UNICEF Procurement and Supply Updates for OPV

Transcription

1 UNICEF Procurement and Supply Updates for OPV 11 th WHO/UNICEF Consultation with OPV/IPV Manufacturers and NRAs UNICEF Supply Division 25 th October 2012 Geneva

2 Presentation overview Overview of OPV procurement for 2012 OPV Supply and Demand & 2013 Tender updates Next steps

3 Overview of historical OPV supply & weighted average prices (WAP) India moved to self-procurement from Q4 2010

4 In 2012, procurement is on track based on the annual forecasted requirement of 1.3 billion doses Afghanistan: 64,110,000 doses Pakistan: 323,575,000 doses Nigeria: 233,942,000 doses DR Congo: 100,000,000 doses > 100 m doses m doses m doses m doses < 10 m doses

5 Overview of OPV utilisation for 2012 Non-availability of product

6 OPV Supply and Demand for 2012 and 2013

7 topv supply and demand outlook in January 2012

8 bopv supply and demand outlook in January

9 a complex year for supply and demand of OPV Loss of availability of OPV (410M doses) due to the delisting of two manufacturers and reduction in availability from one additional manufacturer Significant response from industry to cover the gap PAHO required 20M doses of topv due to delisting; UNICEF re-allocated quantities to meet the PAHO request Changes in epidemiology. Eg, Additional campaigns in 4 Nigeria-bordering countries Outbreaks of WPV and cvdpv in priority countries Epidemiological changes and outbreaks resulted in increased need for topv 20 dose and an imminent gap of 85M doses of topv 20 dose by August 2012 Gap met by manufacturers changing production from bopv to topv & GPEI shifting some campaign requirements to bopv A huge THANK YOU to Industry and Programme for your support

10 2012 overview of topv-20 dose supply and demand (Routine and SIA) as of Expected shortfall of 85M doses by August/September 2012 due to Nigeria and Pakistan campaigns and increased topv requirements. An additional 85M doses was secured. PAHO request for 20M doses Extremely low supply of topv 20 dose and continuing requests.

11 2012 overview of bopv-20 dose supply and demand as of West Africa campaigns postponed due to insufficient funds for operations Supplier de-listing and loss of OPV West Africa campaigns Pakistan and Nigeria

12 Supply and demand for mopv1-20 & mopv3-20 mopv1 Demand for mopv1 is as an initial response to WPV type 1 outbreaks as well as for stockpile, primarily in Pakistan All mopv1 on contract has been utilised mopv3 Currently no demand for mopv3 UNICEF has no mopv3 on contract; however, stocks of semi-finished and finished mopv product remain with one supplier

13 2013 Another complex year ahead in terms of supply An initial gap of >300M doses the first half of 2013 due to insufficient offers from tender UNICEF SD succeeded at filling gap through various mitigation strategies, in collaboration with partners and manufacturers: advocacy done by Supply Division resulting in two manufacturers changing production plans WHO working to fast-track WHO pre-qualification of a new OPV manufacturer monitoring in-country residual quantities to take into account for 2013 shipments WHO revised the demand scenario by shifting low-risk campaigns to Q2 and later in 2013 Although the cumulative availability is high - still very tight supply through Q2: timeline for new supplier: risk for delays requires extra monitoring and additional risk mitigation strategies to help ensure success and give early-alert in case of delay facilitation of registration for other suppliers in Nigeria to ease pressure on the current licensed supplier

14 Revised forecasted demand and supply for 2013 Potential new supplier (if PQ status obtained) Nigeria and Pakistan SIAs Bangladesh

15 Tender Updates and Outcomes

16 OPV tender: /17 The overarching objective of the tender was Vaccine Security - focusing on a reliable supply of assured quality as well as affordable pricing - to meet the needs of GPEI. Longer tender duration than previous arrangements (4 years, plus 1 year possible extension) Offers visibility, steady pricing, continued bulk production A critical period as it crosses the threshold of eradication & potential cessation of OPV / switch to IPV Uncertainties around OPV demand in later years, timing of switch and introduction of IPV Emphasis on Vaccine Security objectives vary throughout the period: : secure sufficient supply to meet high demand : secure lower pricing and spread the bulk risk 2017: sustain bulk production and link to stockpile

17 Tender: summary of offers Initially insufficient supply offered for 2013, but subsequently remedied Sufficient (and excess) offered supply for Several manufacturers required minimum quantities in order to stay in the business. But the Total minimums > Total demand Steady prices Several offers from five (5) manufacturers with non-who pre-qualified product, including three (3) new manufacturers

18 Summary of initial awards Awards issued to manufacturers in mid-october Awarded 2013 WAP for 20 dose vials: $ and awarded 20 dose WAP for the period is $ Actual WAP is $ Weighted Average Number of Weighted Average Number of Weighted Average Number of Weighted Average Number of Price (WAP) Number of suppliers Price (WAP) Number of suppliers Price (WAP) Number of suppliers Price (WAP) Number of suppliers US$/dose vials awarded US$/dose vials awarded US$/dose vials awarded US$/dose vials awarded Number of suppliers awarded Weighted Average Price (WAP) US$/dose Number of Products awarded vials OPV 20 dose vials 60,800, ,500, ,000, ,000, OPV 10 dose vials 6,000, ,000, ,000, ,000, Total OPV (vials) 66,800, ,500, ,000, ,500, ,000,

19 IPV Supply and Demand

20 UNICEF IPV tender IPV tender issued in March and closed in April 2012 for the period of September 2012 December 2013 Demand: 23 million doses plus routine for SIA pilots in in Nigeria and Pakistan Awards: UNICEF awarded 600,000 doses in routine requirements for opt and Lebanon for SIA requirements for Pakistan and Nigeria: postponed until further notice Offered prices ranged from $2.25 to $5.70

21 IPV expectations and next steps Results of the first IPV tender not considered indicative of the longterm market and pricing trajectories Anecdotal data collected by UNICEF suggests supply will be sufficient and pricing could be lower (< $1.00 per dose) should there be sufficient demand based on programmatic and policy guidance Evidence of increased supply capacity to meet GPEI requirements for the End Game and lowered pricing to meet eventual demand

22 Key issues and next steps for OPV and IPV supply Timing of the switch from topv to bopv Very close coordination and careful planning with manufacturers critical to ensure manufacturers are not left with type 2 bulk (lesson learned from mopv and bopv) Beyond 2014, manufacturers will have to receive notification of total quantities by type and will not have flexibility to switch IPV demand, supply and follow on tender Manufacturers ready to meet the demand: requires clear policy, programmatic and technical guidance Clear commitment from regulatory authorities and advisory groups is needed to build the sustained demand required for ramp-up of production. Country acceptance of IPV to be confirmed

23 Thank you Vaccine Suppliers Integral to Achieving Polio Free World

24 2012 overview of OPV-20 dose supply and demand (routine and SIA) as of

25 Monthly overview of OPV procurement in 2012