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http://www.hepb.

org/prevention-and-
diagnosis/vaccination/

Vaccination
Hepatitis B Vaccine
It takes only 3 shots to protect yourself and your loved ones against hepatitis
B for a lifetime.

The hepatitis B vaccine is a safe and effective vaccine that is recommended for all
infants at birth and for children up to 18 years. The hepatitis B vaccine is also
recommended for adults living with diabetes and those at high risk for infection due
to their jobs, lifestyle, living situations, or country of birth. Since everyone is at some
risk, all adults should seriously consider getting the hepatitis B vaccine for a lifetime
protection against a preventable chronic liver disease.

The hepatitis B vaccine is also known as the first “anti-cancer” vaccine because it
prevents hepatitis B, the leading cause of liver cancer worldwide.

You cannot get hepatitis B from the vaccine. All hepatitis B vaccines that have
been used since 1986 are made synthetically – meaning the hepatitis B vaccines do
not contain any blood products. Learn more.

If you have a current HBV infection (HBsAg positive) or have recovered from a past
HBV infection, the hepatitis B vaccine series will not benefit you or clear the virus.
However the vaccine will provide a lifetime of protection for loved ones. Testing is
the only way to know if you or your loved ones have a current infection or have
recovered from a past infection.

Hepatitis B Vaccine Recommendations


The hepatitis B vaccine is recommended for all infants and children up to age 18
years by the World Health Organization (WHO) and the U.S. Centers for Disease
Control and Prevention (CDC). The CDC also recommends that adults in high-risk
groups be vaccinated (see below).

Every person may be at some risk for a hepatitis B infection during their lifetime, so
getting the hepatitis B vaccine should be considered by all people. There are,
however, groups that the CDC recommends should definitely receive the hepatitis B
vaccine, which are listed below:
 All infants, beginning at birth
 All children aged <19 years who have not been vaccinated previously
 Susceptible sexual partners of hepatitis B-positive persons
 Sexually active persons who are not in a long-term, mutually monogamous
relationship (e.g., >1 sex partner during the previous 6 months)
 Persons seeking evaluation or treatment for a sexually transmitted disease
 Men who have sex with men
 Injection drug users
 Susceptible household contacts of hepatitis B-positive persons
 Healthcare and public safety workers at risk for exposure to blood
 Persons with end-stage renal disease, including pre-dialysis, hemodialysis,
peritoneal dialysis, and home dialysis patients
 Residents and staff of facilities for developmentally disabled persons
 Travelers to and families adopting from countries where hepatitis B is common
(e.g. Asia, Africa, South America, Pacific Islands, Eastern Europe, and the Middle
East)
 Persons with chronic liver disease, other than hepatitis B (e.g. cirrhosis, fatty liver
disease, etc.)
 Persons with hepatitis C infection
 Persons with HIV infection
 Adults with diabetes aged 19 through 59 years (clinicians can decide whether or
not to vaccinate their diabetic patients ≥60 years)
 All other persons seeking protection from HBV infection — acknowledgment of a
specific risk factor is not a requirement for vaccination

Hepatitis B Vaccine Schedule


The hepatitis B vaccine is available at your doctor's office and local health
department or clinic. Three doses are generally required to complete the hepatitis B
vaccine series, although there is an accelerated two-dose series for adolescents age
11 through 15 years. It is important to remember that babies born to infected
mothers must receive the first dose of hepatitis B vaccine in the delivery room or
within the first 12 hours of life (learn more about hepatitis B and pregnancy).

 1st Shot - At any given time, but newborns should receive this dose in the delivery
room
 2nd Shot - At least one month (or 28 days) after the 1st shot
 3rd Shot - At least 4 months (16 weeks) after the 1st shot (or at least 2 months
after the 2nd shot)
You do not need to restart the hepatitis B vaccine series if you miss any of the shots.
For example, if you start the vaccine series and stop, then get the 2nd shot when you
can and make sure to get the 3rd shot at least two months later. Or, if you get the first
two doses of vaccine and miss the third dose, then just schedule the last shot when
you can.

To be certain that you are protected against hepatitis B, ask for a simple blood test to
check your “antibody titers” that will confirm whether the vaccination was successful.

