Post on 07-Oct-2020
Global Vaccine Safety Initiative
Portfolio activities
2012-2020
Safety and Vigilance (SAV)
Health Systems and Innovation (HIS)
World Health Organization
Geneva, Switzerland
October 2013
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 2012. 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 2020.
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.
Table 1: GVSI Blueprint main portfolio variables
Activity identification • Activity title • Activity description • Expected end product(s) • Activity duration • Contribution to the Blueprint
Objectives • Activity contact
Prioritization • Impact • Geographical relevance • Feasibility • Usefulness • Sustainability
Guidance
Progress monitoring • Activity status • Expected date of completion • Milestone(s)
Financial aspects • Funding status • 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 Description
Impact Activity’s measurable improvement of vaccine pharmacovigilance and its
tangible contribution to attaining the goal and objectives of the blueprint.
Geographic relevance 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.
Feasibility Ability to measure accomplishment of activity targets according pre-set
parameters
Usefulness Practical worth or applicability evaluated by anticipated frequency, and scope
of use.
Sustainability Capacity to endure according to metrics predicting the ability to maintain
established infrastructures and processes with available local and global
resources and efforts.
Guidance Recommendations from advisory groups, governing bodies or national
committees (e.g., GACVS, SAGE, ITAG).
Figure 1: GVSI prioritization scheme
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
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
Activities Description
1 ‐ AEFI detection
PIN 168778
Activity Title Enhance capacity of National Pharmacovigilance programs for active/targeted Pharmacovigilance, including the design of pilot projects.
Funding status Not Funded
Priority 1
Expected end product
Two protocols developed and piloted in two countries.
Completion date 2015
On hold
Activity Contact person pombomar@who.int
PIN 168727
Activity Title Cohort Event Monitoring in vaccine pharmacovigilance: Using Measles, Mumps, and Rubella (MMR) vaccine and Japanese Encephalitis (JE) vaccine as models in one country.
Funding status Partially Funded
Priority 2
Expected end product
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.
Completion date 2013
Ongoing
Activity Contact person ana_amarasinghe@yahoo.co.
PIN 168817
Activity Title National PV Centres and National EPI Collaboration
Funding status Not Funded
Priority Under review
Expected end product
Joint reporting tools (forms) and use of common IT tools e.g. VigiflowJoint annual newsletters on vaccine and drug safety
Completion date 2014
On hold
Activity Contact person alexooo@yahoo.com
Priority *
Priority 1: Key activity for which funding is immediately needed.
Priority 2: Important activity for which funding is recommended.
Priority 3: Desirable activity that should be part of a full GSVI work plan.
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PIN 168794
Activity Title Promote harmonization through adoption of common post‐marketing surveillance strategy in the 22 AVAREF countries.
Funding status Funded
Priority 1
Expected end product
Trained NRAs and improved PMS.
Completion date 2013
Completed
Activity Contact person akanmorib@who.int
PIN 168792
Activity Title Build regulatory capacity of countries for evaluation of safety data from novel vaccines.
Funding status Funded
Priority 1
Expected end product
Trained NRAs staff from AVAREF countries on reviewing safety data from novel vaccines.
Completion date 2013
Ongoing
Activity Contact person akanmorib@who.int
PIN 168785
Activity Title Develop IT tool for AEFI collection and analysis for selected countries.
Funding status Funded
Priority 1
Expected end product
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.
Completion date 2013
Ongoing
Activity Contact person AjitPalSingh@ivi.int
Priority *
Priority 1: Key activity for which funding is immediately needed.
Priority 2: Important activity for which funding is recommended.
Priority 3: Desirable activity that should be part of a full GSVI work plan.
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PIN 168780
Activity Title 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.
Funding status Funded
Priority 1
Expected end product
Notification forms, updated AEFI investigation forms are finalized.
Completion date 2013
Completed
Activity Contact person guichards@who.int
PIN 168771
Activity Title Study on factors affecting AEFI detection in one SEARO country.
Funding status Not Funded
Priority 1
Expected end product
Analysis of the factor that prevent AEFI reporting at each level of the immunization delivery system.
Completion date
Planned
Activity Contact person guichards@who.int
PIN 168763
Activity Title Development of IT bridges among existing softwares to ensure regional data safety collection and analysis.
