Key points
- Hepatitis B is a liver infection caused by the hepatitis B virus.
- There are vaccines that can protect against hepatitis B.
Overview
Hepatitis B is a vaccine-preventable liver infection caused by HBV. Hepatitis B can range from a mild, short-term, acute illness lasting a few weeks to a serious, long-term, chronic infection.
Available vaccines & manufacturer package inserts
Vaccines against Hepatitis B and manufacturer inserts
Contain only hepatitis B vaccine.
- The FDA approved Engerix-B in 1989 for use in people from birth through adulthood, although the dose varies by age group.
- FDA approved Heplisav-B in 2017 for use in people 18 years and older.
- FDA approved PREHEVBRIO in 2021 for use in people 18 years and older.
- FDA approved Recombivax HB in 1986 for use from birth through adulthood, although the dose varies by age group.
Vaccine against Hepatitis A and B and manufacturer insert
- FDA approved Twinrix in 2001 for use in people 18 years and older. It protects against hepatitis A and hepatitis B.
Childhood vaccines that include Hepatitis B and manufacturer inserts
Contain hepatitis B vaccine plus other vaccines.
- FDA approved Pediarix in 2002 for use in infants and children 6 weeks through 6 years old. It protects against hepatitis B, diphtheria, tetanus, pertussis, and polio.
- FDA approved VAXELIS in 2018 for use in children 6 weeks through 4 years of age. It protects against hepatitis B, diphtheria, tetanus, pertussis, and polio.
Who should & should not get the vaccine
- All infants within 24 hours of birth (usually 3 doses completed over a 6-month period)
- Children and adolescents younger than 19 years of age who have not yet gotten the vaccine
- People who are at increased risk of hepatitis B due to travel to certain countries, exposure to blood in the workplace, household or sexual exposure to an infected person, injection drug use or certain medical conditions
- Anyone who wants protection against hepatitis B
Common side effects
- Pain, soreness, redness, or swelling in the arm where the shot was given.
- Headache.
- Fever.
- Fatigue.
- Irritability, diarrhea, loss of appetite in healthy infants and children who received (Recombivax, Vaxelis, Pediarix).
- Vomiting, crying, drowsiness in children (Vaxelis, Pediarix).
When to call 911
Vaccines, like any medicine, can have side effects. Many people who get a hepatitis B vaccine have no side effects at all. The most common side effects include injection site pain, soreness, or redness, headache, and fatigue, and are usually mild lasting 1-2 days.
Report possible adverse events to VAERS
A closer look at the safety data
- A Vaccine Safety Datalink (VSD) study compared deaths among newborns vaccinated with hepatitis B and unvaccinated newborns. The study found no differences between vaccinated and unvaccinated newborns.1
- CDC reviewed VAERS reports of adverse events following hepatitis B vaccination from 2005 through 2015. During that time, 20,231 reports following hepatitis B or hepatitis B-containing vaccines, were submitted to VAERS. Over half of reports were in persons younger than 2 years of age; the majority of reports (78%) were following hepatitis B-containing vaccines in combination with other vaccines at the same visit. The most frequently reported adverse events for vaccines given in combination were fever, injection site redness, and vomiting. This review of the hepatitis B vaccine did not detect any new or unexpected safety concerns. These findings are consistent with pre-licensure clinical trials and other post-licensure monitoring and research.2
- A separate review of VAERS studied reports made following the administration of hepatitis A (inactivated) and hepatitis B (recombinant) vaccines combined from May 2001 to September 2003. There were no unexpected health problems.3
- In the early 1990s, 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 of increased fevers, sepsis evaluations, allergy or brain problems or medical procedures after to newborn hepatitis B vaccination.4
- 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 newborn babies 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.5
Hepatitis B and multiple sclerosis
Key points
Hepatitis B vaccination does not cause MS
Hundreds of millions of people worldwide have received hepatitis B vaccine without developing MS or any other autoimmune disease. As with all vaccines and any disease, due to the large number of vaccinations administered worldwide, surveillance systems that monitor health concerns after vaccination do expect to receive reports of MS occurring after vaccination that happen by chance alone.
To further explore any possible connection between hepatitis B vaccination and MS, many scientific studies have been conducted, and have concluded that hepatitis B vaccination does not cause MS.67891011
Research on vaccines and other autoimmune diseases
CDC takes concerns about vaccines and immune system diseases and disorders very seriously. Researchers at CDC and elsewhere have conducted studies to examine the possible link between vaccines and autoimmune conditions like MS, diabetes, and asthma. These studies have been reassuring, providing no evidence to suggest a link between vaccines and autoimmune conditions.
