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Hepatitis B Overview

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Hepatitis B: The Disease

Hepatitis B (HBV) is a viral infection that infects the liver and occurs largely in adults with infection transmitted through sexual contact, sharing of needles, syringes and other drug injection equipment. Most acute infections last a few weeks and do not become chronic. Some cases can last 6 months or longer, become chronic, and lead to liver cancer and death. Recovery from acute hepatitis B infection provides lifetime protective immunity.

Symptoms of hepatitis B generally appear in 90 days and last a few weeks, and between 30 and 50 percent of infected adults and children over the age of five will have symptoms, while many children under the age of five will not.Transmission of infection from mother to child during birth is rare now that prenatal screening is conducted in all U.S. states. Symptoms of acute hepatitis B include fever, fatigue, loss of appetite, nausea, vomiting, abdominal pain, dark urine, discolored (clay) bowel movements, joint pain and jaundice (yellowish skin or eyes). Learn more about Hepatitis B…

Hepatitis B Vaccine

There are six recombinant hepatitis B vaccines and one adjuvanted hepatitis B vaccine approved by the FDA in the U.S. The CDC recommends that all infants be vaccinated with three doses of hepatitis B vaccine by six months of age with the first dose given within 24 hours of birth to prevent transmission by an infected mother to her newborn, and the last dose should not be administered before 24 weeks of age. The CDC also recommends hepatitis B vaccination for adults under 60 years of age. Learn more about Hepatitis B vaccine…

Hepatitis B Quick Facts

Hepatitis B

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. Newborn infections are uncommon in the U.S. with screening during pregnancy helping to determine risk of infection to the baby and treatments available to mother and child.

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 bodily 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. Continue reading quick facts…

Hepatitis B Vaccine

There are six recombinant hepatitis B vaccines approved by the FDA for use in the U.S.: Engerix-B; Recombivax HB; PREHEVBRIO; Twinrix (combined with hepatitis A); Pediarix (combined with diphtheria and tetanus toxoids, acellular pertussis adsorbed, and inactivated poliovirus); and VAXELIS (combined with diphtheria and tetanus toxoids, acellular pertussis adsorbed, Haemophilus b conjugate, and inactivated poliovirus)The seventh is Heplisav-B, a recombinant adjuvanted vaccine.
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.

Using the MedAlerts search engine, as of June 30, 2023, there have been more than 104,109 adverse events reported to the federal Vaccine Adverse Events Reporting System (VAERS) in connection with hepatitis B containing vaccines. Nearly 56 percent (57,791) of reported serious hepatitis B vaccine-related adverse events occurred in children under 3 years old, with over 70 percent (1,716) of deaths occurring in children under three years of age. Out of the reports in VAERS there were 2,344 related deaths, 16,008 hospitalizations, and 3,707 related disabilities. Continue reading quick facts...

NVIC encourages you to become fully informed about Hepatitis B and the Hepatitis B vaccine by reading all sections in the Table of Contents below, 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.

What is Hepatitis B?

Hepatitis B (HBV) is a viral infection that infects the liver and requires direct contact with infected blood or other body fluids for transmission.

Symptoms of hepatitis B generally appear in 90 days and last a few weeks. Symptoms include fever, fatigue, loss of appetite, nausea, vomiting, abdominal pain, dark urine, discolored (clay) bowel movements, joint pain and jaundice (yellowish skin or eyes).

About half of infected adults and children over the age of five will have symptoms of the disease, while many children who are under the age of five will not.

Most acute hepatitis B infections do not persist and become chronic, but if the infection lasts six months or longer and persists without being cleared, it could eventually lead to chronic liver disease, liver cancer, and death.

Hepatitis B infection is diagnosed through blood testing. Persons with an acute hepatitis B infection will have a positive hepatitis B surface antigen (HBsAg). HBsAg can be detected in the blood as early as one week after infection onset and may persist as late as nine weeks. Individuals who clear the infection will have a positive hepatitis B surface antibody (HBsAb) that can be detected in the blood. It may take six months or more for blood tests to indicate whether an acute infection has resolved or become chronic. Individuals who recover from an acute hepatitis B infection and clear the virus are immune for life.

