|  What is Hepatitis B ?
Hepatitis B is a type of the Hepatitis that is swelling of
the liver. This is caused by the Hepatitis B virus. The virus can be found in the blood and
body fluids of an infected person. The
virus attacks the liver, and over many years can eventually cause severe
illness or death. 
Are there other types of hepatitis?
Yes, in addition to Hepatitis B, there is Hepatitis A,
Hepatitis C and Hepatitis E.
No vaccine is available for protection against Hepatitis C
and E.
Is there a cure?
Acute jaundice due to Hepatitis B is a self-limiting
illness. There is no known cure for
chronic Hepatitis B infection. The
drugs like Phyllanthus amarus,
Lamivudine and Alpha interferon are being evaluated by Indian
scientists.
The trials with interferon & the antiviral Lamivudine indicate that not only is the duration of
therapy long (about 2 years) but it costs about Rs.175,000
to 200,000 per patient. Even with this regimen the efficacy of therapy is
about 20-40%.
How big a health problem is Hepatitis B in India?
Hepatitis B is a major health problem in India. Based on the prevalence of
Hepatitis B carrier state in the general population, countries are classified
as having high (8% or more), intermediate (2-7%), or low (less than 2%) HBV endemicity. India
has intermediate endemicity of Hepatitis B, with
Hepatitis B surface antigen (HBsAg) prevalence
between 2% and 10% among populations studied.
The prevalence does not vary significantly by region in the country.
The number of HBsAg carriers in India has been estimated to be
over 40 million (4 crore).
What is The World Scenario of Hepatitis B
Prevalence:
Hepatitis B is a major public health problem
worldwide. Approximately 30 percent of
the world’s population, i.e. about 2 billion persons, have
serologic evidence of current or past HBV infection. Of these, an estimated 350 million have
chronic HBV infection and at least one million persons die annually from
HBV-related chronic liver disease, including cirrhosis and liver cancer.
Hepatitis B vaccine is safe and is highly effective in
preventing HBV infection and its serious consequences. Protection afforded by
this vaccine is long lasting. Numerous studies have shown that adding
Hepatitis B vaccine into the Expanded Program of Immunization is highly
cost-effective, even in areas with low HBV endemicity. In 1991, the Global Advisory Group of the
Expanded Program on Immunization of WHO recommended that Hepatitis B vaccine
should be introduced into national immunization programs in all countries by
the year 1997. The World Health
Assembly approved this in 1992. More
than 100 countries have already included this vaccine in their national
immunization programs. In countries that have implemented universal childhood
Hepatitis B immunization, HBV carrier rates have declined markedly and
incidence rates of long-term consequences like liver cancer have shown a
decrease.
What are the symptoms of Hepatitis B?
Infection with HBV can cause both short-term (acute)
disease and long-term (chronic) disease.
Acute HBV: When symptoms occur, they include loss of
appetite, weakness, nausea, vomiting, abdominal pain, jaundice (yellow skin
or eyes), dark urine, skin rashes and joint pain. The incubation period is
usually 3 to 4 months. The case-fatality rate is about 1 to 2 percent.
Chronic HBV infection: Persons with chronic HBV infection
often do not feel sick for decades after infection, but between 15 and 25
percent will die of liver cancer or cirrhosis—scarring of the liver
(Margolis, et al, 1995). Chronic carriers of HBV are also capable of
spreading the disease to others.
Is Hepatitis B a killer disease?
Hepatitis B is one of the major diseases of mankind and is
a serious global public health problem. Of the 2 billion people who have been
infected with the Hepatitis B virus (HBV) in the world, more than 350 million
have chronic (lifelong) infections. These chronically infected persons are at
high risk of death from cirrhosis of the liver and liver cancer, diseases
that kill about one million persons each year.
In India
of the 25 million infants born every year, over one million run the lifetime
risk of developing chronic HBV infection.
Estimates indicate that annually over 100,000 Indians die
due to illness related with HBV infection.
HBV infection and its long-term consequences can be
prevented with the use of a safe vaccine. World Health Organization (WHO)
recommends that Hepatitis B vaccine should be given to all infants.
How is Hepatitis B spread?
Hepatitis B virus is spread by mucous membrane contact
with blood or other infectious body fluids such as saliva, semen, and vaginal
fluid. Hepatitis B virus is not spread by air, food, or water.
Transmission from an infected mother to her baby usually
happens at the time the baby is born.
Who is at risk of getting Hepatitis B?
