Vaccines related epidemiology Programme design and policy options

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Vaccines related epidemiologyProgramme design
and policy options

• First EpiTrain course in
• Advanced Epidemiology
• Jurmala Latvia 29.10.2004
• Hanna Nohynek
• KTL Helsinki Finland

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Vaccination Policy Options
?
Eradication Activities
New Vaccine Introduction
Newer Vaccine Research and Development
Outbreak vs routine control of epidemic diseases
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Evolution of Immunization Programmes
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When planning vaccinating (an individual or) a
population

Vaccine efficacy
Severity of disease
Risk to contract
Adverse events
Coverage
Price
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Basic questions when introducing new vaccines
into a national programme

• Is the vaccine efficacious enough and safe ?
• Is there big enough vaccine preventable disease
  burden in the country ?
• Is the public aware of the importance of the
  disease ?
• Is the vaccine coverage good ?
• How could the vaccine be introduced into the
  national schedule ?
• How can the country assure availability of the
  vaccine in long term ?

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Decision making processes for introducing new
vaccines vary greatly in industrialized countries

• Reasons
• national health systems in place
• funding basis of programme
• gross national product
• national prioritization health vs. other
  values
• within health

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Case Finland Rationale and aims of changes in
programme 2001-

• Opportunity to make major revisions
• arising from decision to stop national vaccine
• production (to end by December 2004)
• Best possible/affordable protection to whole
  population
• National consensus process
• Revisions need to base on scientific evidence and
  cost effectiveness evaluation
• Carefully controlled implementation
• Follow up of implementation and evaluation of
  effectiveness

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National vaccination programme in 2001
Age
Vaccine
Injections
lt1 weeks
BCG
3 mo
DTwP
4 mo
DTwP Hib
5 mo
DTwP
6 mo
Polio Hib
12 mo
Polio
14-18 mo
MMR Hib
20-24 mo
DTwP polio
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Possible programmatic changes discussed

• New combination vaccine
• to replace wP in DTwP

Reductions / omissions BCG
Add ons hepatitis B, pertussis, influenza,
pneumococcus (PPV), tick born encephalitis
(regionally)
New vaccines varicella, pneumococcus (PCV),
(meningococcus C)
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Costs of the Finnish nEPI
Population 5.2 mi, birth cohort 60 000
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nEPI costs...
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Costs of new nEPI ?
5 - fold difference !
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Roles and responsibilities in decision making
for nEPI
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Disease / vaccine specific subgroup reports
VE evidence categorized according to EBM

• Pertussis
• BCG
• Varicella
• Influenza
• Pneumococcus (PPS, PCV)
• Combination vaccines
• Hepatitis B
• TBE

Cost effectiveness analyses
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New decision making process adopted 4 steps
approach

• Factors to consider
• 1) Expected public health benefit
• 2) Safety of vaccine individually
• 3) Safety effects on population level
• 4) Benefit / cost of vaccine

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Outcome of the 4 step evaluation for 7PCV

• 1) Expected public health benefit

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Efficacy of PncCRM vaccine
3ISPPD 2002
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Invasive Pnc infections in Finland in 1995-99
Cases/year
Incidence/100 000/year
7PCV serotype coverage
49,4
67,5
Age, years
Source National Register for Infectious
Diseases
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Incidence of pneumonia strongly affected by case
definition
Also has an impact on expected VE of PCV
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Incidence of Acute Otitis Media
FinOM cohort
Pilot study
AOM is most common among children 7-12 mo of age.
AOM / 100 childmonth
All AOM
AOM by Pnc
Kilpi et al. Pediatr Infect Dis J 200120654-62
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Pnc disease burden in Finland
Birth cohort 60 000 Universal use of 7PCV
potentially prevents annually 50 - 60 cases
of IPD 500 - 1 800 cases of
pneumonia 10 000 episodes of AOM 2 400 otologic
surgery procedures
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4 steps approach for 7PCV

• 1) Expected public health benefit
• 2) Safety of vaccine
• large scale RC trials demonstrated safety
• on individual level

