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Transcript of Vaccines related epidemiology Programme design and policy options First EpiTrain course in Advanced...
Vaccines related epidemiologyProgramme design
and policy options
First EpiTrain course in
Advanced Epidemiology Jurmala Latvia 29.10.2004
Hanna NohynekKTL Helsinki Finland
Vaccination Policy Options
Eradication Activities New Vaccine Introduction
Outbreak vs routine control of epidemic diseases
?
Newer Vaccine Research and Development
Evolution of Immunization Programmes
Pre-vaccine IncreasingCoverage
Loss of Confidence
1 2 3
Outbreak
AdverseEvents
Resumption of Confidence Eradication
4 5
Vaccinations Stops
Disease
Vaccine Coverage
Maturity of programme
Inci
den
ce
Ref: Grabenstein JD, Hospital Pharmacy 1996
When planning vaccinating (an individual or) a
population
Vaccine efficacy
Severity of disease
Risk to contractCoverage
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 2001-Opportunity to make major revisions
arising from decision to stop national vaccineproduction (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 evaluationCarefully controlled implementation Follow up of implementation and evaluation of
effectiveness
Age
<1 weeks
3 mo
4 mo
5 mo
6 mo
12 mo
14-18 mo
20-24 mo
Vaccine
BCG
DTwP
DTwP + Hib
DTwP
Polio + Hib
Polio
MMR + Hib
DTwP + polio
Injections
National vaccination programme in 2001
Possible programmatic changes discussed
New combination vaccine to replace wP in DTwP
Reductions / omissionsBCG
Add ons hepatitis B, pertussis, influenza, pneumococcus (PPV),tick born encephalitis (regionally)
New vaccinesvaricella, pneumococcus (PCV), (meningococcus C)
Costs of the Finnish nEPIMilj. €
Vaccination programme in 2002 4,54
DTaP-Hib-IPV x 3 4,20Savings from stopping ownproduction and single doses -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 12,11Hepatitis B -vaccine x 3(part of a combo vacc) 1,51
New (maximum) 25,75
= 5 - fold difference !
Roles and responsibilities in decision making for nEPI
N ational Advisory C om m itteefor In fectious D iseases
National A dvisory C ommitteefor Vac c ination (K RAR)
Disease / Vaccine Specificw orking groups
KTL Advisory Boardon Vaccines
National Public Health Institute(KTL)
Minis try of Health
Disease / vaccine specific subgroup reports
• Pertussis• BCG• Varicella • Influenza• Pneumococcus (PPS, PCV) • Combination vaccines• Hepatitis B• TBE
VE evidence categorizedaccording to ~EBM
Cost effectiveness analyses
New decision making process adopted
= 4 steps approachFactors 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
0 10 20 30 40 50 60 70 80 90 100
NCKP (all)
FinOM (all)
FinOM (PNC)
FinOM (VT)
Soweto (HIV+)
Soweto (HIV-)
Arizona (RSV-)
NCKP
Soweto
Arizona
NCKP
%
Acute Otitis
Pneumonia (X-ray positive)
Invasive Infections
3ISPPD 2002
Invasive Pnc infections in Finland in 1995-99
0
20
40
60
80
100
<5 5-9 10-14
15-19
20-24
25-29
30-34
35-39
40-44
45-49
50-54
55-59
60-64
65-69
70-74
>750
5
10
15
20
25
30
Age, years
Cases/year
Source: National Register for Infectious Diseases
Incidence/100 000/year7PCV serotypecoverage
67,5 %
49,4%
Incidence of pneumonia strongly affected by case definition
Also has an impact on expected VE of PCV
Incidence of Acute Otitis Media
02468
101214161820
2 3 5 7 9 11 13 15 17 19 21 23
Age, months
AOM / 100 childmonth
FinOM cohort Pilot study
All AOM
AOM by Pnc
AOM is most common among children 7-12 mo of age.
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 AOM2 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
Cost category
No
7PCV
Yes
7PCV
Net cost
€Total medical 26 486 016 22 303 132 - 4 182 884Vaccination programme 0 11 929 766 11 929 766
Health care 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
Productivity 11 798 063 10 348 785 - 1 449 277
Total cost 32 625 232 45 807 980 +6 182 749
Costs € of introducing 7PCV into national program
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 conclusionExpert 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 vaccinesRight 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)
Age
<1 weeks
3 mo
4 mo
5 mo
6 mo
12 mo
14-18 mo
20-24 mo
Vaccine
BCG
DTwP
DTwP + Hib
DTwP
Polio + Hib
Polio
MMR + Hib
DTwP + polio
Injections
National vaccination programme in 2004
Age
<1 weeks
3 mo
4 mo
5 mo
6 mo
12 mo
14-18 mo
20-24 mo
Vaccine
BCG
DTaP-Polio-Hib
MMR
Injections
DTaP-Polio-Hib
DTaP-Polio-Hib
National vaccination programme in 2005
11 countries receiving support from GAVI/VF
Universal newborn
Universal infant
Universal adolescent
No universal Hep B Immunization
Hep B immunization policy WHO European Region, 2004
Haemophilus influenza type b immunizationWHO European Region 2004
Source: Joint reporting form as of 30/09/2004
Euro52.shpUniversal infantPart of the countryNot introducedNo Data
Hib3 coverage in the WHO European Region 2003
>95
90-95
80-90
<80
No data
No immunization
0
5
10
15
20
25
30
35
40
45
50
Icel
and
Fin
land
Sw
eden UK
Sw
itzer
land
Den
mar
k
Isra
el
Net
herla
nds
Spa
in
Nor
way
Aus
tria
Slo
vaki
a
Fra
nce
Luxe
mbu
rg
Irel
and
Ital
y
Slo
veni
a
Cze
ch R
epub
lic
Mal
ta
Ger
man
y
Gre
ece
Pol
and
Bul
garia
Rus
sia
Fed
erat
ion
Cro
atia
Hun
gary
Latv
ia
maxmin
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
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?How accurate is this information?
Vaccine programmes for the rich vs. poor
5
6
7
8
9
10
11
12
13
1975 1985 1995 2004
RichPoor
• Rich: DTP, IPV, MMR + HBV, Hib + Varicella, PCV
+ Influenza• Poor:
BCG, DTP, OPV, M + HBV, (Hib)
• -> GAVI