Western Pacific Regional Strategy for Increasing access to and utilization of new and underutilized vaccines

Transcription

1 Western Pacific Regional Strategy for Increasing access to and utilization of new and underutilized vaccines

2 Table of Contents 1. Context 1.1 Child survival Beyond childhood mortality: premature adult mortality Prevention of long-term disability Current status and achievements ( ) Proposed activities, indicators and targets in the current plan Knowledge management and strategic dissemination of information and new developments Activities Indicators Targets Generation and communication of morbidity and mortality data from diseases targeted by NUV Activities: Indicators: Targets: Developing and using standardized cost-effectiveness and other economic analysis for new vaccines Activities Indicators Targets: Mobilization of resources by regular advocacy with regional/global donors and other stakeholders Activities Indicators Targets ii

3 3.5 Building capacity of the national regulatory authority for licensing and post-marketing surveillance of new vaccines Activities: Indicators Targets Assisting countries with operational and managerial issues related to new vaccine introduction Activities: Indicators Targets Promoting research in the Region to encourage development and production of NUV in developing countries Activities Indicators Targets Budget needs Staff costs ANNEXES ANNEX 1 Table 1: New and underutilized vaccines as of April 2008 ANNEX 2 Cost of fully immunizing a child with particular underutilized and new vaccines at prices in 2008 iii

4 List of Acronyms: AEFI CDC CE CNS EPI GAVI alliance countries GIVS Hib HPV IEC IDP IVB IVR JE ME NRA NUV ORS PCV PIC PNG PMS Priority countries for sentinel surveillance ROK TAG UNICEF WHO WPR WPRO adverse events following immunization Centers for Disease Control, Atlanta, USA cost-effectiveness analysis central nervous system Expanded Programme on Immunization seven countries in the Western Pacific Region eligible for funding from GAVI Alliance. These are Cambodia, Kiribati, Lao People's Democratic Republic, Mongolia, Papua New Guinea, Solomon Islands, Viet Nam Global Immunization and Vision Strategy Haemophilus influenzae type B human papilloma virus information, education and communication Institutional Development Plan Immunization, Vaccines and Biologicals, WHO, HQ Initiative for vaccine research, WHO, HQ Japanese encephalitis meningoencephalitis National Regulatory Authorities new and underutilized vaccines oral rehydration solution pneumococcal conjugate vaccine Pacific island countries and areas Papua New Guinea Post-marketing surveillance These are Cambodia, China, Lao People's Democratic Republic, Papua New Guinea, Mongolia, Philippines, Viet Nam, Fiji Republic of Korea Technical Advisory Group United Nations Children's Fund World Health Organization Western Pacific Region Regional Office for the Western Pacific, World Health Organization iv

5 Executive summary Significant strides have been made towards implementing essential immunization practices in developing countries in the Region. However, complexities of new vaccines and the obstacles faced in bringing them to vulnerable populations demand continued action. The plan outlines the achievements in the Region with regard to new vaccines and presents objectives and future activities aimed at building upon those achievements. The recently developed Global Immunization Vision and Strategy (GIVS) 1 outlines broad strategic direction for introduction and wide-spread use of new and underused vaccines and technologies all of which require long-term programmatic and financial planning, including setting up special surveillance systems. During this plan period, the World Health Organization (WHO) in the Western Pacific Region will concentrate on activities that include preparation for the introduction of new and underused vaccines, continued provision of evidence-based information to country level decision-makers and sharing of experiences from lessons learned. In line with organization policy, several areas of work and components specifically related to standards development, policy and strategy development is centralized to WHO IVB headquarters. To support the advocacy for new vaccine introduction, WPRO will provide evidence of the value of immunization by maintaining regional intelligence on key indicators and disseminating information to guide strategies. In countries that plan to adopt a new vaccine agenda, the WHO Regional Office for the Western Pacific (WPRO) will collaborate with their governments and other partners to develop mechanisms for monitoring immunization financing and programme sustainability. In addition, areas of work and components related to country activities and to implementation are to be decentralized to WHO country offices. The plan describes seven strategic areas: knowledge management and strategic dissemination of information; surveillance for diseases targeted by new and underutilized vaccines; economic analysis; advocacy with national, regional and global stakeholder to mobilize both national and external resources; providing support on different programmatic areas related to new vaccine introduction; ensuring immunization safety and promoting vaccine research. Each strategic area is accompanied by a set of planned activities, indicators and targets. Considering the fast evolving field of new and underutilized vaccines, this strategic plan is envisaged to be a dynamic plan. This is for the guidance of the work in this area, but should not become a reason for 'not doing' something, which is not foreseen at this stage, but may become justified in line with new developments in this field. 1 Global Immunization Vision and Strategy (GIVS), World Health Organization, Geneva (WHO/IVB/05.05), v

