Update on A(H1N1) pandemic and seasonal vaccine availability. July 7, 2009

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1 Update on A(H1N1) pandemic and seasonal vaccine availability July 7, 2009

2 Presentation objectives and approach Presentation Objectives Review production status for Northern Hemisphere vaccine production Review baseline estimates for H1N1 production capacity Review major factors that will impact capacity available to developing countries, within: context of H1N1 contracts next seasonal vaccine production plans Approach Conducted survey of 36 manufacturers, including all current influenza vaccine manufacturers (WHO) Completed by 100% of manufacturers Ties closely to previous capacity estimates (Oliver Wyman) Pursued range of consultations and literature review to build initial map of H1N1 supply contracts (Oliver Wyman) 11 Countries 5 manufacturers FDA & EMEA Evaluated key factors that would impact capacity 2

3 Global seasonal trivalent vaccine production capacity Total annual capacity (10 6 doses) 2008 Northern hemisphere production (10 6 doses) 2009 Southern hemisphere production (10 6 doses) 2009 planned Northern hemisphere production (10 6 doses) Companies A (64%) Companies B (36%) All companies Companies A (n=7): with capacity to produce at least doses of new H1N1 vaccine / week Companies B (n=18): other smaller companies Source: WHO survey 3

4 Mapping of all potential influenza A(H1N1) Vaccine Manufacturers 4

5 Status of Northern Hemisphere seasonal vaccine production H1N1 (seasonal) H3N2 B Trivalent vaccine (H1N1 / H3N2 / B) Status Status Status Status Doses (10 6 ) 31 May % 73.4% 39.5% 38.0% June 2009 (77.4%) 87.9%* (80.9%) 87.6%* (74.4%) 75.7%* (72.2%) 73.6%* 362.7* 31 July 2009 (91.7%) 95.4%* (93.3%) 94.3%* (91.7%) 92.1%* (91.2%) 92.0%* 453.4* * July 1-6, 2009 update as compared with 470 million doses on

6 New A(H1N1) vaccine formulations proposed by manufacturers Total Whole Split Subunit LAIV Recombinant protein Vaccine types of which, adjuvanted

7 Pandemic vaccine baseline capacity was estimated at 94.5M doses per week Assumptions / Methodology Estimated H1N1 Vaccine Capacity At 1:1 yields, most dose-sparing formulation, full capacity Survey sent to 36 potential influenza vaccine manufacturers 100% response rate All 21 current influenza vaccine producers responded 26 manufacturers that intend to produce pandemic vaccines Includes LAIV and one recombinant vaccine capacity H1N1 doses Survey assumes 1:1 H1N1 to seasonal yields Most dose sparing formulation for each manufacturer Use of full production capacity Timeframe Source: WHO survey 7

8 Several factors will determine availability of pandemic vaccine Uncertainties Key Factors Total Capacity Supply reserved by Industrialized Countries Yields achieved Regulatory requirements Antigen per dose Number of doses/immunized person (1 or 2?) How will production capacity be used to produce H1N1 vaccines? Utilization of current downtime Utilization of seasonal SH and/ or 2010/11 NH production window What H1N1 vaccine orders have been negotiated? Number of doses Timing of vaccine delivery What other countries intend to purchase H1N1 vaccine? Available Supply What are the most vulnerable population groups who should priority have access to H1N1 vaccine? 8

9 Countries are drawing against this capacity in different ways Segments Access Strategy Population % of H1N1 Capacity 1 High-income (e.g., U.S., Canada, Europe, Japan, Australia) Mostly open system: Countries negotiate contracts for vaccine with major, industrialized country manufacturers Facilities serve home countries and export to other markets 893 M 90% Low / Middle Income with local supply (e.g., China, Russia) Mostly closed system: Will procure vaccine mainly from within country Limited or no plans by manufacturers to export 3,114 M 10% Low / Middle Income without local supply No current access to H1N1 vaccine 2,662 M N/A 1 Refers to portion of capacity located within these countries. Source: UNPD population dataset, WHO survey 9

10 Current contract commitments are for M doses, with potential to extend to 1.8B Governments have contracted in two ways for specific amounts of production capacity or number of doses On average, governments have committed to 1.0 doses per person in their populations, resulting in contracts for million doses In addition, most countries have options, or are considering additional contracts, to cover their entire populations with 2 doses Would result in 1.8 billion doses Dosage levels, yields, and production schedule choices will impact time required to fill contracts Current Contract Commitments Countries H1N1 Doses Ordered per Person in Population 10

