global vaccine safety initiative portfolio activities 2012 ...€¦ · global vaccine safety...

Global Vaccine Safety Initiative

Portfolio activities

2012-2020

Safety and Vigilance (SAV)

Health Systems and Innovation (HIS)

World Health Organization

Geneva, Switzerland

October 2013

iii

Table of Contents

The Global Vaccine Safety Initiative activities portfolio .............................................................. iv

Portfolio background ..................................................................................................................... iv

Table 1: GVSI Blueprint main portfolio variables ......................................................................... v

Table 2: Criteria for prioritization of GVSI portfolio activities to implement the global vaccine safety Blueprint. .............................................................................................................................. v

Figure 1: GVSI prioritization scheme ............................................................................................ vi

Overview of the GVSI portfolio activities ..................................................................................... vi

Activities Description ................................................................................................................... vii

1 - AEFI detection Page 1 of 28 2- Investigation of Safety Signals Page 4 of 28 3 - Vaccine safety communication Page 7 of 28 4 - Tools and methods Page 9 of 28 5 - Regulatory framework Page 17 of 28 6 - Technical support and trainings Page 19 of 28 7 - Global analysis and response Page 27 of 28 8 - Public private interaction Page 28 of 28

iv

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.

v

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).

vi

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 [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

mailto:[email protected]

vii

Activities Description

1 - AEFI detection

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 [email protected]

PIN 168771

Activity Title Study on factors affecting AEFI detection in one SEARO country.

Funding status Not Funded

Priority 1


Analysis of the factor that prevent AEFI reporting at each level of the immunization delivery system.

Completion date

Planned


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.


Priority 1


Notification forms, updated AEFI investigation forms are finalized.


Completed


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 1 of 28GVSI Porfolio Directory 2012-2020 Version dated 30 October 2013

PIN 168792

Activity Title Build regulatory capacity of countries for evaluation of safety data from novel vaccines.


Priority 1


Trained NRAs staff from AVAREF countries on reviewing safety data from novel vaccines.


Ongoing


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


Development of IT bridges to extract safety data, the solution utilizes ESAVI core variables developed by WHO and GAVCS.


Ongoing


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.


Priority 2


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.


Ongoing

Activity Contact person [email protected].

Priority *





PIN 168785

Activity Title Develop IT tool for AEFI collection and analysis for selected countries.


Priority 1


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.


Ongoing


Priority *





2 - Investigation of Safety Signals

PIN 168810

Activity Title Active monitoring for intussusception following deployment of rotavirus vaccine in one AFRO

Funding status Under review

Priority 1


Research report on an estimated 500 cases of intussusception collected from 6 health facilities in one AFRO country.


Planned


PIN 168782

Activity Title To conduct postmarketing vaccine safety study in one SEARO country.


Priority 1


Background rates of AEFI for all vaccines including for the new vaccines in one selected SEARO country introducing pentavallent vaccines in 2013.


Ongoing


PIN 168814

Activity Title Multi-country collaboration project.


Priority 1


Report defining nessary infrastructure for vaccine safety sentinal sites.


Ongoing


Priority *





PIN 168820

Activity Title Technical support for continuing activities of PMS network for monitoring the safety of pre-qualified vaccines.


Priority



Planned


PIN 168743

Activity Title Review of AEFI surveillance system in one EMRO country.


Priority 1


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.


Ongoing


PIN 168744

Activity Title Implementation of intussusception surveillance activities in one EMRO country introducing rotavirus vaccine.


Priority 1


Development of intussusception surveillance protocol and implementation of intussusception surveillance activities in one EMRO country introducing rotavirus.


Ongoing


Priority *





PIN 168815

Activity Title Inter-country workshop on causality assessment of adverse events following immunization.


Priority 1


Increased capacity to investigate Adverse Events Following Immunization (AEFI) and causality assessment in SEARO region.


Ongoing


Priority *





3 - Vaccine safety communication

PIN 168800

Activity Title Methods for rumor detection in public media.


Priority 1


Method for signal detection of vaccine safety concerns in public media.


Planned

Activity Contact person contact@brightoncollaborati

PIN 168799

Activity Title Understanding geographic and cultural differences of public concerns to guide program implementation.


Priority 2


Geographic and cultural information of public concerns to guide program implementation.


Planned


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.


Priority 3


Cost-benefit analysis of the a one-time public concern leading to withdrawal of Influenza vaccine batch(es).


Planned


Priority *





PIN 168797

Activity Title Convene a Regional Advisory Group on Vaccine Safety.


Priority 1


Scientific advice on vaccine safety.


Ongoing


PIN 168801

Activity Title Quantifying bias in epidemiologic studies introduced by public concern.


Priority 3


Method to quantify unmeasured bias in observational vaccine safety studies e.g., (media attention, diagnostic awareness).


Planned


PIN 168725

Activity Title Vaccine Safety Net.


Priority 1


A web based list of vaccine safety web sites providing reliable information on Vaccine Safety.


Ongoing


Priority *





4 - Tools and methods

PIN 168795

Activity Title Regional consultation for harmonization of guidelines for on surveillance for intussusception surveillance.