Is Hepatitis B contagious?

Unlike other infectious diseases for which vaccines have been developed and mandated in the U.S., hepatitis B is not common in childhood and is not highly contagious in the same way as chickenpox and pertussis. Hepatitis B is primarily an adult disease transmitted most frequently through blood but can also be transmitted through other body fluids such as semen and vaginal secretions. Hepatitis B is NOT transmitted through sneezing, kissing, sharing food or utensils or breastfeeding. In many cases, transmission may be asymptomatic.

Those most at risk of hepatitis B include needle using drug addicts (illegal IV drug users); those who have sexual contact with a person infected with hepatitis B; sexually promiscuous heterosexual and homosexual adults; residents and staff of custodial institutions such as prisons; health care workers exposed to blood; hemodialysis patients, and infants born to infected mothers.

Transmission of hepatitis B from infected mother to infant has always been uncommon and continues to be uncommon in the U.S., primarily due to routine prenatal screening of all pregnant women for hepatitis B infection, which, in many states, is required by law. Infants of mothers who are found to be positive for hepatitis B or whose hepatitis B status is unknown are treated by immunoprophylaxis with hepatitis B immune globulin (HBIG) to prevent transmission from mother to baby.

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.

What is the history of Hepatitis B in America and other countries?

The U.S. and Western Europe have always had among the lowest rates of hepatitis B disease in the world, affecting less than two percent of the general population compared to countries in the Far East and Africa, where the disease affects 5 to 10 percent or more of the population.

According to the CDC, from 1985 through 1993, the reported incidence of hepatitis B decreased 59 percent in the U.S. This decline was caused by the decrease in number of reported cases among homosexual men between 1985 and 1989 and IV drug users between 1989 through 1992. The CDC has attributed the decrease in hepatitis B to the increase in AIDS awareness that resulted in behavioral changes such use of condoms, and safer needle use and sex practices.

Notably, the significant decline in hepatitis B disease in the U.S. occurred prior to the CDC’s Advisory Committee on Immunization Practices (ACIP) 1991 recommendation that all infants be administered a birth dose of hepatitis B vaccine before being discharged from the hospital newborn nursery.

In 1985, the number of cases of hepatitis B peaked at 26,611 and subsequently declined annually. In 1991, when the ACIP recommended all infants receive a birth dose of the hepatitis B vaccination, the number of reported cases of hepatitis B had already decreased to 18,003. By 1996, there were only 10,637 cases of hepatitis B reported in the U.S. with 279 cases reported in children under the age of 14 and the CDC stated that "Hepatitis B continues to decline in most states, primarily because of a decrease in the number of cases among injecting drug users and, to a lesser extent, among both homosexuals and heterosexuals of both sexes."

By 2006, the number of Hepatitis B cases decreased to 4,713 with only 14 cases reported in children less than 14 years of age. In 2020, there were 2,157 reported cases of acute hepatitis B. Nineteen cases of perinatal hepatitis B were reported to the CDC in 2019.

From 2005 through 2020, reported cases of acute hepatitis B in the U.S. were highest in adults aged 30-49 years of age and lowest among individuals 0-19 years of age. There was one reported outbreak of hepatitis B that occurred in a health care setting in 2015. During 2016, there was one outbreak reported in a health care setting, due to multiple infection control breaches, which resulted in two staff members being infected.

According to the CDC, for cases of hepatitis B reported in 2020:

Of the 1,115 case reports that included information about injection-drug use, 36 percent indicated use of injection drugs;
Of the 636 case reports that included information about sexual contact, 19 percent indicated sexual contact with multiple partners.

In 2020, the rate of acute hepatitis B infection ranged from a high of 3.2 cases per 100,000 population in West Virginia to a low of 0.1 cases in California, Kansas, Minnesota, Nebraska, and South Dakota. The largest decrease in rates occurred in Kentucky while the largest increase occurred in South Carolina.