Hepatitis B Vaccine Safety and Side Effects


More than 1 billion doses of the hepatitis B vaccine have been given worldwide and it
is considered one of the safest and most effective vaccines ever made.
Numerous studies looking at the vaccine's safety have been conducted by the World
Health Organization, U.S. Centers for Disease Control and Prevention, and many
different medical societies.

No evidence has been found that the hepatitis B vaccine causes sudden infant
deaths (SIDs), autism, multiple sclerosis, or other neurological disorders.

Common side effects from the hepatitis B vaccine may include soreness, swelling
and redness at the injection site. The vaccine may not be recommended for those
with documented yeast allergies or a history of an adverse reaction to the vaccine.

Guidelines
Standard Schedule - Alternate Schedule for Adolescents
U.S. Guidelines - International Vaccine Considerations

In the United States, there are two hepatitis B vaccines that have been approved for
use in infants, children and adults. Both are equally safe and effective.

 Engerix-B (GlaxoSmithKline)
 Recombivax HB (Merck)These vaccines are synthetically prepared and do not
contain blood products – you cannot get hepatitis B from either of these vaccines.
In November 2017, a third vaccine was approved by the FDA for use in the
U.S. Heplisav-B (Dynavax) is a two-dose vaccine approved for use in adults.

Standard Hepatitis B Vaccine Schedule of Administration


The hepatitis B vaccine is an injection (or shot) that is generally given in the arm and
as a three-dose series on a 0, 1, and 6 month schedule. The recommended doses
depend on the vaccine brand and the person's age.

 1st Shot (0 month) – Start at any time, but newborns should receive this dose in
the delivery room)
 2nd shot (1 month) – At least 1 month (or 28 days) after the 1st shot
 3rd shot (6 month) – Six months after the 1st shot (or at least 2 months after the
2nd shot)
Alternate Hepatitis B Vaccine Schedule for Adolescents
There is a two-dose schedule of the hepatitis B vaccine called “Recombivax HB”
(Merck) that has been approved for children and adolescents 11 through 15 years of
age. After the first dose is given, the second dose is given 4 to 6 months later.

U.S. Hepatitis B Vaccine Guidelines


The U.S. Centers for Disease Control and Prevention have made the following HBV
vaccine recommendations in order to protect all babies, children, teens and adults
from infection with the hepatitis B virus.
Universal Infant Vaccination ("Birth Dose")

ALL infants should receive the first dose of hepatitis B vaccine at birth in the delivery
room (called the “birth dose") or within the first 12- 24 hours of life before they leave
the hospital.

In 1991, universal hepatitis B vaccination of all infants born in the U.S. was
recommended because newborns and babies are at the greatest risk of developing a
lifelong chronic infection if they are exposed to the hepatitis B virus. Giving the "birth
dose" of the hepatitis B vaccine after a baby is born helps to reduce the risk of
transmission from a woman who is infected with hepatitis B to her newborn baby at
the time of delivery. Unfortunately, most pregnant women do not know if they are
infected with hepatitis B; therefore, it is very important that all newborns be protected
against a possible exposure to the hepatitis B virus. There is no second chance to
protect a newborn from a chronic hepatitis B infection after the first 12 - 24 hours of
life.

Children and Adolescents (0 - 18 years)

Since 1997, the CDC has recommended that ALL children and adolescents up to
age 18 years should receive the hepatitis B vaccine.

Young children are at high risk for developing a lifelong chronic infection if they are
exposed to the hepatitis B virus. Currently, one-third of all chronically infected adults
were exposed in childhood. Adolescents are included in this recommendation as well
because of their potentially experimental lifestyle choices that place them at greater
risk of a hepatitis B infection.

Adults (19 years and older)

A schedule of routine adult vaccinations was first published in 2002. The hepatitis B
vaccine is now included in the current list of adult recommendations (> 19 years).

In 2011, the CDC added the recommendation the hepatitis B vaccine be given to all
adults with diabetes (type 1 or 2) who are between 19 - 59 years. Clinicians can
decide whether or not their diabetic patients 60 years or older should receive the
hepatitis B vaccine. This recommendation has also been adopted by the Americans
Diabetes Association. Learn more.

