The GVS blueprint and its implementation

The GVS blueprint and its implementation

Dr Madhava RamMedical Officer

EMP/ SAV

WHO Technical Briefing Seminar | 1 November 20132 |

Unsafe vaccine can have serious consequencesSafety 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:– 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.


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.


Global Vaccine Safety Blueprint

• To optimize the safety of vaccines through effective use of pharmacovigilance principles and methods

MISSION

• Effective vaccine pharmacovigilance systems are established in all countries

VISION


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


8 strategic objectives support 3 goals of the Blueprint

International Collaboration

Minimal Capacity

Obj. 1 Obj. 2 Obj. 3 Obj. 4

AEF

I inv

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AEF

I Det

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Tool

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met

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Vacc

ine

Safe

ty C

omm

unic

atio

n

Directly related to vaccine PV

Obj. 5 Obj. 6 Obj. 7 Obj. 8

Tech

nica

l sup

port

& tr

aini

ngs

Reg

ulat

ory

fram

ewor

k

Publ

ic p

rivat

e in

form

atio

n ex

chan

ge

Glo

bal a

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& re

spon

se

Supporting elementsensuring effectiveness of VPV

Enhanced Capacity


Situation analysis

Blueprint development

Blueprint endorsement

The Global Vaccine Safety

Initiative

Feb-Dec 2010

Jan-Sep 2011

Sep-Dec 2011

2012…

Blueprint Development and Implementation


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

Situation analysis


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).

Blueprint development


Global Vaccine Action Plan

65th World Health Assembly-May 12

Blueprint endorsement

Strategic Advisory Group of Experts- Nov 11

Global Advisory Committee on Vaccine Safety- Dec 11

http://extranet.who.int/iris/restricted/bitstream/10665/70919/1/WHO_IVB_12.07_eng.pdf




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.


Global Vaccine Safety Initiative - structure

Planning group: coordinates work of General

Meeting

WHO Secretariat support

Observers

General meeting:guides the Initiative

Chair5 – 9 participants

Two-years Term of office

•Meet at least once a year. •Review reports of activities of/that result from the Initiative

•Puts forward proposals and make non-binding recommendations to Initiative participants.

•Reviews proposals and recommendations of the Planning Group, and where appropriate, recommend all or part of their content for endorsement by respective GVSI participants.

•Endorses the Initiative work plan.

• Established in March 2012.

• Chair: Alex Dodoo.

• Members: Jan Bonhoeffer, Sandra Deotti, Ajit Pal Singh, Ananda Amarasinghe and Sten Olsson.

• Reviews the Initiative's work plan and budget.

• Reviews activity reports of the Initiative.


PARTICIPANTS

• Intergovernmental organizations • International non-governmental organizations

•Academic institutions•Governmental institutions & agencies involved in regulatory activities

• International industry associations/ umbrella organizations

•WHO Collaborating Centres

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

GVSI collaborating parties


National capacity

Regional office

Pool of experts

IDP

Harmonized tools

Training resources

Training for

industry

Implementation mechanism


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".


Portfolio snapshot


AEFI standard reporting form

…in one year, GVSI …


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.


GVSI

GACVS

Global Vaccine Safety websitehttp://www.who.int/vaccine_safety/en/

http://www.who.int/vaccine_safety/en/


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.


Questions ???


Additional Slides


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

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.


Minimal Capacity includes: Minimal capacity: National Pharmacovigilance capacity

clear strategy for

risk communication Nationalpharmacovigilance

resources

national database or system for collating, managing & retrieving

AEFI reports

national reporting form for AEFI

health-care workers & others encouraged

to report vaccine safety issues

national AEFI expert review

committee harmonized

set of standards implemented


Minimal Capacity includes: Minimal capacity: Managerial requirements to strengthen

vaccine safety

Managerial principles

Clear lines of accountability

for the conduct of vaccine safety

work

Institutional development

planFor

implementation of activities and development of

performance indicators

Commitment to sharing

information on vaccine safety

with other countries.

Regulatory framework

to define provisions for

monitoring and management of

AEFI

National pharmacovigilance resources

Minimal capacity


Enhanced capacity – an increased level of vaccine safety activity

Managerial principles

National pharmacovigilance resources

• 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.


International collaboration in support of countries

Benefits from establishing a global support

structure

sufficient and effective pharmacovigilance if

new vaccine is introduced

regional and international sharing of

vaccine safety data

global and regional expert advisory bodies (GACVS,

SAGE, regional TAGs)

networks of experts

investigational capacity at regional

& international levels & information sharing

centres of excellence to support capacity-building

initiatives and crisis responses

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The GVS blueprint and its implementation

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