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On the financing side, GAVI phase 2 financing allows GAVI eligible countries to purchase the vaccine for a small co-payment through 2015. Many middle income countries have now been able to adopt Hib-containing vaccines. Other, particularly lower-middle income countries, are struggling to find solutions as price is viewed as unaffordable. As more countries move towards adoption of pentavalent vaccines, the market demand becomes more predictable and additional suppliers enter the market, prices may begin to decline. Additional strategies are still needed to address the needs of lower middle income countries to make Hib containing vaccines more accessible.
Global Vaccine Supply and DemandUptake for Hib-containing vaccines has increased rapidly from 2007-2008 and is expected to continue in both GAVI eligible and middle income countries. The more immediate forecasted demand for GAVI eligible countries is expected to exceed 100 million doses in 2009. UNICEF is responsible for short term, supply chain forecasts covering a rolling 18 month time horizon. The Hib Initiative has looked at the longer term outlook for Hib vaccines, and forecasted demand in lower and middle income markets peaking at nearly 350 million doses in the 2015-2017 timeframe. This longer term outlook allows partners, countries, donors and suppliers to review what the potential demand and supply outlook is for Hib-containing vaccines and make production, development and investment decisions accordingly. Over the next couple of years, the Hib Initiative anticipates a shift in demand for liquid formulations of pentavalent vaccines and at this time it appears that there will be sufficient capacity to meet that demand. Hib-containing Vaccines: Products Currently Available and In DevelopmentCurrently, there are a large number of vaccine manufacturers that have Hib-containing vaccines both available and in development. For GAVI-eligible countries, there are suppliers that produce different formulations including pentavalent, monovalent and tetravalent vaccines. These include one liquid/lyophilized vaccine (2 formulations from a single supplier) and an all-liquid vaccine. The UNICEF supply division maintains current lists of available UNICEF-procured vaccines on their website and contains information on how the product is supplied, storage space required and price. As of July 2008, vaccines are available for an average price of $2.50 to $2.60 per dose. Average prices are expected to change and these changes will be announced by UNICEF and made available on their website: View UNICEF’s product menu list. Current Vaccine LandscapeTwo additional pentavalent vaccines are now available for the global market. In July 2008, the WHO pre-qualified Easyfive™ and Shan5™, two Hib-containing pentavalent vaccines:
WHO pre-qualified vaccines: list of vaccines for purchase by UN agencies Products in developmentPre-qualification enables UN agencies such as UNICEF to procure the vaccine:
The process in place at WHO to assess the acceptability of candidate vaccines for purchase was initially published in the thirty-ninth report of the WHO Expert Committee on Biological Standardization (Technical Report Series 786, Annex 1, 1989). It was further revised and replaced in 1996 by the document “Procedure for assessing the acceptability, in principle, of vaccines for purchase by United Nations agencies” (WHO/VSQ/97.06). Qualifying and Distributing VaccinesThe global community is working to ensure a sustainable and affordable supply of Hib vaccines. Increased competition among manufacturers and additional demand for the easy-to-use combination vaccines promise an adequate supply of the vaccine in the years to come. The UNICEF Supply Division is responsible for procuring vaccines and devices for countries on behalf of GAVI. The World Health Organization provides the “pre-qualification” service to UNICEF by assessing the acceptability of vaccines that they may wish to buy from a variety of different sources. In this way, WHO gives GAVI independent advice on the quality of vaccines that they may wish to buy from a variety of sources. “Pre-qualified” vaccines must meet quality, safety, and efficacy standards. Pentavalent vaccine: for years there was only one supplier of pentavalent vaccines. In late 2006 another supplier entered the market, beginning the process for lower prices through competition. In 2008, two additional pentavalent vaccines (all-liquid), already licensed in India, were pre-qualified. By 2015, if manufacturers continue with projected plans, there is a potential for up to 11 pre-qualified pentavalent vaccines, including those that are already available. The development of Hib vaccines, particularly those in combination, took many years, and expertise has now been built in many emerging manufacturers both internally and through technology transfers. All formulations: there are currently five pentavalent (DTwP-HepB-Hib) vaccines pre-qualified by the WHO (three liquid and two liquid/lyophilized from the same supplier). One additional pentavalent vaccine will be pre-qualified in 2008 (liquid/lyophilized). Ten additional pentavalent vaccines are projected to become WHO pre-qualified by 2015 (7 liquid, 3 liquid/lyophilized). View the product menu lists supplied by UNICEF. Pre-qualified products by manufacturer
Demand Forecast AnalysisCountry adoption and adoption assumptions for GAVI-eligible countries Cost Effectiveness
In 2001, the WHO published a field test version of guidelines for estimating the cost-effectiveness of using Hib vaccine. In the guidelines is it explained how to estimate the costs of Hib vaccine introduction and the treatment costs that can be averted from Hib immunization. When combined with Hib burden estimates, these data can be used to estimate the cost-effectiveness of Hib vaccination. The guidelines were developed to be used alongside the Rapid Assessment Tool (RAT) for Hib burden estimation. The intention is that treatment cost data for a cost-effectiveness study should be collected in the same health facilities where laboratory data are being gathered during a RAT study. However, as stated in the guidelines, for extrapolation of the data to the national level, assumptions about access to care and the type of health facilities being used by patients with Hib disease, will have to be made. The guidelines have been used in a number of countries, including Tonga and Russia. Link to WHO guidelines for estimating the potential cost-effectiveness of using Hib vaccine Financing Hib Vaccines through the GAVI Alliance
The GAVI Fund enables eligible* countries to purchase Hib containing vaccine for a small co-pay of 15 to 30 cents per dose, depending on country grouping (see chart below). Additional vaccines can also be adopted for a co-payment of 15 cents per dose. GAVI pays for the remainder of the cost of the vaccine, which is often procured through UNICEF. Countries are eligible for funding through 2015, provided that the vaccine is included in their Comprehensive Multi-Year Plan (cMYP). Hib vaccine is available in combination pentavalent vaccine which protects against diphtheria, tetanus, pertussis, hepatitis B and Hib. Other vaccines eligible for GAVI financing include: pneumococcal conjugate vaccine, rotavirus vaccine, yellow-fever and measles second dose. GAVI Phase 2 has extended funding to allow more countries to provide children with lifesaving vaccines. The increase in predictable demand is already drawing more manufacturers. Prices of pentavalent combinations are expected to decline, making vaccines increasingly more affordable. Affordable co-paymentsCountries will be expected to co-finance purchases of new or under-used vaccine, with the exception of measles second dose, which will be provided free of charge. Countries may cover this co-payment either through national funding, or in some cases, partners. Minimum co-payments have been set by the GAVI Alliance. Most countries will pay a fixed amount per dose through 2010. In 2010 GAVI will review the poorest and intermediate country groups and increase co-pays. Countries in the highest income group of GAVI eligible countries will pay a gradually increasing co-payment towards the predicted long-term price of the vaccine to 2015. GAVI financing provides a longer duration of support, in line with country planning and budgeting cycles - countries can apply for support for the duration of their comprehensive Multi-Year Plan for Immunization (cMYP) or Multi-Year Plan and end by December 2015.
Applying for GAVI SupportApplications require countries to show that decisions were made based on estimated disease burden, potential vaccine impact, alignment with national goals and milestones, performance against alternatives, cost-effectiveness and an analysis of ability to finance long-term. Relevant coordinating bodies must also endorse the plan. The national cMYP or updated multi-year plan should reflect the decision making process and information considered. WHO, The GAVI Alliance, UNICEF and the Hib Initiative provide assistance for countries applying for GAVI support. GAVI application deadlines are on February 8 and May 2 and September 25 each year. Visit the GAVI Alliance for more information on application requirements. For further information about the GAVI Alliance visit www.gavialliance.org |
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The current situation of vaccine supply and financing for Hib containing vaccines has improved considerably for GAVI-eligible countries. Supply is currently available in sufficient quantities and new pre-qualified products from emerging country manufacturers are expected this year, with additional manufacturers becoming pre-qualified in the following years. An analysis completed at the end of 2007 evaluated the supply situation for Hib containing products in both GAVI and middle income countries and found sufficient capacity to meet the needs of the both GAVI and middle income countries, assuming that dose and presentation requirements are communicated on a timely basis to allow for current manufacturers to increase production. 