Can Hepatitis B cause injury and/or death?

For most people hepatitis B is not a deadly disease. Symptoms of acute hepatitis B disease usually begin within one to four months of exposure and include nausea, vomiting, fatigue, low grade fever, pain and swelling in joints, headache, cough and jaundice (yellowing of the skin or eyes). Fatigue and malaise may persist for weeks or months during recovery, as symptoms subside.Fifty percent of adults infected with hepatitis B have will have no symptoms.Hospitalization for acute hepatitis B is low and limited to the elderly, individuals with pre-existing medical conditions and those who require treatment for dehydration from severe nausea and vomiting. On very rare occasions, acute hepatitis B infections can lead to liver failure and death.

Approximately five percent of adults do not recover completely and will become chronic carriers of the virus. Of this number, only 15 percent will develop life-threatening liver disease such as cirrhosis or liver cancer.Chronic infection requires monitoring and avoidance of alcohol and smoking to avoid liver damage. Persons who develop chronic hepatitis B infection during childhood have about a 25 percent risk of dying from a serious hepatitis B complication such as liver cancer or cirrhosis.

In 1988, the Advisory Committee on Immunization Practices (ACIP) recommended that all pregnant women be screened to identify hepatitis B positive expectant mothers and allow for immediate treatment of their newborns with hepatitis B immune globulin (HBIG) and the hepatitis B vaccine. This recommendation was put forth due to the high rate of transmission from hepatitis B positive mothers to their newborns. All pregnant women are now routinely screened early in pregnancy for both hepatitis B surface antigen (HBsAg) and Hepatitis B "e" antigen (HBeAg).

Studies indicate that 90 percent of infants born to a mother who is both positive for HBsAg and HBeAg and between five percent and 20 percent of infants born to a mother who is HBsAg positive but HBeAg negative, will become infected without treatment at birth. Treatment with hepatitis B immune globulin (HBIG) and the hepatitis B vaccine within 24 hours of birth is estimated to be 85 to 95 percent effective in preventing chronic hepatitis B infection in infants born to hepatitis B positive mothers.

Although much attention is focused on the risk of perinatal transmission, a 1996 report issued by the U.S. Preventative Services Task Force, an organization comprised of nationally recognized experts in prevention, evidence-based medicine, and primary care, stated infections during infancy were “estimated to represent only one to three percent of all hepatitis B cases.”However, more recent research indicates rates in the use are likely to be much lower.

Those who recover completely from hepatitis B infection acquire life-long immunity.

Who is at highest risk for getting Hepatitis B?

In the U.S., individuals at highest risk for hepatitis B infection are those who have sexual contact with a person infected with hepatitis B or engage in risky behaviors such as illegal IV drug abuse, prostitution, men who have sex with men, heterosexuals with multiple sexual partners, and hemodialysis patients.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.

Who is at highest risk for suffering complications from Hepatitis B?

For most people, acute hepatitis B is not a serious illness. Most infants and children and 50 percent of all adults have no symptoms. Those most at risk for complications from acute hepatitis B infection include seniors, due to age related decreases in immune function; individuals with pre-existing medical conditions, due to impaired immune function and the inability to adequately clear the virus; and pregnant women, possibly due to pregnancy-related immune changes.

Individuals who are most at risk of chronic hepatitis B include newborns and infants exposed to hepatitis B from their infected mothers during childbirth, individuals with immune deficiencies, and those receiving hemodialysis.

Can Hepatitis B be prevented and are there treatment options?

For most adults, acute hepatitis B does not cause any long-term health issues. Many who are infected are asymptomatic or experience mild flu-like symptoms and fatigue. For those who have an acute hepatitis B infection, treatment options involve rest and hydration. Hospitalization is rare unless severe dehydration from nausea and vomiting occur. Rarely, acute hepatitis B infections can cause acute liver failure (fulminant hepatic failure), and treatment options involve admission to hospital intensive care and a liver transplant.

