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 Divergence of vaccine product line between HIC and LMIC vaccine safety and public confidence in immunization Priority and rational to introduce vaccine in NIPs regulate vaccine safety, quality and efficacy with limited NRA capacity Rationalize and harmonize regulatory standards Roles of manufacturers and University/research centers in vaccine R&D 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, reemerging or new pathogens
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
Some issues of vaccine security in the region. Awareness/access/practices Vaccine hesitancy AEFI Consumer Demand Vaccine production Access Technology Market incentives Accurate forecast DCVMN ASEAN Vac. chapter Manufacturers Clinical Trials University/R&D groups WHO, IVI, PATH DCVRN/ICDRA Vaccine R&D Vaccine security NIP Strategy Nat l proc policy Routine NIP SIA Outbreak & pand. Pool procurement Good Proc. Pract. LTA w/ suppliers NRA assessments WPRO NRA alliance NCL Network Regulatory Civil society Anti-vaccination lobby Religious leaders e.g hallal medicines
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
Basic facts 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
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.
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 mismanagement 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 R&D Regulatory Vaccine security Vaccine production NIP Civil society
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