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Global Vaccine Safety Initiative Portfolio directory
2012-2020
Safety and Vigilance (SAV)
Health Systems and Innovation (HIS)
World Health Organization
Geneva, Switzerland
1 July 2014
i
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.
ii
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
iii
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 i l t d ith hi ll li it d i l t ti
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).
iv
Figure 1: GVSI prioritization scheme
Overview of the GVSI portfolio activities
The current GVSI portfolio includes activities reviewed by the Planning Group at the May 2014 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 [email protected]
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
Portfolio directory
1 - AEFI detection
PIN 168794
Activity Title Promote harmonization through adoption of common post-marketing surveillance strategy in the 23
AVAREF countries.
Funding status Funded
Priority 1
Expected end product
Trained NRAs staff and improved PMS in the 23 AVAREF countries.
Ongoing
Contact person: [email protected]
End product
PIN 187200
Activity Title Development of a web application for assisting users in the field during causality assessment of
AEFIs
Funding status Not Funded
Priority 1
Expected end product
A web platform that extends the algorithm tool developed on paper, with an user interface available
for computers, tablets, and cellular phones. The platform should provide assistance in the application
of the algorithm to users in the field from everywhe
Planned
Contact person: [email protected]
End product
PIN 172449
Activity Title Determine the minimum level of diagnostics certainty required to have sufficient positive predictive
value for AEFI surveillance.
Funding status Not Funded
Priority 1
Expected end product
Analysis of the currently available level of detail for case verification in the 6-8 databases with
Brighton Collaboration case definitions as a reference. Remmendation for minimum level of
diagnostics certainty required to have sufficient positive predic
Planned
Contact person: [email protected]
End product
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.
GVSI Porfolio Directory 2012-2020 Version 1 July 2014 Page 2
PIN 203447
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.
Ongoing
Contact person: [email protected]
End product
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.
Ongoing
Contact person: [email protected]
End product
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 of sustainable pharmacovigilance (IT)
systems in participating countries for analysis of data and response on vaccine safety issues of
regional importance.
Completed
Contact person: [email protected]
End product
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.
GVSI Porfolio Directory 2012-2020 Version 1 July 2014 Page 3
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.
Ongoing
Contact person: [email protected]
End product
PIN 168780
Activity Title Pilot project in one SEARO country to field test new AEFI notification forms including serious and
non-serious AEFI and to update AEFI investigation template which meet the requirements for new
vaccine introduction.
Funding status Funded
Priority 1
Expected end product
Finalized notification forms, updated AEFI investigation template.
Completed
Contact person: [email protected]
End product
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 SEARO country.
Funding status Partially Funded
Priority 2
Expected end product
A comparison of the safety data from spontaneous reports related to MMR and Live JE Vaccine with
the CEM. A broader understanding of CEM as a pharmacovigilance tool to assess safety profile in an
immunization programme in a developing country setting.
Ongoing
Contact person: [email protected]
End product
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.
GVSI Porfolio Directory 2012-2020 Version 1 July 2014 Page 4
PIN 168771
Activity Title Study on factors affecting AEFI detection in one SEARO country.
Funding status Funded
Priority 1
Expected end product
Analysis of factors that prevent AEFI reporting at each level of the immunization delivery system.
Ongoing
Contact person: [email protected]
End product
PIN 199993
Activity Title Meeting to review intussusception surveillance in one EMRO country to monitor the progress and
data.
Funding status Funded
Priority 1
Expected end product
Evaluation of vaccine safety following rotavirus vaccination.
Planned
Contact person: [email protected]
End product
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.
GVSI Porfolio Directory 2012-2020 Version 1 July 2014 Page 5
2 - Investigation of Safety Signals
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.
Completed
Contact person: [email protected]
End product
PIN 168814
Activity Title Multi-country collaboration project.
Funding status Funded
Priority 1
Expected end product
Network of hospital based sentinel sites established to provide timely risk-benefit information on
vaccine safety issues that have the potential to affect national immunization programs, market
availability and indications of new and existing vaccines
Ongoing
Contact person: [email protected]
End product
PIN 168782
Activity Title To conduct post marketing vaccine safety study in one SEARO country.
Funding status Funded
Priority 1
Expected end product
Background rates of AEFI in one SEARO country introducing pentavalent vaccine.
Planned
Contact person: [email protected]
End product
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.
GVSI Porfolio Directory 2012-2020 Version 1 July 2014 Page 6
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.
