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 do not persist but if the infection lasts 6 months or longer, it could lead to chronic liver disease, liver cancer and death.1
- Hepatitis B is not common in childhood in the U.S. and is not highly contagious in the same way that common childhood diseases like pertussis and chicken pox are contagious. In the U.S., hepatitis B is primarily an adult disease (ages 20-50) but the virus also can be transmitted from an infected mother to her newborn baby. Most people do not experience any symptoms during acute infection but may have symptoms, such as yellowing of the skin and eyes (jaundice), dark urine, extreme fatigue, nausea, vomiting and abdominal pain.2,3
- While hepatitis B was not prevalent in the U.S. before childhood vaccination campaigns were introduced in 1991, historically it has been endemic in Asia and Africa. In 1991, there were 18,003 cases of hepatitis B reported in the U.S. out of a total U.S. population of 248 million. In 1996, there were 10,637 cases of hepatitis B reported in the U.S. with 279 cases reported in children under the age of 14.4
- Worldwide, hepatitis B is the cause of up to 80 percent of liver cancer and an estimated 686,000 people die each year from acute or chronic hepatitis B around the world.5,6
- In the U.S., individuals at highest risk for hepatitis B infection are those, who engage in risky behaviors such as illegal IV drug use, prostitution, men who have sex with men, heterosexuals with multiple sexual partners and people who have received blood transfusions using infected blood.7 Healthcare workers, who are 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 at high risk for becoming infected with hepatitis B.8 In 2016, there were 3,218 acute cases of hepatitis B reported in the U.S.9
Hepatitis B Vaccine
- There are six recombinant hepatitis B vaccines approved by the FDA for use in the U.S.: Engerix-B; Recombivax HB; Twinrix (combined with hepatitis A); Pediarix (combined with diphtheria and tetanus toxoids, acellular pertussis adsorbed, and inactivated poliovirus); and HEPLISAV-B, recombinant adjuvanted vaccine, recommended for use in adults by the CDC in 2018.10 HEPLISAV-B, a recombinant, adjuvanted hepatitis B vaccine created through genetic engineering of DNA by inserting a segment of the viral gene in a yeast cell,11 also contains the CpG 1018 adjuvant, not previously used in any vaccine licensed in the U.S.12 A sixth vaccine, VAXELIS, a 6 in 1 combination vaccine containing diphtheria and tetanus toxoids, acellular pertussis adsorbed, inactivated poliovirus, hepatitis B recombinant, and Hib conjugate vaccine, received FDA approval in December 2018.13 VAXELIS is expected to be available for use in the United States in 2020,14 however, at this time the CDC’s Advisory Committee on Immunization Practice (ACIP) has not made any recommendation regarding the use of VAXELIS.
- The CDC recommends that all infants 4.4 lbs and greater born to HBsAg-negative mothers be vaccinated with the first dose of hepatitis B vaccine within 24 hours of birth. Infants weighing less than 4.4 lbs born to HBsAg-negative mothers should have the hepatitis B vaccine delayed until hospital discharge or one month of age. The final dose of hepatitis B vaccine should not be administered prior to 24 weeks of age. In populations with high rates of hepatitis B, vaccination with hepatitis B is recommended at birth, with the final dose recommended to be administered between 6 and 12 months of age. Infants born to HBsAg-positive 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 adults with diabetes; household and sexual contacts of people with chronic hepatitis B infection; healthcare workers; people at increased risk for hepatitis B virus exposure due to occupational, behavioral, or medical factors; and international travelers to countries with high or intermediate hepatitis B infection rates. 15
- The primary reason that the CDC recommended hepatitis B vaccination for all newborns in the United States in 1991 is 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.16,17,18
- Despite hepatitis B affecting mainly adults (aged 20 to 50), by 2014, only 24.5 percent of U.S. adults over 19 years of age had received the vaccine. Further, only 60.7 percent of U.S. health care workers in 2014 had been vaccinated for hepatitis B.19
- Using the MedAlerts search engine, as of May 31, 2019, there have been more than 91,474 adverse events reported to the federal Vaccine Adverse Events Reporting System (VAERS) in connection with Hepatitis B and Hepatitis B containing vaccines. Approximately 50% of those serious Hepatitis B vaccine-related adverse events occurred in children under 3 years old, with approximately 1,663 deaths occurring in children under three years of age. Of the vaccine-related adverse events reported to VAERS there were 2,142 related deaths, 13,990 hospitalizations, and 3,387 related disabilities. 21,112 of the adverse events were associated with Hepatitis B vaccine alone (not combined with other vaccines). Mild side effects such as redness, warmth, or swelling at the injection site where the shot was given have been reported in connection with administration of hepatitis B vaccines. 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. However, more severe reactions have also been reported in both clinical trials with all of the vaccines as well as to the Vaccine Adverse Events Reporting System (VAERS).
