MR Supply and Procurement Roadmap UPDATE January 2014 The Market Shaping Goal Shape vaccine markets to ensure adequate supply of appropriate, quality vaccines at low and sustainable prices for developing countries. GAVI Supply and Procurement Roadmap Measles-Rubella (MR) PUBLIC SUMMARY MR Supply and Procurement Roadmap UPDATE January 2014 Public summary The GAVI Alliance is engaged in measles and rubella (MR) vaccination to accelerate global progress in the control of two life-threatening diseases. Within this context, the GAVI Alliance’s engagement in MR catch-up campaigns is designed to catalyse faster incorporation of rubella containing vaccines in routine immunisation; to rapidly reduce rubella and congenital rubella syndrome cases in 49 GAVI countries; and to impact the global MR market in a way that countries continue to benefit from supply and sustainable prices after GAVI funding of catch-up campaigns ends and GAVI is no longer purchasing MR vaccines. GAVI’s current engagement in MR: Nationwide catch-up campaigns targeting children aged 9 months up to 14 years. These campaigns are designed to catalyse the replacement of the monovalent measles vaccine with a rubella containing vaccine in routine immunisation programmes that will be fully financed by countries. GAVI’s MR exit strategy: GAVI support to MR catch-up campaigns is planned to end when all 49targeted countries have rolled out routine vaccination, and when implementation of the catch-up campaigns is completed. From a market shaping perspective, it is important that the GAVI Alliance engagement over this period results in a healthy MR market served by two to three manufacturers offering prices compatible with sustainable country-financed immunisation programmes. GAVI is not planning to finance MR follow-up campaigns or vaccination of women of childbearing age. Market overview • One manufacturer supplies pre-qualified MR vaccines, Serum Institute of India (SII). Up to three pipeline MR vaccines are expected to gain pre-qualification between 2017 and 2019. • Global demand for MR vaccines in 2013 is expected to reach approximately 100 million doses. This demand will increase to 330 million doses at peak expected in 2016/17, followed by a longterm demand of 150 to 250 million doses per year from 2018/19 onwards. This increase is mostly driven by GAVI-supported countries’ catch-up campaigns 2013 to 2017 and the demand is maintained long term, mostly by the country-funded development of MR routine and follow-up immunisations. Demand will be variable from one year to another beyond 2018 as a function of periodic follow-up campaigns. • Projected supply capacity is expected to meet the demand, provided there is no significant interruption from key manufacturers. • Over the period 2013–2018, demand from GAVI-supported countries is expected to reach approximately 640 million doses, representing a 59% share of volume from low and lower-middle income countries. Few other countries will use MR vaccines and their supply does not interfere with the GAVI market. • Following the 2012 procurement round for supply in 2013–2016, the price of the available MR vaccine is set to gradually increase from USD 0.52/dose in 2013 to 0.61/dose in 2016 (www.UNICEF.org, vaccines price data). • The MR market value in low and lower-middle income countries is expected to reach approximately USD 200 million during peak year and an average of approximately USD 100 million per year in the longer term. 1 MR Supply and Procurement Roadmap UPDATE January 2014 Prioritised supply and procurement objectives The supply and procurement objectives were analysed and weighted according to timeframe, to potential market shaping impact and to GAVI’s potential capacity to influence the market. 1st priority objective: balance of supply and demand. Short-term (2013–2016), the essential MR market-shaping objective is to secure the awarded supply 2013–2016 without which the GAVIfunded catch-up campaigns cannot be achieved. Mid-term, three suppliers are expected to provide further diversity and security of supply. The target outcomes for this area are: Current supplier SII meets commitments to supply annual volumes awarded by the UNICEF Supply Division (UNICEF-SD) tender for supply 2013–2016. One to two new manufacturers supply GAVI by 2018, with new entrants having the capacity to supply over 60 million doses by 2019. 2nd priority objective: cost of vaccine to GAVI and countries. Mid-term (2017–2020), the GAVI market shaping priority shifts to a price-reduction trend during the next supply period. This is essential to sustain country-funded routine immunisation and follow-up campaigns. As such, the target outcomes for this area are: The weighted average price (WAP) starts declining from 2017. Commitments are reached in 2016 with all suppliers that secure GAVI-level prices to countries after GAVI exits the market. 3rd priority objective: appropriate and innovative vaccines. Current vaccines satisfy the medical impact requirements so that GAVI is focused on supply security and price sustainability. The one target outcome for this area is: New 5- to 2-dose presentations with low cold-chain volume requirements are available after peak demand is reached. Information is a cross-cutting objective and enabler. MR specific target outcome: Effective communication on forecasts and measles/rubella strategy ensures well coordinated activities between partners and with manufacturers. Supporting stakeholder action plan An action plan between GAVI Alliance stakeholders is defined to ensure optimised coordination leading to the achievement of the above supply and procurement objectives. Implement procurement and price shaping activities short, mid and long term. Led by UNICEF-SD with support from the GAVI Secretariat: 2013–2020+. In particular: Achieve the best possible supply performance in line with effective demand within the context of the 2012 supply agreements for the period 2013–2016. Prepare and implement the next tender to be issued for MR vaccine supply from 2017. Encourage new entrants to rapidly enter the market, with a targeted supply capacity of 60 million doses per year or more. Led by the Bill and Melinda Gates Foundation (BMGF) with support from the GAVI Secretariat: 2013–2018. Develop an environment supportive of improved pricing trends. Led by the BMGF with support from the GAVI Secretariat: 2013–2018. 2 MR Supply and Procurement Roadmap UPDATE January 2014 Encourage manufacturers to develop adapted and prequalified 5- to 2-dose presentations in time for supply when country financed routine immunisation reaches a large portion of demand (2018/19). Ensure these are offered at conditions sustainable for countries. Led by the BMGF with support from the GAVI Secretariat and the WHO. Maintain regular, complete and transparent forecast communication with current and future suppliers to enable effective production planning. Led by the GAVI Secretariat with support from UNICEF-SD. Develop and implement a joint partner’s communication strategy. 3
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