global vaccine safety initiative portfolio activities 2012 ... · overview of the gvsi portfolio...
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Global Vaccine Safety Initiative
Portfolio activities
2012-2020
Safety and Vigilance (SAV)
Health Systems and Innovation (HIS)
World Health Organization
Geneva, Switzerland
June 2015
ii
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 Strategic Priority Group (SPG) that includes 5 to 9 external experts
complementing WHO staff from headquarters and the six regional offices is appointed. At present, the
SPG members come from the Brighton Collaboration Foundation in Switzerland; the University of Ghana;
the JSS University of Mysore in India; the Public Health Institute in Chile; the Uppsala Monitoring
Centre in Sweden; the Monash Children’s hospital in Australia.
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 SPG 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 SPG 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.
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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.
iv
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 SPG at the May 2015 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
GVSI PORTFOLIO DIRECTORY
1 - AEFI detection
PIN 156121
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
PIN 156168
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
PIN 156169
Activity Title Develop IT tool for AEFI reporting, collection, management and analysis.
Funding status Funded
Priority 1
Expected end
product
Desktop version of VAEIMS 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.
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PIN 156152
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 156175
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 160254
Activity Title Development of AEFI surveillance performance indicators
Funding status Funded
Priority 1
Expected end
product
AEFI indicators that can be easily adapted to the local context in line with the Global Vaccine Action
Plan (GVAP) framework that was approved by the World Health Assembly in May 2012 to achieve
the Decade of Vaccines (DoV) vision
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 156156
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 156222
Activity Title Antenatal and Infant Monitoring Initiative
Funding status Partially Funded
Priority 3
Expected end
product
A mobile technology based solution for anteneatal and AEFI monitoring where information is
provided by mothers rather than by the healthcare system.
Ongoing
Contact person: [email protected]
End product
PIN 156195
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.
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 156205
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
PIN 156208
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 156164
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
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 156216
Activity Title Standard AEFI Investigation form
Funding status Not Funded
Priority 1
Expected end
product
An AEFI investigation form that will help to determine causality
Ongoing
Contact person: [email protected]
End product
PIN 156166
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
PIN 156187
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
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 156135
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 156188
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 156217
Activity Title Aide Memoire for AEFI Investigation
Funding status Not Funded
Priority 1
Expected end
product
a 2 page Aide Memoire
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 156221
Activity Title AEFI field investigation – simulation training
Funding status Not Funded
Priority 1
Expected end product
Training package that will be ready to be used by the countries
Ongoing
Contact person: [email protected]
End product
PIN 156136
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 156214
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.
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PIN 156176
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.
Completed
Contact person: [email protected]
End product
PIN 156213
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.
Completed
Contact person: [email protected]
End product
PIN 159981
Activity Title Guidance on investigating Adverse Events of Special Interest
Funding status Under Review
Priority 1
Expected end
product
A manual to investigate AESI
Planned
Contact person: [email protected] & [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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3 - Vaccine safety communication
PIN 156180
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 156179
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 156182
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
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 10 of 33GVSI Porfolio Directory 2012-2020 Version 8 January 2015
PIN 156191
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 156198
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 156181
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.
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PIN 156119
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_websit
e/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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4 - Tools and methods
PIN 156153
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
PIN 156138
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 156144
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.
Page 13 of 33GVSI Porfolio Directory 2012-2020 Version 8 January 2015
PIN 156202
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
Completed
Contact person: [email protected]
End product
PIN 156171
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 156145
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
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 156218
Activity Title BCG vaccine adverse event as a marker of associated immunodeficiency
Funding status Not Funded
Priority 1
Expected end product
Identify children with localized BCG adverse events with clinical and / or laboratory changes
indicative of immune system dysfunction
Planned
Contact person: [email protected]
End product
PIN 159982
Activity Title Observed rates of vaccine reactions – Development and implementation of an evidence based
approach to inform WHO information sheets
Funding status Under Review
Priority 1
Expected end
product
The end product will be a summary of known adverse vaccine reactions with the rates which will be
incorporated in the Information Sheets to be updated on the WHO website. This summary
information will be cross-referenced (using hyperlinks) to a Summary o
Planned
Contact person: [email protected] & [email protected]
End product
PIN 156141
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_I
MMUNIZATION.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.
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PIN 156211
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
PIN 156172
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 156212
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
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 33GVSI Porfolio Directory 2012-2020 Version 8 January 2015
PIN 156128
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
PIN 156220
Activity Title Framework for developping national guidelines for the surveillance of adverse events following
immunization.
Funding status Not Funded
Priority 1
Expected end
product
A universal national AEFI Guidelines template in a word document freely available in the web that
can be downloaded and adapted to the local context
Ongoing
Contact person: [email protected]
End product
PIN 156122
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.
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PIN 156160
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 156219
Activity Title Global manual on Surveillance of AEFI
Funding status Funded
Priority 1
Expected end
product
A manual available for download from the vaccine safety website of the WHO
Completed
Contact person: [email protected]; [email protected]
End product http://www.who.int/vaccine_safety/publications/Global_Manual_on_Surveillance_of_AEFI.pdf
PIN 156162
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
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 156143
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
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 156161
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.
Ongoing
Contact person: [email protected]
End product
PIN 156157
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 156159
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
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 156142
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 156140
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.
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6 - Technical support and trainings
PIN 156137
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 156133
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 156131
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 156170
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 156173
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 156174
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
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 156130
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
PIN 156129
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
PIN 156177
Activity Title Regional Vaccinology course.
Funding status Partially Funded
Priority 1
Expected end
product
Trained NRAs staff.
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 156120
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.
Ongoing
Contact person: [email protected]
End product
PIN 156132
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 156186
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 156163
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 156165
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 156167
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
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 156158
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
PIN 156151
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
PIN 156207
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
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 156149
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 156206
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 156148
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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PIN 156190
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
PIN 156147
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
PIN 156193
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
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 33GVSI Porfolio Directory 2012-2020 Version 8 January 2015
PIN 156146
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 156196
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 156197
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.
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.
Page 30 of 33GVSI Porfolio Directory 2012-2020 Version 8 January 2015
PIN 156200
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 156204
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
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 156150
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 156155
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/
PIN 156154
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
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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8 - Public private interaction
PIN 156189
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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