety collection and analysis. Development of IT bridges to extract safety data, the solution utilizes ESAVI core variables developed by WHO and GAVCS. Partially Completion date 2014 PIN Cohort Event Monitoring in vaccine pharmacovigilance: Using Measles, Mumps, and Rubella (MMR) vaccine and Japanese Encephalitis (JE) vaccine as models in one country. 1. Safety data from spontaneous reports related to MMR and Live JE Vaccine. 2. Broader understanding of CEM as a as a pharmacovigilance tool to assess safety profile in an immunization programme in a developing country setting. Partially Priority 2 ana_amarasinghe@yahoo.co. : Key activity for which funding is immediately needed. Page 2 of 28

10 PIN Develop IT tool for AEFI collection and analysis for selected countries. Development of effective networks and implementation sustainable pharmacovigilance (IT) systems in participating countries for analysis of data and response on vaccine safety issues of regional importance. : Key activity for which funding is immediately needed. Page 3 of 28

11 2 - Investigation of Safety Signals PIN Active monitoring for intussusception following deployment of rotavirus vaccine in one AFRO Research report on an estimated 500 cases of intussusception collected from 6 health facilities in one AFRO country. Under review Completion date 2015 alexooo@yahoo.com PIN To conduct postmarketing vaccine safety study in one SEARO country. Background rates of AEFI for all vaccines including for the new vaccines in one selected SEARO country introducing pentavallent vaccines in guichards@who.int PIN Multi-country collaboration project. Report defining nessary infrastructure for vaccine safety sentinal sites. lambachp@who.int : Key activity for which funding is immediately needed. Page 4 of 28

12 PIN Technical support for continuing activities of PMS network for monitoring the safety of pre-qualified vaccines. Not Priority Completion date 2020 PIN Review of AEFI surveillance system in one EMRO country. 1-Evaluation of the pharmacovigilance system in one EMRO country and produce institutional development plan (IDP) to strengthen the AEFI surveillance. 2-Protocol to implement intussusception surveillance developed. Partially Completion date 2015 PIN Implementation of intussusception surveillance activities in one EMRO country introducing rotavirus vaccine. Development of intussusception surveillance protocol and implementation of intussusception surveillance activities in one EMRO country introducing rotavirus. Completion date 2014 : Key activity for which funding is immediately needed. Page 5 of 28

13 PIN Inter-country workshop on causality assessment of adverse events following immunization. Increased capacity to investigate Adverse Events Following Immunization (AEFI) and causality assessment in SEARO region. : Key activity for which funding is immediately needed. Page 6 of 28

14 3 - Vaccine safety communication PIN Methods for rumor detection in public media. Method for signal detection of vaccine safety concerns in public media. Not Completion date 2014 contact@brightoncollaborati PIN Understanding geographic and cultural differences of public concerns to guide program implementation. Geographic and cultural information of public concerns to guide program implementation. Not Priority 2 Completion date 2014 contact@brightoncollaborati PIN Impact of public concerns on coverage; seasonal influenza and batch quality an example of a onetime concern leading to withdrawal. Cost-benefit analysis of the a one-time public concern leading to withdrawal of Influenza vaccine batch(es). Not Priority 3 Completion date 2015 contact@brightoncollaborati : Key activity for which funding is immediately needed. Page 7 of 28

15 PIN Convene a Regional Advisory Group on Vaccine Safety. Scientific advice on vaccine safety. akanmorib@who.int PIN Quantifying bias in epidemiologic studies introduced by public concern. Method to quantify unmeasured bias in observational vaccine safety studies e.g., (media attention, diagnostic awareness). Not Priority 3 Completion date 2015 contact@brightoncollaborati PIN Vaccine Safety Net. A web based list of vaccine safety web sites providing reliable information on Vaccine Safety. Completion date 2020 sahinovici@who.int : Key activity for which funding is immediately needed. Page 8 of 28

16 4 - Tools and methods PIN Regional consultation for harmonization of guidelines for on surveillance for intussusception surveillance. Common guidelines for intussusception surveillance developed. akanmorib@who.int PIN Defining essential information for AEFI reporting. AEFI Core Variables identified and available online. Completed Completion date 2012 balakrishnanm@who.int PIN Support harmonization of databases including ESAVIs fields in national Pharmacovigilance systems. 1-Document on basic criteria for database management developed. 2-Two countries with updated pilot databases fields/systems developed. 3-Work group for supporting and monitoring performance established. Not Completion date 2015 pombomar@who.int : Key activity for which funding is immediately needed. Page 9 of 28

17 PIN Update regional ESAVI guidelines and standard operational procedures (SOP), including causality assessment algorithm. Updated safety package of training, which includes ESAVI monitoring, causality assessment and risk communication. Not Completion date 2014 PIN Optimizing signal analysis in VigiBase for vaccine related individual case safety reports (ICSRs). Improved statistical algorithms for routine use by UMC signal review team. Statistical associations are provided to the clinical review team for assessment of validity and public health interest. New signals considered interesting by the clinical reviewer Completion date 2014 PIN Training to strengthen AEFI monitoring and causality assessment in one EMRO country. Training of NRA and EPI staff on AEFI monitoring, causality assessment and strengthening of the national Pharmacovigilance system. : Key activity for which funding is immediately needed. Page 10 of 28