Funding status Partially Funded
Priority 1
Expected end product
Development of IT bridges to extract safety data, the solution utilizes ESAVI core variables developed by WHO and GAVCS.
Completion date 2014
Ongoing
Activity Contact person pamelab@who.int
Priority *
Priority 1: Key activity for which funding is immediately needed.
Priority 2: Important activity for which funding is recommended.
Priority 3: Desirable activity that should be part of a full GSVI work plan.
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2 ‐ Investigation of Safety Signals
PIN 168820
Activity Title Technical support for continuing activities of PMS network for monitoring the safety of pre‐qualified vaccines.
Funding status Not Funded
Priority
Expected end product
Completion date 2020 Activity Contact person sten.olsson@who‐umc.org
PIN 168743
Activity Title Review of AEFI surveillance system in one EMRO country.
Funding status Partially Funded
Priority 1
Expected end product
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.
Completion date 2015
Ongoing
Activity Contact person langarh@who.int
PIN 168744
Activity Title Implementation of intussusception surveillance activities in one EMRO country introducing rotavirus vaccine.
Funding status Funded
Priority 1
Expected end product
Development of intussusception surveillance protocol and implementation of intussusception surveillance activities in one EMRO country introducing rotavirus.
Completion date 2014
Ongoing
Activity Contact person langarh@who.int
Priority *
Priority 1: Key activity for which funding is immediately needed.
Priority 2: Important activity for which funding is recommended.
Priority 3: Desirable activity that should be part of a full GSVI work plan.
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PIN 168803
Activity Title To validate globally standardized BC case definitions in one country.
Funding status Not Funded
Priority Under review
Expected end product
Brighton Collaboration case definitions validated in one country.
Completion date
On hold
Activity Contact person jan.bonhoeffer@gmail.com
PIN 168810
Activity Title Active monitoring for intussusception following deployment of rotavirus vaccine in one AFRO
Funding status Under review
Priority 1
Expected end product
Research report on an estimated 500 cases of intussusception collected from 6 health facilities in one AFRO country.
Completion date 2015
Planned
Activity Contact person alexooo@yahoo.com
PIN 168782
Activity Title To conduct postmarketing vaccine safety study in one SEARO country.
Funding status Funded
Priority 1
Expected end product
Background rates of AEFI for all vaccines including for the new vaccines in one selected SEARO country introducing pentavallent vaccines in 2013.
Completion date 2013
Ongoing
Activity Contact person guichards@who.int
Priority *
Priority 1: Key activity for which funding is immediately needed.
Priority 2: Important activity for which funding is recommended.
Priority 3: Desirable activity that should be part of a full GSVI work plan.
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PIN 168814
Activity Title Multi‐country collaboration project.
Funding status Funded
Priority 1
Expected end product
Report defining nessary infrastructure for vaccine safety sentinal sites.
Completion date 2013
Ongoing
Activity Contact person lambachp@who.int
PIN 168815
Activity Title Inter‐country workshop on causality assessment of adverse events following immunization.
Funding status Funded
Priority 1
Expected end product
Increased capacity to investigate Adverse Events Following Immunization (AEFI) and causality assessment in SEARO region.
Completion date 2013
Ongoing
Activity Contact person guichards@who.int
Priority *
Priority 1: Key activity for which funding is immediately needed.
Priority 2: Important activity for which funding is recommended.
Priority 3: Desirable activity that should be part of a full GSVI work plan.
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3 ‐ Vaccine safety communication
PIN 168725
Activity Title Vaccine Safety Net.
Funding status Funded
Priority 1
Expected end product
A web based list of vaccine safety web sites providing reliable information on Vaccine Safety.
Completion date 2020
Ongoing
Activity Contact person sahinovici@who.int
PIN 168800
Activity Title Methods for rumor detection in public media.
Funding status Not Funded
Priority 1
Expected end product
Method for signal detection of vaccine safety concerns in public media.
Completion date 2014
Planned
Activity Contact person jan.bonhoeffer@gmail.com
PIN 168799
Activity Title Understanding geographic and cultural differences of public concerns to guide program implementation.
Funding status Not Funded
Priority 2
Expected end product
Geographic and cultural information of public concerns to guide program implementation.
Completion date 2014
Planned
Activity Contact person jan.bonhoeffer@gmail.com
Priority *
Priority 1: Key activity for which funding is immediately needed.
