IMAC Vision for Vaccines Symposium

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IMAC Vision for Vaccines Symposium
Michael Nobes PhD Director, Corporate Affairs
Health Strategy
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Background to Wyeth

• Wyeth is a research-based, global pharmaceutical
  company with a long history of pioneering
  developments in the areas of
• Vaccines, Haemophilia, Rheumatoid Arthritis,
  Infectious Diseases, Womens Health,
  Transplantation, Depression, Nutrition and over
  the counter medicines
• Employing more than 52,000 people worldwide,
  Wyeth provides medicines in more than 140
  countries
• Wyeth is currently exploring more than 60 new
  therapies for medical conditions such as
  diabetes, breast cancer, multiple sclerosis, HIV,
  Alzheimers disease and schizophrenia

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Wyeth in New Zealand

• Wyeth has been providing New Zealanders with
  quality healthcare and pharmaceuticals since 1937
• Wyeth NZ employs 10 staff in pharmaceuticals and
  nutritionals
• Currently there are 25 different clinical trials
  of Wyeth products in New Zealand,
  Australia and Asia
• Overall Wyeth sees itself as a partner in health
  working collaboratively with Governments, GPs,
  nurses and patient organisations

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Snapshot of Functional Areas
PRESCRIPTION PRODUCTS
NON-PRESCRIPTION PRODUCTS
NUTRITIONAL PRODUCTS
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Prescription Products
Wyeth is committed to ensuring that New
Zealanders have access to the latest
life-changing life-saving therapies
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Pneumococcal Disease

• Pneumococcal disease is caused by a common
  bacterium, Streptococcus pneumoniae (the
  pneumococcus)
• S. pneumoniae has approximately 90 known
  serotypes, only some of which commonly cause
  disease
• 7 serotypes account for the majority of disease
  in developed countries ? These serotypes are
  contained in Prevenar
• Infection with S. pneumoniae can lead to invasive
  or non-invasive disease manifestations

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Types of Pneumococcal Disease
N O N I N V A S I V E D I S E A S E
I N V A S I V E D I S E A S E
Meningitis
Pneumonia (non-bacteraemic)
Otitis Media
Bacteraemia
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Symptoms of Pneumococcal Meningitis
Source Beers MG, The Merck Manual Paediatric
Handbook 6th ed 2000 384.19
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Risk Factors for Invasive Pneumococcal Disease

• Children under 2 years of age
• Children who attend day care
• Children exposed to one or more courses of
  antibiotics
• Children who have suffered at least one recent
  ear infection
• Maori Pacific Island children, especially
  those aged lt2 years
• People who are immunocompromised
• Sickle-cell disease or asplenia
• Lung, heart or liver disease
• Diabetes or alcoholism

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Burden of Pneumococcal Disease in
New Zealand

• Pneumococcal pneumonia is an important illness
  in the first year of life,
• with high rates among children up to the age
  of 5 years
• Many children who contract pneumococcal disease
  are hospitalised
• Pneumococcus is the bacterium most commonly
  associated with acute
• otitis media
• Pneumococcal meningitis may cause disability of
  greater severity than
• meningococcal meningitis
• Based on a UK study almost a quarter of all
  children who contract
• pneumococcal meningitis in the first year of
  life may be left with a
• moderate or severe disability, or in some
  circumstances may die

Source Bedford H, et al . Meningitis in infancy
in England and Wales follow-up at age 5 years.
BMJ 2001 323533-7
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Epidemiology of Pneumococcal Disease in New
Zealand

• Incidence clustered at age extremes
• High rates of carriage in general population
• Maori Pacific Island children are at increased
  risk of IPD
• Antibiotic resistance emerging
• IPD places a heavy burden on New Zealand
  healthcare resources

Source Adapted from Voss et al, Pediatr Infect
Dis J, 1994 13(10) 873-7 Applied to a birth
cohort of 54,000 NZ infants
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IPD Hospitalisations in New Zealand
Number of hospitalisations due to pneumococcal
pneumonia by age (1988-1996)
Adapted from Mansoor O, Pneumococcal Infections
in New Zealand Vaccine 1999 17 S122-S123
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Antibiotic Resistance of S. pneumoniae

• In New Zealand, pneumococcal resistance to
  penicillin, as well as macrolides,
  tetracyclines, trimethoprim-sulfamethoxazole
  (cotrimoxazole) and cefotaxime has been detected
• Resistance to penicillin in S. pneumoniae has
  increased from approximately 1 of isolates in
  1995 to 7.1 in 2005
•  
•  
•  