11 Four scenarios were considered to evaluate the time required to meet the contracts Average Dosage Used Best Available Dosage (8 ug / dose) High Dosage (15 ug / dose) Current Contracts, Best Dosage Current Contracts, High Dosage Universal Coverage X2, Best Dosage Universal Coverage X2, High Dosage With and without seasonal vaccine production Current Contracts ( M doses) Universal Coverage X2 (1,800M doses) High Income Country Doses Contracted 11

12 Free capacity may become available between November 2009 and April 2010 Surplus H1N1 Capacity Available from High-Income Country Facilities 1 - Assuming 1:1 yields and no seasonal production Total Doses Produced Surplus Doses to July 2010 Date Contracts Met 4.2B 3.3B November 09 H1N1 vaccine doses 4.2B 2.5B 2.5B 2.4B 1.6B 0.7B February 10 January 10 April 10 Source: WHO survey 1 Assumes all facilities switch to H1N1 production at end of July (however, in reality, some facilities are converting earlier) 12

13 Full-scale production of seasonal vaccine will drastically impact availability of pandemic vaccine Surplus H1N1 Capacity Available from High-Income Country Facilities 1 - Assuming 1:1 yields and normal seasonal production 2 Total Doses Produced Surplus Doses to July 2010 Date Contracts Met H1N1 vaccine doses 2.3B 1.4B November B 1.4B 0.5B 0.5B February 10 January B None N/A Source: WHO survey 1 Assumes all facilities switch to H1N1 production at end of July (however, in reality, some facilities are converting earlier) 2 Assumes SH facilities begin seasonal production in December and NH facilities begin seasonal production in February 13

14 Impact of lower yields 14

15 A lower yielding vaccine would considerably push back the timelines Surplus H1N1 Capacity Available from High-Income Country Facilities 1 - Assuming 1:2 yields and no 2010 seasonal production Total Doses Produced Surplus Doses Contracts Met H1N1 vaccine doses 2.1B 1.2B January B 2.1B 0.4B 0.3B April 10 June B None N/A Source: WHO survey 1 Assumes all facilities switch to H1N1 production at end of July (however, in reality, some facilities are converting earlier) 15

16 At 1:3 yields, capacity will only become available if adjuvanted vaccines are used Surplus H1N1 Capacity Available from High-Income Country Facilities 1 - Assuming 1:3 yields and no seasonal production Total Doses Produced Surplus Doses to July 2010 Date Contracts Met H1N1 vaccine doses 1.4B 1.4B 0.8B 0.8B 0.5B None None None April 10 N/A N/A N/A Source: WHO survey; Oliver Wyman analysis. 1 Assumes all facilities switch to H1N1 production at end of July (however, in reality, some facilities are converting earlier) 16

17 Understanding vaccine need: Population Segmentation, non Vaccine-Producing Countries (millions) 100% Low Income 1,654 Lower Middle Income 631 Upper Middle Income 373 Total 2,658 Health Adults Children (<15) 80% ,231 Pregnant Women Obese At-risk 1 Essential Populations % of Segment 60% 40% 20% 0% % 40% 60% 80% 100% % of Total Population Represented Source: UNPD population dataset, WHO World Health Statistics; International Labor Organization Occupation (ILO) Data; Global Security Organization; World Bank; 2007; Global Prevalence of Adult Obesity, 2008; Oliver Wyman analysis. 1. Other at-risk includes ill / immunocompromised & elderly (>65)

18 General conclusions from the survey Manufacturers seems to be on track for completing more than 90% of their planned production for Northern Hemisphere seasonal vaccine by end July > there may be no need to request a "switch" from seasonal to H1N1 vaccine production Current vaccine viruses give less than optimal yields > WHO lab network to generate asap new sets of vaccine viruses (by mid July?) Use of oil-in-water adjuvants will dramatically increase vaccine availability > important role of regulators and industrialized country governments in increasing overall production output and access for poor countries A better understanding of developing country H1N1 vaccine demand is needed Upcoming SH and NH seasonal vaccine production will severely diminish availability of H1N1 vaccine > strategies may be needed to decrease impact (review or epidemiology in Sept 2010)? 18

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