Public Health strategies
Statistics on Hepatitis
B coverage and disease incidence
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Public health strategies
Hepatitis B is a viral infection of the liver. More than
two thousand million people alive today have been infected with the hepatitis B virus.
Approximately 350 million are chronically infected and are at high risk of serious illness
and death from cirrhosis of the liver and primary liver cancer, diseases that kill 500 000
to 750 000 persons a year. Hepatitis B is preventable with a safe and effective vaccine
the first vaccine against cancer.
The prevalence of chronic hepatitis B virus (HBV)
infection is high (more than 8%) in certain areas of the world. These include all of
sub-Saharan Africa, South-East Asia, including China, Indonesia, the Democratic
People's Republic of Korea, and the Philippines; the Eastern Mediterranean except
Israel; South and Western Pacific islands; the interior Amazon Basin; and certain parts of
the Caribbean, i.e. the Dominican Republic and Haiti. The disease is moderately prevalent
(2%7%) in South Central and South-West Asia, Israel, Japan, Eastern and Southern
Europe, the Russian Federation, and most of Central and South America. In Australia, New
Zealand, Northern and Western Europe, and North America,, the prevalence of chronic
hepatitis B viral infection is low (under 2% of the general population).
If the vaccine is administered before infection, it
prevents the development of the disease and the carrier state in almost all individuals.
It has been given to more than 500 million persons and has proved one of the safest, most
immunogenic and effective vaccines. On a population basis, it is most effective when used
routinely as part of the infant immunization schedule, although it can be used in persons
of any age.
Dramatic decreases in the cost of the vaccine in
developing countries, from US$ 20 to $0.250.50 per paediatric dose, have allowed
public health officials to consider the mass use of this vaccine in infants. Additionally,
an increasing number of countries have recognized the disease burden imposed by chronic
HBV infection in terms of chronic liver disease, cirrhosis and liver cancer. These have
been important factors in promoting the integration of hepatitis B vaccine into national
childhood immunization schedules.
Universal infant immunization is now recognized as the
proper strategy for every country for the long-term control of chronic HBV infection and
its sequelae (cirrhosis and liver cancer). The vaccine first became available in the
United States in 1982 when the initial strategy was to give it as pre-exposure vaccination
to populations at high risk for HBV infection (e.g. health care workers, men who have sex
with men, and heterosexual persons with multiple partners). When the vaccine became widely
available, a similar strategy was adopted by other industrialized countries. By the
mid-1980s, several countries with very high prevalence of chronic HBV infection had begun
the routine immunization of infants at birth. In 1992, WHO recommended that hepatitis B
vaccine be integrated into national immunization programme of all countries with a rate of
chronic HBV infection of 8% or higher by 1995, and into the programme of all countries by
1997. More than 135 countries have now done so.
Hepatitis B vaccine should be included in routine
childhood immunization schedules for all children in all countries. Some industrialized
countries administer the vaccine to adolescents as their primary immunization strategy.
The priorities for hepatitis B immunization strategies in
order of importance are:
- routine infant vaccination;
- prevention of perinatal HBV transmission (from mother to
- catch-up vaccination for older age groups.
Routine infant vaccination
The routine vaccination of all infants as an
integral part of national immunization schedules should be the highest priority in all
countries. In countries of high disease endemicity hepatitis B surface antigen (HBsAg )
prevalence (8% or more), routine infant hepatitis B vaccination can rapidly reduce
transmission because most chronic infections are acquired as a result of spread either
from mother to baby or from child to child in the first year of life. In countries of
intermediate hepatitis B viral endemicity (HBsAg prevalence 2%7%) and low endemicity
(HBsAg prevalence below 2%), routine infant hepatitis B vaccination is also the highest
priority. This is because a high proportion of chronic infections are acquired during
childhood in these countries, and most infections acquired during childhood occur among
children born to mothers who are NOT infected with hepatitis B virus. These infections
would not be prevented by perinatal hepatitis B prevention services that screen pregnant
women for HBsAg and provide post-exposure immunization for infants of HBsAg-positive
Hepatitis B vaccine schedules are very flexible. There
are various options for adding the vaccine to established national immunization schedules
without requiring additional visits for vaccination (table 1).