Less than five percent of adults affected with acute hepatitis B will go on to develop chronic hepatitis B infection. Infants and children infected with acute hepatitis B are often asymptomatic; however, a higher percentage of children with acute hepatitis B will develop chronic hepatitis B infections.

There are several ways to prevent hepatitis B infections. The best option for prevention of hepatitis B in infants involves pre-natal screening of all pregnant women for hepatitis B and immediate perinatal care of the infant with immunoglobulins and vaccination if the mother is hepatitis B positive.

For adults, prevention of hepatitis B infection involves safer sex practices (screening of sex partners, use of condoms) and stopping the use of illegal drugs. It is also advisable to ensure any tattoo and piercing business are reputable and use sterile equipment. Health care workers can prevent hepatitis B infection by practicing universal precautions (gowns, masks, caution with needles) to minimize the risk of infection.

Treatment options for chronic hepatitis B include antiviral medication, Interferon alfa-2b and a liver transplant.

What is 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 (combined with diphtheria and tetanus toxoids, acellular pertussis adsorbed, and inactivated poliovirus); VAXELIS, (combined with diphtheria and tetanus toxoids, acellular pertussis adsorbed, inactivated poliovirus, hepatitis B recombinant, and Hib conjugate vaccine), HEPLISAV-B; and PREHEVBRIO.¹ 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.²This vaccine contains the CpG 1018 adjuvant which has not been previously used in any vaccine licensed in the U.S.³PREHEVBRIO, 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.⁴Links to the package inserts for each hepatitis B vaccine can be found on the hepatitis B Quick Facts page.

Recombivax HB - According to Merck, Recombivax HB is a recombinant hepatitis B vaccine approved by the FDA for intramuscular administration in both infants and adults. It is derived from hepatitis B virus surface antigen (HBsAg) produced in yeast cells. A portion of the hepatitis B virus gene is cloned into yeast, and the vaccine for hepatitis B is produced from cultures of this recombinant yeast strain using proprietary methods developed in the Merck research laboratories. The antigen is collected and purified from fermentation cultures of a recombinant strain of the yeast Saccharomyces cerevisiae containing the gene for the adw subtype of HBsAg. This fermentation process involves growth of Saccharomyces cerevisiae on a complex fermentation medium which consists of an extract of yeast, soy peptone, dextrose, amino acids and mineral salts. The HBsAg protein is released from the yeast cells by cell disruption and purified. This purified protein is treated in phosphate buffer with formaldehyde and then coprecipitated with potassium aluminum sulfate and amorphous aluminum hydroxyphosphate sulfate to form the vaccine adjuvant. Each dose of Recombivax HB should contain no more than one percent yeast protein. The vial stopper and the syringe plunger stopper and tip cap contain dry natural latex rubber, which may cause allergic reactions in latex-sensitive individuals.

Recombivax HB is supplied in three formulations. The pediatric/adolescent formulation (approved for birth to age 19) contains 5 mcg of hepatitis B surface antigen in each 0.5ml dose. Adult formulation (> age 20), contains 10 mcg of hepatitis B surface antigen. The dialysis formulation contains 40 mcg of hepatitis B surface antigen in each 1 mL dose.

All formulations contain approximately 0.5 mg of amorphous aluminum hydroxyphosphate sulfate per mL of vaccine. In each formulation, hepatitis B surface antigen is adsorbed onto approximately 0.5 mg of amorphous aluminum hydroxyphosphate sulfate per mL of the vaccine. Recombivax HB contains yeast protein, soy peptone, dextrose, amino acids, mineral salts, potassium aluminum sulfate, amorphous aluminum hydroxyphosphate sulfate, formaldehyde, phosphate buffer. A series of three doses of the Recombivax HB vaccine is recommended on a one, two- and six-month schedule.