Anyone who has not been vaccinated can get HBV. Small
children and adolescents are particularly vulnerable. Children contract the
disease from their mother at birth, or simply from another child while
playing. Though children rarely develop acute illness after infection,
children run the highest risk of developing chronic Hepatitis B, which may
cause liver complications later in life.
Can we afford the cost of including the
Hepatitis B vaccination in Universal Immunization Program in India ?
Several cost-effectiveness analyses of inclusion of
Hepatitis B vaccine in India’s
national immunization program have been performed. These indicate that universal childhood
Hepatitis B immunization in India
will be highly cost-effective. It is thus desirable that the vaccine be
included in India’s
national immunization program at an early date.
How effective is the vaccine?
The Hepatitis B vaccine is 95 percent effective and can be
given safely to infants, children and adults. The vaccine can prevent
infection even when it is applied before or within 7 days after exposure to
infection.
How safe is the vaccine?
Hepatitis B vaccine is very safe. Mild transient side
effects that may occur after vaccination include:
 Soreness at the injection site (3 to 9
percent)
Fatigue, headache, and irritability (8 to 18
percent)
Fever higher than 37.7 °C (0.4 to 8 percent)
These transient signs/symptoms usually start within 1 day
after the vaccine is given and last from 1 to 3 days. When given at the same time as DTP vaccine,
the rate of fever and/or irritability is no higher than when DTP vaccine is
given alone.
Serious allergic reactions to the vaccine (hives,
difficulty in breathing, shock) are rare.
Are there any contraindications to the
Hepatitis B vaccine?
There are only two reasons to withhold or postpone
administration of Hepatitis B vaccine. These are:
Severe allergic reaction to a previous dose of
Hepatitis B vaccine. A child with a history of a severe allergic reaction
(e.g. generalized urticaria, difficulty breathing,
swelling of the mouth and throat, hypotension, shock) to a prior dose of
Hepatitis B vaccine should not receive another dose.
Severe allergic reaction to baker’s yeast (the
kind used in making bread). Children with a history of a severe allergic
reaction to baker’s yeast should not receive formulations of Hepatitis B
vaccine prepared in yeast cells. These children may safely receive
plasma-derived vaccine.
How is the vaccine presented?
The government has procured a plasma-derived recombinant vaccine
through UNICEF from a WHO-qualified producer. It is a cloudy liquid that
comes in a ten-dose vial and does not require reconstitution. If HB vaccine
is allowed to stand for a long time, it separates from the liquid and looks
like fine sand at the bottom of the vial. The vaccine must be mixed by
shaking.
How is the vaccine stored?
The storage temperature for Hepatitis B vaccine is the
same as for DPT vaccine, between 2°C and 8°C. The vaccine is stable for at
least 4 years from the date of manufacture if it is stored at this
temperature. Hepatitis B vaccine should never be frozen. Freezing the vaccine
causes it to lose its potency.
What is the dosage and administration of
the vaccine?
The standard pediatric dose of Hepatitis B vaccine is
0.5ml. Hepatitis B vaccine is administered by intra muscular injection in the
antero lateral aspect of the thigh (infants) or the
deltoid muscle (adults). It can safely be given at the same time when other
vaccines such as DPT and Polio are given. When Hepatitis B vaccine is
administered on the same day as another vaccine, the vaccines should be given
in opposite limbs.
Are there any existing proofs that
Hepatitis B vaccination of larger population groups will help to reduce the
incidence of infection & liver cancer in India ?
Studies have shown that the Hepatitis B vaccine can
significantly lower the carrier prevalence in a country. In China, the vaccine has lowered
the percentage of chronic carriers among children from 14 percent to less
than 2 percent. Routine use of the vaccine can change the endemicity
from “high” to “low” (e.g. China,
Gambia, Indonesia, Thailand,
Alaska).
In countries with low endemicity, we can expect
routine immunization with Hepatitis B vaccine to essentially eliminate
Hepatitis B Virus infection. A reduction in incidence of liver cancer in
immunized children has also been demonstrated in Taiwan.
Is Birth Dose of Hepatitis B Vaccine
included under UIP
?
Hepatitis B e Antigen (HbeAg)
prevalence among pregnant women, who are HBsAg
positive ranges between 8% and 47%, with most studies showing rates of 18% or
less. Therefore, perinatal
transmission is unlikely to be a major route of acquisition of HBV infection
in India.
Further, only about 25% of all births in India take place in
hospitals. Therefore, a birth dose of
Hepatitis B vaccine is not being incorporated in the UIP schedule. Feasibility of providing a birth dose to
neonates of women who deliver in hospital may be considered at a future
date.