Options for adding hepatitis B vaccine to childhood
Antigens given at same visit
No birth dose
With birth dose
OPV1, DTP1, Hib1
OPV2, DTP2, Hib2
OPV3, DTP3, Hib3
* Only given in countries of high disease
(m) = monovalent vaccine (m/c) = monovalent or
combination vaccine (c) = combination vaccine
Programmatically, it is usually easiest if the three
doses of hepatitis B vaccine are given at the same time as the three doses of DTP (table
6, option I). This schedule prevents infections acquired during early childhood, which
account for most of the disease burden related to hepatitis B virus in countries of high
disease endemicity, and also prevents infections acquired later in life. However, this
schedule does not prevent perinatal hepatitis B virus infections because it does not
include a dose of hepatitis B vaccine at birth.
Other schedule options can be used to prevent perinatal
hepatitis B virus infections: a three-dose schedule of monovalent hepatitis B vaccine, the
first dose given at birth and the first and third doses given at the same time as the
first and third doses of DTP vaccine (option 2); or a four-dose schedule in which a birth
dose of monovalent hepatitis B vaccine is followed by three doses of a combination vaccine
(e.g. DTP-HepB) (option 3).
- The three-dose schedule (option 2) is less expensive but
is more complicated to administer because infants receive different vaccines at the second
EPI visit than at the first and third visits. In addition, it may be difficult to achieve
a high level of completion of the three-dose vaccine series with this schedule in
countries where a high percentage of children are not born in hospitals.
- The four-dose schedule (option 3) is easier to administer
programmatically but is more costly.
Prevention of perinatal hepatitis B virus transmission
In order to prevent hepatitis B virus transmission from
mother to baby the first dose of hepatitis B vaccine needs to be given as soon as possible
after birth, preferably within 24 hours. In countries where deliveries take place
predominantly in health facilities the most feasible strategy for preventing transmission
from mother to baby is to give a dose of hepatitis B vaccine to all infants at birth. An
alternative strategy is to screen all pregnant women for HBsAg and provide immunization,
beginning at birth, to infants of infected mothers. However, extensive resources are
required for screening pregnant women and tracking infants of infected mothers. Moreover,
few countries have implemented services that have identified all the expected infants of
infected mothers and tracked these infants so as to assure completion of the hepatitis B
The priority for the incorporation of strategies aimed at
the prevention of perinatal transmission of hepatitis B virus in a particular country
should take into account the relative contribution of such transmission to the overall
hepatitis B disease burden and the feasibility of delivering the first dose of hepatitis B
vaccine at birth. In general it is most feasible to deliver hepatitis B vaccine at birth
to infants who are born in health facilities. In addition,
the availability of monovalent hepatitis B vaccine in prefilled single-dose injection
devices (e.g. Uniject‘ ) can facilitate the administration of hepatitis B vaccine by
birth attendants to infants delivered at home.
When considering whether a birth dose should be given the
following principles should be taken into account.
Achieving a high level of completion
of the vaccine series among all infants should be the highest priority and has the
greatest overall impact on the prevalence of chronic hepatitis B virus infections in
children, regardless of whether it is feasible to administer a birth dose.
- Countries where a high proportion of chronic HBV
infections are acquired perinatally (e.g. in South-East Asia)
A birth dose should be given to
infants who are delivered in hospitals when hepatitis B vaccine is introduced. Efforts
should also be made to give hepatitis B vaccine as soon as possible after birth to infants
delivered at home.
- Countries where a lower proportion of chronic infections
is acquired perinatally (e.g. in Africa)
The administration of a birth dose
may be considered after evaluating the relative contribution of perinatal hepatitis B
virus infections to the overall disease burden, and the feasibility and cost-effectiveness
of providing such a dose.
