Download - Introduction of New vaccines
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Introduction of New vaccines
Hib as an ExampleSt. Petersburg25-27 Jun 2001
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Vaccines use in the world• For the past two decades, in most developing
countries, vaccination restricted only to the initial EPI vaccines
• Where-as in most developed countries, several new vaccines such as HepB, Hib, meningococcal, pneumococcal, were gradually added to the initial EPI vaccines,
• Thus widening the gap in protection against infectious diseases between the rich and the poor
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Number of Childhood Vaccines Routinely Used in Developing and Established Market Countries
56789
10111213
1975 1980 1985 1990 1995 2000
Established Market
Developing CountriesVaricella
Acell pertussisPneumococcal *meningoccoal C*
MeaslesDPTPoliomyelitisBCG
Hepatitis B**
MeaslesMumpsRubellaDPTPoliomyelitis
Haemophilus InfluenzaeHepatitis B
*Estimated future use **Used in ~ 50% of global birth cohort
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Estimated rate (children<5) > 200/100,000100-200/100,00045-100/100,000< 45/100,000
Hib meningitis and pneumonia burden
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Countries using Hib vaccine in their national immunization system, 2000
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Why this difference?• Failure to demonstrate efficacy in
developing country settings early in the course of vaccine development;
• Lack of disease burden data, or awareness of disease burden in developing countries
• Failure to account for production for the developing world
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Why this difference?
• Relatively higher prices of new vaccines; and
• Lack of technical advice and guidance on introduction of new vaccines
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Proportion of Countries introducing Hep B and Hib, by per capita GNP
>$6000 $1000-$6000 <$1000
0
20
40
60
80
%HibHep B
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Causes of death in children less than 5 years old
ARIDiarrheaVPDPerinatalOther
19%
20%
20%
13% The Global Burden of DiseaseMurray and Lopez, editorsTotal - 12.8 million
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Bacterial Meningitis
• Haemophilus influenzae type b (Hib)– 30% -50% of bacterial meningitis
• Pneumococcus– 25- 35% of bacterial meningitis
• Meningococcus – 25 - 35% of bacterial meningitis (except
during epidemics)
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Pneumonia
• Haemophilus influenzae type b (Hib)– 20-25% of all severe bacterial pneumonia– Gambia, Chile, other studies pending
• Pneumococcus– ? 50-60% of severe bacterial pneumonia– South Africa, Gambia, Philippines, etc
• Others (RSV, adenovirus, etc)
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Hib in the world
• Global burden of disease– Most common cause of bacterial meningitis in
children – Second most common cause of serious
bacterial pneumonia in children less than five years of age
– Total - estimated 400,000-500,000 deaths/year in children less than five
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Hib vaccines: Safety and Effectiveness
• Hib vaccines are safe and easily administered within existing regimens
• Hib vaccines have high efficacy against:– Meningitis– Pneumonia– Bloodstream infections– Carriage
• Hib vaccines have prevented disease in unimmunized persons (‘herd immunity’)
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Hib vaccine efficacy studies: Protection against invasive
disease
0%10%20%30%40%50%60%70%80%90%
100%
Gambia Chile USA USA UnitedKingdom
• Hib vaccines have proven their effectiveness in careful studies in Africa, South America, No. America and Europe
• Hib vaccines provide 90-100% protection against invasive Hib disease
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Hib Conjugate vaccines
• Eliminate bacterial meningitis as a public health problem
• Reduce largest single remaining cause of infant mortality (pneumonia) by over 80%
• Safe, immunogenic and highly effective• Widely used in industrialized countries
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Hib vaccine efficacy in the Gambia: Protection against pneumonia and invasive
disease
0
10
20
30
40
50
60
Cases
prevented
Invasive Disease X-ray pneumonia
HIB cases prevented
95% efficacy
21% efficacy
Source: Mulholland et al. Lancet 1996
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Impact of Hib vaccineon Hib meningitis in Uruguay
0
10
20
30
40
50
60
1991 1992 1993 1994 1995 1996
Year
No. Cases
Source: PAHO
Routine Hib vaccination started - with ‘catch up’
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Other conjugate vaccines already in use
• Meningococcus– routine infant immunization in UK, Spain,
Ireland• Pneumococcus
– routine infant immunization in USA
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WHO European Region
Mean annual incidence of Hib meningitis per 100 000 in children <5 years of age
3028 27 27
2220 19
1715
13 12 119 8 8 8 8 7 7 6 6
1 1
14
0
10
20
30
40
50
60
70
Sweden
Switzerl
and
Denmark
Finlan
d
Netherl
ands
UK
Israe
l
Slovak
ia
France
Austria
Repub
lic of
Irelan
d
Sloven
iaMalt
a
German
ySpa
inIta
ly
Greece
Russia
n Fed
eratio
n
Czech
Rep
ublic
Poland
Bulgari
a
Hunga
ryLa
tvia
Region
al mea
n
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The situation in CEE, NIS•From available data, Hib does not appear to be a major public health problem•This could be real or fictitious•If fictitious, the reasons could be
–problem in the collection of csf–lack of lumbar puncture for suspected cases–problem with laboratory technique
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Where do we go?
• Surveillance for Hib disease• Further studies• Hib immunisation needs for special
situations- day care centres, special paediatric units
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The available tools
• Generic protocol for Pop based Hib studies• HibRAT for quick assessment of the Hib
burden based on retrospective analysis of laboratory data
• Management guidelines for those countries that are already using the vaccine