Priority 2: Important activity for which funding is recommended.
Priority 3: Desirable activity that should be part of a full GSVI work plan.
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PIN 168801
Activity Title Quantifying bias in epidemiologic studies introduced by public concern.
Funding status Not Funded
Priority 3
Expected end product
Method to quantify unmeasured bias in observational vaccine safety studies e.g., (media attention, diagnostic awareness).
Completion date 2015
Planned
Activity Contact person jan.bonhoeffer@gmail.com
PIN 168797
Activity Title Convene a Regional Advisory Group on Vaccine Safety.
Funding status Funded
Priority 1
Expected end product
Scientific advice on vaccine safety.
Completion date 2013
Ongoing
Activity Contact person akanmorib@who.int
PIN 168798
Activity Title Impact of public concerns on coverage; seasonal influenza and batch quality an example of a one‐time concern leading to withdrawal.
Funding status Not Funded
Priority 3
Expected end product
Cost‐benefit analysis of the a one‐time public concern leading to withdrawal of Influenza vaccine batch(es).
Completion date 2015
Planned
Activity Contact person jan.bonhoeffer@gmail.com
Priority *
Priority 1: Key activity for which funding is immediately needed.
Priority 2: Important activity for which funding is recommended.
Priority 3: Desirable activity that should be part of a full GSVI work plan.
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4 ‐ Tools and methods
PIN 168736
Activity Title Developing Regional AEFI guidelines.
Funding status Funded
Priority 1
Expected end product
Publication: Immunization Safety Surveillance.
Completion date 2012
Completed
Activity Contact person hossains@who.int
PIN 168791
Activity Title Develop Regional AEFI guidelines
Funding status Funded
Priority 1
Expected end product
1‐Training and capacity building of MOH and NRA staff. 2‐Vaccine safety surveillance system Strengthened.
Completion date 2013
Planned
Activity Contact person akanmorib@who.int
PIN 168789
Activity Title Global Unified AEFI Reference Dataset (GUARD)‐Phase I.
Funding status Under review
Priority Under review
Expected end product
Table of contents for a global version of a Global Unified AEFI Reference Dataset (GUARD) and two to three prototype chapters focused on specific AEFI.
Completion date
On hold
Activity Contact person jan.bonhoeffer@gmail.com
Priority *
Priority 1: Key activity for which funding is immediately needed.
Priority 2: Important activity for which funding is recommended.
Priority 3: Desirable activity that should be part of a full GSVI work plan.
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PIN 168787
Activity Title Web Based Causality Assessment Tool.
Funding status Not Funded
Priority 2
Expected end product
A web based version of the WHO causality assessment algorithm.
Completion date 2014
Planned
Activity Contact person jan.bonhoeffer@gmail.com
PIN 168784
Activity Title Optimizing signal analysis in VigiBase for vaccine related individual case safety reports (ICSRs).
Funding status Funded
Priority 1
Expected end product
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 Activity Contact person sten.olsson@who‐umc.org
PIN 168738
Activity Title Training to strengthen AEFI monitoring and causality assessment in one EMRO country.
Funding status Funded
Priority 1
Expected end product
Training of NRA and EPI staff on AEFI monitoring, causality assessment and strengthening of the national Pharmacovigilance system.
Completion date 2013
Ongoing
Activity Contact person langarh@who.int
Priority *
Priority 1: Key activity for which funding is immediately needed.
Priority 2: Important activity for which funding is recommended.
Priority 3: Desirable activity that should be part of a full GSVI work plan.
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PIN 168795
Activity Title Regional consultation for harmonization of guidelines for on surveillance for intussusception surveillance.
Funding status Funded
Priority 1
Expected end product
Common guidelines for intussusception surveillance developed.
Completion date 2013
Planned
Activity Contact person akanmorib@who.int
PIN 168731
Activity Title Translation of Standardized Brighton Case Definitions.
Funding status Not Funded
Priority 1
Expected end product
Translation of Brighton Collaboration Case definitions in all WHO official languages.
Completion date
Planned
Activity Contact person jan.bonhoeffer@gmail.com
PIN 168812
Activity Title Global Unified AEFI Reference Dataset (GUARD)‐Phase III.
Funding status Not Funded
Priority Under review
Expected end product
GUARD III maintains and expands the meta‐table of Guard II and implements it to serve as a widely shared and used resource.