Recommended Doses of Approved Hepatitis B Vaccines

The CDC publishes a simple chart of approved hepatitis B vaccine doses for children
and adults which can be printed. Learn more.

International Hepatitis B Vaccine Considerations


The World Health Organization recommends all infants receive the first dose of the
hepatitis B vaccine within 24 hours of birth (often called the “birth dose”) and to then
complete the vaccine series at 2 and 6 months. In order to meet this requirement,
the first dose of the hepatitis B vaccine must be the “monovalent vaccine,” which
means it is only the hepatitis B vaccine.

Many countries, however, are offering a “pentavalent vaccine” which protects against
5 diseases, including hepatitis B. Unfortunately, the first dose of the “pentavalent
vaccine” is given at 6 weeks, which means babies are not being protected at birth
against the hepatitis B virus.

It is very important that babies receive the “monovalent” hepatitis B vaccine at birth
(not the “pentavalent vaccine”) in order to protect against a lifelong chronic hepatitis
B infection. Infants born to moms who are infected with hepatitis B are at extremely
high risk of becoming chronically infected after delivery, unless they receive the first
dose of the hepatitis B vaccine within the first 12-24 hours of life.

There is no second chance to protect a newborn or baby from hepatitis B!

Vaccine Safety
Hepatitis B Vaccine Safety
The hepatitis B vaccine is considered one of the most safe and effective
vaccines ever produced.

The most highly respected public health agencies and professional medical
associations have rigorously studied the safety of the hepatitis B vaccine. According
to the World Health Organization (WHO), the U.S. Centers for Disease Control and
Prevention (CDC), and many different medical societies have concluded that there is
no confirmed evidence that the hepatitis B vaccine causes: autism, autoimmune
disorders, chronic fatigue syndrome, chronic illness, guillian-barre syndrome,
multiple sclerosis, optic neuritis, rheumatoid arthritis, seizures, sudden infant death
syndrome (SIDS), or transverse myelitis.

Vaccine Non-Responders
A hepatitis B vaccine “non-responder" refers to a person who does not develop
protective surface antibodies after completing two full series of the hepatitis B
vaccine and for whom an acute or chronic hepatitis B infection has been ruled out.

Although the majority of persons vaccinated against hepatitis B successfully respond


to vaccination, an estimated 5-15% of persons may not respond due to older age,
obesity, smoking, and other chronic illness.

It is also possible that a person who does not respond to the vaccine may already be
infected with hepatitis B. Therefore, testing for the presence of the hepatitis B virus
(hepatitis B surface antigen or HBsAg) is recommended before diagnosing a person
as a "vaccine non-responder."

CDC Recommendations for Hepatitis B Vaccine Non-Responders


 Persons who do not respond to the primary hepatitis B vaccine series (i.e., anti-
HBs <10 mIU/mL) should complete a second 3-dose vaccine series or be
evaluated to determine if they are HBsAg-positive. Persons who do not respond to
an initial 3-dose vaccine series have a 30%--50% chance of responding to a
second 3-dose series.
 Revaccinated persons should be retested at the completion of the second vaccine
series, 1-2 months following the last shot of the series.
 Persons exposed to HBsAg-positive blood or body fluids who are known not to
have responded to a primary vaccine series should receive a single dose of
hepatitis B immunoglobulin (HBIG) and restart the hepatitis B vaccine series with
the first dose of the hepatitis B vaccine as soon as possible after exposure.
Alternatively, they should receive two doses of HBIG, one dose as soon as
possible after exposure, and the second dose 1 month later.
 The option of administering one dose of HBIG and restarting the vaccine series is
preferred for non-responders who did not complete a second 3-dose vaccine
series.
 For persons who previously completed a second vaccine series but failed to
respond, two doses of HBIG are preferred.
Hepatitis B vaccine “non-responders” who test negative for hepatitis B
infection are at risk for being infected and should be counseled regarding how to
prevent a hepatitis B infection and to seek immediate medical care to receive a dose
of hepatitis B immunoglobulin (HBIG) if they have been exposed to potentially
infected blood.

Hepatitis B vaccine “non-responders" to vaccination who test positive for


hepatitis B infection should be counseled regarding how to prevent transmitting the
hepatitis B virus to others and the need for regular medical care and monitoring for
their chronic infection.

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