Ongoing
Contact person: [email protected]
End product
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 production of an
Institutional Development Plan (IDP) to strengthen the AEFI surveillance. 2-A protocol for the
surveillance of the intussusception.
Completed
Contact person: [email protected]
End product
PIN 203642
Activity Title Study on child deaths following pentavalent vaccine administration in one SEARO country
Funding status Funded
Priority 1
Expected end product
Study report and publication to support policy decision making.
Ongoing
Contact person: [email protected]
End product
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.
GVSI Porfolio Directory 2012-2020 Version 1 July 2014 Page 7
PIN 198325
Activity Title Global Network of Immunisation Clinics.
Funding status Not Funded
Priority 1
Expected end product
A database of AEFI clinics/services/centres worldwide (e.g. call among the BC network). Landscape
analysis of centres (e.g., call among the BC network members). Gap analysis.
Planned
Contact person: [email protected]
End product
PIN 203641
Activity Title Study on meningococcal vaccine administered during pregnancy in one AFRO country
Funding status Funded
Priority 1
Expected end product
Study report and publication to support policy decision.
Ongoing
Contact person: [email protected]
End product
PIN 168803
Activity Title To validate standardized case definitions for usefulness in LMIC
Funding status Not Funded
Priority 1
Expected end product
Brighton Collaboration case definitions validated in one country.
Planned
Contact person: [email protected]
End product
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.
GVSI Porfolio Directory 2012-2020 Version 1 July 2014 Page 8
3 - Vaccine safety communication
PIN 172445
Activity Title Public confidence assessment as an integral part of comprehensive safety monitoring in Latin
America
Funding status Not Funded
Priority 1
Expected end product
Language concepts, terminology mappings, pertinent to the specified concerns. Results from
published literature available. Geographic mapping of the evolution of the concerns. Analysis of local
contextual risk factors of the concern. Description of approa
Planned
Contact person: [email protected]
End product
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).
Planned
Contact person: [email protected]
End product
PIN 168800
Activity Title Methods for rumor detection in public media.
Funding status Funded
Priority 1
Expected end product
Method for signal detection of vaccine safety concerns in public media.
Ongoing
Contact person: [email protected]
End product
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.
GVSI Porfolio Directory 2012-2020 Version 1 July 2014 Page 9
PIN 168799
Activity Title Crystallising the drivers of public concern to understanding geographic and cultural differences in
concern evolution
Funding status Not Funded
Priority 2
Expected end product
Geographic and cultural information of public concerns to guide program implementation.
Planned
Contact person: [email protected]
End product
PIN 168798
Activity Title Understanding the impact of public concerns on coverage of new or new to market vaccines;
example pentavalent vaccine in the signalling country in SEARO and beyond.
Funding status Not Funded
Priority 3
Expected end product
Cost-benefit analysis of the concern and mitigation efforts for program stability.
Planned
Contact person: [email protected]
End product
PIN 168725
Activity Title Vaccine Safety Net.
Funding status Funded
Priority 1
Expected end product
A web based list of websites providing reliable information on vaccine safety posted on the WHO
website.
Ongoing
Contact person: [email protected]
End product http://www.who.int/vaccine_safety/initiative/communication/network/approved_vaccine_safety_website/en/index.html
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.
GVSI Porfolio Directory 2012-2020 Version 1 July 2014 Page 10
4 - Tools and methods
PIN 203522
Activity Title Global Unified AEFI Reference Dataset (GUARD)-Phase II.
Funding status Not Funded
Priority 1
Expected end product
GUARD II tests, refines and expands GUARD I and prepares business plan for maintenance.
Planned
Contact person: [email protected]
End product
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.
Ongoing
Contact person: [email protected]
End product
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
Ongoing
Contact person: [email protected]
End product
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.
GVSI Porfolio Directory 2012-2020 Version 1 July 2014 Page 11
PIN 203529
Activity Title CIOMS working group on vaccine safety: develop a template dossier to support countries with limited
regulatory capacity when introducing a new product
Funding status Funded
Priority 1
Expected end product
Template dossier to support vaccine introduction in countries with limited regulatory capacities.
Ongoing
Contact person: [email protected]
End product
PIN 204838
Activity Title Translation of the pharmacovigilance toolkit into various languages.
Funding status Not Funded
Priority 1
Expected end product
Pharmacovigilance toolkit available online in various languages.
Planned
Contact person: [email protected]
End product
PIN 203528
Activity Title CIOMS working group on vaccine safety: develop a guidance document to setup active surveillance
system
Funding status Funded
Priority 1
Expected end product
A guideline for setting up an active surveillance system.