Completion date
On hold
Activity Contact person jan.bonhoeffer@gmail.com
Priority *
Priority 1: Key activity for which funding is immediately needed.
Priority 2: Important activity for which funding is recommended.
Priority 3: Desirable activity that should be part of a full GSVI work plan.
Page 11 of 31GVSI Porfolio Directory 2012‐2020 Version dated 30 October 2013
PIN 168816
Activity Title Pilot deployment of electronic patient management systems to comprehensively capture immunization history including AEFIs in LMIC
Funding status Not Funded
Priority Under review
Expected end product
Electronic patient management system capturing comprehensive immunization history (dates, vaccines used, lot numbers, etc) as well as any adverse events following immunization.
Completion date 2015
On hold
Activity Contact person alexooo@yahoo.com
PIN 168733
Activity Title Automatic case classification of spontaneous reports.
Funding status Funded
Priority 1
Expected end product
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
Completion date 2013
Planned
Activity Contact person jan.bonhoeffer@gmail.com
PIN 168818
Activity Title External, prospective and longitudinal assessment of the global vaccine safety initiative (GVSI)
Funding status Not Funded
Priority Under review
Expected end product
Reports on the activities of the GVSI and how they meet the vision and strategic objectives of the GVSI
Completion date 2016
On hold
Activity Contact person alexooo@yahoo.com
Priority *
Priority 1: Key activity for which funding is immediately needed.
Priority 2: Important activity for which funding is recommended.
Priority 3: Desirable activity that should be part of a full GSVI work plan.
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PIN 168821
Activity Title Maintenance and development of the vaccine dictionary.
Funding status Not Funded
Priority
Expected end product
Updated vaccine dictionary
Completion date 2020 Activity Contact person sten.olsson@who‐umc.org
PIN 169706
Activity Title New designs for integrated benefit risk assessment
Funding status Funded
Priority 1
Expected end product
Methods for integrated benefit/risk assessment of vaccines.
Completion date 2015
Planned
Activity Contact person jan.bonhoeffer@gmail.com
PIN 168732
Activity Title Ad hoc case definition development.
Funding status Not Funded
Priority 1
Expected end product
Ad hoc case definition as prioritized by WHO.
Completion date 2020
Planned
Activity Contact person jan.bonhoeffer@gmail.com
Priority *
Priority 1: Key activity for which funding is immediately needed.
Priority 2: Important activity for which funding is recommended.
Priority 3: Desirable activity that should be part of a full GSVI work plan.
Page 13 of 31GVSI Porfolio Directory 2012‐2020 Version dated 30 October 2013
PIN 168728
Activity Title Development and evaluation of narcolepsy case definition and investigation of reporting patterns of narcolepsy over time.
Funding status Funded
Priority 1
Expected end product
Publication of narcolepsy case definition and report on changes of reporting patterns in international databases.
Completion date 2013
Ongoing
Activity Contact person jan.bonhoeffer@gmail.com
PIN 168729
Activity Title Algorithms for case validation of AEFI following influenza vaccines.
Funding status Not Funded
Priority 3
Expected end product
Algorithms for all AEFI developed.
Completion date
Planned
Activity Contact person jan.bonhoeffer@gmail.com
PIN 168730
Activity Title Standardized disease concepts for international collaborative studies.
Funding status Not Funded
Priority 3
Expected end product
Library of mapped and standardized disease concepts across different coding terminologies for international collaborative studies.
Completion date
Planned
Activity Contact person jan.bonhoeffer@gmail.com
Priority *
Priority 1: Key activity for which funding is immediately needed.
Priority 2: Important activity for which funding is recommended.
Priority 3: Desirable activity that should be part of a full GSVI work plan.
Page 14 of 31GVSI Porfolio Directory 2012‐2020 Version dated 30 October 2013
PIN 168811
Activity Title Global Unified AEFI Reference Dataset (GUARD)‐Phase II.
Funding status Not Funded
Priority Under review
Expected end product
GUARD II tests, refines and expands GUARD I and prepares business plan for maintenance.
Completion date
On hold
Activity Contact person jan.bonhoeffer@gmail.com
PIN 168751
Activity Title Development of standard AEFI reporting form.
Funding status Funded
Priority 1
Expected end product
Model AEFI reporting form available online.
