Update on A(H1N1) pandemic
and seasonal vaccine
availability
July 7, 2009
Presentation objectives and approach
Presentation Objectives
Approach
  Review production status for
2009-2010 Northern
Hemisphere vaccine production
  Review baseline estimates for
H1N1 production capacity
  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)
  Review major factors that will
impact capacity available to
developing countries, within:
–  context of H1N1 contracts
–  next seasonal vaccine
production plans
  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
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Extraordinary SAGE meeting | 7 July, 2009
Global seasonal trivalent vaccine production
capacity
Total annual
capacity
(106 doses)
2008 Northern 2009 Southern
hemisphere
hemisphere
production
production
(106 doses)
(106 doses)
2009 planned
Northern
hemisphere
production
(106 doses)
Companies A
560.1 (64%)
299.6
103.0
322.8
Companies B
316.4 (36%)
170.4
9.5
170.0
All companies
876.4
470.0
112.5
492.8
Companies A (n=7): with capacity to produce at least 2.106 doses of new H1N1 vaccine / week
Companies B (n=18): other smaller companies
Source: WHO survey
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Extraordinary SAGE meeting | 7 July, 2009
Mapping of all potential influenza A(H1N1)
Vaccine Manufacturers
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Extraordinary SAGE meeting | 7 July, 2009
Status of Northern Hemisphere seasonal vaccine
production
31 May 2009
30 June 2009
H1N1
(seasonal)
H3N2
B
Status
Status
Status
Status
Doses (106)
65.8%
73.4%
39.5%
38.0%
187.3
(77.4%)
(80.9%)
(74.4%)
(72.2%)
87.9%* 87.6%* 75.7%*
(91.7%)
31 July 2009
(93.3%)
Trivalent vaccine (H1N1 / H3N2 / B)
73.6%*
(91.7%)
95.4%* 94.3%* 92.1%*
(91.2%)
92.0%*
• * July 1-6, 2009 update
• °°° as compared with 470 million doses on 2008
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Extraordinary SAGE meeting | 7 July, 2009
362.7*
453.4* °°°
New A(H1N1) vaccine formulations proposed by
manufacturers
Total
Whole
Split
Subunit
LAIV
Recombinant
protein
Vaccine types
33
9
14
4
5
1
…of which,
adjuvanted
12
6
3
3
-
-
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Extraordinary SAGE meeting | 7 July, 2009
Pandemic vaccine baseline capacity was
estimated at 94.5M doses per week
Estimated H1N1 Vaccine Capacity
At 1:1 yields, most dose-sparing formulation, full capacity
Assumptions / Methodology
–  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 sent to 36 potential
influenza vaccine manufacturers
  Survey assumes
–  1:1 H1N1 to seasonal yields
–  Most dose sparing formulation for
each manufacturer
–  Use of full production capacity
Timeframe
Source: WHO survey
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Extraordinary SAGE meeting | 7 July, 2009
Several factors will determine availability of
pandemic vaccine
Uncertainties
  Yields achieved
Total Capacity
  Regulatory requirements
  Antigen per dose
  Number of doses/immunized
person (1 or 2?)
Supply reserved by
Industrialized Countries
Key Factors
  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
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Extraordinary SAGE meeting | 7 July, 2009
 What are the most vulnerable
population groups who should
priority have access to H1N1
vaccine?
Countries are drawing against this capacity in
different ways
Population
% of H1N1
Capacity1
893 M
90%
(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
Low / Middle
Income with
local supply
  Mostly closed system: Will procure vaccine
mainly from within country
–  Limited or no plans by manufacturers to
export
3,114 M
10%
  No current access to H1N1 vaccine
2,662 M
N/A
Segments
High-income
(e.g., China, Russia)
Low / Middle
Income without
local supply
Access Strategy
1 Refers to portion of capacity located within these countries.
Source: UNPD population dataset , WHO survey
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Extraordinary SAGE meeting | 7 July, 2009
Current contract commitments are for 850
-900M doses, with potential to extend to 1.8B
  Governments have contracted in two
ways – for specific amounts of
production capacity or number of doses
Current Contract Commitments
H1N1 Doses Ordered per Person in Population
  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
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Extraordinary SAGE meeting | 7 July, 2009
Countries
  On average, governments have
committed to 1.0 doses per person in
their populations, resulting in contracts
for 850-900 million doses
Average Dosage Used
Four scenarios were considered to evaluate
the time required to meet the contracts
Best
Available
Dosage
(8 ug / dose)
High Dosage
(15 ug / dose)
Current
Contracts,
Best Dosage
Universal
Coverage
X2,
Best Dosage
Current
Contracts,
High Dosage
Universal
Coverage
X2,
High Dosage
Current Contracts
(850 – 900M doses)
Universal Coverage X2
(1,800M doses)
High Income Country Doses Contracted
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Extraordinary SAGE meeting | 7 July, 2009
With and without
2010-11 seasonal
vaccine production
Free capacity may become available between
November 2009 and April 2010
H1N1 vaccine doses
Surplus H1N1 Capacity Available from High-Income Country Facilities1
- Assuming 1:1 yields and no 2010-11 seasonal production
Total
Doses
Produced
Surplus
Doses to
July 2010
Date
Contracts
Met
4.2B
3.3B
November 09
4.2B
2.4B
February 10
2.5B
1.6B
January 10
2.5B
0.7B
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)
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Extraordinary SAGE meeting | 7 July, 2009
Full-scale production of 2010-11 seasonal vaccine
will drastically impact availability of pandemic vaccine
H1N1 vaccine doses
Surplus H1N1 Capacity Available from High-Income Country Facilities1
- Assuming 1:1 yields and normal 2010-11 seasonal production2
Total
Doses
Produced
Surplus
Doses to
July 2010
Date
Contracts
Met
2.3B
1.4B
November 09
2.3B
1.4B
0.5B
0.5B
February 10
January 10
1.4B
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
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Extraordinary SAGE meeting | 7 July, 2009
Impact of lower yields
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Extraordinary SAGE meeting | 7 July, 2009
A lower yielding vaccine would considerably
push back the timelines
H1N1 vaccine doses
Surplus H1N1 Capacity Available from High-Income Country Facilities1
- Assuming 1:2 yields and no 2010 seasonal production
Total
Doses
Produced
Surplus
Doses
Contracts
Met
2.1B
1.2B
January 10
1.3B
2.1B
0.4B
0.3B
April 10
June 10
1.3B
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)
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Extraordinary SAGE meeting | 7 July, 2009
At 1:3 yields, capacity will only become available if
adjuvanted vaccines are used
Surplus H1N1 Capacity Available from High-Income Country Facilities1
- Assuming 1:3 yields and no 2010-11 seasonal production
Surplus
Doses to
July 2010
Date
Contracts
Met
1.4B
0.5B
April 10
1.4B
0.8B
0.8B
None
None
None
N/A
N/A
N/A
H1N1 vaccine doses
Total
Doses
Produced
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)
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Extraordinary SAGE meeting | 7 July, 2009
Understanding vaccine need: Population
Segmentation, non Vaccine-Producing Countries
(millions)
Lower Middle Upper Middle
Income
Income
631
373
Low Income
1,654
100%
Total
2,658
Health Adults
80%
772
Pregnant
Women
Obese
At-risk1
Essential
Populations
% of Segment
Children (<15)
297
162
1,231
94
861
7
34
72
91
60
324
60%
40%
584
20%
0%
183
51
22
186
39
20%
14
35
40%
60%
78
25
80%
15
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)
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Extraordinary SAGE meeting | 7 July, 2009
79
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)?
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Extraordinary SAGE meeting | 7 July, 2009