The GVS blueprint and its
implementation
Dr Madhava Ram
Medical Officer
EMP/ SAV
Unsafe vaccine can have serious consequences
Safety crises derail immunization programs
 Real incidents:
– Intussusception following Rotavirus vaccine.
– Polio following IPV.
– Narcolepsy and H1N1 vaccination.
 Real safety issues:
–
–
–
–
Programme errors.
Anaphylaxis.
VAPP/ VDPV.
Disseminated BCG disease.
 Rumours, poor science and over-reaction:
–
–
–
–
–
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Pertussis vaccine coverage in the UK.
Multiple Sclerosis and hepatitis B vaccine in France.
OPV and chronic diseases in Nigeria.
Thiomersal and neuro-developmental disorders.
Pentavalent vaccine in Asian countries.
WHO Technical Briefing Seminar | 1 November 2013
Global Vaccine Safety Blueprint
Developed with and for low- and middle-countries:
 A capacity-building model towards, at least, a minimal capacity for
vaccine pharmacovigilance.
 Solutions for enhancing vaccine pharmacovigilance capacity to
adequately monitor newly available vaccine products.
 Access to technical support from institutions with adequate
expertise, cultural and geographical proximity through an
integrated network.
 Pharmacovigilance business models aligned with those for drugs
and other medicinal products.
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WHO Technical Briefing Seminar | 1 November 2013
Global Vaccine Safety Blueprint
MISSION
• To optimize the safety of vaccines through effective
use of pharmacovigilance principles and methods
VISION
• Effective vaccine pharmacovigilance systems are
established in all countries
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WHO Technical Briefing Seminar | 1 November 2013
Blueprint’s 3 strategic goals
To assist low and middle income countries (LMIC)
to have at least minimal capacity for vaccine
safety activities
To enhance capacity for vaccine safety assessment in
countries that introduce newly-developed vaccines, that
introduce vaccines in settings with novel characteristics, or
that both manufacture and use prequalified vaccines
to establish a global vaccine safety
support structure
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WHO Technical Briefing Seminar | 1 November 2013
8 strategic objectives support 3 goals of the Blueprint
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WHO Technical Briefing Seminar | 1 November 2013
Obj. 4
Obj. 5
Obj. 6
Obj. 7
Obj. 8
Tools & methods
Regulatory framework
Technical support & trainings
Global analysis & response
Public private information exchange
International
Collaboration
Obj. 3
Vaccine Safety Communication
Enhanced
Capacity
Obj. 2
AEFI investigation
Minimal
Capacity
Obj. 1
AEFI Detection
Directly related to vaccine PV
Supporting elements
ensuring effectiveness of VPV
Blueprint
Development and
Implementation
Blueprint
development
Situation
analysis
Jan-Sep 2011
Feb-Dec 2010
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WHO Technical Briefing Seminar | 1 November 2013
The Global
Vaccine
Safety
Initiative
Blueprint
endorsement
Sep-Dec 2011
2012…
Situation analysis
1. Experts perception of gaps and needs
2. SWOT of existing international activities
3. Regulators perception
4. Industry perception
5. Descriptive analysis of 11 countries
6. NRA assessment data
7. Financial analysis
http://whqlibdoc.who.int/hq/2012/WHO_IVB_12.04_eng.pdf
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WHO Technical Briefing Seminar | 1 November 2013
Blueprint development
 Blueprint strategy designed as framework for collaborative support
to national strengthening of vaccine safety systems.
 Many stakeholders contributed to Blueprint development:
– Collaborative Group.
– Consultative Committee (vaccine safety experts, regulators, industry, national
and WHO HQ/regional staff).
– Individual briefings (CIOMS/WHO work group, IABS, international vaccine
safety meetings, manufacturers organizations, GACVS, IPAC).
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WHO Technical Briefing Seminar | 1 November 2013
Blueprint endorsement
 Strategic Advisory Group of
Experts- Nov 11
 Global Advisory Committee on
Vaccine Safety- Dec 11
Global Vaccine Action Plan
65th World Health Assembly-May 12
http://extranet.who.int/iris/restricted/bitstream/10665/70919/1/WHO_IVB_12.07_eng.pdf
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WHO Technical Briefing Seminar | 1 November 2013
The Global Vaccine Safety Initiative (GVSI)
for implementing the Blueprint
 Serve as a forum for vaccine safety stakeholders.
 Guided by a General Meeting and steered by a Planning
Group.
 Proposals and recommendations constitute a reference
for participating organizations' or institutions' guidelines,
official policy or other action.
 WHO provides the institutional base for Blueprint
implementation and serves as secretariat to the Initiative.
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WHO Technical Briefing Seminar | 1 November 2013
• Established in March 2012.
• Chair:
Dodoo.
• Meet
at Alex
least
once a year.
Global Vaccine Safety Initiative
- structure
• Members: Jan Bonhoeffer, Sandra Deotti,
Ajit Palreports
Singh, Ananda
Amarasinghe and
• Review
of
activities
Sten Olsson.
of/that result from the Initiative
• Reviews
the Initiative's
work plan and
Planning
group:
budget.
Chair
General meeting:
guides the Initiative
Observers
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coordinates
work of General
• Puts
forward proposals
and
• Reviews activity
reports of the Initiative.
Meeting
make
non-binding
to Initiative
5 – recommendations
9 participants
participants.
• Reviews proposals and
recommendations of the
Planning Group,
and where
Two-years Term of office
appropriate, recommend all or
part of their content for
endorsement by respective
GVSI participants.
WHO Secretariat support
WHO Technical Briefing Seminar | 1 November 2013
• Endorses the Initiative work
plan.
