Global Vaccine Safety Initiative: Impact on and Benefits to East Mediterranean Region Countries

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Global Vaccine Safety Initiative:

Impact on and Benefits to

East Mediterranean Region Countries

Dr Houda Dr Houda

Vaccines Regulation and Production

Department of Communicable Diseases Prevention and Control

The First EMR/Arab countries Meeting of 22-26 September

Rabat, Morocco Rabat, Morocco

Vaccine Safety Initiative:

Impact on and Benefits to

East Mediterranean Region Countries

Houda LANGAR Houda LANGAR

Vaccines Regulation and Production

Department of Communicable Diseases Prevention and Control

First EMR/Arab countries Meeting of Pharmacovigilance September 2014

Rabat, Morocco Rabat, Morocco

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Global Vaccine Safety Blueprint

Global Vaccine Safety Blueprint

• To optimize the safety of vaccines through

MISSION

• To optimize the safety of vaccines through effective use of pharmacovigilance

principles and methods

• Effective vaccine pharmacovigilance

VISION

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• Effective vaccine pharmacovigilance systems are established in all countries

http://extranet.who.int/iris/restricted/bitstream/

Global Vaccine Safety Blueprint

Global Vaccine Safety Blueprint

To optimize the safety of vaccines through To optimize the safety of vaccines through effective use of pharmacovigilance

Effective vaccine pharmacovigilance Effective vaccine pharmacovigilance systems are established in all countries

_eng.pdf 07 . 12 /WHO_IVB_ 1 / 70919 / 10665 http://extranet.who.int/iris/restricted/bitstream/

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Global Vaccine Safety Blueprint

Global Vaccine Safety Blueprint

Blueprint’s strategic goals are threefold:

supporting all countries in reaching at least minimal capacity for supporting all countries in reaching at least minimal capacity for vaccine safety activities;

enhancing capacity for vaccine safety assessment in countries that introduce newly available vaccines and countries that

manufacture and use prequalified vaccines;

supporting countries through international collaboration, training and information exchange.

and information exchange.

Global Vaccine Safety Blueprint

Global Vaccine Safety Blueprint

threefold:

supporting all countries in reaching at least minimal capacity for supporting all countries in reaching at least minimal capacity for

enhancing capacity for vaccine safety assessment in countries that introduce newly available vaccines and countries that

manufacture and use prequalified vaccines;

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GVS Blueprint objectives

GVS Blueprint objectives

Directly Related to VPV

1. Strengthen vaccine safety 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

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promptly

4. Develop internationally harmonized tools and methods for vaccine pharmacovigilance

GVS Blueprint objectives

GVS Blueprint objectives

Supporting elements ensuring effectiveness of VPV

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

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Global Vaccine Safety Initiative

Global Vaccine Safety Initiative

Implementation mechanism of the Serve as a forum for vaccine safety

GVSI according to their areas of expertise GVSI according to their areas of expertise Guided by a General Meeting and

international experts advising WHO’s prioritizing GVSI activities into an initial Proposals and recommendations

participating organizations' or institutions' participating organizations' or institutions' other action.

WHO provides the institutional base serves as secretariat to the Initiative

Global Vaccine Safety Initiative

Global Vaccine Safety Initiative

the Blueprint, initiated in February 2012 safety stakeholders to collaborate in the

expertise and respective interests. expertise and respective interests. and steered by a Planning Group of WHO’s secretariat in identifying and

initial work plan.

recommendations constitute a reference for institutions' guidelines, official policy or institutions' guidelines, official policy or

base for Blueprint implementation and Initiative

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GVSI Products

GVSI Products

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GVSI Products

GVSI Products

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GVSI Products

GVSI Products

GVSI Products

GVSI Products

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GVSI Products

GVSI Products

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GVSI Products

GVSI Products

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GVSI Products

GVSI Products

GVSI Products

GVSI Products

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GVSI Products

GVSI Products

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GVSI Products

GVSI Products

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GVSI Products

GVSI Products

GVSI Products

GVSI Products

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GVSI Products

GVSI Products

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GVSI Products

GVSI Products

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GVSI Products

GVSI Products

Multi-country collaboration studies GACVS

GACVS

Quarterly bulletin providing updates on the GVSI activities Roster of expertise

WHO website: All these products

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

GVSI Products

GVSI Products

country collaboration studies

providing updates on the GVSI activities

products are publicly available

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Palestine

East Mediterranean Region

Pop: Pop: Pop:

Pop: 555 555 555 555 MillionMillionMillionMillion LB:

LB: LB:

LB: 16161616....4 4 4 Million4 MillionMillionMillion

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GAVI eligible: GAVI eligible: GAVI eligible:

GAVI eligible: 7 7 7 7 countries, countries, countries, countries, 565656% 56% % % LMIC:

LMIC: LMIC:

LMIC: 6 6 6 6 countries, countries, countries, 38countries, 383838....5555% % % % HIC:

HIC: HIC:

HIC: 6 6 6 6 countries, countries, countries, 3333% of LBcountries, % of LB% of LB% of LB UMIC:

UMIC: UMIC:

UMIC: 3 3 3 3 countries, countries, countries, 2222....5555%countries, %%%

Palestine

East Mediterranean Region

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Status of Pharmacovigilance

Source of Vaccines in EMR countries

Status of Pharmacovigilance

Source of Vaccines in EMR countries

GAVI eligible countries:

(7) through UNICEF, WHO PQ

Vaccines (AFG, DJI, PAK, SOM, SUD, South SUD, YEM).

••

Self-procuring countries:

KSA, BAH, KUW, UAE, QAT, OMA,

SYR, JOR, LIB, TUN, EGY, IRA,

Vaccine producing countries:

5

Countries self-procuring via UNICEF

Private sector and majority of non EPI vaccines: self

procurement of imported vaccines.

Pharmacovigilance of Vaccines

Source of Vaccines in EMR countries

Pharmacovigilance of Vaccines

Source of Vaccines in EMR countries

) through UNICEF, WHO PQ

Vaccines (AFG, DJI, PAK, SOM, SUD, South SUD, YEM).

KSA, BAH, KUW, UAE, QAT, OMA,

SYR, JOR, LIB, TUN, EGY, IRA, PAK.

5 (EGY, IRA, PAK, TUN, KSA)

procuring via UNICEF

: LEB, MOR, EGY.

Private sector and majority of non EPI vaccines:

self-procurement of imported vaccines.

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Status of Pharmacovigilance

Status of Pharmacovigilance

3 tiers of countries:

Countries with operational AEFI surveillance system

(3 in 2007 and currently 5

Countries with weak AEFI surveillance

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Countries with no AEFI surveillance

Pharmacovigilance of Vaccines

Pharmacovigilance of Vaccines

Countries with operational AEFI surveillance system

5).

AEFI surveillance system (12).

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Impacts on and benefits of GVSI to EMR

countries

Impacts on and benefits of GVSI to EMR

countries

Platform for sharing and exchange information Situation of the region with regard to the

Better vision and planning based on optimization of resources.

Platform for sharing, exchange information regions.

Expanding participation of EMR countries

Bring countries to the international collaborative Bring countries to the international collaborative (Iran and Sudan).

Capacity building of EMR countries adopted to the context of each country.

Impacts on and benefits of GVSI to EMR

countries

Impacts on and benefits of GVSI to EMR

countries

information.

the other regions.

on prioritization of the activities and

information and lessons learnt from other

countries (GPMS-2 MS and GVSI-6 MS).

collaborative activities such MCC studies collaborative activities such MCC studies

through specific training adapted and

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Impacts on and benefits to EMR countries

Impacts on and benefits to EMR countries

Comprehensive review of AEFI surveillance system in Organizing AEFI training based on the

Organizing AEFI training based on the

Support specific activities such as intussusception surveillance following the administration of rotavirus

Annual regional meeting on vaccine pharmacovigilance Support to the countries to develop

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Support to the countries to develop

plan for strengthening the AEFI surveillance.

Impacts on and benefits to EMR countries

Impacts on and benefits to EMR countries

of AEFI surveillance system in 3 countries. on the needs of the countries.

on the needs of the countries. as intussusception surveillance rotavirus vaccine.

meeting on vaccine pharmacovigilance since 2012. develop and implement 2014-17 country develop and implement 2014-17 country the AEFI surveillance.

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Remaining challenges

Remaining challenges

Weak quality management

weak recording system.

weak recording system.

Lack of independence of

committee when it exists.

No systematic reporting of

Analysis of AEFI cases not

Some countries are under

Some countries are under

surveillance system is not

be taken into consideration

Remaining challenges

Remaining challenges

management system and particularly

of AEFI causality assessment

.

of AEFI.

not properly performed.

under crisis and in this case AEFI

under crisis and in this case AEFI

not considered as important to

consideration and not functioning.

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THANK YOU

THANK YOU

THANK YOU

THANK YOU

THANK YOU

THANK YOU

THANK YOU

THANK YOU

Vaccines Regulation and

Department of Communicable Diseases Prevention and Control

WHO/ Eastern Mediterranean Regional

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WHO/ Eastern Mediterranean Regional

emrgovrp@who.int

l

THANK YOU

THANK YOU

THANK YOU

THANK YOU

THANK YOU

THANK YOU

THANK YOU

THANK YOU

Regulation and Production

Department of Communicable Diseases Prevention and Control

/ Eastern Mediterranean Regional Office / Eastern Mediterranean Regional Office

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