6 Strategic Plan for New Vaccine ( ) 1. Context 1.1 Child survival The coverage with the current vaccines included in national immunization programme remains high in most of the countries in the Western Pacific Region. Major gains have been made in child survival and reduction in premature adult mortality and morbidity (e.g. from hepatitis B related morbidity and mortality) in the last two decades. Limited further reduction in childhood mortality and morbidity is expected with the current vaccines against the traditional 6 Expanded Programme on Immunization (EPI) diseases 2. Seventy five percentage of all under-5 year deaths in the Region occur in 6 countries China, Cambodia, Lao People's Democratic Republic, Viet Nam, Philippines and Papua New Guinea. Forty-seven percentage of all under-5 deaths in the Region are estimated to occur in the first month of life from neonatal causes. Only a small percentage of these neonatal deaths can be prevented by vaccines (vaccination of antenatal mothers with two doses of tetanus toxoid). Diarrhoea and acute respiratory tract infections are responsible for majority of post-neonatal death in the Region, and are estimated to account for 18% and 13% of all under-5 deaths, respectively, or one-third and onefourth of all post-neonatal deaths, respectively. The coverage with current public health tools, e.g. oral rehydration solution for diarrhoea (ORS) and access to services (e.g. improved case management for pneumonia) still remain limited especially in low income countries with highest child mortality and is not likely to improve substantially at least in the near term due to major The strategies for prioritization of introduction of new vaccines and acceleration of new vaccine introduction in the Western Pacific Region, at least in the regional level, must take into account diversity in the Region. The countries range with per capita gross national income from more than US$ in Japan and US$ in Australia to less than $365 in Cambodia and Lao People's Democratic Republic. The under-5 mortality ranges from 4 to 7 deaths per in Singapore, Japan and The Republic of Korea to more than 100 in certain countries. system constraints. Some of the underutilized e.g. haemophilus influenzae type b (Hib) and new vaccines (pneumococcal and rotavirus) target the two major causes of morbidity and mortality diarrhoea and pneumonia--among children in the Region. These vaccines can contribute substantially to the reduction of under-5 child mortality, particularly, in the low-income countries in the Region. 2 These six diseases include: diphtheria, pertussis, measles, polio, tetanus and tuberculosis. 1