Catch-up vaccination for older age groups
When hepatitis B vaccine is incorporated into routine
childhood vaccination schedules, over several years the child population will gradually
become protected against HBV infection, and the prevalence of chronic HBV infection will
decline. The need for catch-up vaccination for older age groups such as adolescents and
adults is determined by the baseline epidemiology of HBV infection in the country, the
priority given to rapidly reducing the incidence of the disease and considerations of
cost-effectiveness. In all countries, health-care workers who are exposed to blood in
their work are likely to be at high risk for HBV infection and should be considered for
In countries of high endemicity (HBsAg prevalence 8% or
more) the routine vaccination of infants rapidly reduces the transmission of HBV. In this
circumstance, catch-up vaccination of older children is not usually warranted. Catch-up
vaccination for older age groups has relatively little impact, since most adults have
already been infected.
In countries of intermediate endemicity (HBsAg prevalence
2%7%) and low endemicity (HBsAg prevalence under 2%) there may be a substantial
disease burden attributable to chronic infections acquired by older children, adolescents
and adults. Catch-up strategies targeted on these older age groups, in addition to routine
infant vaccination, may be considered. Possible target groups for catch-up vaccination
include cohorts such as adolescents and persons with risk factors for acquiring hepatitis
B viral infection.
Booster doses: These are not
recommended. Studies have shown that infants, children and adults who have responded to a
three-dose hepatitis B immunization series are protected from hepatitis B for at least 15
years even if they lose detectable antibodies over time. Long-term protection relies on
the immunological memory, which allows a protective anamnestic antibody response after
exposure to HBV.
Public concern: Although concerns have been
expressed over the past 20 years that certain chronic illnesses might be caused by
hepatitis B vaccine, no evidence exists that any of these diseases are caused by the
vaccine. For example, in the mid-1990s, concern was expressed that the vaccine might cause
multiple sclerosis. However, studies do not support this, and a report in 2002 by the
United States Institute of Medicine found no evidence of a causal relationship between
hepatitis B vaccination in adults and multiple sclerosis.
Number of doses
|Recombinant DNA or
Three doses given by the
intramuscular route into upper thigh of infant and deltoid muscle of adult
Several options (see above)
Anaphylactic reaction to a previous dose
Local soreness and redness, rarely anaphylactic reaction
Birth dose must be given if there is a risk of perinatal
Andre FE, Zuckerman AJ. Review: protective efficacy of
hepatitis B vaccine in neonates. Journal of Medical Virology, 1994, 44:14451.
Centers for Disease Control and Prevention. Hepatitis B
virus: a comprehensive strategy for eliminating transmission in the United States through
universal childhood vaccination: recommendations of the Immunization Practices Advisory
Committee (ACIP). Morbidity and Mortality Weekly Report, 1991, 40(No.
Centers for Disease Control and Prevention. Achievements
in Public Health: Hepatitis B vaccination, United States, 1982-2002. Morbidity and
Mortality Weekly Report, 2002, 51(25): 549552.
Chang MH, Cen CJ, Lai MS, et al. Universal hepatitis B
vaccination in Taiwan and the incidence of hepatocellular carcinoma in children. New
England Journal of Medicine, 1997, 336:18551859.
European Consensus Group on Hepatitis B Immunity. Are
booster immunisations needed for lifelong hepatitis B immunity? Lancet, 2000,
Harpaz R, McMahon BJ, Margolis HS, et al. Elimination of
chronic hepatitis B virus infections: results of the Alaska immunization program. Journal
of Infectious Diseases, 2000, 181:413418.
Hepatitis B immunization. Introducing hepatitis B into
national immunization services.
(Fact sheet.) Geneva, 2001 (unpublished document WHO/V&B/01.28; available from
Vaccines and Biologicals, World Health Organization, 1211 Geneva 27, Switzerland and on
the Internet at www.who.int/vaccines-documents/DocsPDF01/www598.pdf).
Institute of Medicine Immunization Safety Review
Committee. In: Straton K, Almario D, McCormack MC, eds. Hepatitis B vaccine and
demyelinating disorders, 2002. Washington DC: National Academy Press, 2002.
Other relevant sites and
bank; Useful facts, figures and safety of commonly used vaccines
available on the internet
National Centre for
Infectious Diseases; Home page for Viral Hepatitis
Fact Sheet on Hepatitis B
Viral Hepatitis Prevention
Board; Home page
and Health; Vaccination Requirements and Health Advice
Updated February 2003
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