Post00341 : PRIORITIES FOR DEVELOPMENT

Post00341 PRIORITIES FOR DEVELOPMENT 10 May 2001 CONTENTS 1. VACCINE DELIVERY TECHNOLOGIES AND SYSTEMS: PRIORITIES FOR DEVELOPMENT *This discussion paper by John Lloyd, PATH-CVP, sets out the key technology and systems development priorities for removing the obstacles to the more equitable, safer and more efficient delivery of vaccines to children. Opinion, comments and additions please: [log in to unmask] or use your reply button ___________________________________________________________________________ *VACCINE DELIVERY TECHNOLOGIES AND SYSTEMS: PRIORITIES FOR DEVELOPMENT Vaccine delivery technologies and systems should facilitate high performance immunization services; services that reach children equitably, that are safely delivered and that are provided at the lowest recurrent cost. In these respects, the performance of immunization services is weak in many of the countries eligible for GAVI Fund assistance. Changes in technology should bring long-overdue improvement to the performance of existing services while also preparing logistical systems for the delivery of new vaccines with different characteristics. 'ROADBLOCKS' TO GAVI The highest priority should be given to the development and introduction of changes which will remove 'roadblocks' to the implementation of the GAVI vision for more equitable, safer and more efficient delivery of vaccines to children - now and in the future. Four such 'roadblocks' need to be tackled: * First, the current lack of minimal standards of safety for children, health workers and the community of vaccine administration using conventional, multi-dose vials. This is a barrier that threatens safety both in routine immunization services and in supplementary immunization operations, affecting both existing vaccines and the introduction of new and under-used vaccines. * Second, the lack of an efficient technology for the future to present and administer new vaccines at high standards of safety for the client, the health worker and the community and at the lowest cost in use. * Third, the burden of the maintenance of refrigeration for vaccines from arrival to the point of use in tropical countries with scarce energy availability and scarce resources. * Finally, the continuing inability of Governments to manage the vaccine distribution system, maintenance of the cold chain and transport for service delivery in the weaker immunization systems. This impairs access to potent vaccines and to immunization services and has not improved, rather worsened in the last 10 years. STRATEGIES In response to these four roadblocks, four strategies should be pursued consistently for the next five to ten years in order to see significant progress. They are: 1. To ensure safer injections with multi-dose vials by: * The expanded use of Auto-disable syringes in routine immunization * The re-introduction of safe multi-dose, needle free injections for mass immunization 2. To move towards mono-dose, self-contained vaccination devices by: * Introduction of pre-filled injection devices * Prioritizing development of non-invasive, vaccination technologies 3. Reduce dependency on the cold chain by: * Implementation Vaccine Vial Monitors to drive vaccine management * Development and introduction thermo-stable vaccine products 4. Transform the management and financing of logistic systems for immunization in countries with weak immunization services by: * Introduction of private/public partnership in transport management for service delivery * Research and introduce private/public partnership for all immunization logistics Each of these strategies is aimed, simultaneously towards several criteria of a high performance vaccine delivery system. Each strategy has objectives that are a mix of different types including product research, operational research, training for introduction, marketing, and policy development. The rationale, objectives and suggested indicators follow and a conclusion summarizes the objectives by type. Expanded use of Auto-disable (AD) syringes in routine immunization RATIONALE The rationale for the use of AD syringes in immunization services is to prevent re-use and transmission of blood-borne pathogens both within health services and to prevent re-use following recuperation from the garbage. The introduction of the AD syringe has provided an opportunity to incorporate the means for safe handling, to minimize accidental needle-stick (Compared with handling reusable syringes for cleaning and sterilization) and to create advocacy that will sensitize users to safety procedures. OBJECTIVES Although nearly half of all injections for immunization are currently given with sterilizable equipment in developing countries, the objective of WHO and UNICEF is to introduce the AD syringe with safe disposal for all immunizations by the end of 2003. To achieve this the following objectives should be pursued as a priority: * AD syringes should be available from local and international producers in sufficient quantities for all immunizations at a price premium compared to disposables of less than 10%, * All injection devices used for immunization should be AD, including syringes for intradermal injection and reconstitution, * All health workers should have been trained to use AD syringes, * Financing should be found to switch entirely to AD syringes for all vaccines where the GAVI Fund has offered AD syringes with new and under-used vaccines, * Sharps waste management and facilities for final disposal should be