- As of July 1, 2019, there had been 926 claims filed in the federal Vaccine Injury Compensation Program (VICP) for injuries and deaths following hepatitis B containing vaccinations, including 97 deaths and 829 serious injuries.20
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.
Food & Drug Administration (FDA)
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)
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.
« Return to Vaccines & Diseases Table of Contents
1 CDC. Viral Hepatitis - Hepatitis B information.
2 World Health Organization (WHO). Media Centre Fact Sheets. Hepatitis B. July 2017.
3 CDC. Hepatitis B Information for Health Professionals. Hepatitis B Vaccination FAQs for Health Professionals. Revised Aug. 4, 2016.
4 CDC. Summary of Notifiable Diseases, United States 1996. Table 2 – Notifiable Diseases – Summary of reported cases, United States 1991 and 1996. MMWR Oct. 31, 1997; 45(53): 1-89.
5 World Health Organization. Media Centre Fact Sheets. Hepatitis B.
6 CDC. Vaccines: The Pink Book. Hepatitis B. 13th Edition. 2015.
7 CDC. Hepatitis B FAQs for Health Professionals: Who is at risk for HBV infection? Revised May 31, 2015.
8 Wassem, M, Body Fluid Exposures. Medscape Revised Jul. 12, 2017.
9 CDC. Surveillance for Viral Hepatitis – United States, 2016. Hepatitis B. Table 3.1 Reported cases of acute hepatitis B, national and by state or jurisdiction – United States, 2011-2015. Revised Oct. 1, 2018.
CDC. Viral Hepatitis – Statistics and Surveillance. May 19, 2016.
10 FDA. Vaccines, Blood & Biologics. Complete List of Vaccines Licensed for Immunization and Distribution in the U.S. Nov.16, 2018.
11 CDC. Vaccines: The Pink Book. Principles of Vaccination. 13th Edition. 2015.
12 FDA. Hepatitis B Vaccine (Recombinant), Adjuvanted (HBV Surface Antigen (HBsAg) Protein with CpG 1018 adjuvant). Jul. 28. 2017
13 FDA December 21, 2018 Approval Letter- VAXELIS Dec. 21, 2018
14 Raines, K FDA Approves 6 in 1 Combo Vaccine for Babies The Vaccine Reaction Jan. 3, 2019
15 CDC. Prevention of Hepatitis B Virus Infection in the United States: Recommendations of the Advisory Committee on Immunization Practices MMWR. Jan. 12, 2018; 67(1);1–31
16 Kasper D, Fauci A, Longo D, et al. Disorders of the Gastrointestinal System: Prophylaxis: Hepatitis B. Harrison’s Principles of Internal Medicine 16th Edition. 2005. pp 1836-1837.
17 Viral Hepatitis Prevention Board. Antwerp VHPB Report. Editorial. Control of viral hepatitis in Europe. Viral Hepatitis, 1996, 4(2).
18 CDC. Hepatitis B Virus: A Comprehensive Strategy for Eliminating Transmission in the United States through Universal Childhood Vaccination: Recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR Nov. 22, 1991, 40(RR-13);1-19
19 CDC. Surveillance of Vaccination Coverage Among Adult Populations – United States 2014 MMWR Feb. 5, 2016, 65(1);1–36
20 DHHS. Petitions Filed, Compensated and Dismissed by Alleged Vaccine, Since the Beginning of the VICP 10/01/1988 through 07/01/2019. HRSA July, 2019.