Hepatitis B Vaccine Safety

Hepatitis B Disease and How to Protect Against It

The Hepatitis B virus causes a contagious liver disease that can cause cancer and cirrhosis (scarring of the liver).  It is spread when infected blood, semen, or other body fluid enters the body of a person who is not infected.  You can protect against Hepatitis B with safe, effective vaccination.

Hepatitis B Vaccine Side Effects

The Hepatitis B vaccine is very safe, and it is effective at preventing the Hepatitis B disease. Vaccines, like any medicine, can have side effects. Most people who get the Hepatitis B vaccine have no side effects at all. Some people report having very mild side effects, like a sore arm from the shot for a day or two. The most common side effects are usually mild and last 1 or 2 days.

On extremely rare occasions, people may experience severe (anaphylactic) allergic reactions after a Hepatitis B shot.  Hepatitis B vaccine is not recommended for anyone who is allergic to yeast, or to any other component of the vaccine.

 Top of Page

Available Hepatitis B Vaccines

There are four Hepatitis B vaccines approved for use in the United States, two of which are combined with vaccines for other diseases.

• Engerix-B [PDF – 110 KB]: The Food and Drug Administration (FDA) approved this vaccine in 1989 for use in people from birth through adulthood, although the dose varies. Hepatitis B vaccination is especially recommended for infants and adults getting hemodialysis treatment.
• Recombivax HB [PDF – 100 KB]: FDA approved this vaccine in 1983 for use in people from birth through adulthood, although the dose varies. Hepatitis B vaccination is especially recommended for infants and adults getting hemodialysis treatment.
• Pediarix [PDF – 242 KB]: FDA approved this combination vaccine in 2002 for use in infants and children 6 weeks through 6 years old. This vaccine protects against Hepatitis B, diphtheria, tetanus, pertussis, and polio.
• Twinrix [PDF – 134 KB]: FDA approved this vaccine in 2001 for protection against Hepatitis A and Hepatitis B. It is approved for use in people 18 years and older.

 Top of Page

How CDC Monitors Hepatitis B Vaccine Safety

CDC and FDA continuously monitor the safety of vaccines after they are approved.  If a problem is found with a vaccine, CDC and FDA will inform health officials, health care providers, and the public.

CDC uses three systems to monitor vaccine safety:

• The Vaccine Adverse Event Reporting System (VAERS): an early warning system that helps CDC and FDA monitor problems following vaccination.  Anyone can report possible vaccine side effects to VAERS.
• The Vaccine Safety Datalink (VSD): a collaboration between CDC and nine health care organizations which allows ongoing monitoring and proactive searches of vaccine-related data.
• The Clinical Immunization Safety Assessment (CISA) Project: a partnership between CDC and several medical centers that conducts clinical research on vaccine-associated health risks.

 Top of Page

A Closer Look at the Safety Data

• A VSD study compared deaths among newborns vaccinated with Hepatitis B and unvaccinated newborns.  The study found no differences between the vaccinated and unvaccinated newborns.
• CDC studied VAERS reports after the combination Hepatitis A Inactivated and Hepatitis B (Recombinant) vaccine from May 2001 to September 2003.  There were no unexpected health problems. 
• In the early 1990’s, CDC conducted a study of healthy, full-term newborns to determine whether Hepatitis B vaccination of newborns increases the risk of fever and/or suspected sepsis.   The study found no evidence that newborn Hepatitis B vaccination is linked with any increase in fevers, sepsis evaluations, or allergy or brain problems.  The study did not find any increase in medical procedures related to babies getting a Hepatitis B vaccine.
• In a 4-year case series review of Hepatitis B vaccine reports among newborns, there were no serious health problems linked to the Hepatitis B vaccine. This was the largest case series review of Hepatitis B vaccination reports among neonates and infants. Several studies have evaluated a possible link between Hepatitis B vaccination and multiple sclerosis or optic neuritis.  The studies did not show any link.

 Top of Page

More Resources

• Hepatitis B Vaccine Information Statement
• Hepatitis B Vaccine: Who Should Not Get Vaccinated
• Hepatitis B: Who Needs to Be Vaccinated?
• Frequently Asked Questions: Is the Hepatitis B vaccine safe?

 Top of Page

Related Scientific Articles

DeStefano F, Verstraeten T, Chen RT. Hepatitis B vaccine and risk of multiple sclerosis. Expert Rev Vaccines. 2002 Dec;1(4):461-6.
 

DeStefano F, Verstraeten T, Jackson LA, Okoro CA, Benson P, et al. Vaccinations and risk of central nervous system demyelinating diseases in adults. Arch Neurol. 2003 Apr;60(4):504-9.
 

DiMiceli L, Pool V, Kelso JM, Shadomy SV, Iskander J; VAERS Team. Vaccination of yeast sensitive individuals: review of safety date in the US vaccine adverse event reporting system (VAERS). Vaccine. 2006 Feb 6;24(6):703-7.
 

Eriksen EM, Perlman JA, Miller A, Marcy SM, Lee H, et al. Lack of association between hepatitis B birth immunization and neonatal death: A population-based study from the Vaccine Safety Datalink project. Pediatr Infect Dis J. 2004 Jul;23(7):656-62.
 

Hocine MN, Farrington CP, Touze E, Whitaker HJ, Fourrier A, et al. Hepatitis B vaccination and first central nervous system demyelinating event: Reanalysis of a case-control study using the self-controlled case series method. Vaccine. 2007;25(31):5938-5943.
 

Lewis E, Shinefield HR, Woodruff BA, Black SB, Destefano F, et al. Safety of neonatal hepatitis B vaccine administration. Pediatr Infect Dis J. 2001 Nov;20(11):1049-54.
 

Niu MT, Davis DM, Ellenberg S. Recombinant hepatitis B vaccination of neonates and infants: emerging safety data from the Vaccine Adverse Event Reporting System. Pediatr Infect Dis J. 1996 Sep;15(9):771-6.
 

Niu MT, Rhodes P, Salive M, Lively T, Davis DM, et al. Comparative safety of two recombinant hepatitis B vaccines in children: Data from the Vaccine Adverse Event Reporting System (VAERS) and Vaccine Safety Datalink (VSD). J Clin Epidemiol. 1998 Jun;51(6):503-10.
 

Woo EJ, Miller NB, Ball R. Adverse events after hepatitis A B combination vaccine. Vaccine. 2006 Mar 24;24(14):2685-91.
 

Yu O, Bohlke K, Hanson CA, Delaney K, Rees TG, et al. Hepatitis B vaccine and risk of autoimmune thyroid disease: A Vaccine Safety Datalink study. Pharmacoepidemiol Drug Saf. 2007 Jul;16(7):736-45.

 Top of Page