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me›=
3;
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Steven Wiersma
Training in Reproductive Health Research
Geneva 2006
Geneva 2006
Introducing Hepatitis B Vaccine into=
National Immuniza=
tion
Programmes
New Vaccine Introduction
=
•Assess disease burden
=
•Assess effectiveness of intervention
=
•Address programmatic issues
=
•Assure sustainable vaccine supply
=
•
Hepatitis B Virus Infection
Global Disease Burden
Global Disease Burden
•2,000 million have markers of current or past infection
•350 million have chronic infection
–15%-25% will die from chronic liver <=
/span>disease (liver cancer and cirrhosis)&=
#13;
–at least 1 million deaths per year
–
Geographic
Distribution of Chronic HBV Infection
HBsAg Prevalence
8% - High
2-7% - Intermediate
<2% - Low
Chronic HBV infection
Study
Year
No.=
Tested
Age
(yrs)
Vaccine
Coverage
Before
Program
After
Program
Alaska
1995
268
1-10
96%
16%
0%
Taiwan
1994
424
7-10
73%
10%
1.1%
Samoa
1996
435
7-8
87%
7%
0.5%
Lombok
1994
2519
4
> 9=
0%
6.2%
1.9%
Saipan
1994
200
3-4
94%
9%
0.5%
Ponape
1994
364
3-4
82%
NA
1.0%
Micronesia
1992
544
2
40%
12%
3.0%
Effect of
Routine Infant Immunization on the
Prevalence of Chronic HBV Infection
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Prevalence of Chronic HBV Infection
Start o=
f HepB
vaccination
1975
1978
1981
1984
1987
1990
1993
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
Year
![3D"Text](3D"slide0160_image002.png")
=
Incidence per 100,000
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////pdmf3QAAAAF0Uk5TAEDm2GYAAAAJcEhZcwAAB00AAAdNAdycFlUAAAAZdEVYdFNvZnR3YXJl
AE1pY3Jvc29mdCBPZmZpY2V/7TVxAAAAo0lEQVQ4y2NgGEzgDwMD838GBnbmBgY2RgRmBvJB4iB5
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Liver
Cancer Death Rates among
0-9 Year Old Children, 1974-1993,Taiwan
0-9 Year Old Children, 1974-1993,Taiwan
45th World Health Assembly, 1992
•By
1995 HepB vaccine introduced in countries with HBsAg prevalence ł8%
•By
1997 in all countries
GAVI, 2000
•By
2002 HepB introduced in 80% of countries =
w/adequate vaccine delivery =
•By
2007 in all countries
Hepatitis B Vaccination Targets
No HepB in schedule (34 countries or 18%)
The boundaries and names shown a=
nd
the designations used on this map do not imply the expression of any opinion whatsoever on the pa=
rt
of the World Health Organization concerning the legal status of any country, territory, city or area=
or
of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approxi=
mate
border lines for which there may not yet be full agreement.
ă WHO 2005. All rights reserved
Source: WHO/IVB database, 2005
192 WHO Member States. Data as of September 2005
Date of slide: 15 September 2005
HepB in schedule* (158 countries or 82%)
*
includes partial and among adolescents
Slide Date: September 05
Countries where HepB=
not
introduced in national immunization schedul=
e ,
2004
Number of countries introduced HepB vaccine
a= nd global infant HepB3 coverage, 1989-2004
a= nd global infant HepB3 coverage, 1989-2004
Slide Date: September 05
excluding 5 countries where HepB administered for adolescence
and WHO/UNICEF coverage estimates
Programmatic Iss=
ues
•Schedule/Administration
•Formulations
•Cold chain
•Injection equipment/safety
•Vaccine wastage
•Revision of EPI forms and materials=
3;
•Training
•IEC needs
•Evaluation of programme impact
Hepatitis B Immunization Programs
Objective
Objective
Prevent=
chronic
HBV infections
•prevent chronic liver disease
•reduce the reservoir for transmission of new infections
Age of Acquisition of Chronic HBV <=
span
style=3D'position:absolute;top:16.57%;left:2.05%;width:96.06%;height:9.55%=
'>Infections in High Endemic Cou=
ntries
Perinatal
10-30
Young children
65-85
Adolescents/Adults
<5
%
of Chronic Infections
Age
of Acquisition
Priority of Perinatal Hepatitis B Prevention