Completion date 2012
Completed
Activity Contact person balakrishnanm@who.int
PIN 168777
Activity Title Support harmonization of databases including ESAVIs fields in national Pharmacovigilance systems.
Funding status Not Funded
Priority 1
Expected end product
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.
Completion date 2015
Planned
Activity Contact person pombomar@who.int
Priority *
Priority 1: Key activity for which funding is immediately needed.
Priority 2: Important activity for which funding is recommended.
Priority 3: Desirable activity that should be part of a full GSVI work plan.
Page 15 of 31GVSI Porfolio Directory 2012‐2020 Version dated 30 October 2013
PIN 168764
Activity Title Update regional ESAVI guidelines and standard operational procedures (SOP), including causality assessment algorithm.
Funding status Not Funded
Priority 1
Expected end product
Updated safety package of training, which includes ESAVI monitoring, causality assessment and risk communication.
Completion date 2014
Planned
Activity Contact person pamelab@who.int
PIN 168756
Activity Title Information sheets on vaccine reaction rates.
Funding status Funded
Priority 1
Expected end product
Information sheets on vaccine reaction rates.
Completion date 2013
Ongoing
Activity Contact person lambachp@who.int
PIN 168755
Activity Title Development of a Vaccine Pharmacovigilance Toolkit.
Funding status Funded
Priority 1
Expected end product
A WHO Vaccine Pharmacovigilance Toolkit.
Completion date 2013
Ongoing
Activity Contact person alexooo@yahoo.com
Priority *
Priority 1: Key activity for which funding is immediately needed.
Priority 2: Important activity for which funding is recommended.
Priority 3: Desirable activity that should be part of a full GSVI work plan.
Page 16 of 31GVSI Porfolio Directory 2012‐2020 Version dated 30 October 2013
PIN 168753
Activity Title AEFI Causalty Assessment classification.
Funding status Funded
Priority 1
Expected end product
A tool for assessing causality at individual level including a manual and aide‐memoire.
Completion date 2013
Completed
Activity Contact person balakrishnanm@who.int
PIN 168770
Activity Title Scoping exercise on innovative clinical trial design & optimal allocation of safety data collection at each phase of the product development cycle
Funding status Not Funded
Priority 1
Expected end product
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
Completion date
Planned
Activity Contact person hombachj@who.int
PIN 168747
Activity Title Provide a repository for the storage of national AEFI reports.
Funding status Funded
Priority 1
Expected end product
A national electronic repository linked to the UMC database.
Completion date 2014
Ongoing
Activity Contact person balakrishnanm@who.int
Priority *
Priority 1: Key activity for which funding is immediately needed.
Priority 2: Important activity for which funding is recommended.
Priority 3: Desirable activity that should be part of a full GSVI work plan.
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PIN 168748
Activity Title Defining essential information for AEFI reporting.
Funding status Funded
Priority 1
Expected end product
AEFI Core Variables identified and available online.
Completion date 2012
Completed
Activity Contact person balakrishnanm@who.int
PIN 168775
Activity Title Develop norms and reference documents on risk‐benefit reports and risk management.
Funding status Not Funded
Priority 1
Expected end product
New documents on risk management and periodic safety update reports. Good Pharmacovigilance practices updated.
Completion date 2014
Planned
Activity Contact person pombomar@who.int
Priority *
Priority 1: Key activity for which funding is immediately needed.
Priority 2: Important activity for which funding is recommended.
Priority 3: Desirable activity that should be part of a full GSVI work plan.
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5 ‐ Regulatory framework
PIN 168750
Activity Title Updated benchmarks for vaccine pharmacovilance function of the NRA assessments.
Funding status Funded
Priority 1
Expected end product
Revised list of indicators and sub‐indicators of the vaccine pharmacovigilance function of the WHO NRA assessment tool.
Completion date 2012
Completed
Activity Contact person maurec@who.int
PIN 168772
Activity Title Support NRA exchange and analysis of information for decision making on vaccine safety issues.
Funding status Partially Funded
Priority 1
Expected end product
Establishment of Network for monitoring and analyzing reports in pharmacovigilance centers in two PAHO countries.
Completion date 2015
Planned
Activity Contact person pombomar@who.int
PIN 168776
Activity Title Improve National PV centres performance through a quality evaluation program.