Ongoing
Contact person: [email protected]
End product
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.
GVSI Porfolio Directory 2012-2020 Version 1 July 2014 Page 12
PIN 168789
Activity Title Global Unified AEFI Reference Dataset (GUARD)-Phase I.
Funding status Partially Funded
Priority 1
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.
Completed
Contact person: [email protected]
End product
PIN 203524
Activity Title Global Unified AEFI Reference Dataset (GUARD)-Phase III.
Funding status Not Funded
Priority 1
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.
Planned
Contact person: [email protected]
End product
PIN 178165
Activity Title Establishment of an AEFI surveillance system in 3 WPRO countries.
Funding status Not Funded
Priority 1
Expected end product
Functional AEFI surveillance system established in 3 WPRO countries.
Planned
Contact person: [email protected]
End product
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.
GVSI Porfolio Directory 2012-2020 Version 1 July 2014 Page 13
PIN 168795
Activity Title AFRO regional consultation to develop harmonized methodology for the surveillance of the
intussusception.
Funding status Funded
Priority 1
Expected end product
An harmonized AFRO regional strategy for the surveillance of the intussusception.
Ongoing
Contact person: [email protected]
End product
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.
Ongoing
Contact person: [email protected]
End product
PIN 198318
Activity Title Adverse events of special interest following immunization during pregnancy and guidance for their
assessment
Funding status Funded
Priority 1
Expected end product
A core list of maternal and neonatal adverse events of special interest (AESI) following maternal or
neonatal immunization. A set of draft standardized AESI definitions. A set of AESI definitions in need
of standardization. A guidance document for monitor
Ongoing
Contact person: [email protected]
End product
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.
GVSI Porfolio Directory 2012-2020 Version 1 July 2014 Page 14
PIN 178172
Activity Title Development of a communication guideline for vaccine safety response.
Funding status Not Funded
Priority 1
Expected end product
A communication guideline for vaccine safety response available for the WPRO region.
Ongoing
Contact person: [email protected]
End product
PIN 168791
Activity Title Adapt existing AFRO regional AEFI guidelines.
Funding status Funded
Priority 1
Expected end product
Training and capacity building of MOH and NRA staff in AFRO region. Vaccine safety surveillance
system strengthened.
Ongoing
Contact person: [email protected]
End product
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.
Completed
Contact person: [email protected]
End product
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.
GVSI Porfolio Directory 2012-2020 Version 1 July 2014 Page 15
PIN 168751
Activity Title Development of standard AEFI reporting form.
Funding status Funded
Priority 1
Expected end product
Model AEFI reporting form available online.
Completed
Contact person: [email protected]
End product http://www.who.int/vaccine_safety/REPORTING_FORM_FOR_ADVERSE_EVENTS_FOLLOWING_IMMUNIZATION.pdf
PIN 168753
Activity Title AEFI Causality Assessment classification.
Funding status Funded
Priority 1
Expected end product
A tool for assessing causality at individual level including a manual and an aide-memoire.
Completed
Contact person: [email protected]
End product http://www.who.int/vaccine_safety/publications/aevi_manual.pdf
PIN 168755
Activity Title Development of a Vaccine Pharmacovigilance Toolkit.
Funding status Funded
Priority 1
Expected end product
A Vaccine Pharmacovigilance Toolkit available online.
Completed
Contact person: [email protected]
End product http://pvtoolkit.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.
GVSI Porfolio Directory 2012-2020 Version 1 July 2014 Page 16
PIN 168756
Activity Title Information sheets on vaccine reaction rates.
Funding status Funded
Priority 1
Expected end product
Information sheets on vaccine reaction rates.
Ongoing
Contact person: [email protected]
End product http://www.who.int/vaccine_safety/initiative/tools/vaccinfosheets/en/index.html
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.
Completed
Contact person: [email protected]
End product http://www.who.int/vaccine_safety/news/AEFI_Core_Variables_2013.pdf
PIN 168736
Activity Title Developing Regional AEFI guidelines.
Funding status Funded
Priority 1
Expected end product
Publication: Immunization Safety Surveillance.
Completed
Contact person: [email protected]
End product http://www.wpro.who.int/topics/immunization_safety/ImmunizationSafetySurveillance.pdf
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.
GVSI Porfolio Directory 2012-2020 Version 1 July 2014 Page 17
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
Planned
Contact person: [email protected]
End product
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.
