Overview of OPV supply: current status and looking forward. Presentation to the OPV/IPV Manufacturer s Meeting October 10, 2013

Transcription

1 Overview of OPV supply: current status and looking forward Presentation to the OPV/IPV Manufacturer s Meeting October 10, 2013

2 OPV procurement through UNICEF from bopv is introduced Reduction in mopv1 & 3 demand Increased bopv demand OPV supply through UNICEF for both SIA and routine requirements Product development and transitions illustrate interdependence between program strategies, epidemiology and supply. Awards currently covering By end 2013, UNICEF expected to procure at least billion doses 2

3 General vaccine supply overview (Jan Sept 2013) Entered 2013 with tight supply period Able to meet most of the endemic and priority country demand with some shifts in lower priority activities (postponed or reduced) and/or type Demand increase in both OPV types: ~370mds+ bopv demand increased by ~275mds (continued increase) Increased requests often with short lead times and for significant quantities ~437mds in additional awards (May and July/August), also covering some early Q1 SIAs Maximized capacity of suppliers through Q Implications for building sufficient stocks of OPV Demand increases from Nigeria & Pakistan Additional Awards made Additional Awards made bopv supply & demand: Jan-Sep 2013 HoA Additional Awards made Additional Awards made

4 2013 demand as of October 2012 vs. actual 2013 implemented and planned demand by OPV type (20 dose vials) 4

5 In 2013, almost 1.7 billion doses will be procured by the end of the year Afghanistan: 89,782,800 doses Horn of Africa 211,000,000 Pakistan: 306,000,000 doses Bangladesh 47,000,000 Nigeria: 460,810,000 doses DR Congo: 53,000,000 > 100 m doses m doses m doses m doses < 10 m doses Huge volumes for Nigeria and Pakistan; Nigeria represents 60% of overall increase Challenges due to limited number of licensed suppliers in both countries HoA and other outbreaks requiring sustained response and supply New outbreak in Sudan, West Bank/Gaza Plans for additional activities

6 Significant efforts on part of Industry Niger outbreak HoA Nigeria funding delays Afghanistan funding delays and flight challenges

7 Current OPV supply and demand status: Q Dec 2014 topv from Q Dec 2014 bopv from Q Dec 2014 Partial demand HoA outbreak response Convert topv to bopv Partial demand Large topv SIAs in 1 st H of 2014 Possibility for some countries to switch to bopv 1H due to outbreak, and topv 2H 2014 topv forecast in 2014: 772 mds topv forecast in 2014: 772 mds bopv forecast in 2014: 613 mds

8 Demand outlook for 2014 Expect continued high demand similar to 2013 requirements, possibly higher. Heavy demand for 1H to stop WPV outbreaks and prevent further spread in HoA and Middle East bopv priority to stop WPV transmission But still need for topv for cvpdv, routine Next steps to ensure 2014 supply of ~ mds more than current estimates with early awards Targeted use of mopv1 in some infected areas Forecast review with program planned for mid-october

9 mopv1 Previously limited demand for mopv1 and minimal awarded quantities Shift to use mopv1 in targeted areas and for WPV type 1 outbreak response in a few countries 94mds awarded in addition to current bopv and topv awards May require additional mopv1 for 2015 and beyond

10 Asks for manufacturers and NRAs 2014 Maximize filling in 2014: additional awards likely Urgent need to accelerate/prepone production for Q1 Build buffer stocks for rapid, emergency response for outbreaks and for buffer stocks for endemic countries Accelerate release of supply

11 Expect increased demand, in particular for 2015 & 2016 Current SIA plans + buffer Tender demand

12 Looking forward: OPV2 withdrawal and the switch to bopv Need to ensure sufficient buffer of bopv stocks by end 2015 to meet a global synchronised switch from topv to bopv At same time - avoid shortages of topv and ensure sufficient supply for immunity boosting activities Early forecasting with program critical Regulatory aspects need to be in place (label change, national licensing and registration in countries) Developing strategy and plan for operationalising the upstream aspects of the switch Prepositioning bopv stocks in countries a few months in advance? Will require careful planning with countries (funding transfers, etc)

13 Asks for manufacturers for Continue / maintain bulk production to ensure sufficient supply to meet continued high global SIA and routine demand for Need to build sufficient buffer stocks of bopv to plan for the switch, while ensuring sufficient topv to meet immunity-boosting activities prior to switch Register bopv product in all OPV using countries Ensure availability mopv1

14 Next steps for planning Work with Program and partners to update forecast for with estimates by type: topv, bopv and mopv Develop a strategy for operationalizing the switch both upstream and downstream, including risk mitigation plans Discussions with manufacturers to plan for switch Work/advocate with countries for fast tracking bopv registration of multiple suppliers

15 Thank you