Updated: January 27, 2009
Hepatitis B virus (HBV) is transmitted from one person to another through blood and body fluids, and primarily infects the liver. In the United States, it is most commonly spread through sexual contact or injection drug use. Health care workers and others exposed to infected blood or body fluids are also at high risk for infection. Worldwide, it is most commonly spread to infants by their infected mothers.
Approximately 30% of those who become infected with HBV have no known risk factors.
More than half of those infected with the disease show no signs or symptoms, although they may become chronic carriers of the disease and may develop liver disease or liver cancer later in life (usually by age 40). Symptoms of HBV infection vary and may include loss of appetite, fatigue, nausea, and jaundice (yellow eyes and skin), joint pain, and skin rashes.
Worldwide, over 350 million people have chronic HBV infection, and approximately 1 million HBV patients die annually. An estimated 1.25 million people in the U.S. have chronic HBV infection. Each year, approximately 4,000 to 5,000 children are infected with HBV in the United States. The younger the patient is when the disease is acquired, the more likely it is that he or she will develop chronic liver disease or liver cancer.
Approximately 90% of infants who are infected from their mothers at birth, and between 30 and 50% of those infected before age five, become chronic HBV carriers, while people who are newly infected as adults have only a 6 to 10% risk of chronic infection. For these reasons, hepatitis B immunizations are recommended for routine administration at birth. There are specific protocols to identify infected expectant mothers, for managing children born to infected mothers, and to manage children born to mothers with unknown HBV infection status.
The hepatitis B vaccine is available as:
Product: Engerix-B® (HBV-Recombinant)
Year licensed: 1989
Product: Recombivax HB® (HBV-Recombinant)
Year licensed: 1986
Product: Comvax® (HBV and Hib conjugate vaccine)
Year licensed: 1996
Product: Twinrix® (HAV and HBV combination vaccine)
Year licensed: 2001
Product Name: PediarixTM (HBV, DTaP, and inactivated polio vaccines)
Year licensed: 2002
None of these formulations contain thimerosal preservative. For information on the thimerosal content in these vaccines, see:
The current form of the hepatitis B vaccine has been used in the United States since 1986. To make the vaccine, researchers copy the genetic sequence of a protein contained in the virus into a yeast cell, which is then cultured, purified, and prepared into a vaccine. These recombinant vaccines are safe, induce an immune response, and are incapable of infecting recipients with the hepatitis B virus.
Prior to 1991, the vaccine was recommended only for people who were identified to be at a high risk for acquiring the infection.
In 1991, the recommendation was extended to include all infants as well. This new recommendation was made for several reasons, including:
In 2005, a comprehensive strategy to eliminate HBV transmission in the US was published. This includes the recommendation for
Who should receive the vaccine?
Who should not receive the vaccine?
This vaccine is recommended by:
The complete childhood immunization schedule can be found at the CDC Web site.
The summary of adolescent/adult immunization recommendations can be found at the CDC Web site.
Most people should get three doses of the hepatitis B vaccine. All newborns should receive a dose of hepatitis B vaccine at birth. For children between the ages of six weeks and seven years, HBV in combination with the DTaP and inactivated polio vaccines (PediarixTM1, GlaxoSmithKline) may be given. Or, HBV and Hib conjugate vaccine (Comvax®, Merck) may be given to children between 6 weeks and 15 months. Dialysis patients and immunocompromised people may require additional doses
Receiving combination vaccines from different manufacturers, which may include different component vaccines, can make the dose schedule more complex. However, since giving combination vaccines means fewer shots overall for a child, healthcare providers will usually choose to administer them. Healthcare professionals should attempt to select vaccines for their patients, especially children who have been seen by other practices, based on what they have already been given.
The hepatitis A and B combination vaccine (Twinrix®, GlaxoSmithKline) is approved for people 18 years and older, and is given on a 0-, 1-, and 6-month schedule.
The series of immunizations with recombinant hepatitis B vaccines are 95% effective at inducing sero-immunity. Because the vaccine has only been in use 20 years, that is how long immunity is known to last. Immunity is probably lifelong.
The majority of people who receive the hepatitis B vaccine (65%) do not experience any reactions to it.
About 3% of those immunized will develop pain and tenderness where the shot was given; low-grade fever occurs in about 1% to 6% of vaccine recipients.
Serious reactions are extremely rare. In far less than 1 out of 10,000 shots given, or about .001%, serious allergic reactions including anaphylaxis (a rapid life-threatening allergic response affecting more than one part of the body; it can also be a systemic, whole-body response that causes the airway to swell, close off, and prevent the intake of oxygen) may occur.
The hepatitis A and B combination vaccine has been shown to be as safe and effective as HAV and HBV vaccines given separately.
Allegations that the hepatitis B vaccine causes multiple sclerosis have been made. All scientific research conducted to date disproves this claim. For more information refer to: