Pentavalent (DTwP-HepB-Hib) Vaccine
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1 UNICEF/UNI196303/Georgiev Pentavalent (DTwP-HepB-Hib) Vaccine Vaccine Industry Consultation 2017 Yalda Momeni
2 Presentation outline Recap on the Outcomes and Implementation of last tender Update on 2017 increased demand: Maintaining a Healthy Market Context Challenges & Opportunities Looking forward
3 Recap on the Outcomes of the Tender Objectives: 1. Balance of Supply & Demand, 2. Cost, 3. Innovation & 4. Information Pentavalent Market - UNICEF Six out of seven WHO pre-qualified suppliers were awarded: Five have research & development (R&D) pipelines, representing a total of six product under development Increased availability and competition resulted in reduction of WAP; Prices more affordable for countries and donors Resulting in sustainability of Immunization program, especially for those transitioning from Gavi support Convergence of prices between Gavi and non Gavi markets: Providing equitable access to affordable prices Long term implications on the health of the Penta market: Price was a key factor of determining value for money procurement decisions, but not the only factor Different attributes of the HMF were used to analyse potential trade-offs Reaching a balance of the objectives of the tender, was the basis of the allocations & awards
4 Additional demand and award increase in 2017 Penta 1 dose Demand in single dose presentation 3 manufacturers were awarded Awards were made based on principle approach: 1. Countries preference and registration coverage 2. Availability and ability to meet requested timelines 3. Maintaining long term health and sustainability of the market Further price reduction from one manufacturer s single dose presentation, following application of MFN Clause
5 Context: Supply & Demand A mature market with 7 WHO pre-qualified manufacturers and ample supply availability, and moderate geographical diversification: One manufacturer will exit Pentavalent market end 2017 High competition: Current global production capacity across all current WHO prequalified pentavalent vaccines estimated to be MDS per year Procurement through UNICEF during the tender period is +/-150 MDS annually: Declined from MDS in 2016 and 235 MDS in 2015 Demand from countries that self finance and procure through UNICEF have increased in 2017; Total 21 MDS vs. forecasted 12 MDS
6 Challenges & Opportunities Long terms Health of the Market as a key priority. NRA diversification Multiple suppliers Opportunities for innovation Regulatory requirement from countries: Challenging flexibility to meet countries demand Stability and predictability on pricing: As this market matures, we expect to see pricing that is more stable and is enabling budget planning for countries routine EPI Forecast accuracy: Stock levels, wastage rate, target population and coverage assumptions. Gavi s co-financing policy for countries in the preparatory transition based on the presentation s WAP, may result in switch in presentation Countries co-financed share of demand (across presentation) will increase up to 20-30% by 2020 Innovation: Demand for combination vaccines including IPV or DTaP, may materialize for next tender period
7 Looking forward Continuous dialogue with industry to ensure the long-term health of pentavalent vaccine market Continue to advance the HMF and elaborate on each attributes terms and trade-offs Continue having a dialogue with MICs countries to encourage multi-year planning and forecast accuracy In collaboration with WHO PQT; encourage implementation of WHO Collaborative Procedure Next Tender: Plan and consultation with manufacturers in 2018 UNICEF will continue to work with countries to ensure greater accuracy in demand forecasting based on stock levels, improved wastage rate information, and adjustments in target population and coverage assumptions.
8 UNICEF/SUDA2014-XX228/Noorani
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