Hepatitis B Vaccine Safety

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.

  • FDA approved Recombivax HB in 1986 for use from birth through adulthood, although the dose varies by age group.
  • 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. On November 15, 2024, VBI Vaccines, Inc. initiated a voluntary nationwide recall of all remaining PreHevbrio due to the restructuring of the company and discontinuing operations.

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.
Keep Reading: Vaccine Information Statement

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
Keep Reading: Hepatitis B Vaccination

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

Severe allergic reactions following vaccination are rare, but can be life threatening. If someone experiences symptoms of a severe allergic reaction, which can include hives, swelling of the face and throat, difficulty breathing, a fast heartbeat, dizziness, and weakness.

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
‎

The Vaccine Adverse Event Reporting System (VAERS) is an early warning system, co-managed by CDC and FDA, that monitors for potential vaccine safety problems. Healthcare providers and vaccine manufacturers are required by law to report certain adverse events (any side effect or health problem after vaccination that is concerning to you, even if you are not sure if the vaccine caused the event) following vaccination to VAERS; patients and caregivers can also submit reports.

Submitting a Vaccine Adverse Event Reporting System (VAERS) Report and Using VAERS Data

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

In 1998, some research caused concern that hepatitis B vaccination might be linked with multiple sclerosis (MS), a progressive nerve disease. Numerous studies have evaluated a possible relationship between hepatitis B vaccination and MS. A large body of scientific evidence now shows that hepatitis B vaccination does not cause or worsen MS.

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

Keep Reading: About CDC's Vaccine Safety Monitoring Program

Resources

Hepatitis B Basics
Hepatitis B ACIP Vaccine Recommendations
ACIP Recommendations on Hepatitis B and other MMWR articles. Advisory Committee on Immunization Prac...
Hepatitis B Vaccine Administration
Hepatitis B vaccination is recommended for adults at risk for HBV infection, including persons at ri...
Clinical Overview of Hepatitis B
Contraindications and Precautions
Contraindications and Precautions: General Best Practice Guidelines for Immunization. Advisory Commi...
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Content Source:
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)
  1. 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
  2. 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
  3. 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
  4. 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
  5. 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
  6. 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
  7. 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
  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).
  9. 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
  10. 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
  11. 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