Funding status Not Funded
Priority 2
Expected end product
Develop indicators to assess the performance of PV centers and pilot in two PAHO countries.
Completion date 2015
Planned
Activity Contact person pombomar@who.int
Priority *
Priority 1: Key activity for which funding is immediately needed.
Priority 2: Important activity for which funding is recommended.
Priority 3: Desirable activity that should be part of a full GSVI work plan.
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PIN 168774
Activity Title Staff in information centres trained on critical information appraisal and communication and supporting the pharmacovigilance network. Bulletin of medicines information centers designed and disseminated.
Funding status Partially Funded
Priority 1
Expected end product
Staff in information centres trained on critical information appraisal and communication and supporting the pharmacovigilance network.
Completion date 2015
Ongoing
Activity Contact person pombomar@who.int
PIN 168752
Activity Title Perform national vaccine PV system evaluation against agreed benchmarks (NRA assessment tool).
Funding status Funded
Priority 1
Expected end product
Perform national vaccine PV system assessment in at least 5 countries per year.
Completion date 2020
Ongoing
Activity Contact person maurec@who.int
PIN 168742
Activity Title Review of AEFI surveillance system in one EMRO country.
Funding status Funded
Priority 1
Expected end product
Review of NRA system in one EMRO country and establishment of institutional development plan.
Completion date 2012
Completed
Activity Contact person langarh@who.int
Priority *
Priority 1: Key activity for which funding is immediately needed.
Priority 2: Important activity for which funding is recommended.
Priority 3: Desirable activity that should be part of a full GSVI work plan.
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6 ‐ Technical support and trainings
PIN 168759
Activity Title Basic training toolkit for trainers in countries.
Funding status Funded
Priority 1
Expected end product
PPT training package developed in collaboration with international experts.
Completion date 2012
Completed
Activity Contact person lambachp@who.int
PIN 168758
Activity Title E‐learning training material on Vaccine Safety.
Funding status Funded
Priority 1
Expected end product
E‐learning course on Vaccine Safety.
Completion date 2012
Completed
Activity Contact person lambachp@who.int
PIN 168813
Activity Title Annual global vaccine safety update.
Funding status Partially Funded
Priority 3
Expected end product
Annual one day scientific conference and publication
Completion date 2020
Ongoing
Activity Contact person jan.bonhoeffer@gmail.com
Priority *
Priority 1: Key activity for which funding is immediately needed.
Priority 2: Important activity for which funding is recommended.
Priority 3: Desirable activity that should be part of a full GSVI work plan.
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PIN 168757
Activity Title Global learning resource centre.
Funding status Funded
Priority 1
Expected end product
Web‐platform linking to E‐learning tools, trainer databases, PPT toolkits and a contact to organize WHO trainings in countries.
Completion date 2012
Completed
Activity Contact person lambachp@who.int
PIN 168754
Activity Title Establish global pool of qualified trainers for WHO trainings in countries
Funding status Funded
Priority 1
Expected end product
Development of a Web based database of experts.
Completion date 2013
Ongoing
Activity Contact person bellaham@who.int
PIN 168760
Activity Title Strengthening of ESAVI Committees and members.
Funding status Partially Funded
Priority 1
Expected end product
Regional Standard Operational Procedures Guidelines, to support the constitution of ESAVI Committees at the national level.
Completion date 2013
Ongoing
Activity Contact person pamelab@who.int
Priority *
Priority 1: Key activity for which funding is immediately needed.
Priority 2: Important activity for which funding is recommended.
Priority 3: Desirable activity that should be part of a full GSVI work plan.
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PIN 168762
Activity Title Enhance the causality assessment capacity of vaccine pharmacovigilance officers.
Funding status Partially Funded
Priority 1
Expected end product
Report and insights to continuously improve the methodology.
Completion date 2013
Ongoing
Activity Contact person pamelab@who.int
PIN 170799
Activity Title Global Vaccine Safety Risk Communication Training
Funding status Not Funded
Priority
Expected end product
Regional workshops held.
Completion date 2015
Ongoing
Activity Contact person lambachp@who.int
PIN 168749
Activity Title Strengthening network countries capacity for data analysis and signal detection.
Funding status Funded
Priority 1
Expected end product
1‐Standard training package on AEFI data analysis and signal detection. 2‐Workshop conducted in the 12 network countries.
