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Hepatitis B Quick Facts
- Hepatitis B (HBV) is a viral infection that infects the liver and requires direct contact with infected blood or other body fluids for transmission. Most acute hepatitis B infections last several weeks but, in some cases, they can last for up to 6 months. Individuals who recover from an acute hepatitis B infection and clear the virus are immune for life. If the infection lasts 6 months or longer and becomes chronic, it can lead to serious health problems including chronic liver disease, liver cancer, and death.
- According to the U.S. Centers for Disease Control and Prevention (CDC) occurs largely in adults and infection is most often transmitted through sexual contact, sharing of needles, syringes and other drug injection equipment. Most infections are without any symptoms. Symptoms include yellowing of the skin and eyes (jaundice), dark urine, extreme fatigue, nausea, vomiting and abdominal pain.
- In the U.S., hepatitis B is primarily an adult disease, with most cases occurring in persons between 40 and 49 years of age. The virus can also be transmitted from an infected mother to her newborn baby, however, newborn infections are rare in the U.S. due to routine screening of all women during pregnancy. Screening determines whether the mother has an acute or chronic hepatitis B infection that may be transmitted to the newborn during the delivery and allows for treatments to be made available to reduce the risk of newborn infection. Without treatment at birth, up to 90 percent of infants born to hepatitis B infected mothers may go on to develop chronic hepatitis B infection. In 2019, the CDC reported only 19 hepatitis B infections from transmission between an infected mother and her newborn baby during childbirth.
- Populations at highest risk for infection include illegal IV drug users, prostitutes, men who have sex with men, individuals with multiple sexual partners, and people receiving hemodialysis. Healthcare workers exposed to infected blood or body fluids of patients through contact with needles or medical devices used on patients, or when breaches in proper hygiene and/or infection control practices occur, are also at high risk for becoming infected.
- Worldwide, hepatitis B is the cause of up to 80 percent of liver cancer and an estimated 820,000 people die each year from acute or chronic hepatitis B, and is historically endemic in Asia and Africa. Prior to U.S. vaccination campaigns introduced in 1991, hepatitis B was not prevalent in the U.S., with only 18,003 cases of hepatitis B reported, representing .00007 percent of the total U.S population. In 1996, 10,637 cases of hepatitis B were reported in the U.S. with 279 cases reported in children under the age of 14. By 2020, there were 2,157 acute cases of hepatitis B reported in the U.S.
Hepatitis B Vaccine
- There are seven recombinant hepatitis B vaccines approved by the FDA for use in the U.S.: Engerix-B; Recombivax HB; Twinrix (combined with hepatitis A); Pediarix, a 5 in 1 combination vaccine containing diphtheria and tetanus toxoids, acellular pertussis adsorbed, and inactivated poliovirus; VAXELIS, a 6 in 1 combination vaccine containing diphtheria and tetanus toxoids, acellular pertussis adsorbed, inactivated poliovirus, hepatitis B recombinant, and Hib conjugate vaccine; HEPLISAV-B; and PREHEVBRIO. HEPLISAV-B, approved for use in adults 18 years and older, is a recombinant adjuvanted vaccine created through genetic engineering of DNA by inserting a segment of the viral gene in a yeast cell. This vaccine contains the CpG 1018 adjuvant which has not been previously used in any vaccine licensed in the U.S. PREHEVBRIO, approved by the FDA in 2020 for use in persons 18 and older, targets all known hepatitis B subtypes and is produced using Chinese hamster ovary cells.
- According to the package insert for hepatitis B vaccines, side effects include redness, warmth, or swelling at the injection site and fever over 99.9 degrees F may occur and can last one to two days. Systemic reactions include irritability, diarrhea, fatigue, weakness, diminished appetite and rhinitis. Serious side effects from hepatitis B vaccine, however, have been reported to both the federal Vaccine Adverse Events Reporting System (VAERS), and in the medical literature, including lupus, arthritis, Guillain Barre Syndrome (GBS), demyelinating disorders such as optic neuritis, Bell’s palsy, transverse myelitis, demyelinating neuropathy and multiple sclerosis, diabetes, chronic fatigue syndrome, vascular disorders, and more. Animal reproduction studies have not been conducted on hepatitis B vaccines and it is unknown whether the vaccine can cause fetal harm or affect reproduction. They have also not been studied for carcinogenic or mutagenic potential, or for their potential to impair fertility.
- In 1991, the CDC recommended hepatitis B vaccination for all newborns in the U.S. because public health officials and doctors could not persuade adults in high risk groups (primarily IV drug users and persons with multiple sexual partners) to get the vaccine.
- The CDC recommends 3 doses of hepatitis B vaccine by 6 months of age, regardless of maternal infection status. Infants weighing 4.4 lbs and greater receive the first dose within 24 hours of birth, with those weighing less than 4.4 lbs delaying vaccination until hospital discharge or one month of age. Infants born to infected mothers are recommended to receive hepatitis B vaccine, along with hepatitis B immune globulin (HBIG) within 12 hours of birth. The CDC also recommends hepatitis B vaccination for all adults aged 18 through 59 years, and for adults aged 60 and older with known risk factors for hepatitis B.
- Despite hepatitis B affecting mainly adults (aged 30 to 59), by 2018, only 30 percent of U.S. adults over 19 years of age had received the vaccine. Only 67.2 percent of U.S. health care workers in 2018 had been vaccinated for hepatitis B.
- Using the MedAlerts search engine, as of March 31, 2023, there have been more than 102,881 adverse events reported to the federal Vaccine Adverse Events Reporting System (VAERS) in connection with hepatitis B containing vaccines. Nearly 56 percent (57,336) of reported serious hepatitis B vaccine-related adverse events occurred in children under 3 years old, with over 70 percent (1,711) of deaths occurring in children under three years of age. Out of the reports in VAERS there were 2,334 related deaths, 17,032 hospitalizations, and 3,692 related disabilities.
- As of April 1, 2023, there had been 1,005 claims filed in the federal Vaccine Injury Compensation Program (VICP) for injuries and deaths following hepatitis B containing vaccinations, including 102 deaths and 903 serious injuries.
Food & Drug Administration (FDA)
- Recombinant Hepatitis B Vaccine Product Insert and Licensing Information
- Adjuvanted Recombinant Hepatitis B Vaccine Product Insert and Licensing Information
- Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined Product Insert and Licensing Information
- Hepatitis A Inactivated & Hepatitis B (Recombinant) Vaccine Product Insert and Licensing Information
- Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine Vaccine Product Insert and Licensing Information
Search for Vaccine Reactions
NVIC hosts MedAlerts, a powerful VAERS database search engine. MedAlerts examines symptoms, reactions, vaccines, dates, places, and more.
Reporting a Vaccine Reaction
Since 1982, the NVIC has operated a Vaccine Reaction Registry, which has served as a watchdog on VAERS. Reporting vaccine reactions to VAERS is the law. If your doctor will not report a reaction, you have the right to report a suspected vaccine reaction to VAERS.
Vaccine Reaction Symptoms & Ingredients
Our Ask 8, If You Vaccinate webpage contains vaccine reaction symptoms and more.
Centers for Disease Control (CDC)
- CDC on Hepatitis B
- CDC on Hepatitis B Vaccination
- Hepatitis B Vaccine Information Sheet (VIS)
- Your Child’s First Vaccines Vaccine Information Sheet (VIS)
- State Screening Requirements for Pregnant Women
IMPORTANT NOTE: NVIC encourages you to become fully informed about Hepatitis B and the Hepatitis B vaccine by reading all sections in the Table of Contents , which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.