18 PIN Web Based Causality Assessment Tool. A web based version of the WHO causality assessment algorithm. Not Priority 2 Completion date 2014 contact@brightoncollaborati PIN Scoping exercise on innovative clinical trial design & optimal allocation of safety data collection at each phase of the development cycle A plan of work for will be developed that will be implemented during the subsequent years of the US FDA umbrella grant. The work should help operationalize aspects of the global regulatory science agenda as developed in context of the Global Vaccine Actio Not Completion date hombachj@who.int PIN Developing Regional AEFI guidelines. Publication: Immunization Safety Surveillance. Completed Completion date 2012 hossains@who.int : Key activity for which funding is immediately needed. Page 11 of 28

19 PIN Develop norms and reference documents on risk-benefit reports and risk management. New documents on risk management and periodic safety update reports. Good Pharmacovigilance practices updated. Not Completion date 2014 PIN Automatic case classification of spontaneous reports. An application programming interface (API) is produced and integrated in a target spontaneous reporting system allowing the reporter and/or the receiver to automatically classify submitted cases. The tool also informs the classifier about missing informat contact@brightoncollaborati PIN Ad hoc case definition development. Ad hoc case definition as prioritized by WHO. Not Completion date 2020 contact@brightoncollaborati : Key activity for which funding is immediately needed. Page 12 of 28

20 PIN Translation of Standardized Brighton Case Definitions. Translation of Brighton Collaboration Case definitions in all WHO official languages. Not Completion date PIN Standardized disease concepts for international collaborative studies. Library of mapped and standardized disease concepts across different coding terminologies for international collaborative studies. Not Priority 3 Completion date contact@brightoncollaborati PIN Algorithms for case validation of AEFI following influenza vaccines. Algorithms for all AEFI developed. Not Priority 3 Completion date contact@brightoncollaborati : Key activity for which funding is immediately needed. Page 13 of 28

21 PIN Development and evaluation of narcolepsy case definition and investigation of reporting patterns of narcolepsy over time. Publication of narcolepsy case definition and report on changes of reporting patterns in international databases. PIN Develop Regional AEFI guidelines 1-Training and capacity building of MOH and NRA staff. Strengthened. 2-Vaccine safety surveillance system PIN Development of standard AEFI reporting form. Model AEFI reporting form available online. Completed Completion date 2012 : Key activity for which funding is immediately needed. Page 14 of 28

22 PIN Information sheets on vaccine reaction rates. Information sheets on vaccine reaction rates. PIN Development of a Vaccine Pharmacovigilance Toolkit. A WHO Vaccine Pharmacovigilance Toolkit. alexooo@yahoo.com PIN AEFI Causalty Assessment classification. A tool for assessing causality at individual level including a manual and aide-memoire. Completed balakrishnanm@who.int : Key activity for which funding is immediately needed. Page 15 of 28

23 PIN Maintenance and development of the vaccine dictionary. Updated vaccine dictionary Not Priority Completion date 2020 PIN Provide a repository for the storage of national AEFI reports. A national electronic repository linked to the UMC database. Completion date 2014 balakrishnanm@who.int : Key activity for which funding is immediately needed. Page 16 of 28

24 5 - Regulatory framework PIN Support NRA exchange and analysis of information for decision making on vaccine safety issues. Establishment of Network for monitoring and analyzing reports in pharmacovigilance centers in two PAHO countries. Partially Completion date 2015 pombomar@who.int PIN Staff in information centres trained on critical information appraisal and communication and supporting the pharmacovigilance network. Bulletin of medicines information centers designed and disseminated. Staff in information centres trained on critical information appraisal and communication and supporting the pharmacovigilance network. Partially Completion date 2015 pombomar@who.int PIN Updated benchmarks for vaccine pharmacovilance function of the NRA assessments. Revised list of indicators and sub-indicators of the vaccine pharmacovigilance function of the WHO NRA assessment tool. Completed Completion date 2012 maurec@who.int : Key activity for which funding is immediately needed. Page 17 of 28

25 PIN Review of AEFI surveillance system in one EMRO country. Review of NRA system in one EMRO country and establishment of institutional development plan. Completed Completion date 2012 PIN Improve National PV centres performance through a quality evaluation program. Develop indicators to assess the performance of PV centers and pilot in two PAHO countries. Not Priority 2 Completion date 2015 pombomar@who.int PIN Perform national vaccine PV system evaluation against agreed benchmarks (NRA assessment tool). Perform national vaccine PV system assessment in at least 5 countries per year. Completion date 2020 maurec@who.int : Key activity for which funding is immediately needed. Page 18 of 28

