1. EPI in development: HepB/Hib combination vaccine tender overview Pre-tender meeting UNICEF Supply Division, 10-11 December 2008 Meredith Shirey

2. Assessment of HepB & Hib combination vaccine procurement objectives Objective 1. A healthy market: ensuring the sustainable quantity of supply through a diverse supplier base 2. Select products and presentations that best meet the need of client countries 3. Achieving a long-term affordable price that countries can eventually finance in a sustainable manner Assessment (2007-2009) 1.Significant improvements in supplier base (1 to 5 WHO PQ penta products from 4 manufacturers) 2. Increased availability of liquid products as per country preference, but close management required 3. Mixed. Decline in DTP-HepB price; beginning to see decline in penta price

3. The positive effect of competition on affordability Weighted Average Prices for Vaccines

4. Introduced/Approved penta Introduced Hib- containing GAVI has been a catalyst for Hib introduction. From 2009, 53 GAVI-supported countries using or approved to introduce Hib-containing vaccines with procurement through UNICEF - 51 countries with Pentavalent, covering birth cohort of ~37.6 million children per year - 2 countries with other Hib-containing vaccines, covering a birth cohort of ~0.79 million children per year -8 additional countries applied to GAVI in October 2008, covering an additional birth cohort of ~11 million children per year* - 6 GAVI eligible countries remaining for Hib introduction (likely procurement through UNICEF**) Applied for penta *India did not apply for nationwide introduction **7 additional GAVI-eligible countries not procuring through UNICEF

5. Healthy market developing, marked by increased availability & evolving pipeline and expect to see significant price decreases in the next tender period. Pipeline products Weighted average price PQ products

6. Steady increase introduction of GAVI support from 2001 with significant increases in 2008 and 2009 due increased availability and introduction in large population countries DTP-HepB/Hib – Procurement Overview – Historical

7. Upcoming Tender Period Steady increase introduction of GAVI support from 2001 with significant increases in 2008 and 2009 due increased availability and introduction in large population countries DTP-HepB/Hib – Procurement Overview – Forecast

8. DTP-HepB/Hib – Demand scenario by country product preference Strong preference from countries for fully liquid vaccine Currently 1,2 and 10 dose presentations with WHO PQ. Countries beginning to state interest in multi-dose vials for fully liquid vaccines Possible demand: largely driven by Myanmar & Nigeria

9. Country preference and inter-changeability of products Country preference: For vaccines with two pharmaceutical forms available: Vaccines covering the same diseases will be considered as one product for the purpose of the request; However in the tender, we will also indicate the estimated number of doses required for each formulation based on country preferences. But not at the expense of other procurement objectives (healthy market and affordable prices) Non Inter-changeability: Restricts the short term supply management flexibility, but not the longer term security achieved by a healthy market with multiple suppliers.

10. DTP-HepB/Hib: starting to see some demand from non-GAVI eligible countries. Tender strategy still under review for non-GAVI eligible countries (MICs).

11. DTP-HepB/Hib – introduction in India Demand approx. 40-50 million doses per year, based on the application to GAVI Planned introduction in 2009 Preference for fully liquid, multi-dose vials Considering whether separate tender should be issued to cover India demand, pending final approvals from GOI/GAVI

12. Summary of DTP-HepB/Hib tender quantities *Tender strategy still under review for non-GAVI eligible countries (MICs). Quantities do not include India (approx. 40-50 million doses per year).

13. Upcoming Tender Period Steady decrease as countries shift to combination vaccines, although some new countries may introduce with GAVI support during the next tender period (possible demand) DTP-HepB – Procurement Overview – Historical & Forecast

14. Majority of demand from GAVI supported countries Some possible demand from new countries in next tender period DTP-HepB – Procurement Overview – Forecast demand scenarios

15. Summary of DTP-HepB tender quantities

16. Upcoming Tender Period Hib – Procurement Overview – Historical & Forecast Demand from 1 GAVI-supported country Limited quantities of non-GAVI demand

17. Upcoming Tender Period DTP/Hib – Procurement Overview – Forecast LTA established for GAVI quantities only. Non-GAVI quantities through ad hoc procurement Demand remains stable during the tender period

18. Majority of DTP/Hib demand for non-GAVI eligible countries (mostly Morocco)

19. Summary of Hib and DTP/Hib tender quantities *Tender strategy still under review for non-GAVI eligible countries (MICs).

20. HepB & Hib combination vaccine procurement objectives 1. A healthy market: ensuring the sustainable quantity of supply through a diverse supplier base 2. Select products and presentations that best meet the need of client countries 3. Achieving a long-term affordable price that countries can eventually finance in a sustainable manner

21. UNICEF VACCINES Thank You