What is the plan of Govt. of India regarding introduction of Hepatitis B
Vaccination in the country?
Hepatitis B vaccination is being introduced in the first
phase in selected 15 cities & 32 districts in the country. The main
consideration for selecting these locations is coverage of more than
80percent eligible children through routine immunization based on coverage
evaluation surveys.
According to the strategy decided by Govt. of India the
children below the age of one year in only the slums of the above stated
selected cities & all the infants in selected districts will be offered
free Hepatitis B vaccination.
Then depending on the experience of above pilot the
Hepatitis B vaccination can be expanded gradually to cover infants in the
whole country.
What are the names of 15 cities going to be
covered & how many infants are planned to be covered in the initial
phase?
In year 2002-03 seven lac &
twenty seven thousand (727,806) infants will be covered in 15 cities across
11 states of the country. The names of these cities include Greater Mumbai, Kolkatta, Chennai, Delhi, Hyderabad, Bangalore, Kanpur, Ahmedabad,
Pune, Lucknow,
Vadodra, Jaipur, Indore, Patna and Bhopal. In year 2003-04, 32 districts will
be added covering additional eleven lac & sixty
four thousand (1,164,240) infants.
Is Hepatitis B vaccination going to be
another vertical programme ?
It is emphasized that introduction of Hepatitis B vaccine
is not a separate vertical program. It is to be integrated in the existing
routine/ universal immunization.
One of the main consideration of selecting specific cities
& districts for introducing this new vaccine is achievement of Immunization
coverage of 80% or more under routine immunization of infants with the
existing vaccines on the basis of coverage evaluation surveys. This strategy
may be helpful to encourage more cities & districts to improve their
routine immunization coverage as the program is expanded.
The additional inputs being provided in cities/ districts
selected for introduction of this new vaccine in the form of AD syringes,
renewed emphasis on maintenance of cold chain, safe injection practices &
safe disposal of AD syringes & needles are the opportunities to improve
our system of universal immunization as a whole & not related only with
introduction of Hepatitis B vaccine.
The safe disposal of AD syringes & proper maintenance
of cold chain for example is not only going to help proper introduction of
Hepatitis B vaccine but it is going to attract attention to the bigger issues
of Hospital waste management & proper maintenance of cold chain for
ensuring potency of all the vaccines.
How the issues about Injection Safety will
be addressed with one more injectable
vaccine being added in the U.I.P.?
Currently, reusable glass syringes and needles and
sterilization equipment like autoclaves/double rack steam sterilizers are
used throughout India.
There is evidence that in some areas the quality and safety of injection
techniques and sterilization is uncertain.
The Government desires to improve injection safety and is planning to
conduct a comprehensive injection safety assessment and use the findings to
outline a national policy on the injection safety. However, UIP is moving from using re-sterilizable syringes and needles to auto-disable (AD)
syringes in accordance with the WHO-UNICEF-UNFPA policy statement on
injection safety. It is planned that in all the 15 cities and 32 districts
included under initial launching of Hepatitis B vaccination, AD syringes will
be used for all routine immunization of infants, including Hepatitis B vaccines.
How AD Syringes are different from other
syringes?
The full form of AD syringes is Auto Destruct Syringes.
These syringes get locked after using them once, thus preventing the
possibility of reuse.
Will AD syringes create a waste problem?
The use of AD syringes should not significantly impact the
already large medical waste volume in India. Immunization sharps
account for only 5 to 6 percent of medical waste produced in the country.
However, all health programs must responsibly manage waste and minimize
negative health impacts to the community and the environment. Currently, it
is suggested that in outreach immunization sessions, Sub centre & PHC (in
rural areas) where number of AD syringes used per day are not in large
quantity these can be collected in a safety container/ box (a card board box for safe disposal
of AD syringes & needles) & the filled up safety boxes can be buried
in a large pit prepared for disposal of other waste also from the clinics of
the institution. This pit should be located in a safe area ear marked for
this purpose within or close to the campus of Sub center/ PHC where the
access of rag pickers & patients may be prevented.
In urban clinics & hospitals where number of AD
syringes & other medical waste used per day are comparatively more the
arrangements & techniques are required to minimize the waste, to collect
the waste safely, where required segregate it for disposal by different
methods, disinfect & then dispose, in compliance with available
guidelines of pollution control. Different solutions are being tested now and
may be available in the coming years
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