7 However, the mortality estimates associated with these diseases represent only the tip of the iceberg. The associated morbidity and disability associated with different diseases is equally important, and may be underestimated. This disease burden may not only strain the fragile health systems resources but also push many households into perpetual poverty. 1.2 Beyond childhood mortality: premature adult mortality Most of the focus of impact assessment of immunization programmes in the past had been only in terms of number of under-5 deaths prevented. The current vaccines and new vaccines may have major impact on premature adult mortality as well as prevention of disability. For example, hepatitis B vaccine is now widely used in the Region, is estimated to prevent almost future deaths from liver cirrhosis and liver cancer each year. In addition, cervical cancer caused by A Mongolian man with hepatitis B related liver cirrhosis. Photo credits: Manju Rani human papilloma virus (HPV) strikes relatively young women and is estimated to cause cases and deaths worldwide. These chronic diseases also lead to severe strain on household resources. Since adults (especially women) are major caregivers for children, this indirectly has a huge impact on childhood morbidity and mortality, though not quantified currently. The current public health tools for control of cervical cancer (e.g. regular screening of women in the age group from 35 to 59 followed by treatment) are programmatically very challenging to implement in low and middle income countries. Two vaccines against major oncogenic serotypes of HPV (16 &1 8) have been licensed in and will help to prevent substantial morbidity and mortality among young women. 1.3 Prevention of long-term disability Immunization has helped to prevent substantial life-long disability due to measles and poliomyelitis in the last two decades. Approximately children are estimated to become permanently disabled in the Region from Japanese encephalitis (JE) and Hib alone, putting a very high burden on the families and social systems. Expansion of the programme with the inclusion of underutilized vaccines (e.g. vaccines for Hib, JE, and rubella) and A child left disabled by Japanese Encephalitis in Lao PDR. Photo Credits: Keith Feldon 2

8 introduction of new vaccines in the future such as for pneumococcal conjugate vaccine (PCV) will prevent substantial permanent disability among children. ] Due to the substantial anticipated public health impact of some of the new vaccines, introduction and expansion of new and underutilized vaccines (NUV) has been identified as one of the four strategic areas in the Global Immunization Vision and Strategy (GIVS) 1 ( ) jointly developed by UNICEF and WHO. Box 1.0: What are new and underutilized vaccines? New vaccines include vaccines that are either in the advanced stage of testing or have commercially licensed in the last 10 years and is being used on a very limited scale by very few countries. Examples of new vaccines include vaccines against meningococcus, pneumococcus, rotavirus, and HPV. Underutilized vaccines are defined as vaccines commercially available for more than 10 years now but are used by only a few countries. These include vaccines against Hib, typhoid, rubella, varicella and JE, among others. However, the underutilized and new vaccines are not mutually exclusive and new vaccines will soon become underutilized vaccines, if uptake remains slow. New and underutilized vaccines, however, do not include the vaccines that have been introduced by most of the countries in their national programmes but the coverage of these vaccines is low due to problems with the immunization service delivery systems. Table 1 in Annex A gives the list of NUV as of April Current status and achievements ( ) The Regional office work in the area of NUV ranges from dissemination of standards and policies developed by WHO IVB headquarters to countries, knowledge management, programmatic support for introduction of new vaccines, setting-up surveillance for decision-making in the pre-introduction stage to impact assessment and adverse effects following immunization (AEFI) monitoring in post-introduction stage. The following paragraphs present highlights of achievements in the last 5 years ( ). 1) Support for introduction of vaccines 3

9 During this period, 8 countries 3 introduced Hib vaccine and Cambodia decided to introduce the vaccine from 2010; 11 countries (9 PIC, Australia and New Zealand) introduced pneumococcal conjugate vaccines; China and Viet Nam expanded (or took the decision) the JE vaccine nationwide and Cambodia decided to introduce JE vaccine from The support for vaccine introduction included: technical assistance for assessment of disease burden (rapid assessment of Hib disease burden in Viet Nam in 2007; disease burden assessments for cervical cancer in Fiji and Tonga in ) to help towards decision for vaccine introduction, setting up of sentinel surveillance to generate disease burden data; technical assistance for assessment of cold chain capacity for inclusion of new vaccine (in Lao People's Democratic Republic, Kiribati, Papua New Guinea, Solomon Islands, and Viet Nam for inclusion of pentavalent Hib vaccine); financial analysis to assess the financial implications of new vaccine introduction on the national EPI budget and development of financial sustainability strategies (in Lao People's Democratic Republic, Kiribati, Papua New Guinea, Solomon Islands, and Viet Nam for inclusion of pentavalent Hib vaccine); cost-effectiveness analyses for Hib and JE vaccines; assistance on procurement of new vaccines, co-financing, etc.; development of training and information, education and communication (IEC) materials to assist the introduction of new vaccine (for Hib vaccines in Tonga and for pentavalent vaccine in other countries); preparation of GAVI application: Lao People's Democratic Republic, Kiribati, Mongolia, Papua New Guinea, Solomon Islands and Viet Nam introduced the Hib vaccine with GAVI support and were assisted with GAVI application including analysis of all the programmatic data; discussions and technical consultation with the technical working groups in the countries to raise awareness of new vaccines to stimulate discussions and decision-making with regard to new vaccines. 3 Lao People's Democratic Republic, Macao (China), Kiribati, Mongolia, Papua New Guinea, Solomon Islands, Tonga, and Viet Nam. 4