Priority 1


Common guidelines for intussusception surveillance developed.


Planned


PIN 168748

Activity Title Defining essential information for AEFI reporting.


Priority 1


AEFI Core Variables identified and available online.


Completed


PIN 168777

Activity Title Support harmonization of databases including ESAVIs fields in national Pharmacovigilance systems.


Priority 1


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.


Planned


Priority *





PIN 168764

Activity Title Update regional ESAVI guidelines and standard operational procedures (SOP), including causality assessment algorithm.


Priority 1


Updated safety package of training, which includes ESAVI monitoring, causality assessment and risk communication.


Planned


PIN 168784

Activity Title Optimizing signal analysis in VigiBase for vaccine related individual case safety reports (ICSRs).


Priority 1


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


Planned


PIN 168738

Activity Title Training to strengthen AEFI monitoring and causality assessment in one EMRO country.


Priority 1


Training of NRA and EPI staff on AEFI monitoring, causality assessment and strengthening of the national Pharmacovigilance system.


Ongoing


Priority *





PIN 168787

Activity Title Web Based Causality Assessment Tool.


Priority 2


A web based version of the WHO causality assessment algorithm.


Planned


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


Priority 1


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


PIN 168736

Activity Title Developing Regional AEFI guidelines.


Priority 1


Publication: Immunization Safety Surveillance.


Completed


Priority *





PIN 168775

Activity Title Develop norms and reference documents on risk-benefit reports and risk management.


Priority 1


New documents on risk management and periodic safety update reports. Good Pharmacovigilance practices updated.


Planned


PIN 168733

Activity Title Automatic case classification of spontaneous reports.


Priority 1


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


PIN 168732

Activity Title Ad hoc case definition development.


Priority 1


Ad hoc case definition as prioritized by WHO.


Planned


Priority *





PIN 168731

Activity Title Translation of Standardized Brighton Case Definitions.


Priority 1


Translation of Brighton Collaboration Case definitions in all WHO official languages.

Completion date

Planned


PIN 168730

Activity Title Standardized disease concepts for international collaborative studies.


Priority 3


Library of mapped and standardized disease concepts across different coding terminologies for international collaborative studies.

Completion date

Planned


PIN 168729

Activity Title Algorithms for case validation of AEFI following influenza vaccines.


Priority 3


Algorithms for all AEFI developed.

Completion date

Planned


Priority *





PIN 168728

Activity Title Development and evaluation of narcolepsy case definition and investigation of reporting patterns of narcolepsy over time.


Priority 1


Publication of narcolepsy case definition and report on changes of reporting patterns in international databases.


Ongoing


PIN 168791

Activity Title Develop Regional AEFI guidelines


Priority 1


1-Training and capacity building of MOH and NRA staff. 2-Vaccine safety surveillance system Strengthened.


Planned


PIN 168751

Activity Title Development of standard AEFI reporting form.


Priority 1


Model AEFI reporting form available online.


Completed


Priority *





PIN 168756

Activity Title Information sheets on vaccine reaction rates.


Priority 1


Information sheets on vaccine reaction rates.


Ongoing


PIN 168755

Activity Title Development of a Vaccine Pharmacovigilance Toolkit.


Priority 1


A WHO Vaccine Pharmacovigilance Toolkit.


Ongoing


PIN 168753

Activity Title AEFI Causalty Assessment classification.


Priority 1


A tool for assessing causality at individual level including a manual and aide-memoire.


Completed


Priority *





PIN 168821

Activity Title Maintenance and development of the vaccine dictionary.


Priority


Updated vaccine dictionary


Planned


PIN 168747

Activity Title Provide a repository for the storage of national AEFI reports.


Priority 1


A national electronic repository linked to the UMC database.


Ongoing


Priority *





5 - Regulatory framework

PIN 168772

Activity Title Support NRA exchange and analysis of information for decision making on vaccine safety issues.


Priority 1


Establishment of Network for monitoring and analyzing reports in pharmacovigilance centers in two PAHO countries.


Planned


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.


Priority 1


Staff in information centres trained on critical information appraisal and communication and supporting the pharmacovigilance network.


Ongoing


PIN 168750

Activity Title Updated benchmarks for vaccine pharmacovilance function of the NRA assessments.


Priority 1


Revised list of indicators and sub-indicators of the vaccine pharmacovigilance function of the WHO NRA assessment tool.


Completed


Priority *





PIN 168742

Activity Title Review of AEFI surveillance system in one EMRO country.


Priority 1


Review of NRA system in one EMRO country and establishment of institutional development plan.


Completed


PIN 168776

Activity Title Improve National PV centres performance through a quality evaluation program.


Priority 2


Develop indicators to assess the performance of PV centers and pilot in two PAHO countries.


Planned


PIN 168752

Activity Title Perform national vaccine PV system evaluation against agreed benchmarks (NRA assessment tool).


Priority 1


Perform national vaccine PV system assessment in at least 5 countries per year.


Ongoing


Priority *





6 - Technical support and trainings

PIN 168749

Activity Title Strengthening network countries capacity for data analysis and signal detection.