As part of ongoing vaccine safety surveillance, CDC continues to conduct research to examine the effects vaccines may have on the immune system.
How CDC monitors vaccine safety
CDC and the Food and Drug Administration (FDA) are committed to ensuring that vaccines provided to the public are safe and effective. Once vaccines are licensed or authorized for emergency use in the United States, CDC and FDA continuously monitor them through several safety systems.
- Eriksen, E. M., Perlman, J. A., Miller, A., Marcy, S. M., Lee, H., Vadheim, C., Zangwill, K. M., Chen, R. T., DeStefano, F., Lewis, E., Black, S., Shinefield, H., & Ward, J. I. (2004). Lack of association between hepatitis B birth immunization and neonatal death: a population-based study from the vaccine safety datalink project. The Pediatric infectious disease journal, 23(7), 656–662. https://doi.org/10.1097/01.inf.0000130953.08946.d0
- Haber, P., Moro, P. L., Ng, C., Lewis, P. W., Hibbs, B., Schillie, S. F., Nelson, N. P., Li, R., Stewart, B., & Cano, M. V. (2018). Safety of currently licensed hepatitis B surface antigen vaccines in the United States, Vaccine Adverse Event Reporting System (VAERS), 2005-2015. Vaccine, 36(4), 559–564. https://doi.org/10.1016/j.vaccine.2017.11.079
- Woo, E. J., Miller, N. B., Ball, R., & VAERS Working Group (2006). Adverse events after hepatitis A B combination vaccine. Vaccine, 24(14), 2685–2691. https://doi.org/10.1016/j.vaccine.2005.10.049
- Lewis, E., Shinefield, H. R., Woodruff, B. A., Black, S. B., Destefano, F., Chen, R. T., Ensor, R., & Vaccine Safety Datalink Workgroup (2001). Safety of neonatal hepatitis B vaccine administration. The Pediatric infectious disease journal, 20(11), 1049–1054. https://doi.org/10.1097/00006454-200111000-00009
- Lewis, E., Shinefield, H. R., Woodruff, B. A., Black, S. B., Destefano, F., Chen, R. T., Ensor, R., & Vaccine Safety Datalink Workgroup (2001). Safety of neonatal hepatitis B vaccine administration. The Pediatric infectious disease journal, 20(11), 1049–1054. https://doi.org/10.1097/00006454-200111000-00009
- Mikaeloff, Y., Caridade, G., Rossier, M., Suissa, S., & Tardieu, M. (2007). Hepatitis B vaccination and the risk of childhood-onset multiple sclerosis. Archives of pediatrics & adolescent medicine, 161(12), 1176–1182. https://doi.org/10.1001/archpedi.161.12.1176
- Sadovnick, A. D., & Scheifele, D. W. (2000). School-based hepatitis B vaccination programme and adolescent multiple sclerosis. Lancet (London, England), 355(9203), 549–550. https://doi.org/10.1016/S0140-6736(99)02991-8
- Institute of Medicine (US) Immunization Safety Review Committee, Stratton, K., Almario, D., & McCormick, M. C. (Eds.). (2002). Immunization Safety Review: Hepatitis B Vaccine and Demyelinating Neurological Disorders. National Academies Press (US).
- Confavreux, C., Suissa, S., Saddier, P., Bourdès, V., Vukusic, S., & Vaccines in Multiple Sclerosis Study Group (2001). Vaccinations and the risk of relapse in multiple sclerosis. Vaccines in Multiple Sclerosis Study Group. The New England journal of medicine, 344(5), 319–326. https://doi.org/10.1056/NEJM200102013440501
- Ascherio, A., Zhang, S. M., Hernán, M. A., Olek, M. J., Coplan, P. M., Brodovicz, K., & Walker, A. M. (2001). Hepatitis B vaccination and the risk of multiple sclerosis. The New England journal of medicine, 344(5), 327–332. https://doi.org/10.1056/NEJM200102013440502
- DeStefano, F., Verstraeten, T., Jackson, L. A., Okoro, C. A., Benson, P., Black, S. B., Shinefield, H. R., Mullooly, J. P., Likosky, W., Chen, R. T., & Vaccine Safety Datalink Research Group, National Immunization Program, Centers for Disease Control and Prevention (2003). Vaccinations and risk of central nervous system demyelinating diseases in adults. Archives of neurology, 60(4), 504–509. https://doi.org/10.1001/archneur.60.4.504
- Groom HC, Irving SA, Koppolu P, Smith N, Vazquez-Benitez G, Kharbanda EO, Daley MF, Donahue JG, Getahun D, Jackson LA, Tse Kawai A, Klein NP, Nordin JD, Sukumaran L, Naleway AL. Uptake and safety of Hepatitis B vaccination during pregnancy: A Vaccine Safety Datalink study.Vaccine. 2018 Oct 1; 26(41): 6111-6116. Epub 2018 Sep 5.