Completion date 2014
Ongoing
Activity Contact person maurec@who.int
Priority *
Priority 1: Key activity for which funding is immediately needed.
Priority 2: Important activity for which funding is recommended.
Priority 3: Desirable activity that should be part of a full GSVI work plan.
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PIN 168745
Activity Title Regional Vaccine Safety Workshop in Asia.
Funding status Not Funded
Priority 1
Expected end product
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.
Completion date 2013
Planned
Activity Contact person AjitPalSingh@ivi.int
PIN 168793
Activity Title Training for AEFI for two countries each in ITST West and IST Central Africa
Funding status Funded
Priority 1
Expected end product
Training and capacity building for MOH and NRA staff on vaccine safety.
Completion date 2013
Ongoing
Activity Contact person akanmorib@who.int
PIN 168726
Activity Title Training course on vaccines safety provided by US FDA (CBER) to participants of UMC annual pharmacovigilance training course and others
Funding status Funded
Priority 1
Expected end product
A training for healthcare professionals with a special interest in vaccine safety assessment, specifically as applied by US FDA.
Completion date 2013
Ongoing
Activity Contact person sten.olsson@who‐umc.org
Priority *
Priority 1: Key activity for which funding is immediately needed.
Priority 2: Important activity for which funding is recommended.
Priority 3: Desirable activity that should be part of a full GSVI work plan.
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PIN 168781
Activity Title To conduct refresher training on AEFI detection and reporting in one SEARO country.
Funding status Funded
Priority 1
Expected end product
Trained 79 trainers who in turn trained 523 EPI and AEFI focal persons on AEFI detection analysis and reporting at the district level.
Completion date 2013
Completed
Activity Contact person guichards@who.int
PIN 168741
Activity Title First regional meeting on pharmacovigilance of vaccines.
Funding status Funded
Priority 1
Expected end product
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.
Completion date 2012
Completed
Activity Contact person langarh@who.int
PIN 168779
Activity Title Support to the establishment of the national AEFI secretariat in one SEARO country
Funding status Funded
Priority 1
Expected end product
Operational national AEFI committee to collect, analyze and report AEFI cases.
Completion date 2013
Completed
Activity Contact person guichards@who.int
Priority *
Priority 1: Key activity for which funding is immediately needed.
Priority 2: Important activity for which funding is recommended.
Priority 3: Desirable activity that should be part of a full GSVI work plan.
Page 25 of 31GVSI Porfolio Directory 2012‐2020 Version dated 30 October 2013
PIN 168737
Activity Title AEFI training workshop for countries in WPRO region.
Funding status Partially Funded
Priority 1
Expected end product
Capacity building for EPI and NRA staff on vaccine safety in WPRO region.
Completion date 2018
Ongoing
Activity Contact person hossains@who.int
PIN 168786
Activity Title Provide access to online training for vaccine safety to avaref countries.
Funding status Funded
Priority 1
Expected end product
NRA staff trained on vaccine safety.
Completion date 2013
Planned
Activity Contact person akanmorib@who.int
PIN 168773
Activity Title Support NRA capacity building.
Funding status Partially Funded
Priority 1
Expected end product
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.
Completion date 2015
Ongoing
Activity Contact person pombomar@who.int
Priority *
Priority 1: Key activity for which funding is immediately needed.
Priority 2: Important activity for which funding is recommended.
Priority 3: Desirable activity that should be part of a full GSVI work plan.
Page 26 of 31GVSI Porfolio Directory 2012‐2020 Version dated 30 October 2013
PIN 168739
Activity Title Second regional meeting on pharmacovigilance of vaccines.
Funding status Funded
Priority 1
Expected end product
Training and capacity building on vaccine safety communication.
Completion date 2013
Ongoing
Activity Contact person langarh@who.int
PIN 168809
Activity Title Develop a vaccine safety fellowship training programme.
Funding status Not Funded
Priority Under review
Expected end product
Annual training of 2 to 4 vaccine safety specialists.
Completion date
On hold
Activity Contact person jan.bonhoeffer@gmail.com
PIN 168735
Activity Title Training modules for pharmacoepidemiologic vaccine safety studies.
Funding status Not Funded
Priority 1
Expected end product
Development of 4 advanced modules for vaccine safety assessment with specific focus on standard methodology, signal verification and hypothesis testing.