10 2) Dissemination of standards and policies to countries Several position papers on new and underutilized vaccines were developed by IVB HQ (e.g. on Hib, pneumococcal, typhoid, rotavirus vaccines) between 2006 and Besides providing technical inputs to HQ in development of these position paper, the Regional office actively discussed and disseminated these policy papers in several regional (e.g. in annual meetings of technical advisory group) and country forums. 3) Capacity building of country offices A staff training course on new and underutilized vaccines was organized for WHO and United Nations Children's Fund (UNICEF) country staff in April 2008 to build their capacity to provide improve support to the national counterparts in this area. 4) Knowledge management A detailed review of disease burden, impact assessment and cost-benefit analysis of Hib vaccine in the Western Pacific Region was done and published in Organization of regional/national forums/meetings: Biregional meeting on JE (2005, 2007); Regional forum on prevention of childhood meningitis and pneumonia (2006); national meeting on new and underutilized vaccine (Cambodia-2008) 5) Surveillance for diseases targeted by new and underutilized vaccines: Major progress was made in setting up surveillance system for new vaccines in this period. Assistance was provided to Cambodia, China, Lao People's Democratic Republic, Mongolia, Papua New Guinea, and Viet Nam in setting up sentinel surveillance system for meningitis/ meningoencephalitis and rotavirus. In addition, assistance is being provided to set-up sentinel surveillance networks for rotavirus diarrhoea. These surveillance and assessments will provide help decisions for new vaccine introduction and impact assessment post-vaccine introduction. 6) Collaboration with other partners: International Vaccine Institute (IVI), US Centers for Disease Control and Prevention (CDC), GAVI Alliance, and UNICEF 3. Proposed activities, indicators and targets in the current plan 3.1. Knowledge management and strategic dissemination of information and new developments 5

11 The field of new and underutilized vaccines is fast evolving in the last few years with many new vaccines getting licensed with new information coming out very rapidly on the results of clinical trials, post-marketing surveillance, duration of protection etc. WHO HQ has been trying to update/develop vaccine position papers on a regular basis. Strategic dissemination of this information is critical to accelerate the decision-making and to fine tune programmatic strategies for immunization with these vaccines Activities - Regular updates of national EPI managers on recent developments in the field of new vaccines relevant to the countries in the Region; strategic dissemination of new vaccine position papers and other technical updates to all the EPI managers, members of national technical working group and other stakeholders in the Member States keeping updates on new and underutilized vaccines as a regular agenda item on the technical meetings and workshops organized at the regional and sub-regional level - Organizing regional workshops on new and underutilized vaccines every other year; - Organizing national workshops involving wide-range of national stakeholders on new and underutilized vaccines; - Developing communication materials targeted at variety of audience in the countries to communicate about different NUV Indicators - Number of priority countries organizing national workshops on new and underutilized vaccines in a year; - Periodic update on new and underutilized vaccines on the agenda of the regional Technical Advisory Group (TAG) meeting: Yes/No; - Number of new and underutilized vaccines for which communication materials were developed; - Organization of at least one regional forum on NUV Yes/No 6

