Pneumococcal Vaccines: Suppliers, pipelines, and availability

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Pneumococcal Vaccines Suppliers, pipelines, and
availability

• Maria Deloria Knoll, PhD
• GAVIs PneumoADIP
• Johns Hopkins Bloomberg School of Public Health
• netSPEAR 4th Annual Network Conference
• 9-10 November 2006
• Nairobi, Kenya

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Vaccine Supply

• Supply begins with 7v 1 manufacturer
• 2008-2015 2 suppliers, 10v 13v vaccines
• 2016 ? 2-5 suppliers proteins, conjugates,
• MNCs Emerging Suppliers

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Vaccine Supply Environment - 2006Vaccine
Pipeline Competitive Landscape
Launched
Clinical Trial Phase III
Clinical Trial Phase II
Clinical Trial Phase I
Preclinical stage
13-valent
Multi-nationals
Prevnar (7-valent)
20 vaccines in research/ preclinical
stage (includes conjugate protein-based vaccine
s)
9-valent
10-valent
Expected launch 2008
7-valent
11-valent
Emerging suppliers
Conjugated vaccines 3 suppliers
Discontinued
Based on publicly available information,
PneumoADIP discussions with potential emerging
suppliers and BCG Emerging Supplier Study 2005
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Pnc Vaccines Licensed Tested
? Significant protective efficacy - Not
evaluated P Pending Trial results
Immunogenicity bridging
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Pnc Vaccines Licensed Tested
? Significant protective efficacy - Not
evaluated P Pending Trial results
Immunogenicity bridging
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Pnc Vaccines Licensed Tested
? Significant protective efficacy - Not
evaluated P Pending Trial results
Immunogenicity bridging
Shown effective in 2 major RCTs in Africa
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Supply Situation 2006

• Wyeth 7v vaccine
• Serotypes 4, 6B, 9V, 14, 18C, 19F, 23F
• Single dose pre-filled syringe

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Wyeth 7v

• Routine use in USA
• Direct and indirect effects

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7v Wyeth

• Expected health impact equal to or better than
  some other priority vaccines
• 40-50 of pediatric Pnc serotypes in Africa
• Incidence of preventable disease Hib

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Proportion of pediatric pneumococcal disease
prevented by vaccination
7-valent
71
86
38
62
60
73
Assumes cross protection within serogroup 6
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Expected impact of PCV-7 in Kenya, Gambia, and
Bangladesh exceeds that in US and Australia
Cases Prevented /100,000
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PCV-7 could prevent more cases than Hib vaccine
in Kenya
Refs Brent AJ, et al. Lancet 2006
Cowgill KD, et al. JAMA 2006
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10v (GSK)

• Serotypes 7-valent 1, 5, 7F
• Novel carrier (H. influenza protein D)
• May protect against non-typeable Hi disease
• Similar to 11-valent (10v type 3)
• Efficacy proven against O.M.

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Proportion of pediatric pneumococcal disease
prevented by vaccination
10-valent
84
88
66
81
81
81
Assumes cross protection within serogroup 6
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10v Future plans

• Ph3 trial in Latin America (CAP AOM)
• Immunogenicity/Safety studies to support IPD
  WHO recommendation
• Exp. EMEA license late 2008

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13v (Wyeth)

• Serotypes 10-valent 3, 6A, 19A
• Same carrier protein as 7v, 9v (CRM197)
• Probable single multi-dose vials

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Proportion of pediatric pneumococcal disease
prevented by vaccination
13-valent
89
92
73
87
87
86
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13v Future Plans

• Licensure on immunogenicity
• Expected in late 2009
• Studies in Africa/Asia likely for WHO
  recommendation pre-qualification

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2015 Beyond

• Emerging market suppliers
• Multivalent conjugates
• MNCs
• Mutlivalent conjugates
• Common proteins

Global formulations secure supply
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Potential vaccine supply timeline
Licensure (FDA, EMEA) Avail for emerging markets
(developing countries)
7-valent 4, 6B, 9V, 14, 18C, 19F,
23F 10-valent 7-valent 1, 5, 7F 13-valent
10-valent 3, 6A, 19A
Vaccine serotypes
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Introducing Pnc vaccine into developing countries
Vaccine 7-valent (Wyeth)
Avail for DCs
2006
2007
2008
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Introducing Pnc vaccine into developing countries
2006
2007
2008
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Introducing Pnc vaccine into developing countries
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Introducing Pnc vaccine into developing countries
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Introducing Pnc vaccine into developing countries
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Summary Key Messages

• 7v PCV could be available to developing countries
  as early as January 2008
• 7v PCV is expected to prevent 2-3 times the
  number of cases per 100k population in Africa as
  in countries where it is currently in use
• 10v and 13v vaccines that contain important
  serotypes for Africa and Asia are in final stages
  of clinical development
• Action needs to be taken by suppliers, WHO, GAVI
  and countries

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Thank you!
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Supply Security multinational emerging
suppliers
Multinational suppliers with current vaccines
accelerates introduction
Emerging suppliers needed to support high volumes
with additional capacity