Hepatitis B Vaccines
About Hepatitis B
Hepatitis B is a liver infection caused by the hepatitis B virus. It is spread when infected blood, semen, or other body fluids enters the body of a person who is not infected. This can happen through sexual contact, sharing needles or other drug-injection equipment, or from mother to baby at birth. The virus can spread from an infected individual even if they do not look or feel sick.
For some people, hepatitis B is a short-term illness with symptoms that can include fever, tiredness, loss of appetite, nausea, vomiting, jaundice, abdominal pain, dark urine, clay-colored bowel movements, joint pain, and jaundice (yellow color in the skin or eyes). But for others, it can become a long-term, chronic infection that might not have symptoms. Risk for chronic infection is related to age at infection: approximately 90% of infected infants become chronically infected, compared with 2%–6% of adults. Chronic hepatitis B can lead to serious health issues, like cirrhosis or liver cancer.
There are safe and effective vaccines that can protect against hepatitis B.
Vaccine Information Statements (VISs) are information sheets produced by CDC that explain both the benefits and risks of a vaccine.
- Hepatitis BHepatitis B vaccine
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There are 5 licensed hepatitis B vaccines currently available in the United States: 3 single antigen vaccines and 2 combination vaccines.
Who Should Get Hepatitis B Vaccine
Hepatitis B vaccine is given as a series of 2, 3, or 4 shots, depending on the vaccine formula and health needs of the person getting vaccinated. CDC recommends hepatitis B vaccine for:
- 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, work exposure to blood, high-risk sexual behavior, injectable drug use, living situations, and certain medical conditions.
- Anyone who wants protection against hepatitis B
For more information, see Who should get vaccinated against hepatitis B.
Manufacturer Package Inserts
These shots contain only hepatitis B vaccine.
- Engerix-B [PDF – 16 Pages]external icon: The Food and Drug Administration (FDA) approved this vaccine in 1989 for use in people from birth through adulthood, although the dose varies by age group.
- Heplisav-B [PDF – 10 Pages]external icon: FDA approved this vaccine in 2017 for use in people 18 years and older.
- Recombivax HB [PDF – 10 Pages]external icon: FDA approved this vaccine in 1983 for use from birth through adulthood, although the dose varies by age group.
These shots contain hepatitis B vaccine plus other vaccines, combined into a single dose.
- Pediarix [PDF – 24 Pages]external icon: FDA approved this combination vaccine in 2002 for use in infants and children 6 weeks through 6 years old. It protects against hepatitis B, diphtheria, tetanus, pertussis, and polio.
- Twinrix [PDF – 14 Pages]external icon: FDA approved this combination vaccine in 2001 for use in people 18 years and older. It protects against hepatitis A and hepatitis B.
Severe allergic reactions following vaccination are rare, but can be life threatening.
Symptoms of a severe allergic reaction can include hives, swelling of the face and throat, difficulty breathing, a fast heartbeat, dizziness, and weakness.
If such reactions occur, call 9-1-1 and get the person to the nearest hospital.
Common Side Effects
- Soreness, redness, or swelling in the arm where the shot was given
Who Should Not Get Hepatitis B Vaccine
Tell your vaccine provider if the person getting the vaccine:
- Has had an allergic reaction after a previous dose or any component of a hepatitis B vaccine
- Has had an allergic reaction to yeast
- Has had an allergic reaction to neomycin (contraindication for Twinrix)
Note: Until safety data are available, providers should not vaccinate pregnant women needing hepatitis B vaccination with Heplisav-B.
Women who might receive Heplisav-B during pregnancy (usually before knowing they are pregnant) are encouraged to enroll in the Heplisav-B pregnancy registry. Contact Dynavax Technologies Corporation, phone: 1-844-443-7734.
People with minor illnesses, such as a cold, may be vaccinated. People who are moderately or severely ill should usually wait until they recover before getting hepatitis B vaccine.
People getting a combination shot should talk to their doctor about contraindications to other vaccines.
More information about contraindications and precautions.
- Hepatitis B Questions and Answers for the Public
Learn more about the hepatitis B virus and the vaccines that provide protection.
- Who Should Not Get Vaccinated
Some people should not get certain vaccines or should wait before getting them. Read the CDC guidelines for each vaccine
- Hepatitis B Vaccine – ACIP Recommendations and Guidance
Official guidance on hepatitis B vaccine from the Advisory Committee on Immunization Practices (ACIP).
- Hepatitis B Questions and Answers for Health Professionals
Information for clinicians on hepatitis B virus, vaccination, and treatment.
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 following vaccination to VAERS; patients and caregivers can also submit reports.
For more information, see Report an Adverse Event to VAERSexternal icon.
- 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.Source: Lack of association between hepatitis B birth immunization and neonatal death: a population based study from the Vaccine Safety Datalink project [Pediatric Infect Dis J. 2004]external icon
- CDC reviewed Vaccine Adverse Event Reporting System (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.Source: Safety of currently licensed hepatitis B surface antigen vaccines in the United Stated, Vaccine Adverse Event Reporting System (VAERS), 2005-2015 [Vaccine. 2018]external icon
- 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.Source: Adverse events after hepatitis A B combination vaccine [Vaccine. 2006]external icon
- 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 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 newborn hepatitis B vaccination.Source: Safety of Neonatal hepatitis B vaccine administration [Pediatr Infect Dis J. 2001]external icon
- 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.Source: Safety of Neonatal Hepatitis B Vaccine Administration [Pediatr Infect Dis J. 2001]external icon
Which adverse events are considered “serious”?
By the Code of Federal Regulations (CFR) Title 21external icon, an adverse event is defined as serious if it involves any of the following outcomes
- A life-threatening adverse event
- A persistent or significant disability or incapacity
- A congenital anomaly or birth defect
- Hospitalization, or prolongation of existing hospitalization
Learn more about adverse events.
CDC and FDA 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 3 systems to monitor vaccine safety:
- The Vaccine Adverse Event Reporting System (VAERS): an early warning system, co-managed by CDC and FDA, to monitor for potential vaccine safety problems. Anyone can report possible vaccine side effects to VAERS.
- The Vaccine Safety Datalink (VSD): a collaboration between CDC and 9 health care organizations that conducts vaccine safety monitoring and research.
- The Clinical Immunization Safety Assessment (CISA) Project: a partnership between CDC and several medical research centers that provides expert consultation and conducts clinical research on vaccine-associated health risks.
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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.
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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 methodexternal icon. Vaccine. 2007;25(31):5938-5943.
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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)external icon. 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 projectexternal icon. Pediatr Infect Dis J. 2004 Jul;23(7):656-62.
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Lewis E, Shinefield HR, Woodruff BA, Black SB, Destefano F, Chen RT, Ensor E, Vaccine Safety Datalink Workgroup. Safety of neonatal hepatitis B vaccine administrationexternal icon. Pediatr Infect Dis J. 2001 Nov;20(11):1049-54.
DeStefano F, Verstraeten T, Chen RT. Hepatitis B vaccine and risk of multiple sclerosisexternal icon. 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)external icon. J Clin Epidemiol. 1998 Jun;51(6):503-10.
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