12 3.1.3 Targets - 100% national EPI managers in the Region are fully aware of the update vaccine position papers as issued by WHO HQ and have been discussed at least once by the Technical Working Group (TWG) in the country. - All the 8 priority countries assisted to organize national workshop on NUVs at least once each year; - Updates on NUVs on agenda of TAG each year; - At least one regional forum organized on NUV once in two years; - Communication materials are developed for Hib, pneumococcal, rotavirus and HPV vaccines. 3.2 Generation and communication of morbidity and mortality data from diseases targeted by NUV Lack of clear disease burden (both morbidity and mortality) information may be an obstacle to the introduction of a new vaccine especially when the new vaccine is expensive and the disease prevented by the new vaccine causes a variety of syndromes and clinical conditions, and not a single clinical condition. For example, the diarrhoea caused by rotavirus is not clearly distinguishable from diarrhoea caused by other viral and bacterial agents and is generally treated on the basis of a syndromic approach irrespective of the etiology. Little credible data may be available on the countries on the proportion of diarrhoea caused by rotavirus and other etiological agents. Hence, in this situation, introduction of a vaccine targeting a multi-etiologic public health problem (e.g. diarrhoea or pneumonia) will require accurate estimates on disease burden, proportion of public health problem likely to be prevented by the vaccine, and impact of vaccines and other public health interventions currently in place for that particular public health problem Activities Assist in the development/strengthening of surveillance systems for diseases targeted by NUVs based on standard guidelines and laboratory practices. Establishment of regional surveillance networks with monthly reporting of data to regional office which will be used to establish disease burden of the diseases targeted by new vaccines. Development and strengthening of laboratory networks to support surveillance activities in the local, national and regional level. 7

13 3.2.2 Indicators Number of countries with established sentinel surveillance for acute central nervous system (CNS) infections Number of countries that has established sentinel surveillance for rotavirus gastroenteritis Number of countries reporting results of sentinel surveillance on a monthly basis to the Regional office Targets All non-pacific island countries (PIC) and key PIC (e.g. Fiji) have established well functioning sentinel surveillance for acute CNS infection and rotavirus by Monthly data reporting systems are established linking the entire sentinel surveillance site in the country by 2009, with data reporting to the Regional office by all countries. A regional reference laboratory and national reference laboratory are designated for selected NUV (Hib, pneumococcus, meningococcus, JE and rotavirus; regional reference lab for HPV) in all priority countries by Developing and using standardized cost-effectiveness and other economic analysis for new vaccines. Demonstration of cost-effectiveness (CE) may be sought in some countries to guide decision-making for introduction of a NUV in the national immunization programmes. However, many of the existing CE studies are characterized by non-standardized methods, inputs, and assumptions, which result in lack of transparency and reduced credibility among the decision makers. Hence, standardized tools need to be made available for CE analysis. In addition, most of these CE analyses are conducted by partner agencies or by researchers based in developed countries. Efforts need to be made to develop the capacity of researchers based in the countries of the Region. 8

14 3.3.1 Activities Work with IVD/HQ and other regions to develop and disseminate standardized tools for CE analysis for different NUVs. Identify institutions within key priority countries and build their capacity to conduct CE and other economic analysis for NUV. Assisting with CE and other economic analysis in key priority countries for selected NUVs. Compilation of an inventory at regional level with information on economic analysis done by different countries in the Region or outside the Region Indicators Number of priority countries that conducted CE or other economic analysis for particular NUV Targets Development and dissemination of a standardized tool for CE analysis by 2009 Development of an inventory of economic analyses at regional level by Mobilization of resources by regular advocacy with regional/global donors and other stakeholders In the Western Pacific Region, only seven countries 4 accounting for less than 10% of the regional population are eligible to receive GAVI Alliance funding for NUV on subsidized basis. The new vaccines are much more expensive than the currently used vaccines, at least in the initial years of their availability. While many of these vaccines may be cost-effective even at the current price, these may not be affordable especially by lower and lower middle income countries and in some instances even by higher middle income 5 countries. This may require additional advocacy efforts with national governments and use of innovative financing mechanisms or mobilization of initial external financing from sources other than GAVI Alliance until the vaccine market prices go down substantially. 4 These seven countries are Cambodia, Lao People's Democratic Republic, Kiribati, Mongolia, Papua New Guinea, Solomon Islands, and Viet Nam. 5 Based on World Bank categorization of different countries into low income, lower-middle, higher-middle and higher-income countries. 9

