UNICEF supply update for OPV

Seventh WHO/UNICEF Consultation with OPV/IPV Manufacturers and NRAs

UNICEF Supply Division30 October 2008Geneva

Vaccine Security and provision of OPV

Vaccine Security – that is sustained and uninterrupted supply of affordable polio vaccine of assured quality – has been and will continue to be a key objective for UNICEF.

The conditions and premise for ensuring Vaccine Security are complex as the programme recommendation moves with refined tools from massive campaign requirements, to targeted products – and eventually cessation after Certification.

UNICEF and WHO believes that the key to ensure polio vaccine security is a continued dialog with the vaccine manufacturers oncurrent short term demand and supply planning, as well as current information sharing on strategic decision concerning the Programme and the general vaccine production.

As of June: OPV demand through UNICEFProcurement 2001– 2007,

Total programme forecast for 2008-2012.

-

500

1,000

1,500

2,000

2,500

2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012

Mill

ions

Dos

es

tOPV mOPV3 mOPV1 tOPV-forecast mOPV3-forecast mOPV1-forecast

OPV demand through UNICEFProcurement 2001– 2007, current UNICEF

forecast for 2008-2010.

• 2009 include awards, plus potential India and Pakistan additions • 2010 The split between mOPVs continue to need refinement as we move forward

-

500

1,000

1,500

2,000

2,500

2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010

Mill

ions

Dos

es

tOPV mOPV3 mOPV1 tOPV-forecast mOPV3-forecast mOPV1-forecast

Status of 2008 utilization of LTAs

2008:tOPV – expect utilization rates of around 70% of LTA quantities, as

has been consistently communicated to manufacturers. The reason being the increased use of mOPVs.

mOPV1- 100% utilization of 2008 LTAs. Substantial additional awards have been made throughout the year.

mOPV3 – 100% utilization of LTAs for 2008. Timing of utilization for India is likely to extend into early Q2 2009 as anticipated in the original tender. The delayed uptake is due to a shift towards mOPV1 demand.

Establishment of 2009-2010 LTAs

In July 2008 we issued an RFP for 2009 and 2010 OPV requirements

Objective was to provide industry with a complete picture of theanticipated demand by the polio programme, not just demand channelled through UNICEF

First time in many years that all Unicef demand could be handled through one tender.

Tender was concluded in August/September and awards communicated to manufacturers mid September.

Projected 2009-2010 OPV demand from GPEI, June 2008 and included in the UNICEF RFP document.

1,528.2 322.0 322.0 884.2 2,017.4 531.5 457.7 1,028.2 Total

168.0 42.0 42.0 84.0 200.0 36.0 76.0 88.0 Pakistan

630.0 90.0 90.0 450.0 810.0 270.0 90.0 450.0 India

730.2 190.0 190.0 350.2 1,007.4 225.5 291.7 490.2 UNICEF sub total

TotalmOPV3mOPV1tOPVTotalmOPV3mOPV1tOPV

2010*2009

• The requirement presented in the tender included Pakistan and India projected needs to ensure maximum visibility to industry.

• Awards made did not cover the full projected programme needs, and the awards were a conservative estimate of the expected demand through UNICEF based on confirmed programmatic requirement and confirmed country procurement strategies at the time of award.

UNICEF OPV awards 2009-2010

tOPV mOPV1 mOPV3 Total tOPV mOPV1+3 TotalTotal 490.2 457.7 225.5 1,173.4 350.2 644.0 994.2

2009 2010*

• At the time of award the unawarded quantities equal the tOPV requirements for India and Pakistan for both 2009 and 2010, the mOPV3 requirements for India and Pakistan for 2009 and ~20million doses of mOPV1 for 2009 were reserved for later awards.

• For 2010 all known requirements were awarded, but as set forth in the tender the awarded quantities of mOPV 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.

• Since awards were made we anticipate that a larger part of the demand will be channelled through Unicef in 2009. Programme development and countries procurement strategy could add another 3-400 million ds of OPV for 2009 through Unicef.

• Drivers of this potential additional demand are developments in India and Pakistan, and the upcoming IEAG meeting will help clarify for the India 2009 needs. As demand is confirmed we will come back to manufacturers for additional availability.

Total OPV Forecast 2008/2009

- This reflects all demand expected through Unicef through first half 2009- mOPV1 needs will be largely in the beginning of the year. Any additional potential awards for 2nd half of 2009.

0

50,000

100,000

150,000

200,000

27-Oct

03-Nov

10-Nov

17-Nov

24-Nov

01-Dec

08-Dec

15-Dec

22-Dec

29-Dec

05-Jan

12-Jan

19-Jan

26-Jan

02-Feb

09-Feb

16-Feb

23-Feb

02-Mar

09-Mar

16-Mar

23-Mar

30-Mar

06-Apr

13-Apr

20-Apr

27-Apr

04-May

11-May

18-May

25-May

01-Jun

08-Jun

15-Jun

22-Jun

29-Jun

SIA Routine OPV Availability

Additional UNICEF polio tenders

Upcoming and potential tenders

• IPV for Palestine to be issued shortly.Estimated need is 230,000 doses throughout 2009

• Pending results of the clinical trials with bi-valent OPV - tender in Q1 2009??

• If requested by Government of India to procure IPV- tender in Q4 2008?

mOPV Stockpile – status and next steps• Through the industry reponse to the RCI 2006-2007 manufacturers confirmed their

principal interest in participating in a stockpile, and a number of defining technical constraints identified.

• The planned stockpile demand is 750 mio ds for each serotype = a total of 2.25 billion ds

Revised tender timeline following January 2008 WHA meeting:

• GAPIII revisions required following WHA Executive Board meeting in January 2008 (=> primary, secondary and tertiary safeguards)

• mOPV Stockpile tender delayed from December 2008 to December 2009

• Risk assessments of filling post-cessation to be conducted 6-12 months prior to tender issuance => to define manufacturer specific primary safeguard requirements

• Tentative timing of Stockpile demand 2012 - 2014 depending on epidemiological development

Thank you.

mOPV1 Forecast 2008- June09

0

20,000

40,000

60,000

80,000

100,000

27-Oct

03-Nov

10-Nov

17-Nov

24-Nov

01-Dec

08-Dec

15-Dec

22-Dec

29-Dec

05-Jan

12-Jan

19-Jan

26-Jan

02-Feb

09-Feb

16-Feb

23-Feb

02-Mar

09-Mar

16-Mar

23-Mar

30-Mar

06-Apr

13-Apr

20-Apr

27-Apr

04-May

11-May

18-May

25-May

01-Jun

08-Jun

15-Jun

22-Jun

29-Jun

SIA OPV Availability

- This reflects all demand expected through Unicef through first half 2009- mOPV1 needs will be largely in the beginning of the year. Any additional potential awards for 2nd half of 2009.

mOPV3 Forecast 2008- June09

- This reflects all demand expected through Unicef through first half 2009

0

10,000

20,000

30,000

40,000

50,000

60,000

70,000

80,000

90,000

27-Oct

03-Nov

10-Nov

17-Nov

24-Nov

01-Dec

08-Dec

15-Dec

22-Dec

29-Dec

05-Jan

12-Jan

19-Jan

26-Jan

02-Feb

09-Feb

16-Feb

23-Feb

02-Mar

09-Mar

16-Mar

23-Mar

30-Mar

06-Apr

13-Apr

20-Apr

27-Apr

04-May

11-May

18-May

25-May

01-Jun

08-Jun

15-Jun

22-Jun

29-Jun

SIA OPV Availability