Completion date 2014
On hold
Activity Contact person jan.bonhoeffer@gmail.com
Priority *
Priority 1: Key activity for which funding is immediately needed.
Priority 2: Important activity for which funding is recommended.
Priority 3: Desirable activity that should be part of a full GSVI work plan.
Page 27 of 31GVSI Porfolio Directory 2012‐2020 Version dated 30 October 2013
PIN 168796
Activity Title Regional Vaccinology course.
Funding status Partially Funded
Priority 1
Expected end product
Trained NRAs staff.
Completion date 2013
Planned
Activity Contact person akanmorib@who.int
PIN 168765
Activity Title Identify and establish accredited training institutions at global, regional, and sub‐regional levels.
Funding status Not Funded
Priority 1
Expected end product
Availability of a training network with harmonized curriculas, translation of training materials, adaptation of training modules based on the evolution of science.
Completion date 2015
Planned
Activity Contact person lambachp@who.int
PIN 168740
Activity Title Training on AEFI and causality assessment in one EMRO country.
Funding status Funded
Priority 1
Expected end product
Training of NRA and EPI staff on AEFI monitoring, causality assessment and strengthening of the national Pharmacovigilance system.
Completion date 2013
Ongoing
Activity Contact person langarh@who.int
Priority *
Priority 1: Key activity for which funding is immediately needed.
Priority 2: Important activity for which funding is recommended.
Priority 3: Desirable activity that should be part of a full GSVI work plan.
Page 28 of 31GVSI Porfolio Directory 2012‐2020 Version dated 30 October 2013
PIN 168808
Activity Title Vaccine safety fellowship.
Funding status Not Funded
Priority Under review
Expected end product
A framework and curriculum for a Vaccine Safety Fellowship
Completion date
On hold
Activity Contact person jan.bonhoeffer@gmail.com
PIN 168783
Activity Title Conduct AEFI training workshop in two SEARO countries.
Funding status Funded
Priority 1
Expected end product
60 EPI and AEFI focal persons trained on AEFI detection and reporting.
Completion date 2012
Completed
Activity Contact person guichards@who.int
Priority *
Priority 1: Key activity for which funding is immediately needed.
Priority 2: Important activity for which funding is recommended.
Priority 3: Desirable activity that should be part of a full GSVI work plan.
Page 29 of 31GVSI Porfolio Directory 2012‐2020 Version dated 30 October 2013
7 ‐ Global analysis and response
PIN 168761
Activity Title Establishment of a Regional Advisory Group on Vaccine Safety.
Funding status Partially Funded
Priority 1
Expected end product
Regional meeting to review selected safety cases and publication of a report and article for each meeting.
Completion date 2013
Ongoing
Activity Contact person pamelab@who.int
PIN 168767
Activity Title Publish GACVS assessments in WER within 6 weeks of the committee deliberations.
Funding status Funded
Priority 1
Expected end product
Up‐to‐date GACVS review of vaccine safety profiles published in WER since 1999.
Completion date 2020
Ongoing
Activity Contact person zuberp@who.int
PIN 168766
Activity Title Rapidly and effectively deal with serious vaccine‐related adverse events in order to maintain confidence in a vaccine.
Funding status Funded
Priority 1
Expected end product
Technical support for investigation, analysis and response with the possibility of prompt independent expert advice.
Completion date 2020
Ongoing
Activity Contact person zuberp@who.int
Priority *
Priority 1: Key activity for which funding is immediately needed.
Priority 2: Important activity for which funding is recommended.
Priority 3: Desirable activity that should be part of a full GSVI work plan.
Page 30 of 31GVSI Porfolio Directory 2012‐2020 Version dated 30 October 2013
8 ‐ Public private interaction
PIN 168819
Activity Title To put in place systems for information exchange mechanisms between national governments, multilateral agencies and manufacturers.
Funding status Partially Funded
Priority 1
Expected end product
Improved information exchange mechanisms between industry and public sector.
Completion date 2013
Planned
Activity Contact person info@cioms.ch
Priority *
Priority 1: Key activity for which funding is immediately needed.
Priority 2: Important activity for which funding is recommended.
Priority 3: Desirable activity that should be part of a full GSVI work plan.
Page 31 of 31GVSI Porfolio Directory 2012‐2020 Version dated 30 October 2013