15 3.4.1 Activities Development and annual update through the mechanism of Joint Reporting Form (JRF) of aggregate demand forecasts of different vaccines at the regional level to negotiate with different manufacturers and suppliers at the regional or global level. Innovative financing mechanisms: collective bargaining with the manufacturers based on total demand estimation. Piloting co-financing/cost-sharing by users under the umbrella of EPI programme in selected countries. Annual cost estimation for activities related to new vaccine introduction including surveillance costs and presenting funding proposals to different potential donors in the Region and globally in collaboration with IVD/HQ. Promote mobilization of domestic resources for vaccine introduction Indicators Aggregate demand estimates made each year: Yes/No Number of lower and higher middle-income countries that are not GAVI eligible that introduced selected NUVs Targets Internal and external resources mobilized to facilitate introduction of Hib vaccines in remaining four PICs (Cooks Island, Nauru, Vanuatu, and Tuvalu) by 2009 Pilots of cost-sharing by end-users for selected new vaccine (Hib, pneumococcal or HPV vaccine) conducted in one middle-income country by 2010 Hib vaccine introduced in the Philippines (a lower middle-income country) by 2010 with funds mobilized either domestically or using alternate financing mechanisms 3.5 Building capacity of the national regulatory authority for licensing and post-marketing surveillance of new vaccines The manufacturers are approaching individual countries to license the new vaccines in the developing countries. In many instances, the vaccine efficacy is not 10

16 measured in the context of that particular country or Region. Though demonstration of vaccine efficacy of a particular vaccine in each country is not feasible, some analysis may be required to estimate the potential impact on the disease, especially for diseases caused by several serotypes of a particular organism with varying geographical distribution and in the context where some extraneous factors such as malnutrition rates, prevalence of human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS) may adversely affect the efficacy of the vaccines. In addition, some of the new vaccines are not licensed or used in the countries where they are manufactured and have limited follow-up data on effectiveness, duration of protection and long-term safety. Hence, capacity of national regulatory authority (NRA) needs to be built including strengthening of post-marketing surveillance in the countries Activities:. WHO NRA assessments against published NRA indicators conducted and completed by end of 2009 in all priorities countries, NRA institutional Development plan (IDP) developed and endorsed to address gaps and optimize existing strengths to achieve objectives by end of 2009 Training to address gaps identified through assessments planned and conducted for priority regulatory functions: training on a) licensing including clinical evaluation, b) AEFI/PMS and for some countries on c) lot release, d) laboratory access, e) Regulatory inspections and f) Oversight of clinical trials. Monitoring of progress in implementation of IDP through follow up visits (at least twice a year per country), Providing technical expertise to guide clinical evaluation for licensing, causality assessment for AEFI, assessment of clinical trials protocol, review of summary lot protocol, and quality control of priority vaccines Indicators Number of priority countries having build upon an existing drug regulatory authority a system to regulate vaccines as per the criteria 6 laid out by WHO Number of priority countries having an IDP for NRAs to address gaps identified during assessment Number of priority countries with legally established system to regulate vaccine, a marketing authorization and an AEFI surveillance system in place, documented and functioning against indicators established by WHO for NRAs. Monitoring doses of assured quality used for national immunization programmes, imported and produced in target countries Targets 6 Some of these criteria relate to independence of NRA and legal statutory basis. 11

