Update on A(H1N1) pandemic and seasonal vaccine

availability

July 7, 2009

Extraordinary SAGE meeting | 7 July, 2009 2 |

Presentation objectives and approach

Presentation Objectives

  Review production status for 2009-2010 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

Extraordinary SAGE meeting | 7 July, 2009 3 |

Global seasonal trivalent vaccine production capacity

Total annual capacity

(106 doses)

2008 Northern hemisphere production

(106 doses)

2009 Southern hemisphere production

(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

Extraordinary SAGE meeting | 7 July, 2009 4 |

Mapping of all potential influenza A(H1N1) Vaccine Manufacturers

Extraordinary SAGE meeting | 7 July, 2009 5 |

Status of Northern Hemisphere seasonal vaccine production

H1N1 (seasonal) H3N2 B Trivalent vaccine (H1N1 / H3N2 / B)

Status Status Status Status Doses (106)

31 May 2009 65.8% 73.4% 39.5% 38.0% 187.3

30 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 2008

Extraordinary SAGE meeting | 7 July, 2009 6 |

Total Whole Split Subunit LAIV Recombinant protein

Vaccine types 33 9 14 4 5 1

…of which, adjuvanted 12 6 3 3 - -

New A(H1N1) vaccine formulations proposed by manufacturers

Extraordinary SAGE meeting | 7 July, 2009 7 |

Assumptions / Methodology

  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

  Survey assumes –  1:1 H1N1 to seasonal yields –  Most dose sparing formulation for

each manufacturer –  Use of full production capacity

Pandemic vaccine baseline capacity was estimated at 94.5M doses per week

H1N

1 do

ses

Estimated H1N1 Vaccine Capacity At 1:1 yields, most dose-sparing formulation, full capacity

Timeframe Source: WHO survey

Extraordinary SAGE meeting | 7 July, 2009 8 |

Several factors will determine availability of pandemic vaccine

Uncertainties

Total Capacity

Supply reserved by Industrialized Countries

Available Supply

  Yields achieved

  Regulatory requirements   Antigen per dose

  Number of doses/immunized person (1 or 2?)

  What H1N1 vaccine orders have been negotiated?

–  Number of doses –  Timing of vaccine delivery

  What other countries intend to purchase H1N1 vaccine?

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 are the most vulnerable population groups who should priority have access to H1N1 vaccine?

Extraordinary SAGE meeting | 7 July, 2009 9 |

Segments

High-income (e.g., U.S., Canada, Europe, Japan, Australia)

Low / Middle Income with local supply (e.g., China, Russia)

Low / Middle Income without local supply

Access Strategy

  Mostly open system: Countries negotiate contracts for vaccine with major, industrialized country manufacturers

–  Facilities serve home countries and export to other markets

  Mostly closed system: Will procure vaccine mainly from within country

–  Limited or no plans by manufacturers to export

  No current access to H1N1 vaccine

Population

Countries are drawing against this capacity in different ways

% of H1N1 Capacity1

893 M

3,114 M

2,662 M

90%

10%

N/A

1 Refers to portion of capacity located within these countries. Source: UNPD population dataset , WHO survey

Extraordinary SAGE meeting | 7 July, 2009 10 |

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

  On average, governments have committed to 1.0 doses per person in their populations, resulting in contracts for 850-900 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

H1N1 Doses Ordered per Person in Population

Current Contract Commitments

Cou

ntrie

s

Extraordinary SAGE meeting | 7 July, 2009 11 |

Four scenarios were considered to evaluate the time required to meet the contracts

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)

Best Available Dosage

(8 ug / dose)

High Dosage (15 ug / dose)

High Income Country Doses Contracted

Aver

age

Dos

age

Use

d

With and without 2010-11 seasonal vaccine production

Extraordinary SAGE meeting | 7 July, 2009 12 |

Free capacity may become available between November 2009 and April 2010

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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

2.5B

4.2B

4.2B

2.5B

0.7B

3.3B

2.4B

1.6B

April 10

November 09

February 10

January 10

Source: WHO survey 1 Assumes all facilities switch to H1N1 production at end of July (however, in reality, some facilities are converting earlier)

Extraordinary SAGE meeting | 7 July, 2009 13 |

Full-scale production of 2010-11 seasonal vaccine will drastically impact availability of pandemic vaccine

H1N

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Total Doses

Produced

Surplus Doses to July 2010

Date Contracts

Met

1.4B

2.3B

2.3B 1.4B

None

1.4B

0.5B 0.5B

N/A

November 09

February 10 January 10

Surplus H1N1 Capacity Available from High-Income Country Facilities1

- Assuming 1:1 yields and normal 2010-11 seasonal production2

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

Extraordinary SAGE meeting | 7 July, 2009 14 |

Impact of lower yields

Extraordinary SAGE meeting | 7 July, 2009 15 |

A lower yielding vaccine would considerably push back the timelines

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Total Doses

Produced Surplus Doses

Contracts Met

1.3B

2.1B

2.1B 1.3B

None

1.2B

0.3B 0.4B

N/A

January 10

June 10 April 10

Surplus H1N1 Capacity Available from High-Income Country Facilities1

- Assuming 1:2 yields and no 2010 seasonal production

Source: WHO survey 1 Assumes all facilities switch to H1N1 production at end of July (however, in reality, some facilities are converting earlier)

Extraordinary SAGE meeting | 7 July, 2009 16 |

At 1:3 yields, capacity will only become available if adjuvanted vaccines are used

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Surplus H1N1 Capacity Available from High-Income Country Facilities1

- Assuming 1:3 yields and no 2010-11 seasonal production

Total Doses

Produced

Surplus Doses to July 2010

Date Contracts

Met

0.8B

1.4B 1.4B 0.8B

None

0.5B None None

N/A

April 10 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)

Extraordinary SAGE meeting | 7 July, 2009 17 |

186

584

772

1,654

78

35

183

297

631

60

34

94

162

373

0%

20%

40%

60%

80%

100%

20% 40% 60% 80% 100%

51 22

14 7

% o

f Seg

men

t

Low Income Lower Middle Income

Upper Middle Income

Total

2,658

1,231

861

91 324 79

Health Adults

Children (<15)

At-risk1

Essential Populations

Pregnant Women

% of Total Population Represented

Obese

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)

72

Understanding vaccine need: Population Segmentation, non Vaccine-Producing Countries

(millions)

39 25 15

Extraordinary SAGE meeting | 7 July, 2009 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)?