Planned
Contact person: [email protected]
End product
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.
Planned
Contact person: [email protected]
End product
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.
GVSI Porfolio Directory 2012-2020 Version 1 July 2014 Page 18
PIN 168730
Activity Title Develop a global reference map of disease codes across coding terminologies (e.g., MedDRA, ICD
9, ICD10) to promote global data comparability
Funding status Not Funded
Priority 3
Expected end product
Library of mapped and standardized disease concepts across different coding terminologies for
international collaborative studies.
Planned
Contact person: [email protected]
End product
PIN 168729
Activity Title Algorithms for diagnosis and clinical care of patients with AEFI
Funding status Not Funded
Priority 3
Expected end product
Algorithms for all AEFI developed.
Planned
Contact person: [email protected]
End product
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.
Completed
Contact person: [email protected]
End product
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.
GVSI Porfolio Directory 2012-2020 Version 1 July 2014 Page 19
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.
Ongoing
Contact person: [email protected]
End product
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.
GVSI Porfolio Directory 2012-2020 Version 1 July 2014 Page 20
5 - Regulatory framework
PIN 168776
Activity Title Improve National Pharmacovigilance centres performance through a quality evaluation program.
Funding status Not Funded
Priority 1
Expected end product
Develop indicators to assess the performance of pharmacovigilance centres and pilot in two PAHO
countries.
Planned
Contact person: [email protected]
End product
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.
Ongoing
Contact person: [email protected]
End product
PIN 168750
Activity Title Updated benchmarks for vaccine pharmacovigilance 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.
Completed
Contact person: [email protected]
End product
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.
GVSI Porfolio Directory 2012-2020 Version 1 July 2014 Page 21
PIN 168752
Activity Title Perform national vaccine pharmacovigilance system evaluation against agreed benchmarks (NRA
assessment tool).
Funding status Funded
Priority 1
Expected end product
Perform national vaccine pharmacovigilance system assessment in at least 5 countries per year.
Ongoing
Contact person: [email protected]
End product
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 a network for monitoring and analyzing reports in pharmacovigilance centres in two
PAHO countries.
Ongoing
Contact person: [email protected]
End product
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.
Completed
Contact person: [email protected]
End product
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.
GVSI Porfolio Directory 2012-2020 Version 1 July 2014 Page 22
6 - Technical support and trainings
PIN 187631
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.
Planned
Contact person: [email protected]
End product
PIN 199956
Activity Title Training course on AEFI investigation for one EMRO country.
Funding status Under Review
Priority 1
Expected end product
Develop AEFI investigation form as per WHO recommendations for one EMRO country.
Planned
Contact person: [email protected]
End product
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.
Ongoing
Contact person: [email protected]
End product
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.
GVSI Porfolio Directory 2012-2020 Version 1 July 2014 Page 23
PIN 200035
Activity Title Participation to a workshop for strengthening pharmacovigilance in Arabic speaking countries from
22-26 September 2014.
Funding status Funded
Priority 1
Expected end product
Raising awareness about the GVSI, the Blueprint and what WHO can offer as technical assistance.
Participants will learn methodologies for data analysis and AEFI causality assessment.
Planned
Contact person: [email protected]
End product
PIN 187621
Activity Title EMRO regional training workshop on WHO revised methodology for AEFI causality assessment.
Funding status Funded
Priority 1
Expected end product
Trained staff to understand and implement the new methodology for assessing the AEFI cases in
their respective countries. An action plan to improve the effectiveness of the AEFI monitoring by
addressing the reporting, analysis, investigation and causality
Planned
Contact person: [email protected]
End product
PIN 168739
Activity Title Second EMRO regional meeting on vaccine pharmacovigilance.
Funding status Funded
Priority 1
Expected end product
Training and capacity building on vaccine safety communication in EMRO region.
Completed
Contact person: [email protected]
End product
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 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.
Planned
Contact person: [email protected]
End product
PIN 200158
Activity Title Review of AEFI surveillance system performance in one EMRO country
Funding status Funded
Priority 1
Expected end product
Mission report to be issued.
Completed
Contact person: [email protected], [email protected] and balakrishnanm
End product
PIN 178169
Activity Title Vaccine safety training workshop for 7 WPRO countries.
Funding status Partially Funded
Priority 1
Expected end product
Capacity building for AEFI surveillance system for 7 WPRO countries.
Planned
Contact person: [email protected]
End product
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 178166
Activity Title WPRO regional training workshop on AEFI causality assessment.
