Vaccine Information

Entry last updated: May 27, 2004

- Understanding the Disease
- Available Vaccines
- History of the Vaccine
- Who Should and Should Not Receive the Vaccine
- Dose Schedule
- Effectiveness of the Vaccine
- Known Side Effects
- Related Issues
- Key References and Sources of Additional Information
- State Vaccine Requirements
- Important Facts for Parents to Know
- Frequently Asked Questions
- CDC Vaccine Information Statement

Understanding the Disease

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. However, approximately 30% of those infected have no known risk factors. Worldwide, it is most commonly spread to infants by their infected mothers.

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 hepatitis B 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 in early infancy.

Available Vaccines

The hepatitis B vaccine is available as:

• HBV Recombinant (alone)
• HBV in combination with Haemophilus influenzae type b (Hib) vaccine
• HBV in combination with DTaP (Diphtheria-Tetanus-acellular Pertussis) and inactivated polio vaccines
• HBV in combination with hepatitis A (HAV) vaccine

Product: Engerix-B� (HBV-Recombinant)
Manufacturer: GlaxoSmithKline
Year licensed: 1989

Product: Recombivax HB� (HBV-Recombinant)
Manufacturer: Merck
Year licensed: 1986

Product: Comvax� (HBV and Hib conjugate vaccine)
Manufacturer: Merck
Year licensed: 1996

Product: Twinrix� (HAV and HBV combination vaccine)
Manufacturer: GlaxoSmithKline
Year licensed: 2001

Product Name: Pediarix^TM (HBV, DTaP, and inactivated polio vaccines)
Manufacturer: GlaxoSmithKline
Year licensed: 2002

For information on the thimerosal content in these vaccines, see the Food and Drug Administration at www.fda.gov/cber/vaccine/thimerosal.htm#t3
or Johns Hopkins University's Institute for Vaccine Safety at
www.vaccinesafety.edu/thi-table.htm

History of the Vaccine

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:

• Approximately 30% of people who get hepatitis B do not have any identified risk factors, so people at high risk often were not immunized.
• When infants and children are infected with hepatitis B, the odds that they will develop chronic liver disease or cancer are at least three times higher than those infected as adults. Therefore, preventing infection in infants and children is very important.�

Who Should and Should Not Receive this Vaccine

Who should receive the vaccine?

• Everyone 18 years and younger should receive the HBV vaccine.
• Adults over 18 who are at risk for hepatitis B should receive the HBV vaccine. Adults are at risk for hepatitis B virus infection if they have had more than one sex partner during a six month period; are health care workers, or are otherwise exposed to infected blood or body fluids; are men who have sex with other men; or use injection drugs.
• People aged 18 and older who are at risk for both HAV and HBV may receive the hepatitis A and B combination vaccine. Adults are at risk for hepatitis A if they are poor; are of certain ethnicities, especially Native Americans, Alaskan Natives, and Mexican Americans; travel to or work where HAV is common; are men who have sex with men; use illicit drugs; work with HAV-infected primates, or HAV virus itself in a laboratory; receive clotting factor concentrates; are infected with other hepatitis viruses; have chronic liver disease and are not already immune to HAV; or have received, or are waiting to receive, a liver transplant.

Who should not receive the vaccine?

• Those who have had a serious allergic reaction to a previous dose of the vaccine should not receive additional doses.
• People who are moderately or severely ill should consult with their physician before receiving any vaccine.

This vaccine is recommended by:

• Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention
• American Academy of Pediatrics
• American Academy of Family Physicians
• American Thoracic Society

The complete childhood immunization schedule can be found at:
www.cdc.gov/nip/recs/child-schedule.PDF

The summary of adolescent/adult immunization recommendations can be found at: www.cdc.gov/nip/recs/adult-schedule.pdf

Dose Schedule

Most people should get three doses of the hepatitis B vaccine.� Dialysis patients and immunocompromised people may require additional doses.� For children between the ages of six weeks and seven years, HBV in combination with the DTaP and inactivated polio vaccines (Pediarix^TM1, GlaxoSmithKline) may be given.� Or, HBV and Hib conjugate vaccine (Comvax�, Merck) may be given to children between 6 weeks and 15 months.

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.�

First Dose:

• An infant whose mother is infected with the virus should receive the HBV vaccine (not a combination vaccine) within 12 hours of birth.
• An infant whose mother is not infected with virus should receive the vaccine between birth and two months of age.� If a combination vaccine is given, it should be given after the infant is six weeks old.
• Older children, adolescents, or adults can receive the hepatitis B vaccine (not hepatitis B vaccine combined with other vaccines) at any time, although it is preferable to give the vaccine by 11 to 12 years of age to previously unimmunized children.

Second Dose:

• Child of an infected mother: between one and two months of age (at least one month after the first dose)
• Child of an uninfected mother: between one and four months of age (at least one month after the first dose)
• Older child, adolescent or adult: one to two months after first dose

Third Dose:

• Child of an infected mother: at six months of age (at least two months after the second dose, and at least four months after the first dose)
• Child of an uninfected mother: between 6 and 18 months of age
• Older child, adolescent, or adult: four to six months after first dose

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.

Effectiveness of the Vaccine

The recombinant hepatitis B vaccines are 95% effective. Because the vaccine has only been in use 15 years, that is how long immunity is known to last. Immunity is probably lifelong.�

Known Side Effects

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.