- Schillie S, Vellozzi C, Reingold A, Harris A, Haber P, Ward JW, Nelson NP. Prevention of Hepatitis B Virus Infection in the United States: Recommendations of the Advisory Committee on Immunization Practices.MMWR Recomm Rep 2018 Jan 12: 67(No. RR-1): 1-31.
- Haber P, Moro PL, Ng C, Lewis PW, Hibbs B, Schillie SF, Nelson NP, Li R, Stewart B, Cano MV. Safety of currently licensed hepatitis B surface antigen vaccines in the United States, Vaccine Adverse Event Reporting System (VAERS), 2005-2015.Vaccine. 2018 Jan 25; (4): 559-564. Epub 2017 Dec 11.
- Moro PL, Zheteyeva Y, Barash F, Lewis P, Cano M. Assessing the safety of hepatitis B vaccination during pregnancy in the Vaccine Adverse Event Reporting System (VAERS), 1990-2016.Vaccine. 2018 Jan 2; 36(1): 50-54. Epub 2017 Nov 27.
- Schillie S, Murphy TV, Sawyer M, Ly K, Hughes E, Jiles R, de Perio MA, Reilly M, Byrd K, Ward JW. CDC Guidance for Evaluating Health-Care Personnel for Hepatitis B Virus Protection and for Administering Postexposure Management.MMWR Recomm Rep. 2013 Dec 20: 62(RR10); 1-19.
- Sawyer MH, Hoerger TJ, Murphy TV, Schillie SF, Hu D, Spradling PR, Byrd KK, Xing J, Reilly ML, Tohme RA, Moorman A, Smith EA, Baack BN, Jiles RB, Klevens M, Ward JW, Kahn HS, Zhou F. Use of Hepatitis B Vaccination for Adults with Diabetes Mellitus: Recommendations of the Advisory Committee on Immunization Practices (ACIP).MMWR. 2011 Dec 23: 60(50); 1709-1711.
- Yu O, Bohlke K, Hanson CA, Delaney K, Rees TG, Zavitkovsky A, Ray P, Mullooly J, Black SB, Benson P, Thompson WW, Davis RL, Jackson LA. Hepatitis B vaccine and risk of autoimmune thyroid disease: A Vaccine Safety Datalink study. Pharmacoepidemiol Drug Saf. 2007 Jul;16(7):736-45.
- Hocine MN, Farrington CP, Touze E, Whitaker HJ, Fourrier A, Moreau T, Tubert-Bitter P. 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.
- Woo EJ, Miller NB, Ball R. Adverse events after hepatitis A B combination vaccine. Vaccine. 2006 Mar 24;24(14):2685-91.
- 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, Vadheim C, Zangwill KM, Chen RT, Destefano F, Lewis E, Black S, Shinefield H, Ward JI. 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.
- DeStefano F, Verstraeten T, Jackson LA, Okoro CA, Benson P, Black SB, Shinefield HR, Mullooly JP, Likosky W, Chen RT, Vaccine Safety Datalink Research Group, National Immunization Program, CDC. Vaccinations and risk of central nervous system demyelinating diseases in adults. Arch Neurol. 2003 Apr;60(4):504-9.
- Lewis E, Shinefield HR, Woodruff BA, Black SB, Destefano F, Chen RT, Ensor E, Vaccine Safety Datalink Workgroup. Safety of neonatal hepatitis B vaccine administration. Pediatr Infect Dis J. 2001 Nov;20(11):1049-54.
- DeStefano F, Verstraeten T, Chen RT. Hepatitis B vaccine and risk of multiple sclerosis. Expert Rev Vaccines. 2002 Dec;1(4):461-6.
- Niu MT, Rhodes P, Salive M, Lively T, Davis DM, Black S, Shinefield H, Chen RT, Ellenberg SS. 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.
- 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.
- PREHEVBRIO vaccine is the only hepatitis B vaccine that does not contain yeast, making it safe for people who are allergic to yeast.