4th Global Meeting on Implementing New and Under-utilized Vaccines, 23-25 June 2010
I. Global NUVI Plan of Action: Update and progress report
The updated NUVI Plan of Action was presented and discussed. It will again undergo a further update based on the discussions at this meeting related to its work areas: Norms and Standards, Country Decision Making, Planning, Financing and Procurement, Vaccine Delivery and Monitoring and Surveillance.
The Global New & Under-utilized Vaccines Introduction Plan of Action is updated regularly based on outcomes and recommendations from the annual global NUVI meeting. Highlights in 2009 and 2010 include the following:
- Prequalification of Cervarix™, Gardasil™, Synflorix™ vaccines
- Vaccines slightly better adapted for DC use (PCV7 single dose vial, RV fully liquid)
- Strengthening of NRAs with focus on priority producing countries; DCVRN and AVAREF meetings; Interactions between NRAs and NITAGs initiated
- Clinical research: Project on optimizing paediatric schedules initiated; AVI TAC Special Studies on track
- Launch of the Immunization Practices Advisory Committee (IPAC)
- Policy guidance - position papers (RV update 12/09, Cholera 3/10)
- Burden of Disease estimates for Hib, Spn for 2000
- Multiple studies on drivers and barriers of new vaccine adoption
- cMYP workshops with revised budgets for surveillance and integrated approaches
- Pricing analysis conducted for Hib, PCV, RV, polio vaccines
- Gates pledge: Decade of Vaccines
- HR: Regional training workshops conducted in AFR, EMR, AMR;
- CCL: Tools for cold chain and logistics planning, EPI forecasting, Effective Vaccine Management developed or upgraded
- Communication Framework for Pneumonia and Diarrhoea Control finalized
- Immunization coverage of RV and PCV published
- Global and regional IBD and RV surveillance bulletins published
- HPV coverage and impact monitoring methods developed
- PIEs conducted in 11 countries - sharing experience from early introductions
- Global Network for Post-Marketing Surveillance of Pre-qualified Vaccines established with 12 countries
However, there are several challenges:
- Review and update the prequalification procedure - Finalise White Paper on programmatic suitability of vaccines
- Manage recall of vaccines due to quality issues
- Provide clear information on newly discovered adventitious agents in rotavirus vaccines
- Assist countries with substantially more complex GAVI processes
- Provide high-quality data: BoD updates for Hib, Spn, Rotavirus
- Provide assessment of cost-effectiveness tools conducted for Hib, PCV, RV, and HPV
- Assist LMICs and graduating countries in sustaining NUVI
- Make vaccine more affordable – reduce prices
- Update demand and supply forecasts following GAVI Board decisions
- Support shift from co-financing to increased allocation of domestic resources
- Retain donor commitment in times of belt-tightening in industrialised countries
- Develop further pooled procurement options for interested Regions
- Strengthen immunization systems – e.g. microplanning guidelines using RED approach
- Assist countries in assessing their NUVI 'readiness' and addressing systems shortfalls
- Work towards supply chain innovations
- Investigate potential 'collateral effects' of NVI on immunization and health systems (SAGE)
- Prepare for MenA introduction in Burkina Faso, Mali, Niger
- Transition IBD and RV GE surveillance network sites to national ownership and funding
- Improve data reporting, quality and management
- Further develop PIE tool to better inform countries and partners
- Establish integrated surveillance platform: e.g. SURVAC project in Central Africa
To confront these challenges, several initiatives have been undertaken and are being continued under the various areas of work under the NUVI plan of action. The main priorities for moving forward are the following:
- Support Hib vaccine introduction in remaining countries
- Support PCV10 and PCV13 introductions
- Support Rotavirus vaccine introductions
- Support HPV vaccine introductions
- Support introduction of vaccines of regional importance: YF, JE, MenA, Typhoid, Cholera
- Support integrated approaches to disease prevention and control
- Strengthen immunization systems
- Further develop cost-effectiveness tools
- Make vaccines more affordable
- Support country cold chain and logistics preparedness
- Further support HCW training activities
- Improve surveillance data quality, and establish integrated surveillance platforms
- Monitor vaccine safety and establish crisis and pre-emptive communication
- Support middle income countries
- Assess programmatic suitability of vaccines
- Support NITAGs and NRAs
- Achieve sustainable financial support
- Improve NUVI communications
II. Cold Chain and Logistics: Availability and functionality as key NUVI component
Global cold chain capacity is estimated to be markedly limited, and will be further strained over the next 10 years as it adapts to support vaccine volumes that will increase by an estimated 3-4 fold. Cold chain management capacity is also weak with a key limitation being the lack of recognition of logistics as a profession in many countries with no attractive career path, and no dedicated educational structure. Progress in strengthening the global cold chain capacity during 2009 included development of guidance materials (e.g. Logistics Planning Tool, Vaccine Volume Calculator, Large Store Assessment Tool, Inventory and Forecasting tool), training of staff, Optimize demonstration projects to integrate and streamline activities, enhancement of a PQS system that will be fully operational by the end of the year, and initiation of resource mobilization activities.
The future strategy for the NUVI cold chain system management includes incorporation of a proper cold chain estimation of needs over the next 5-10 years into each national multi-year plan. Additionally, infrastructure expansion is needed for primary and intermediate stores, and peripheral stores must be optimized with priority given to ensuring access to electric cold chain and solar panels. Information system improvements are needed to ensure efficiency, and appropriate vaccine stock management and immunization data management systems. Management capacity needs to be enhanced to cope with the increased workload and complexity of the process. To support the implementation of the strategy, a technical network has already been established (Technet website).
