Development of Vaccine Security at the Regional Levelnvi.ddc.moph.go.th/AEC_2014/03.pdf · 2014. 10. 14. · Development of vaccine security at global level WHO NRA capacity building

Workshop among ASEAN Countries on Opportunities for Regional Vaccine Security, September 30 - October 3, 2014, Phuket, Thailand

Workshop among ASEAN countries on Opportunities for Regional Vaccine Security

September 30 to October 3, 2014, Cape Panwa, Phuket, Thailand

Development of Vaccine Security at the Regional Level

Stephane Guichard WHO SEARO Regional Advisor

Vaccine Supply and Quality

Definition

• In the late 90s early 2000s global vaccine shortages drove international vaccine community to rethink vaccine security

• UNICEF defines vaccine security as “a sustained uninterrupted supply of affordable vaccines”. – The strategy for vaccine security requires guaranteed

production of vaccines, secured multi-year allocations for vaccine financing, the development of long term forecasting of vaccine requirement, and limited vaccine wastage.


forecast vaccine needs

and vaccine demands

Priority and rational to introduce vaccine in NIPs vaccine safety and

public confidence in immunization regulate vaccine safety,

quality and efficacy with limited NRA

capacity

Rationalize and harmonize regulatory

standards

Strategy for national vaccine procurement

policy for public sector

Vaccine price policy to ensure affordability for LIC as well as

stimulate/support R&D for NTD vaccines

Novel virus strain, re-emerging or new pathogens

Divergence of vaccine product line between

HIC and LMIC

Roles of manufacturers and University/research centers in vaccine R&D



Multiple factors contribute to vaccine security for which not all are national but rather regional or global level providing strong justification to enhance collaboration among countries/regions

Anti-vaccination lobby Religious leaders e.g hallal medicines

Manufacturers

University/R&D groups Clinical Trials

DCVMN ASEAN Vac. chapter

WHO, IVI, PATH

Market incentives

Access Technology

Accurate forecast

Some issues of vaccine security in the region.

NCL Network

WPRO NRA alliance

NRA assessments

DCVRN/ICDRA


Consumer Demand

Vaccine security

Vaccine production

NIP

Civil society

Regulatory

Vaccine R&D

Routine NIP SIA Outbreak & pand.

Pool procurement Good Proc. Pract. LTA w/ suppliers

Nat’l proc policy

Strategy

Vaccine hesitancy

Awareness/access/practices

AEFI

Development of vaccine security at global level


Development of vaccine security at global level

WHO NRA capacity building and vaccine Pre-Qualification contributed to make more vaccine of assured quality available

• In 2001, 9 WHO PQ vaccines available through UNICEF from 13 Manufacturers.

• 2014, 36 WHO PQ vaccines from 28 manufacturers from 21 countries.

• The number of vaccine producers in LMIC increased from 15% in 2001 to 35% in 2014


• New guidelines for production, QA/QC and licensing of new vaccines were developed. E.g – seasonal and pandemic influenza vaccine – IPV introduction as part of the “end game”

strategy to eradicate polio.

• More producers in LMIC of seasonal influenza vaccines and IPV with other NIPs vaccines e.g DTP-HepB-Hib, MMR.


• New immunization partners have joined efforts to address global and regional challenges to expand access to new vaccines vaccine and immunization services GAVI, BMGF, CDC, etc…


Development of vaccine security at regional level


• Most of the vaccines used in the NIPs in South East Asia are produced in the region with India, Indonesia, Thailand and more recently Bangladesh and in the western pacific region, Australia, China, Japan, Korea, Vietnam.

• NRA assessed functional by WHO in China, India, Indonesia, Japan, Korea, Thailand.

• Comprehensive Institutional Development Plan with road map to implement capacity building activities in the others


Basic facts

Collaboration among NCL

• NCL network for the production of Regional Working Reference Standards (RWRS)for the potency testing of vaccines

• Founding members: – Central Drugs Laboratory CRI-Kasauli, India – National Quality Control Laboratory of Drug and

Food, Indonesia – Institute of Biological Products Department of

Medical Sciences, Thailand


Achievements

• RWRS established for Pertussis and advanced development of RWRS for JE and mOPV

• Central storage facility for reference standards established at Thai NCL

• Expansion with new members: – National Institute for Control of Vaccine and

Biologicals (NICVB), Vietnam – National Institutes for Food and Drug Control (NICBP),

China – Other including NIFDSE, MFDS, Korea, have

manifested interest to join as well. Workshop among ASEAN Countries on

Opportunities for Regional Vaccine Security, September 30 - October 3, 2014, Phuket, Thailand

Inter country workshop on causality of Adverse Events Following Immunization

To establish a plate-form to share information on VP and expertise on AEFI causality assessment.

– National AEFI committee representatives from 10 SEA

countries and one from WP met for 3 days in Bangkok to: • share experience and discuss challenges to

establish vaccine pharmacovigilence system and AEFI reporting and;

• conduct causality assessment of selected AEFI cases from the SEA region


AEFI and rumors of sub-standard vaccine quality • Vaccine have never been as safe as today thanks to

government commitments and supports from external funding partners; GAVI, BMGF, CDC and others to strengthen regulatory capacity in LMIC for safe, quality and efficacy of medicines.

• Misunderstanding of vaccine safety and mis-management of Adverse Events Following Immunization (AEFI) cases evolved in crisis with loss of public confidence in the immunization programme with drop of coverage and risks of VPD re-emerge when programme is suspended for several months.


The rational for collaboration on AEFI

• Countries of South East Asia share same vaccine supplier sources and vaccine specifications for their NIPs with largest and also smallest population in the world.

• Expertise for AEFI is multi-disciplinary (epidemio, pediatricians, pathologist, neurologist, forensic, etc) not always available in LIC.

• Access to expertise at regional and international level is critical to conduct AEFI causality assessment and maintain public confidence


Beyond WHO SEA

• NRA alliance in Western Pacific region establish to discuss and develop solutions to address regulatory challenges for safe, quality and efficacy of vaccines and medicines.

• Other example of collaborative initiatives in the South East Asia and Western Pacific region which contribute to vaccine security in the region


• Prospective Models of Vaccine Security Collaborations in: – Research and Development

(R&D) – Production – National Regulatory Authority

(NRA) – National Immunization

Programme (NIP)


Consumer Demand

Vaccine security

Vaccine production

NIP

Civil society

Regulatory

Vaccine R&D

Thank You

Documents

Development of Vaccine Security at the Regional Levelnvi.ddc.moph.go.th/AEC_2014/03.pdf · 2014. 10. 14. · Development of vaccine security at global level WHO NRA capacity building