Funding status Partially Funded
Priority 1
Expected end product
Workshop in causality assessment provided to 9 WPRO countries.
Ongoing
Contact person: [email protected]
End product
PIN 168741
Activity Title First regional meeting on vaccine pharmacovigilance.
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 the use of rotavirus vaccine and BCG vaccine.
Completed
Contact person: [email protected]
End product
PIN 175302
Activity Title VAEMS - AEFI reporting, collection, management and analysis tool.
Funding status Partially Funded
Priority 1
Expected end product
Web based VAEMS tool, central vaccine safety database.
Ongoing
Contact person: [email protected]
End product
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 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.
Completed
Contact person: [email protected]
End product
PIN 168793
Activity Title Training for AEFI for 15 countries in IST East, West and Central Africa.
Funding status Funded
Priority 1
Expected end product
Training and capacity building for MOH and NRA staff on vaccine safety.
Completed
Contact person: [email protected]
End product
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.
Ongoing
Contact person: [email protected]
End product
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 168779
Activity Title Support the establishment of the national AEFI committee in one SEARO country.
Funding status Funded
Priority 1
Expected end product
An operational national AEFI committee to review, analyze and provide feedback on serious AEFI
cases.
Completed
Contact person: [email protected]
End product
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.
Completed
Contact person: [email protected]
End product
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.
Ongoing
Contact person: [email protected]
End product
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 168786
Activity Title Provide access to online training in vaccine safety to 23 AVAREF countries.
Funding status Funded
Priority 1
Expected end product
NRA staff of the 23 AVAREF countries trained on vaccine safety.
Completed
Contact person: [email protected]
End product
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 national level.
Ongoing
Contact person: [email protected]
End product
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.
Completed
Contact person: [email protected]
End product http://www.who.int/vaccine_safety/initiative/tech_support/ebasic/en/index.html
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 175154
Activity Title Establish a global pool of qualified trainers for WHO trainings in countries.
Funding status Funded
Priority 1
Expected end product
A web based roster of vaccine safety experts.
Ongoing
Contact person: [email protected]
End product
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.
Completed
Contact person: [email protected]
End product http://www.who.int/vaccine_safety/initiative/tech_support/en/
PIN 168796
Activity Title Regional Vaccinology course.
Funding status Partially Funded
Priority 1
Expected end product
Trained NRAs staff.
Planned
Contact person: [email protected]
End product
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 168808
Activity Title Development of Vaccine safety fellowship program
Funding status Not Funded
Priority 1
Expected end product
A framework and curriculum for a Vaccine Safety Fellowship
Planned
Contact person: [email protected]
End product
PIN 168809
Activity Title Implement a vaccine safety fellowship training programme.
Funding status Not Funded
Priority 1
Expected end product
Annual training of 2 to 4 vaccine safety specialists.
Planned
Contact person: [email protected]
End product
PIN 168813
Activity Title Annual Hot Topic Stakeholder Symposium
Funding status Partially Funded
Priority 3
Expected end product
Annual one day scientific conference/symposium and publication in Biologicals
Ongoing
Contact person: [email protected]
End product
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 168749
Activity Title Strengthening network countries capacity for data analysis and signal detection.
Funding status Funded
Priority 1
Expected end product
Standard training package on AEFI data analysis and signal detection. Workshop conducted in the
12 network countries.
Ongoing
Contact person: [email protected]
End product
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.
Completed
Contact person: [email protected]
End product
PIN 170799
Activity Title Global Vaccine Safety Risk Communication Training
Funding status Not Funded
Priority 1
Expected end product
Regional workshops held.
Ongoing
Contact person: [email protected]
End product
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 Organize regional vaccine safety workshop in Asia.
Funding status Funded
Priority 1
Expected end product
Enhanced capacity for vaccine safety assessment by NRAs, AEFI advisory committees in countries
that introduce newly developed vaccines in settings with novel characteristics and/or use prequalified
vaccines either directly or through UN supply.
Ongoing
Contact person: [email protected]
End product
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.
Completed
Contact person: [email protected]
End product http://www.who.int/vaccine_safety/initiative/tech_support/en/
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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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.
Ongoing
Contact person: [email protected]
End product
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.
Ongoing
Contact person: [email protected]
End product
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.
Ongoing
Contact person: [email protected]
End product http://www.who.int/vaccine_safety/committee/reports/en/
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.
GVSI Porfolio Directory 2012-2020 Version 1 July 2014 Page 34
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.
Ongoing
Contact person: [email protected]
End product
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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