GVSI collaborating parties
PARTICIPANTS
•Intergovernmental organizations
• International non-governmental
organizations
•Academic institutions
•Governmental institutions &
agencies involved in regulatory
activities
•International industry associations/
umbrella organizations
•WHO Collaborating Centres
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WHO Technical Briefing Seminar | 1 November 2013
OBSERVERS
•Organizations, agencies or institutions
involved in activities which are relevant to
all or part of the mandate of the Initiative
Observers may
• make a statement to present their
views or position on the issue under
consideration (upon invitation of Chair).
Observers may not
• participate in discussions and
deliberations of the Initiative,
• have a role in decision making process
Implementation mechanism
Regional
office
Training
for
industry
Pool of
experts
National
capacity
Training
resources
IDP
Harmoniz
ed tools
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WHO Technical Briefing Seminar | 1 November 2013
GVSI portfolio of activities
 Public version available online 16 April 2013.
 Includes activities that are:
– Planned, on-going or completed.
– Funded, partially funded, unfunded.
– Prioritized according to need and feasibility.
 Public version reviewed twice yearly by planning group.
 Working version includes new proposals on a rolling basis
- "under review".
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WHO Technical Briefing Seminar | 1 November 2013
Portfolio snapshot
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WHO Technical Briefing Seminar | 1 November 2013
AEFI standard reporting form
…in one year,
GVSI …
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WHO Technical Briefing Seminar | 1 November 2013
Selected ongoing GVSI priority projects
 Web-based national AEFI data system (on- and off-line data
processing application).
 Active surveillance for new vaccines (rotavirus, MenA
conjugate in pregnancy).
 Hypothesis testing for rare AEFI through multi-country
collaboration of sentinel sites.
 Expansion of national vaccine PV systems assessments.
 Vaccine safety training through UMC course.
 Translation of training and other reference materials.
 Vaccine pharmacovigilance toolkit.
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WHO Technical Briefing Seminar | 1 November 2013
Global Vaccine Safety website
http://www.who.int/vaccine_safety/en/
Training
resources,
etc…
GACVS
GVSI
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WHO Technical Briefing Seminar | 1 November 2013
The way forward
 Global Vaccine Safety Initiative supports Member States as a forum to
coordinate – and where possible synergize – existing efforts.
 Initial implementation through existing mechanisms:
–
–
–
–
–
Vaccine pharmacovigilance network.
Decentralized support (regional office and partner organizations).
WHO collaborating centres and other partners.
Work with CIOMS on industry.
Progress monitored through SAGE and GACVS.
 Diversify funding sources:
– Direct support for contributing partners.
– Seek predictable and sustainable resources.
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WHO Technical Briefing Seminar | 1 November 2013
Questions ???
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WHO Technical Briefing Seminar | 1 November 2013
Additional Slides
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WHO Technical Briefing Seminar | 1 November 2013
Blueprint objectives
 1. Strengthen vaccine safety
monitoring systems
 2. Strengthen ability to evaluate
vaccine safety signals
 3. Develop vaccine safety
communication plans, understand
perceptions of risk, and prepare for
managing any AEFI and crises
promptly
 4. Develop internationally
harmonized tools and methods for
vaccine pharmacovigilance
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WHO Technical Briefing Seminar | 1 November 2013
 5. Establish a legal, regulatory and
administrative framework at all levels
 6. Strengthen regional and global
technical support platforms for
vaccine pharmacovigilance
 7. Make expert scientific advice on
vaccine safety issues available
 8. Put in place systems for
appropriate interaction between
national governments, multilateral
agencies, and manufacturers
Minimal capacity includes
 National dedicated pharmacovigilance
resources.
 Managerial principles.
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WHO Technical Briefing Seminar | 1 November 2013
Minimal capacity: National Pharmacovigilance capacity
Minimal Capacity includes:
national reporting
form for AEFI
clear strategy
for
risk communication
health-care workers
& others encouraged
to report vaccine
safety issues
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National
pharmacovigilance
resources
harmonized
set of standards
implemented
WHO Technical Briefing Seminar | 1 November 2013
national database
or system for collating,
managing & retrieving
AEFI reports
national AEFI
expert review
committee
Minimal capacity: Managerial requirements to
strengthen vaccine safety
Minimal Capacity includes:
National pharmacovigilance resources
Minimal
capacity
Regulatory
framework
Clear lines of
accountability
Institutional
development
plan
to define
provisions for
monitoring and
management of
AEFI
for the conduct of
vaccine safety
work
For
implementation
of activities and
development of
performance
indicators
Managerial principles
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WHO Technical Briefing Seminar | 1 November 2013
Commitment to
sharing
information on
vaccine safety
with other
countries.
Enhanced capacity –
an increased level of vaccine safety activity
•Is judged to be necessary in countries:
–
Introducing newly developed vaccines.
– Manufacturing vaccines.
•Includes:
– Ability to carry out active surveillance rather than relying solely on
spontaneous reporting of AEFI for the purpose of signal detection.
– When necessary, ability to carry out epidemiological studies.
National pharmacovigilance resources
Managerial principles
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WHO Technical Briefing Seminar | 1 November 2013
International collaboration in
support of countries
global and regional
expert advisory bodies (GACVS,
SAGE, regional TAGs)
centres of excellence
to support capacity-building
initiatives and crisis
responses
sufficient and
effective pharmacovigilance if
new vaccine is introduced
Benefits from
establishing a global support
structure
investigational
capacity at regional
& international levels &
information sharing
regional and
international sharing of
vaccine safety data
networks of experts
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WHO Technical Briefing Seminar | 1 November 2013