Download Vaccines related epidemiology Programme design and

Vaccines related epidemiology
Programme design
and policy options
First EpiTrain course in
Advanced Epidemiology
Jurmala Latvia 29.10.2004
Hanna Nohynek
KTL Helsinki Finland
Vaccination Policy Options
?
Eradication Activities
Outbreak vs routine
control of epidemic
diseases
New Vaccine
Introduction
Newer Vaccine
Research and
Development
Evolution of Immunization Programmes
1
2
3
4
5
Resumption of
Loss of
Pre-vaccine Increasing
Confidence Eradication
Confidence
Coverage
Incidence
Disease
Vaccinations
Stops
Outbreak
Vaccine
Coverage
Adverse
Events
Maturity of programmeRef: Grabenstein JD, Hospital
Pharmacy 1996
When planning vaccinating
(an individual or) a
population
Vaccine efficacy
Severity of disease
Risk to contract
Coverage
Adverse events
Price
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 ?
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
Case Finland:
Rationale and aims of
changes in programme 2001Opportunity 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
National vaccination programme in 2001
Age
Vaccine
<1 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
Injections
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)
Costs of the Finnish nEPI
Milj. €
Vaccination programme in 2002
4,54
DTaP-Hib-IPV x 3
Savings from stopping own
production and single doses
4,20
-1,68
d/DTaP to >6-year olds
0,77
Influenza to >65-year olds
0,89
New (mandatory additions)
8,72
Population 5.2 mi, birth cohort 60 000
nEPI costs...
Milj. €
New (mandatory additions)
8,72
BCG-vaccine reductions
-0,03
Stopping polio boosters
-0,49
New (minimum)
8,20
Costs of new nEPI ?
Milj. €
New (minimum)
8,20
Varicella x 2
3,93
Pnc-conjugate x 4
Hepatitis B -vaccine x 3
(part of a combo vacc)
12,11
New (maximum)
25,75
1,51
= 5 - fold difference !
Roles and responsibilities
in decision making for nEPI
Ministry of Health
National Advisory Committee
for Infectious Diseases
National Public Health Institute
(KTL)
National Advisory Committee
for Vaccination (KRAR)
KTL Advisory Board
on Vaccines
Disease / Vaccine Specific
working groups
Disease / vaccine
specific subgroup reports
•
•
•
•
•
•
•
•
VE evidence categorized
Pertussis
according to ~EBM
BCG
Cost effectiveness analyses
Varicella
Influenza
Pneumococcus (PPS, PCV)
Combination vaccines
Hepatitis B
TBE
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
Outcome of the 4 step evaluation
for 7PCV
1) Expected public health benefit
+
Efficacy of PncCRM vaccine
3ISPPD 2002
NCKP
Arizona
Soweto
NCKP
Invasive Infections
Arizona (RSV-)
Pneumonia (X-ray positive)
Soweto (HIV-)
Acute Otitis
Soweto (HIV+)
FinOM (VT)
FinOM (PNC)
FinOM (all)
NCKP (all)
%
0
10
20
30
40
50
60
70
80
90
100
Invasive Pnc infections in Finland
in 1995-99
Cases/year
100
7PCV serotype
coverage
Incidence/100 000/year
30
25
80
49,4%
60
40
20
15
67,5 %
10
20
5
0
0
<5 5-9 10- 15- 20- 25- 30- 35- 40- 45- 50- 55- 60- 65- 70- >75
14 19 24 29 34 39 44 49 54 59 64 69 74
Age, years
Source: National Register for Infectious Diseases
Incidence of pneumonia strongly
affected by case definition
Also has an
impact on
expected
VE of PCV
FinOM cohort
Pilot study
Incidence of
Acute Otitis Media
AOM / 100 childmonth
20
18
16
14
12
10
8
6
4
2
0
AOM is most common
among children
7-12 mo of age.
All AOM
AOM by Pnc
2
3
5
7
9 11 13 15 17 19 21 23
Age, months
Kilpi et al. Pediatr Infect Dis J 2001;20:654-62
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
4 steps approach for 7PCV
1) Expected public health benefit
+
2) Safety of vaccine
+
large scale RC trials
demonstrated safety
on individual level
4 steps approach for 7PCV
1) Expected public health benefit
+
2) Safety of vaccine
+
3) Population level effects
+ herd effect
?/- replacement
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
Costs € of introducing 7PCV into national program
Cost
category
No
7PCV
26 486 016
Yes
7PCV
22 303 132
Net cost
€
- 4 182 884
0
11 929 766
11 929 766
26 486 016
34 232 898
7 746 882
Travel
1 342 152
1 226 297
- 114 856
Total direct
27 827 169
35 459 195
+ 632 026
11 798 063
10 348 785
- 1 449 277
32 625 232
45 807 980
+6 182 749
Total medical
Vaccination
programme
Health care
Productivity
Total cost
Salo H et al. ESPID 2003
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 > life years saved
Salo H et al. ESPID 2003
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.
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.
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.)
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 !
In October 2004, Finland is
- Getting ready to introduce a new routine
infant immunization programme
without 7PCV (January 2005->)
- Recalculating costs and benefits taking
into consideration accumulating evidence
of the effects of 7PCV (herd immunity,
need of less than 4 doses, replacement)
National vaccination programme in 2004
Age
Vaccine
<1 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
Injections
National vaccination programme in 2005
Age
Vaccine
<1 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
Injections
Hep B immunization policy
WHO European Region, 2004
Universal newborn
Universal infant
Universal adolescent
No universal Hep B
Immunization
11 countries receiving support from GAVI/VF
Haemophilus influenza type b immunization
WHO European Region 2004
Euro52.shp
Universal infant
Part of the country
Not introduced
No Data
Source: Joint reporting
form as of 30/09/2004
Hib3 coverage in the WHO European
Region 2003
>95
90-95
80-90
<80
No data
No immunization
Latvia
Hungary
Croatia
Russia Federation
Bulgaria
40
Poland
Greece
Germany
Malta
Czech Republic
Slovenia
Italy
Ireland
Luxemburg
France
Slovakia
Austria
Norway
Spain
Netherlands
Israel
Denmark
Switzerland
UK
Sweden
Finland
Iceland
Annual incidence of Hib meningitis in children
<5 years of age before the introduction of immunization
based on about 70 studies in countries of the WHO European Region
50
45
max
min
35
30
25
20
15
10
5
0
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 aPcontaining 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?
Vaccine programmes for
the rich vs. poor
• Rich:
DTP, IPV, MMR
+ HBV, Hib
+ Varicella, PCV
+ Influenza
• Poor:
BCG, DTP, OPV, M
+ HBV, (Hib)
• -> GAVI
13
12
11
10
Rich
Poor
9
8
7
6
5
1975
1985
1995
2004