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

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

Wild Poliovirus infected districts*, 03 Jun 2008 – 02 Dec 2008 *Excludes vaccine derived polio virus and virus detected from environmental surveillance. district infected with wild polio virus type 1 district infected with wild polio virus type 3 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 All rights reserved district infected with wild polio virus types 1 and 3 Data in WHO HQ as of 02 Dec 2008

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 % - WPV1 40% - WPV3

Programmatic Updates Programme strategy is still to prioritise interruption of WPV1 (due to its higher paralytic rate and propensity to spread to polio free areas) while maintaining control on WPV3 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 OPV demand from GPEI, June 2008 and included in the UNICEF RFP document * tOPVmOPV1mOPV3TotaltOPVmOPV1mOPV3Total UNICEF sub total , India Pakistan Total 1, , ,528.2 The requirement presented in the tender included Pakistan and India projected needs to ensure maximum visibility to industry.

UNICEF OPV awards Currently the unawarded quantities equal: tOPV requirements for India and Pakistan for both 2009 and 2010, mOPV3 requirements for India and Pakistan for 2009 ~20million doses of mOPV1 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. Awarded quantities

Supply & Demand Forecast for 2009

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

mOPV1 Supply & Demand 2009 Now 6 WHO PQ/Recommend Suppliers for mOPV1 Expect to revert to all suppliers about the availability of additional mOPV1 in early 2009

mOPV3 Supply & Demand 2009 Includes expected demand from Pakistan in second half of 2009 Demand may increase as WPV1 cases reduce and Programme moves to interrupting WPV3

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 (bOPV - types 1 and 3) Factors influence demand for bOPV 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 bOPV use: bOPV will not replace the role of tOPV 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 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.

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