Source Adapted from ESR Antimicrobial
susceptibility of invasive Streptococcus
pneumoniae, 2005 www.surv.esr.cri.nz
W20060500
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Vaccine for Pneumococcal Disease
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Capsular Polysaccharide
Carrier Protein Conjugation
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Indication

• Active immunisation of infants and children from
  6 weeks to 9 years of age
  against invasive disease, pneumonia and otitis
  media caused by Streptococcus pneumoniae 1
• Prevenar is active against 7 Streptococcus
  pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and
  23F
• Surveys have shown that the 7 serotypes in
  Prevenar are likely to cover approximately 86 of
  invasive isolates found in New Zealand children
  under 2 years of age2

1. Prevenar Data Sheet, 30 January 2006 2. ESR
2005 data
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Dosage for Previously Unvaccinated Infants

• Prevenar is a sterile suspension (0.5mL) supplied
  in a single-use pre-filled syringe for
  intra-muscular injection
• The primary vaccination series consists of 3
  doses commencing at 6-8 weeks of age, with an
  interval of at least 4 weeks between doses
• A single booster injection should be administered
  in the second year, at least 2 months after the
  primary series

Source Prevenar Data Sheet, 30 January 2006
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Benefits of Prevenar for Children

• Children are protected against IPD caused by
  vaccine-specific serotypes

Decline in IPD Incidence Following Routine
Vaccination with Prevenar in Northern California
Kaiser Permanente (NCKP)
Source Black S, et al. Pediatr Infect Dis J
200423485-489
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Australian Experience High-Risk Program

• Free pneumococcal conjugate vaccine (Prevenar)
  for high risk groups administered in a 31 series
  from July 2001
• All Aboriginal and Torres Strait Islander
  children (lt2 years of age)
• Aboriginal children in Central Australia and
  any other region with a high
• incidence of pneumococcal infection (2-5 years
  of age)
• Non-Aboriginal children in Central Australia
  (lt2 years of age)
• Children with impaired immunity or medical risk
  factors that predispose
• them to high rates or severity of
  pneumococcal infection (lt5 years of age)

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IPD among Indigenous and non-Indigenous children
aged lt2 years, Australia
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3 fold difference
92 - 94
75
Roche et al. CDI 2006 3080-92
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Universal Pneumococcal Program

• Program commenced on 1 January 2005
• Free pneumococcal conjugate vaccine (Prevenar)
  at 2, 4 and 6 months
• of age for all children born on or after 1
  January 2005
• All children born from 1 January 2003 to 31
  December 2004 were also
• eligible for free catch-up program until the
  end of 2005
• Children in specific high risk groups (as per
  original schedule)
• are also eligible for free booster doses

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IPD among Indigenous and non-Indigenous children
aged lt2 years, Australia
92 - 94
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Source Enhanced IPD Surveillance Working Group
as presented at PHAA, July 2006
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Invasive pneumococcal disease among children aged
0-4 years, Australia
56
7vPCV (children)
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??
Source http//www9.health.gov.au/cda/Source/CDA-i
ndex.cfm. NNDSS website accessed 6 September 2006
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Invasive pneumococcal disease among adults ? 65
years, Australia
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7vPCV (children)23vPPV (older adults)
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??
Source http//www9.health.gov.au/cda/Source/CDA-i
ndex.cfm. NNDSS website accessed 11 August 2006
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Prevenar in New Zealand
From 1 February 2006, certain high-risk
populations are eligible to receive free
pneumococcal vaccination in New Zealand
In June 2006, Prevenar was also launched on the
private market in New Zealand
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High-Risk Pneumococcal Vaccination Program in
New Zealand

• From 1 February 2006, the following high-risk
  populations are eligible to receive free
  pneumococcal vaccination in New Zealand
• Children of any age pre- or post-splenectomy
  or with functional asplenia
• Children under five years of age with the
  following medical risks
• on immunosuppressive therapy or radiation
  therapy, when there is expected to be
• sufficient immune response
• with primary immune deficiencies
• with HIV infection
• with renal failure, or nephrotic syndrome
• immune suppressed following organ
  transplantation
• with cochlear implants or intracranial shunts

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IMAC Vision for Vaccines Symposium
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