Issues to Conside= r
Issues to Conside= r
<=
span
style=3D'font-size:88%;display:none'>
•1. Relative contribution of perinatal transmission
to overall hepatitis B disease burden
•% of HBsAg-positive pg women who are HBeAg-positive
•Rate of transmission: HBeAg-positive ~85%
<=
/div>
– <=
/span>HBeAg-negative ~10%
•2. Feasibility of delivering the first dose at birth
•Most feasible in hospitals
Priorit=
y of
Perinatal Hepatitis B Prevention
•High
proportion of chronic infections acquired perinatally (e.g., SE Asia)
•A birth dose should be given when feasible (e.g., in birthing hospitals)
•Efforts should be made to administer HepB vaccine to infants who deliver at home
•Low proportion of chronic infections acquired perinatally (e.g., Africa)
•A birth dose may be considered after evaluating disease burden, cost-effectiveness, and
feasibility
•
•
Age
Visi=
t
Other
Antigens
HepB
Options
9-12
months
4
Measles
III*<=
/b>
I
Birth
0
BCG
OPV0
HepB
10
weeks
2
OPV2
DTP2
HepB/Combination
HepB
6
weeks
1
OPV1
DTP1
HepB/Combination
14
weeks
3
OPV3
DTP3
HepB
HepB/Combination
*schedule to prevent perinatal HBV infection=
II*
Combination
Combination
Combination
HepB
Options for Adding Hepatitis B Vaccine to =
=
Existing EPI Schedules
HepB/Hib
Vaccine Administration
•IM injection:
=
–=
anterolateral thigh (infants)
=
–=
deltoid (older children)
•Can be safely given at the same time =
as other
vacc=
ines:
<=
span
style=3D'mso-special-format:bullet;position:absolute;left:-2.98%'>–=
DTP, OPV, Hib/HepB, BCG, measles, yello=
w fever
•Injection equipment same as for DTP/H=
ib:
=
–=
1.0 or 2.0 mL syringe
=
–=
25 mm, 22 or 23 gauge needle
Available HepB Products
•Monovalent HepB (1, 2, 6, or 10 dose vials)
–Recombinant
–Plasma-derived
(discontinued in 2003)
•Monovalent HepB in Uniject
•Hep B and DTP combo-pack (2 and 10 dose vials)
<=
/span>
•DTP-Hep B (10 dose vials)
•DTP-Hep B + lyophilized Hib (2 dose vials)
Formulation Choices –
Issues to Consider
Issues to Consider
<=
span
style=3D'font-size:94%;color:white'>•Monovalent vs. combination vaccines=
3;
<=
span
style=3D'font-size:94%;color:white'>•Liquid vs. lyophilized vaccines (Hib)&=
#13;
<=
span
style=3D'font-size:94%;color:white'>•Recombinant vs. plasma-derived vaccines
(HepB)
•Cost
•Available cold chain storage capacity&=
#13;
•Single vs. multi-dose vials
•Limited supplies of some desirable
products
•
Hepatitis B Va=
ccine
Formulations
•Monovalent
=
–=
can be used for any dose in the HepB
schedule
=
–=
must be used for vaccination at birth&#=
13;
•Combination (DTP-HepB, DTP-Hib-HepB,
Hib-HepB)
=
–=
can be used any time all antigens are i=
ndicated
–=
cannot be used before 6 weeks of age (b=
ecause of reduced DTP/Hib immunogenicity)
• <=
/span>Recombinant
–Prepared from HBsAg synthesized by yeast or mamm=
alian
cells
•Plasma-derived
–Prepared from HBsAg obtained from plasma
of persons with chronic HBV infection
•Both have excellent safety and efficacy
<=
/div>
•Until recently, plasma-derived was cheaper
•Plasma-derived discontinued in 2003
Types of Hepatitis B Vaccine
Issue=
Monovalent Combination
Costs ++ Vaccine +++ Vaccine
++ Program + Program
Injections 1 additional No additional
++ Program + Program
Injections 1 additional No additional
Flexibi=
lity Increased Less (no monovalent)
Vaccine
security Problem Problem not likely
Cold ch=
ain Increased Modest increase
Training=
More demand Less demand
Local DTP
production Not a problem Could displace
Monova=
lent
versus Combination Vaccines: Issues
UNIC=
EF
Hepatitis B Vaccine Prices, 2001
0.64-1.31
1
R
HepB (incl. syringe)
R
R
R
PD
R
Type*
0.35
10
HepB
2
10
10
6-20
Doses
0.26-0.54
HepB
0.48
DTP+HepB (combo-pack)
1.10
DTP-HepB
3.50
DTP-HepB+Hib
Price, US$
Vaccine
*R =3D recombinant; PD =3D plasma-derived
Cold Chain Issue=
s
•Introducti=
on of
HepB/Hib vaccines will require assessm=
ents
at all administrative levels:
=
•to assure adequate cold chain storage
capacity
•to assure policies and procedures are i=
n place to prevent freezing vaccine
HepB
Vaccine Storage Volumes (cm3/dose) *
---
---
---
24.6
HepB
(Uniject)
---
---
9.7
---
=
DTP-HepB+Hib
3.0
---
---
---
=
DTP-HepB
(combined)
8.2
---
---
---
=
HepB
+ DTP
=
(combo-pack)
3.=
0
=
;
3.=
2
=
;
4.=
8
=
;
9.7
=
HepB
monovalent
10 dose
vials
6 dose
vials
2 dose
vials
1 dose
vials
=
Vaccine
*vial plus packet containing vial plus ot=
her
packaging <=
span
style=3D'mso-special-format:lastCR;display:none'>
Single-Dose vs. Multi-Dose Vials
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•Si=
ngle
dose vials
•less
wastage
•higher
cost/dose
•more
storage volume
•Mu=
lti
dose vials
•more
wastage
•lower
cost/dose
•less
storage volume
‹header›
‹date/time›
‹footer›
‹#›
Click to edit Master text styles
Second level
Third level
Fourth level
Fifth level
Geographic Distribution of Chronic HBV Infection
<=
/div>
The world can be divided into areas of high, intermediate, and low endemic=
ity
based on the prevalence of HBsAg in the population. Areas of high endemicity are those in =
which
the prevalence of HBsAg >8%.
Southeast Asia, East Asia, many of the Pacific Islands, and parts of
South America and Africa are areas of high endemicity. Areas of intermediate endemicity are t=
hose
in which the prevalence of HBsAg is 2%-7%, and include Eastern Europe, the=
Middle
East, and central Asia. Areas of =
low
endemicity, in which <2% of the population is HBsAg positive, include
Australia, North America, and Western Europe.
Routine infant hepatitis B vaccin=
ation is
the primary essential element of hepatitis B prevention strategies in all
countries.
In 1992, the 45th World Health Assembly established global hepatitis B
vaccination targets
Note:
3 countries introduced HepB prior to 2000, counted=
under
1999
2 countries introduced HepB between 2000-2003 coun=
ted
under 2003
Countries introduced partially counted under year parti=
al
introduction started
Sweden introduced partially, year unknown, counted=
under
2004,
T=
he most
important factor in determining the =
critical
ages for vaccination to interrupt HBV transmission
is the proportion of chronic infecti=
ons
that are acquired in each age group.
In
countries with a high endemicty of infection, virtually all chronic infections are acquired either perinatally or from transmission among young childre -- so vaccination programs in these countries should pimarily target these age groups=
for vaccination.
Preventing perinatal and=
early
childhood transmission is also impor=
tant
in low-endemic countriesbecause abou=
t 1/3
of chronic infections are acquired in
these age groups.
In addition , vaccination programs targeted to adolescents and adults at high risk of infection =
are needed in these countries, because the majority o=
f chronic infections are acquired among adolescents=
and adults.
=
HepB vaccine schedules very flexible
multiple options for adding the vaccine to existing schedules w/o addition=
al
visits
Programmatically easiest to give HepB at same time as DTP (opti=
on1)
Schedule
will prevent early childhood infections, which account for most of the HepB
disease burden in high endemic countries, and will also prevent infections
acquired later in life
However, option 1 will not prevent perinatal HBV
infections because it does not include a birth dose
2 options to prevent perinatal transmission:
3 dose schedule of monovalent vaccine and
4 dose schedule in which birth dose of monovalent vaccine is followed by 3
doses of combination vaccine
3 dose is less expensive but more complic=
ated
to administer because different vaccines given at 2nd than at 1st and 3rd =
EPI visits.
4
dose schedule is easier to administer programmatically, but is more costly.
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