Priority 1


1-Standard training package on AEFI data analysis and signal detection. 2-Workshop conducted in the 12 network countries.


Ongoing


PIN 168760

Activity Title Strengthening of ESAVI Committees and members.


Priority 1


Regional Standard Operational Procedures Guidelines, to support the constitution of ESAVI Committees at the national level.


Ongoing


PIN 168813

Activity Title Annual global vaccine safety update.


Priority 3


Annual one day scientific conference and publication


Ongoing


Priority *





PIN 168737

Activity Title AEFI training workshop for countries in WPRO region.


Priority 1


Capacity building for EPI and NRA staff on vaccine safety in WPRO region.


Ongoing


PIN 168754

Activity Title Establish global pool of qualified trainers for WHO trainings in countries


Priority 1


Development of a Web based database of experts.


Ongoing


PIN 168796

Activity Title Regional Vaccinology course.


Priority 1


Trained NRAs staff.


Planned


Priority *





PIN 168726

Activity Title Training course on vaccines safety provided by US FDA (CBER) to participants of UMC annual pharmacovigilance training course and others


Priority 1


A training for healthcare professionals with a special interest in vaccine safety assessment, specifically as applied by US FDA.


Ongoing


PIN 168793

Activity Title Training for AEFI for two countries each in ITST West and IST Central Africa


Priority 1


Training and capacity building for MOH and NRA staff on vaccine safety.


Ongoing


PIN 168757

Activity Title Global learning resource centre.


Priority 1


Web-platform linking to E-learning tools, trainer databases, PPT toolkits and a contact to organize WHO trainings in countries.


Completed


Priority *





PIN 168758

Activity Title E-learning training material on Vaccine Safety.


Priority 1


E-learning course on Vaccine Safety.


Completed


PIN 168759

Activity Title Basic training toolkit for trainers in countries.


Priority 1


PPT training package developed in collaboration with international experts.


Completed


PIN 168745

Activity Title Regional Vaccine Safety Workshop in Asia.


Priority 1


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.


Planned


Priority *





PIN 168783

Activity Title Conduct AEFI training workshop in two SEARO countries.


Priority 1


60 EPI and AEFI focal persons trained on AEFI detection and reporting.


Completed


PIN 168739

Activity Title Second regional meeting on pharmacovigilance of vaccines.


Priority 1


Training and capacity building on vaccine safety communication.


Ongoing


PIN 168781

Activity Title To conduct refresher training on AEFI detection and reporting in one SEARO country.


Priority 1


Trained 79 trainers who in turn trained 523 EPI and AEFI focal persons on AEFI detection analysis and reporting at the district level.


Completed


Priority *





PIN 168740

Activity Title Training on AEFI and causality assessment in one EMRO country.


Priority 1


Training of NRA and EPI staff on AEFI monitoring, causality assessment and strengthening of the national Pharmacovigilance system.


Ongoing


PIN 168779

Activity Title Support to the establishment of the national AEFI secretariat in one SEARO country


Priority 1


Operational national AEFI committee to collect, analyze and report AEFI cases.


Completed


PIN 168762

Activity Title Enhance the causality assessment capacity of vaccine pharmacovigilance officers.


Priority 1


Report and insights to continuously improve the methodology.


Ongoing


Priority *





PIN 168765

Activity Title Identify and establish accredited training institutions at global, regional, and sub-regional levels.


Priority 1


Availability of a training network with harmonized curriculas, translation of training materials, adaptation of training modules based on the evolution of science.


Planned


PIN 168773

Activity Title Support NRA capacity building.


Priority 1


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


PIN 168741

Activity Title First regional meeting on pharmacovigilance of vaccines.


Priority 1


1-Training and capacity building of NRA, pharmacovigilance and EPI staff on AEFI surveillance system. 2-Updated information on AEFI with use of rotavirus vaccine and BCG vaccine.


Completed


Priority *





PIN 170799

Activity Title Global Vaccine Safety Risk Communication Training


Priority


Regional workshops held.


Ongoing


PIN 168786

Activity Title Provide access to online training for vaccine safety to avaref countries.


Priority 1


NRA staff trained on vaccine safety.


Planned


Priority *





7 - Global analysis and response

PIN 168766

Activity Title Rapidly and effectively deal with serious vaccine-related adverse events in order to maintain confidence in a vaccine.


Priority 1


Technical support for investigation, analysis and response with the possibility of prompt independent expert advice.


Ongoing


PIN 168761

Activity Title Establishment of a Regional Advisory Group on Vaccine Safety.


Priority 1


Regional meeting to review selected safety cases and publication of a report and article for each meeting.


Ongoing


PIN 168767

Activity Title Publish GACVS assessments in WER within 6 weeks of the committee deliberations.


Priority 1


Up-to-date GACVS review of vaccine safety profiles published in WER since 1999.


Ongoing


Priority *





8 - Public private interaction

PIN 168819

Activity Title To put in place systems for information exchange mechanisms between national governments, multilateral agencies and manufacturers.


Priority 1


Improved information exchange mechanisms between industry and public sector.


Ongoing


Priority *





global vaccine safety initiative portfolio activities 2012 ...€¦ · global vaccine safety...

Documents