17 Establishment of independent and functional NRAs in each of the priority countries by 2015 (so far 3 out of 7 have a drug regulatory system that deal with vaccines too but none of them is so far functional in 2008 against WHO NRA indicators) Establishment of an independent and functional NRA in Viet Nam (the only producing country) by Ensuring access to vaccines of assured quality for all new vaccines 3.6 Assisting countries with operational and managerial issues related to new vaccine introduction. Introducing new vaccines requires actions in several programmatic aspects. These include assessing and preparing cold chain to accommodate NUV; training of health workers in new immunization schedule, handling and administering new vaccines; implementing special (IEC) programmes to increase the community demand for new vaccines; and creating systems to assess the new vaccine coverage and its impact on the disease burden and epidemiology. IVD/ HQ developed new vaccines introduction guidelines in 2005 to guide policy makers and national programme managers to make informed decisions about new vaccine introduction. Special efforts will also be required to improve vaccine management to reduce vaccine wastage as new vaccines are substantially more expensive than the current traditional vaccines Activities Assistance with cold chain capacity assessment before vaccine introduction Helping to mobilize resources for expansion of cold chain capacity if additional resources are required Assistance for economic analysis for new vaccine introduction Assistance with development of training and IEC materials for new vaccine introduction Assistance with revision of immunization cards, registers and other recording and reporting forms for immunization services. Assistance with impact assessment after vaccine introduction Indicators 12

18 Percentage of countries that achieve NUV coverage similar to diphtheriapertussis-tetanus (DPT3) within one year of NUV introduction Percentage of countries conducting an impact assessment for NUV within three years of vaccine introduction Targets 100% of countries that introduced a NUV will have undertaken a cold chain and financial analysis before vaccine introduction 100% of countries will have conducted vaccine impact assessment within three years of vaccine introduction 100% of countries will have achieved at least the same coverage as DPT3 within one year of nationwide introduction 3.7 Promoting research in the Region to encourage development and production of NUV in developing countries. Most of the NUVs (e.g. Hib, pneumococcal conjugate vaccine, meningococcal conjugate vaccine, HPV, rotavirus) are currently produced by few manufacturers in developed countries. One of the key factors that drove down the price of hepatitis B vaccine in 1990s was the production of vaccine by several additional manufacturers in the developing countries. The vaccine producing countries in the Region include Australia, China, The Republic of Korea, Japan and Viet Nam. Support should be mobilized for either technology transfer or for independent research to enable these manufacturers in the Region to develop and produce NUVs Activities Coordinate with IVR/HQ to explore potential technology transfer for NUV to manufacturers in the Region Coordinate with IVR/HQ to organize consultation with leading manufacturers in the Region to develop the research agenda and to assist with the research activities Indicators Number of manufacturers in WPR with ongoing research for development of NUVs 13

19 3.7.3 Targets At least one developing country manufacturer in the Region that can produce a new and underutilized vaccine not produced earlier in the Region of assured quality by Budget needs 4.1 Staff costs Regional level Two professional staff dealing with new vaccine pre-introduction including surveillance and laboratory issues, introduction and post-introduction activities (impact assessment, financial sustainability) will be needed at the regional level. In addition, professional; staff working on NRA or AEFI issues will also cover these issues with respect to new vaccines Country level It is estimated that current country staff have to spend at least 30% to 40% of country staff time on activities related to NUV. A special services agreement (SSA) or national programme officer may be required in some of the priority country to deal with additional work load. 4.2 Activity costs Funds for implementation of different activities (not all of these to be financed from external sources) besides the cost of vaccines and staff at the country and regional level: 1) Surveillance for the diseases targeted by new vaccines 2) Regional and national workshops 3) Production of IEC materials 4) Training of health staff at different levels at the time of introduction of vaccines 5) Cold chain expansion and other logistics issues 6) Post-introduction impact assessment 7) Cost related to NRA assessment and capacity building Table 1 gives the estimated costs for these activities (besides the cost of vaccines and staff). 14