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4 steps approach for 7PCV

• 1) Expected public health benefit
• 2) Safety of vaccine
• 3) Population level effects
• herd effect
• ?/- replacement

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4 steps approach for 7PCV

• 1) Expected public health benefit
• 2) Safety of vaccine
• 3) Population level effects
• herd effect, ? replacement
• 4) Benefit / cost of vaccine
• - with 4 doses

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Costs of introducing 7PCV into national program
Salo H et al. ESPID 2003
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Cost effectiveness of 7PCV in Finland

• 1) The price of 7PCV should be third (half) the
  price
• 2) Effect of reducing number of 7PCV doses and/or
  using 23PncPS for boosting needs to be evaluated
• 3) Benefits quality of life gt life years saved
• Salo H et al. ESPID 2003

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Conclusion from step 4 evaluation

• Introduction of 4 doses of 7PCV
• would almost triple the costs of universal
  childhood vaccination program
• compared to the 2001 level,
• even if all savings achieved
• by reduced disease burden
• were taken into account.
•  

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Final conclusion

• Expert consensus even if pneumococcus causes
  substantial public health disease burden, 7PCV is
  safe and possibly has positive herd effect
  extending to older age groups, 7PCV is not cost
  efficacious if given according to the recommended
  4-dose schedule therefore, at the time being
  7PCV is not recommended to be implemented into
  national vaccination program in Finland.

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Further comment by WG

• Introduction of new vaccines
• should not be compared to
• introduction of old vaccines
• Right comparision new vaccines vs. any other
  preventive health intervention (screening for
  prostate cancer, hip replacement, etc.)

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Further comment by WG

• 1. Introduction of new vaccines should not be
  compared to introduction of old vaccines
• Right comparision new vaccines vs. any other
  preventive health intervention (screening for
  prostate cancer, hip replacement, etc.)
• 2. Any health intervention to be introduced
  should have a firm scientific evidence base
• 3. Limited resources should be targeted at
  interventions with equal benefit obtained with
  least amount of costs

Shift of paradigm !
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In October 2004, Finland is

• Getting ready to introduce a new routine infant
  immunization programme
• without 7PCV (January 2005-gt)
• Recalculating costs and benefits taking into
  consideration accumulating evidence of the
  effects of 7PCV (herd immunity, need of less than
  4 doses, replacement)

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National vaccination programme in 2004
Age
Vaccine
Injections
lt1 weeks
BCG
3 mo
DTwP
4 mo
DTwP Hib
5 mo
DTwP
6 mo
Polio Hib
12 mo
Polio
14-18 mo
MMR Hib
20-24 mo
DTwP polio
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National vaccination programme in 2005
Age
Vaccine
Injections
lt1 weeks
BCG
3 mo
DTaP-Polio-Hib
4 mo
5 mo
DTaP-Polio-Hib
6 mo
12 mo
DTaP-Polio-Hib
14-18 mo
MMR
20-24 mo
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Hep B immunization policy WHO European Region,
2004
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Haemophilus influenza type b immunizationWHO
European Region 2004
Source Joint reporting form as of 30/09/2004
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Hib3 coverage in the WHO European Region 2003
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Annual incidence of Hib meningitis in childrenlt5
years of age before the introduction of
immunization based on about 70 studies in
countries of the WHO European Region
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Other new and under-used antigens in the
European Region (as shown on the WHO/UNICEF
Joint Reporting Forms for 2003)

• Accellular pertussis vaccine (aP and
  aP-containing vaccines)
• 25 countries (WE and CCEE)
• Meningococcal conjugate vaccine
• 10 WE countries
• Pneumococcal conjugate vaccine
• 6 WE countries
• Varicella vaccine
• 2 WE countries

How accurate is this information?
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Vaccine programmes for the rich vs. poor

• Rich DTP, IPV, MMR HBV, Hib Varicella,
  PCV
• Influenza
• Poor BCG, DTP, OPV, M HBV, (Hib)
• -gt GAVI

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