Polio Update Pre Tender Meeting 11 th December

Polio Update Pre Tender Meeting 11 th December 2008 UNICEF Supply Division

- Programme status update - Update on OPV contracts for 2009 - Supply & Demand forecast 2009 - Additional OPV requirements - IPV update

Wild Poliovirus infected districts*, 03 Jun 2008 – 02 Dec 2008 district infected with wild polio virus type 1 district infected with wild polio virus type 3 district infected with wild polio virus types 1 and 3 *Excludes vaccine derived polio virus and virus detected from environmental surveillance. Data in WHO HQ as of 02 Dec 2008 The boundaries and names shown and the designations used on this map do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. WHO 2008. All rights reserved

Summary of WPV for 2006 to 2008 WPV cases in 2008 Endemic 1, 427 Non-endemic 105

Summary of Wild Polio Virus by Type for 2007 and 2008 60% - WPV 1 40% - WPV 3

Programmatic Updates • Programme strategy is still to prioritise interruption of WPV 1 (due to its higher paralytic rate and propensity to spread to polio free areas) while maintaining control on WPV 3 • India • • Effective programme Sub-optimal OPV efficacy in key northern India states • Nigeria • • Sub-optimal campaign quality 60% of children not fully immunised • Pakistan/Afghanistan • • Insecurity which is limiting access to communities Pakistan has very efficient virus transmission which require further operational improvements • Non Endemic Countries • 5 countries (Angola, Chad, DRC, Niger & Sudan) have persistent transmission > 12 months

Update on OPV contracts for 2009

Projected 2009 -2010 OPV demand from GPEI, June 2008 and included in the UNICEF RFP document. 2009 t. OPV UNICEF sub total 490. 2 291. 7 225. 5 1, 007. 4 350. 2 190. 0 730. 2 India 450. 0 90. 0 270. 0 810. 0 450. 0 90. 0 630. 0 Pakistan 88. 0 76. 0 36. 0 200. 0 84. 0 1, 028. 2 457. 7 531. 5 2, 017. 4 884. 2 Total m. OPV 1 2010* m. OPV 3 Total t. OPV m. OPV 1 m. OPV 3 42. 0 322. 0 Total 168. 0 1, 528. 2 • The requirement presented in the tender included Pakistan and India projected needs to ensure maximum visibility to industry.

UNICEF OPV awards 2009 -2010 Awarded quantities • Currently the unawarded quantities equal: • t. OPV requirements for India and Pakistan for both 2009 and 2010, • m. OPV 3 requirements for India and Pakistan for 2009 • ~20 million doses of m. OPV 1 for 2009/10 were reserved for later awards. • For 2010 the awarded quantities of OPV were not specified by type in order to retain the flexibility to respond to programme needs. The specific OPV type required will be specified to the relevant manufacturers during 2009, in line with the required timelines. • The awards made are not for a any specified geographic destination.

Supply & Demand Forecast for 2009

t. OPV Supply & Demand 2009 • Pakistan procuring through UNICEF in Second half 2009 • India procuring its own t. OPV for their two NIDs in early 2010

m. OPV 1 Supply & Demand 2009 • Now 6 WHO PQ/Recommend Suppliers for m. OPV 1 • Expect to revert to all suppliers about the availability of additional m. OPV 1 in early 2009

m. OPV 3 Supply & Demand 2009 • Includes expected demand from Pakistan in second half of 2009 • Demand may increase as WPV 1 cases reduce and Programme moves to interrupting WPV 3

Summary of OPV by Type 2000 to 2010

Additional OPV needs for 2009 UNICEF Supply Division

Potential OPV Requirements Additional OPV requirements in the range of 400 million doses for second half of 2009 bi-valent OPV (b. OPV - types 1 and 3) • Factors influence demand for b. OPV • Results of the clinical trials expect end March 2009 • Epidemiological situation • UNICEF and WHO will share with industry potential demand scenarios based on the possible clinical trial outcomes • WHO will establish & share regulatory pathways • Some guiding principle to b. OPV use: • b. OPV will not replace the role of t. OPV in maintain immunity in polio free areas • Main potential role will be in areas for co-circulating serotypes 1 & 3 where sub-optimal delivery is a major problem. • Not expecting a substantial role in areas of sub-optimal OPV efficacy • Possible requirement in second half of 2009, depending on trial result

IPV Update

IPV Supply for 2009 • UNICEF regularly procures around 250, 000 doses of IPV for OPT (Palestine) • IPV for India Potential tool to address sup-optimal efficacy of OPV in certain areas of WUP (India). This approach has also been endorsed by the IEAG , SAGE and ACPE. Rapid market survey in October to assess potential availability. Summary Information shared with GOI and the Programme to inform decision-making. The final decision to go ahead and implement the recommendation is with the GOI. The potential quantities needed are still not confirmed, but will be determined by the final target age range for the activities and the available supply. Indicated quantity between 1. 5 - 4. 5 million doses for the first round. If the vaccine is requested through UNICEF, WHO pre-qualified vaccine will be preferred. Acknowledging that delays in issuing a tender might impact on vaccine availability, UNICEF will only proceed upon a request from GOI.

Thank you