Animal reproduction studies have not been conducted and it is unknown whether the vaccine can cause fetal harm or affect reproduction. It has not been studied for carcinogenic or mutagenic potential, or for impairment of fertility.⁵

Engerix B – According to GlaxoSmithKline, Engerix B is a recombinant hepatitis B vaccine approved by the FDA for intramuscular administration in both infants and adults. It is comprised of a suspension of hepatitis B virus surface antigen (HBsAg) and contains purified surface antigen of the hepatitis B virus obtained by culturing genetically engineered Saccharomyces cerevisiae cells (yeast cells), which carry the surface antigen gene of the hepatitis B virus. The HBsAg expressed in the cells is purified and adsorbed on aluminum hydroxide. Engerix B should contain no more than 5 percent yeast protein. The tip caps of the prefilled syringes contain natural rubber latex which may cause allergic reactions.

Each 0.5-mL pediatric/adolescent (birth through age 19) dose contains 10 mcg of HBsAg on 0.25 mg aluminum hydroxide. Each 1 mL adult (> age 20) dose contains 20 mcg of HBsAg adsorbed on 0.5 mg aluminum hydroxide. Engerix B also contains sodium chloride, disodium phosphate dihydrate and sodium dihydrogen phosphate dihydrate. A series of three doses of the Engerix B is recommended on a one, two- and six-month schedule.

Twinrix - According to GlaxoSmithKline, Twinrix [Hepatitis A & Hepatitis B (Recombinant) Vaccine] contains the antigen components used to produce Havrix (Hepatitis A Vaccine) and Engerix B [Hepatitis B Vaccine (Recombinant)]. Twinrix is administered intramuscularly and contains inactivated hepatitis A virus (strain HM175) and noninfectious hepatitis B virus surface antigen (HBsAg). The hepatitis A virus is propagated in MRC-5 human diploid cells and inactivated with formalin. The HBsAg is obtained by culturing genetically engineered Saccharomyces cerevisiae yeast cells that contain the surface antigen gene of the hepatitis B virus. Bulk preparations of each antigen are adsorbed onto aluminum salts and then pooled during formulation. The tip caps of the prefilled syringes contain natural rubber latex which may cause allergic reactions.

Each 1-mL dose of the vaccine contains 720 ELISA Units of inactivated hepatitis A virus and 20 mcg of recombinant HBsAg protein. It also contains 0.45 mg of aluminum in the form of aluminum phosphate and aluminum hydroxide as adjuvants, amino acids, sodium chloride, phosphate buffer, polysorbate 20, MRC-5 (human diploid cells) proteins, neomycin sulfate, residual formalin, yeast protein and water for Injection.

Twinrix is approved in adults > 18 years of age and administered in a series of three doses on a one, two- and six-month schedule. It is also approved for an accelerated four dose series to be administered on days 0, 7, 21 to 30 with a booster at 12 months.⁷

Pediarix – According to GlaxoSmithKline, Pediarix and contains Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine.

Each 0.5 mL dose is formulated to contain 25Lf of diphtheria toxoid, 10 Lf of tetanus toxoid, 25 mcg of inactivated pertussis toxin (PT), 25 mcg of filamentous hemagglutinin (FHA), 8 mcg of pertactin( 69 kiloDalton outer membrane protein), 10 mcg of HBsAg, 40 D-antigen Units (DU) of Type 1 poliovirus (Mahoney), 8DU of Type 2 poliovirus (MEF-1), and 32 DU of Type 3 poliovirus (Saukett). The diphtheria, tetanus, and pertussis components are the same as those in Infanrix and Kinrix. The hepatitis B surface antigen (HBsAg) is the same as that in Engerix B.

Each 0.5 mL dose contains formaldehyde, glutaraldehyde, aluminum hydroxide, aluminum phosphate, lactalbumin hydrolysate, polysorbate 80, neomycin sulfate, polymyxin B, yeast protein, calf serum, Fenton medium (containing bovine extract), modified Latham medium (derived from bovine casein), modified Stainer-Scholte liquid medium and Vero (monkey kidney) cells.

The tip caps of the prefilled syringes contain natural rubber latex.