made available to all primary health centers. The re-introduction of safe multi-dose, needle free injections for mass immunization RATIONALE The multi-dose, needle-free injector used for over 40 years, delivered an injection at less than half the system cost of an AD syringe, three times more rapidly and with a fraction of the waste hazard. Research has shown that cross infection risks associated with earlier injectors have now been reduced to acceptable levels. These new, safe injectors are the best suited to mass immunization once they are made available on the market. OBJECTIVES * At least one model of multi-dose needle-free injector should be trailed, certified for use in immunization services and made available, by 2003, at a price less than the system cost of AD syringes. * Policies, both global WHO and national governments, should be revised to declare the use of these injectors, once more, acceptable * Training should be made available for teams to use and to maintain the injectors in the field. Introduction of pre-filled injection devices RATIONALE The pre-filled, AD injection device guarantees the safety of the injection and the integrity of the dose of liquid vaccine. It also assures that everything required to accomplish an effective vaccination is bundled into a single self-contained system. Devices available on the market now have also been shown to be simpler to use by less trained health personnel and they permit higher immunization coverage by bringing the vaccination closer to the family. They are also more easily disposed than syringes. The cost of storing these devices in the cold chain is higher but opportunities may exist for distribution out of the cold chain. In addition to devices to deliver liquid vaccine that exist, there may also be possibilities to deliver dried vaccine, reconstituted automatically during the injection. In the future, many of these self-contained unit dose delivery systems will be needle-free. OBJECTIVES * The experience of early adopters of pre-filled, AD injection devices (e.g. UniJect[TM] by BD) should be gleaned and used to sensitize managers in developing countries to the benefits and impact of using UniJect * Global WHO Policy should be amended to prefer the use of these devices in applications where safety may be compromised by syringes, where public health impact may be minimized by local storage and use, where users are likely to be less trained and for certain immunizations such as the birth dose of Hepatitis B. * The storage temperature of certain vaccine/device products, such as Hepatitis B should be amended to reflect the results of field research on the use of vaccine in UniJect out of the cold chain. Prioritize development of non-invasive, vaccination technologies RATIONALE The ultimately safe and convenient presentation is a non-invasive self- contained delivery system that requires no other commodity or equipment to administer the dose.. This has been demonstrated by the impact of oral polio vaccine that has reached most of the children that were previously un- reached by immunization globally. No other vaccine delivery technology can have greater potential impact on system performance than this. Ambitious though the goal is, much progress has already been made towards the development of a range of different vaccine-and-administration technologies. Commitment and funding are needed to propel the most promising technologies through the barriers of doubt and risk. OBJECTIVES * Array the current competing technologies against the range of current and new vaccines in an cost/benefit, evaluative framework that will facilitate priority setting * Mobilize the necessary commitment and financial support needed to propel the best technologies through the development phases to vaccine products Implement Vaccine Vial Monitors to drive vaccine management RATIONALE VVMs provide the health worker with a clear warning when vaccine should be discarded due to heat exposure, before the expiry date. VVMs are already implemented on oral polio vaccine and are in the process of implementation on all other vaccines. Polio eradication national immunization days have demonstrated that VVMs can be used to remove vaccine from the cold chain for significant periods without compromising the potency of the vaccine - even using the most heat labile of all currently used vaccine. VVMs are therefore a powerful managerial tool to enable other, more stable vaccines to be removed from the cold chain and to determine where refrigeration standards need to be high, and where they can be relaxed. OBJECTIVES * Work with WHO and the IFPMA to change the instructions regarding storage and transport of vaccines and to modify global cold chain policy appropriately, * Obtain the agreement of PAHO to sanction the use of VVMs on all vaccines used in the Americas * Research and develop an integrated freeze warning for the current VVM or, if necessary, a separate freeze indicator label * Train managers in all countries to use the VVM as a monitoring tool to manage the cold chain and as a vaccine handling tool for health workers * Conduct operational research to demonstrate the potency of vaccine used, with VVMs, outside the cold chain * Develop alternative sources of supply and technology transfer for the production of VVMs. Develop and introduce thermo-stable vaccine products RATIONALE VVMs help to reduce dependence on the cold chain but vaccines are not yet sufficiently stable to be released from the refrigerated storage altogether. The addition of new vaccines and the move towards mono-dose presentations of vaccine will increase the overall volume of vaccine to be distributed. This will raise the capital and recurrent cost burden of the cold chain significantly. Also, the current need for ice at the point of use is a constraint on immunization coverage in rural areas. Thermostable vaccine that does not require refrigeration and is not affected by freezing would reduce the cost of immunization and increase the accessibility of vaccines for children in areas of low population density. OBJECTIVES * To develop and introduce a thermo-stable version of an existing, multi- dose, single antigen vaccine product for large scale to evaluate the system cost benefits and the public health and logistic impact, * To develop and introduce a pre-filled AD injection device which can administer a dose of thermo-stable vaccine without manual reconstitution, * To assess the technical feasibility, costs and potential benefits of processing new, combination vaccines as thermo-stable products presented in pre-filled, AD injection devices. Introduction of private/public partnership in transport management for service delivery RATIONALE Several African countries have made successful use of outsourcing to the private sector of the management of transport for service delivery. These countries have demonstrated that fleet management is improved and vehicle availability is high. On this basis, good operational management of service delivery can obtain high public health impact. In contrast, the ministries of health in countries in Africa with weak infrastructure still attempt unsuccessfully to manage their own transport fleets which remain, after many years of development, a major constraint to immunization coverage. There is therefore great potential to replicate the experience of the more successful African countries in a way that could be sustainable in other African countries. OBJECTIVES * To introduce outsourced management of vehicle fleets together with enhanced operational management of immunization outreach services through the WHO/UNICEF/UNF Sustained Outreach Services project and the WHO/PEI surveillance vehicle management system. * To develop sustainable systems of government and external partner financing of the kilometer tariff required by outsourcing companies/NGOs Research and introduce private/public partnership for all immunization logistics RATIONALE: *Outsourcing is proving to be a successful mechanism to improve transport management in some countries or areas with weak infrastructure. On this basis, a broader outsourcing of the cold chain, communications, supply, disposal and transport system of immunization services could also remove the 'roadblock' of inefficient and ineffective logistics in some countries. Consequently, public health operational management would be more likely to be successful in reaching high levels of immunization coverage. Such a system may be sustained with government funding with cross-subsidization from parallel commercial use of transport and other resources. OBJECTIVES: * Operational research to assess the impact of outsourced distribution of vaccine and syringes to the point of use in countries with weak infrastructures and a history of logistics mal-performance. The research should include the evaluation of cross-subsidization opportunities to offset the high cost of creating the distribution infrastructure. * Literature research to study the costs and benefits and critical success factors of outsourced distribution systems in industrialized and emerging economies. CONCLUSION: The changes to immunization technologies and systems inferred by the above program of work need to be managed. Work is needed in the areas of product research, operational research, training for introduction, marketing, and policy development. Product research priorities include the development of a safe multi-dose needle-free injector, a freeze sensitive VVM, a thermo-stable vaccine, an auto-reconstitution system for dried vaccine and to prioritize non-invasive vaccine administration technologies for support. Operational research priorities include the assessment of the impact of pre- filled, A-D injection devices, the development of sharps waste management and disposal systems, the use of vaccine out of the cold chain and the logistic, financing and impact on vaccine coverage of outsourced transport or whole logistic systems. Training programs are needed to aid the introduction of VVMs, AD syringes, multi-dose needle-free injectors and to assure good operational management and supervision of outsourced transport or whole logistic systems. Marketing and information is needed to sensitize managers to changes in technology and systems including the early experience of vaccines in pre- filled AD injection devices, the use of AD intradermal and reconstitution syringes, the costs and benefits of outsourcing examples and the operational planning of mass immunization using multi-dose needle-free injectors. Policy development and effective application is needed for the full, global introduction of VVMs, the use of vaccine outside the cold chain, the switch to mono-dose vaccine presentations and the use of outsourcing logistic systems for immunization services. John Lloyd Resident Adviser PATH-CVP Centre d'Aumard 55 Avenue Voltaire 01210 Ferney Voltaire France Tel: (33) 450 28 06 09 Mobile: (33) (0) 671 175 247 Fax: (33) 450 28 04 07 ____________________________________*_________________________________