20 Table 1: Estimated costs of different activities related to NUVI strategy Name of activity Expected cost Focus countries 7 Financing Gap Surveillance Hib, pneumococcus and JE (integrated ME surveillance) Rotavirus surveillance HPV disease burden assessment $ /year $ /yr $ /yr Cambodia, Lao PDR, China, Philippines, Viet Nam, Fiji, Mongolia Same as above Same as above GAVI, Gates Foundatio n, national governme nts National workshop on new vaccines Regional workshop Production of IEC materials and other publications Training of staff at different levels Expansion of cold chain to accommodate new vaccines Post-introduction vaccine impact assessment $ /year Same as above GAVI Alliance work plan funds $50 000/year All countries GAVI, other bilateral donors $25 000/year Focal countries GAVI funds to national govt $ Focal countries National governme nts $ Cambodia, Lao PDR, PHL, VTN $ /year Countries that introduced a NUV in this plan period Bilateral donors (e.g. JICA, Govt. of Luxembou rg, national govt.) May vary from year to year, as donor announce their financial commitments on annual basis Subject to actual introduction of vaccine 7 While the activity is recommended for all the countries, the focus countries may be considered for financial assistance from WHO or other international donors 15

21 Annex 1: Table 1: Status of utilization of NUVs in Western Pacific Region as of April 2008 Vaccine Year of licensure Current use in the Western Pacific Underutilized vaccines Rubella pacific Island countries (except Solomon Islands and Kiribati), and 8 Non-PIC (except Cambodia, China,, Japan, Lao PDR, Mongolia, Philippines, PNG, Viet Nam) Japanese encephalitis (live attenuated) 1990?? China Haemophilus Influenzae (Hib) 1987 All 8 except China, Singapore, Hong Kong (China), Japan, Republic of Korea, Philippines and 4 PIC Varicella Late 1990s Brunei, Republic of Korea Seasonal influenza vaccines Typhoid vaccines New vaccines Seven-valent pneumococcal conjugate vaccine (PCV-7) Australia, New Zealand Viet Nam, China, ROK in limited geographical areas 2000 Australia, New Zealand, 9 PIC Rotavirus vaccine 2006/2007 Australia, Federated State of Micronesia, Niue Human papilloma virus (HPV) vaccine 2006 Australia, Federated State of Micronesia, Guam, Niue Conjugate meningococcal vaccines??? New vaccines under development Malaria 2012? HIV/AIDS 2015? Tuberculosis 2012? Expected year of commercial licensure 8 Lao PDR and Viet Nam intend to introduce Hib pentavalent vaccine (DPT-HepB-Hib) from January 2009 subject to approval of their application submitted in May 2008; Cambodia intends to introduce from January

22 Annex 2: Cost of fully immunizing a child with particular underutilized and new vaccines at prices 9 in 2008 Name of vaccines Pentavalent Hib vaccine (DPT-HepB- Hib) Doses recommended per person (price per dose) Total cost per child 10 Comments 3 ($3.60) $ 10.8 UNICEF price for 2008 Rubella (MR vaccine) 2 ($0.50) $1 UNICEF price for 2008 Varicella 1 (??) Not WHO prequalified Typhoid Japanese encephalitis (live attenuated vaccine) 2 ($0.20) $0.40 The price based on PATH negotiation with Chengdu Institute for countries with GNI per capita<usd 1000 New vaccines PCV-7 3 ($75) $225 per dose A contract is being negotiated between UNICEF and supplier, UNICEF price still not known. Price based on current estimated market price in developed/private market Same as above Rotavirus 2 (GSK) 3 (Merck) $7-9 per dose HPV 3 ($75-100) $225-$300 Same as above Conjugate??????? meningococcal vaccine 9 UNICEF prices are used if available for a vaccine, otherwise the best market prices are used. 10 Gives only the cost of vaccine. The actual cost may be higher due to associated vaccine wastage, need for injection equipment and other incremental programme costs. 17