Related Issues

The hepatitis A and B combination vaccine has been shown to be as safe and effective as HAV and HBV vaccines given separately.

Because toxic mercury exposure has a wide range of adverse health effects, currently in the United States there is a public health effort to reduce human exposure to mercury from all sources. As part of this effort, in July 1999, the U.S. Public Health Service (US PHS) and the American Academy of Pediatrics (AAP) issued a joint statement formally requesting that manufacturers eliminate or reduce the amount of thimerosal (a mercury-containing compound) in vaccines.

When the statement was issued, available hepatitis B vaccines contained thimerosal, and concern arose that newborn babies might be exposed to too much mercury if they got the vaccine. For this reason, this joint statement also recommended that � until a thimerosal-free hepatitis B vaccine became available � hepatitis B immunization should be delayed until two to six months of age for infants born to mothers who tested negative for the disease. Waiting until the newborns were older gave them time to grow so that the amount of mercury would be less in comparison to their body weight.

On August 27, 1999, one thimerosal-free formulation of hepatitis B vaccine was licensed, and on March 28, 2000 the U.S. Food and Drug Administration approved a second preservative-free pediatric hepatitis B vaccine. With the availability of these vaccines, in July 2000, CDC recommended that infants routinely be immunized against hepatitis B at birth.

For additional information, see the NNii feature article, Mercury in Vaccines�and Effects of the Joint Statement on Thimerosal on Hepatitis B Immunization.

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:

• Ascherio A, Szhang SM, Hernan MA, Olek MJ, Coplan PM, Brodovicz K, and Walker AM. (2001). Hepatitis B vaccination and the risk of multiple sclerosis. New England Journal of Medicine, 344(5), 327-332.
• DeStefano F and Verstraeten T. (2001). Multiple sclerosis [Letter to the Editor]. New England Journal of Medicine, 344(5).
• Halsey NA, Duclos P, Van Damme P, and Margolis H. (1999). Hepatitis B vaccine and central nervous system demyelinating diseases. Pediatric Infectious Disease Journal, 18(1), 23-24.
• Institute of Medicine. (2002). Immunization Safety Review: Hepatitis B Vaccine and Demyelinating Neurological Disorders. Washington, DC: National Academy Press.
• Institute of Medicine. (1994). Adverse events associated with childhood vaccines: Evidence bearing on causality. Washington, DC: National Academy Press.
• National Multiple Sclerosis Society. (2001, February). Reports indicate no association between vaccines and MS [Research Report]. New York: Author.
• Niu MT, Salive ME, and Ellenberg SS. (1999). Neonatal deaths after hepatitis B vaccine. Archives of Pediatric Adolescent Medicine, 153(12), 1279-1282.
• Sadovnick AD and Scheifele DW. (2000). School-based hepatitis B vaccination programme and adolescent multiple sclerosis [Research Letter]. Lancet, 355(9203), 549-550.
• Zimmerman RK, Ruben FL, and Ahwesh ER. (1997). Hepatitis B infection, hepatitis B vaccine, and hepatitis B immune globulin. Journal of Family Practice, 45(4), 295-315.�

Key References and Sources of Additional Information

• American Academy of Pediatrics, Committee on Infectious Diseases. (2003). Hepatitis B. In LK Pickering (Ed.), Red Book: Report of the Committee on Infectious Diseases (26th ed., pp. 318-336). Elk Grove Village, IL: Author.
• Centers for Disease Control and Prevention (CDC). (2000). Hepatitis B vaccine: What you need to know [Vaccine Information Statement (VIS)].
• CDC. (2001). Notice to readers: FDA approval for a combined hepatitis A and B vaccine. Morbidity and Mortality Weekly Report, 50(37), 806-807.
• CDC. (2001). Viral hepatitis B [Online fact sheet].
• CDC, National Immunization Program (NIP). (2004). Hepatitis B. In Epidemiology and prevention of vaccine-preventable diseases (�The Pink Book�) (8th ed.). Atlanta: Author.
• CDC, NIP. (2000). Hepatitis B. In Vaccine-preventable childhood diseases [Online fact sheet]. 
• Combination vaccines for childhood immunization: Recommendations of Advisory Committee on Immunization Practices (ACIP), the American Academy of Pediatrics (AAP), and the American Academy of Family Physicians (AAFP). (1999). Pediatrics, 103(5), 1064-1077.
• Food and Drug Administration. (2001). New combination vaccine approved for protection against two hepatitis viruses [Press Office release to FDA personnel].
• Food and Drug Administration. (2002). Product approval information � Licensing action.  
• Humiston SG and Good C. (2000). Vaccinating your child: Questions and answers for the concerned parent. Atlanta: Peachtree Publishers.
• Hurie MB, Saari TN, and Davis JP. (2001). Impact of the joint statement by the American Academy of Pediatrics/US Public Health Service on thimerosal in vaccines on hospital infant hepatitis B vaccination practices, Pediatrics, 107(4), 755-758.
• Joines RW, Blatter M, Abraham B, Xie F, De Clercq N, Baine Y, Reisinger KS, Kuhnen A, and Parenti DL. (2001). A prospective, randomized, comparative U.S. trial of a combination hepatitis A and B vaccine (Twinrix�) with corresponding monovalent vaccines (Havrix� and Engerix-B�) in adults. Vaccine,19(32), 4710-4709.
• Offit PA and Bell LM. (1999). Vaccines: What every parent should know (Rev. ed.). New York: IDG Books.

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