III. Coordination between NRAs and NITAGs and/or Immunization Managers
As a joint WHO and SIVAC activity, the coordination between National Regulatory Authorities (NRAs) and National Technical Advisory Groups (NITAGs) has been assessed. This activity was an outcome from the June 2009 NUVI working group session which concluded that lack of coordination between these organizational bodies can result in delayed vaccine introduction. Subsequently, a work shop was held in Bali, Indonesia that brought together members of NRAs, NITAGs, and MoH. Countries presented models for NRA and NITAG cooperation, and it was noted that many different models exist that could work effectively. However, enhanced interaction between NRAs and NITAGS is warranted, and formal interactions should be established as early as possible in the process of introducing a vaccine. A possible mechanism to achieve this would be to have NRA representatives serve as ex-officio members on the NITAG, and conversely, for NITAG members to serve as experts for market evaluation experts groups. NRAs and NITAGs should be able to effectively communicate while ensuring the independence of each entity. As follow-up points from this discussion, WHO's global guidance has been updated to include the NRA-NITAG interaction indicator in the NRA assessment tool. Additionally, the meeting report will be published in a peer-reviewed journal to ensure broad dissemination of the thought process and the final recommendations.
IV. NUVI financing and prioritization and update on GAVI Board decisions
The GAVI Board met during the week before the Global NUVI Meeting. The official minutes of the Board meeting will be published in due course. The Board endorsed GAVI's five-year strategy for 2011-2015 which has 4 Strategic Goals: New Vaccines, Health Systems, Financing, and Shaping Markets. GAVI faces a financial gap of $2.6 billion for existing commitments and plans a replenishment meeting in October 2010.
The Board decided, in principle, to fund applications which had been reviewed by the IRC in October 2009 from 15 developing countries and to call for a new round of applications. A meeting of the Executive Committee of the Board in July will consider the amounts to be committed for the October 2009 IRC-recommended applications and will also set the date for the new round of applications. Country eligibility for GAVI funding will change to a GNI of < USD 1,500. GAVI will implement a pilot prioritisation mechanism for two funding rounds: countries will only be approved for one vaccine per funding round and applications will be ranked according to health impact, value for money, and need. Cash-based applications will be ranked according to need and financial sustainability. This prioritisation mechanism will be applied to vaccines which are already in the GAVI portfolio. The Board also separately approved funding windows for country applications for yellow fever preventative campaigns, and for meningitis A catch-up, and routine immunisation. For HPV, typhoid, Japanese encephalitis, and rubella vaccines, the GAVI Secretariat will continue preparatory work to open new application windows following the pilot period.
The Board will maintain the focus on vaccines as GAVI's core business but recognises the importance of health systems for immunisation and for achieving the Millenium Development Goals so will re-visit the maximum share of funding for cash-based applications at its next meeting, in light of the progress with the HSS funding platform. The Board agreed to fully fund introduction of pentavalent vaccine in 5 states in India provided that India has started to implement introduction by 1 December 2010. The Board decided to allow all 72 countries which were eligible for GAVI funding in 2003 to have access to pneumococcal vaccine through the Advanced Market Commitment but countries will have to have achieved DTP3 coverage above 70% in order to purchase under the AMC agreement and completely self-finance the vaccine tail price once GAVI support has ended. The Board approved the objectives of co-financing and a new method for allocating health systems strengthening funds based upon a country's total population and gross national income.
During discussion of this presentation, it was noted that HSS funding is not having a major impact on immunization – should it be earmarked for cold chain and logistics upgrades? In addition, GAVI was requested to urgently prepare a Q&A communication to be shared with countries clarifying recent policy changes and resource situation.
V. Roll out of Meningitis A vaccine in West Africa
The Meningitis Vaccine Project is a novel 10 year partnership between WHO and PATH, created through core funding from the Bill & Melinda Gates Foundation in June 2001 with the goal of eliminating meningitis epidemics as a public health problem in sub-Saharan Africa through the development, testing and licensure of affordable conjugate vaccines. Clinical trials of MenA conjugate vaccine (MenAfriVax™) were conducted in 8 clinical sites in 5 countries and vaccine was licensed in India in December 2009. MenAfriVax was WHO pre-qualified on 23 June 2010. An initial introduction is planned for September 2010 in selected districts of 3 hyper-endemic countries in West Africa (Burkina Faso, Mali, Niger), followed by phased introduction in the remaining districts of these 3 countries. At this time, no funds have been identified for further introductions after 2010 and continued funding of the MenA investment case is very uncertain. Key next steps at this time are to mobilise champions and resources (soft loans, grants, etc.) for introduction of MenAfriVac in rest of the Meningitis Belt.
VI. Update on WHO vaccine donations policy
The updated WHO-UNICEF Joint Statement on Vaccine Donations will be published and posted to the WHO website in the coming weeks. The 5 minimum requirements are that donated vaccine should be
- suitable epidemiologically and programmatically,
- sustainable after donation,
- licensed in the recipient country and licensed for the intended use by the NRA of the donor country,
- supplied with at least 12 months shelf life remaining or shelf life sufficient to fulfill intended purpose of donation (for epidemic or emergency campaigns),
- shipped only on confirmation with responsible officials of the national immunization programme in the recipient country who should be informed of all donations.