26 6 - Technical support and trainings PIN Strengthening network countries capacity for data analysis and signal detection. 1-Standard training package on AEFI data analysis and signal detection. the 12 network countries. 2-Workshop conducted in Completion date 2014 maurec@who.int PIN Strengthening of ESAVI Committees and members. Regional Standard Operational Procedures Guidelines, to support the constitution of ESAVI Committees at the national level. Partially pamelab@who.int PIN Annual global vaccine safety update. Annual one day scientific conference and publication Partially Priority 3 Completion date 2020 contact@brightoncollaborati : Key activity for which funding is immediately needed. Page 19 of 28

27 PIN AEFI training workshop for countries in WPRO region. Capacity building for EPI and NRA staff on vaccine safety in WPRO region. Partially Completion date 2018 PIN Establish global pool of qualified trainers for WHO trainings in countries Development of a Web based database of experts. bellaham@who.int PIN Regional Vaccinology course. Trained NRAs staff. Partially akanmorib@who.int : Key activity for which funding is immediately needed. Page 20 of 28

28 PIN Training course on vaccines safety provided by US FDA (CBER) to participants of UMC annual pharmacovigilance training course and others A training for healthcare professionals with a special interest in vaccine safety assessment, specifically as applied by US FDA. sten.olsson@who-umc.org PIN Training for AEFI for two countries each in ITST West and IST Central Africa Training and capacity building for MOH and NRA staff on vaccine safety. akanmorib@who.int PIN Global learning resource centre. Web-platform linking to E-learning tools, trainer databases, PPT toolkits and a contact to organize WHO trainings in countries. Completed Completion date 2012 lambachp@who.int : Key activity for which funding is immediately needed. Page 21 of 28

29 PIN E-learning training material on Vaccine Safety. E-learning course on Vaccine Safety. Completed Completion date 2012 PIN Basic training toolkit for trainers in countries. PPT training package developed in collaboration with international experts. Completed Completion date 2012 PIN Regional Vaccine Safety Workshop in Asia. Enhanced capacity for vaccine safety assessment by NRAs, AEFI & vaccination advisory committees in countries that introduce newly developed vaccines in settings with novel characteristics and use prequalified vaccines either directly or through UN supply. Not : Key activity for which funding is immediately needed. Page 22 of 28

30 PIN Conduct AEFI training workshop in two SEARO countries. 60 EPI and AEFI focal persons trained on AEFI detection and reporting. Completed Completion date 2012 PIN Second regional meeting on pharmacovigilance of vaccines. Training and capacity building on vaccine safety communication. PIN To conduct refresher training on AEFI detection and reporting in one SEARO country. Trained 79 trainers who in turn trained 523 EPI and AEFI focal persons on AEFI detection analysis and reporting at the district level. Completed : Key activity for which funding is immediately needed. Page 23 of 28

31 PIN Training on AEFI and causality assessment in one EMRO country. Training of NRA and EPI staff on AEFI monitoring, causality assessment and strengthening of the national Pharmacovigilance system. PIN Support to the establishment of the national AEFI secretariat in one SEARO country Operational national AEFI committee to collect, analyze and report AEFI cases. Completed PIN Enhance the causality assessment capacity of vaccine pharmacovigilance officers. Report and insights to continuously improve the methodology. Partially : Key activity for which funding is immediately needed. Page 24 of 28

32 PIN Identify and establish accredited training institutions at global, regional, and sub-regional levels. Availability of a training network with harmonized curriculas, translation of training materials, adaptation of training modules based on the evolution of science. Not Completion date 2015 lambachp@who.int PIN Support NRA capacity building. Online and face to face training and capacity building for NRA staff on causality assessment, performance evaluation, ESAVIs and risk management in 7 PAHO countries. Partially Completion date 2015 pombomar@who.int PIN First regional meeting on pharmacovigilance of vaccines. 1-Training and capacity building of NRA, pharmacovigilance and EPI staff on AEFI surveillance system. 2-Updated information on AEFI with use of rotavirus vaccine and BCG vaccine. Completed Completion date 2012 langarh@who.int : Key activity for which funding is immediately needed. Page 25 of 28

33 PIN Global Vaccine Safety Risk Communication Training Regional workshops held. Not Priority Completion date 2015 PIN Provide access to online training for vaccine safety to avaref countries. NRA staff trained on vaccine safety. : Key activity for which funding is immediately needed. Page 26 of 28

34 7 - Global analysis and response PIN Rapidly and effectively deal with serious vaccine-related adverse events in order to maintain confidence in a vaccine. Technical support for investigation, analysis and response with the possibility of prompt independent expert advice. Completion date 2020 zuberp@who.int PIN Establishment of a Regional Advisory Group on Vaccine Safety. Regional meeting to review selected safety cases and publication of a report and article for each meeting. Partially pamelab@who.int PIN Publish GACVS assessments in WER within 6 weeks of the committee deliberations. Up-to-date GACVS review of vaccine safety profiles published in WER since Completion date 2020 zuberp@who.int : Key activity for which funding is immediately needed. Page 27 of 28

35 8 - Public private interaction PIN To put in place systems for information exchange mechanisms between national governments, multilateral agencies and manufacturers. Improved information exchange mechanisms between industry and public sector. Partially info@cioms.ch : Key activity for which funding is immediately needed. Page 28 of 28