Pediarix is approved for use as a three-dose series in infants born of hepatitis B surface antigen (HBsAg)-negative mothers. Pediarix may be given as early as six weeks of age through six years of age (prior to the 7th birthday).⁸

HEPLISAV-B – According to Dynavax, HEPLISAV-B is a preservative free, .05 mL single dose vial vaccine adjuvanted with 3,000 mcg of CpG 1018, and also contains 20 mcg of HBsAg (recombinant Hansenula polymorpha yeast), sodium phosphate, sodium chloride, and polysorbate 80. Vial stoppers are not made with natural rubber latex.⁹

HEPLISAV-B was approved in 2018 for use in the U.S. for use in adults 18 years of age and older as and intramuscular two dose injection series spaced one month apart.¹⁰

There are no clinical studies of HEPLISAV-B in pregnant women and it is not known if the vaccine is excreted in breast milk, or would have an impact on milk production or on the breastfed infant. HEPLISAV-B has not been studied for carcinogenic or mutagenic potential, or for impairment of fertility. Animal data on female rats showed no adverse impacts prior to mating, pre and post-natal development up to the time of weaning, and no fetal malformations. There is a lack of clinical data on the use of this vaccine in children and adults on hemodialysis.¹¹

VAXELIS - is manufactured in partnership by Sanofi Pasteur and Merck (MCM Vaccine Company) and contains Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus influenzae type b, and hepatitis B recombinant. According to the manufacturer’s product insert, each 0.5 mL dose of VAXELIS is formulated to contain 15 Lf diphtheria toxoid, 5 Lf tetanus toxoid, acellular pertussis antigens, 20 mcg detoxified pertussis toxin (PT), 20 mcg filamentous hemagglutinin (FHA), 3 mcg pertactin (PRN), 5 mcg fimbriae types 2 and 3 (FIM), inactivated polioviruses (29 D-antigen units (DU) Type 1 Mahoney, 7 DU Type 2 MEF-1, 26 DU Type 3 Saukett, 3 mcg polyribosylribitol phosphate (PRP) of H. influenzae type b bound to 50 mcg of the outer membrane protein complex (OMPC) of Neisseria meningitidis serogroup B, and 10 mcg hepatitis B surface antigen (HBsAg). Each 0.5 mL dose of VAXELIS contains 319 mcg of aluminum salts as an adjuvant.

Additional ingredients in each 0.5ml dose of VAXELIS includes 319 mcg of aluminum salts as the adjuvant, <0.0056 percent polysorbate 80, less than or equal to 14 mcg residual formaldehyde, less than or equal to 50 ng residual glutaraldehyde, less than or equal to 50 ng residual bovine serum albumin, less than 25 ng of polymyxin B sulfate, less than 5ng of neomycin, less than 200ng of streptomycin sulfate, less than or equal to 0.1ng yeast protein, and less than or equal to 0.125 ng ammonium thiocyanate. VAXELIS does not contain any preservatives.¹²

VAXELIS is approved for use in infants and children ages 6 weeks through 4 years of age (prior to the fifth birthday). It is injected into the muscle in a 3-dose schedule and recommended to be administered at 2, 4, and 6 months of age.¹³

PREHEVBRIO – According to VBI Vaccines, PREHEVBRIO is a preservative free recombinant hepatitis B vaccine containing three hepatitis B surface antigens, small (S), middle (pre-S2), and large (pre-S1), that is purified with cells from Chinese Hamster Ovaries, and cultured in a growth medium containing vitamins, minerals, amino acids, and fetal bovine serum.

Each dose of the vaccine contains 10mcg of each hepatitis B surface antigens absorbed on aluminum hydroxide for an aluminum content of 0.5mg/mL. Each 1mL dose also contains potassium sodium chloride, potassium dihydrogen phosphate anhydrous, disodium hydrogen phosphate dodecahydrate and water for injections. Doses may also contain residual formaldehyde, Chinese Hamster Ovary DNA, and Bovine Serum Albumin.

PREHEVBRIO is approved as a 3-dose series given intramuscularly (IM) on a 0, 1, and 6-month schedule in adults 18 years of age and older.¹⁴

Hepatitis B Vaccination Recommendations

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.¹⁵

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. Persons 60 years of age and older without known risk factors for hepatitis B may also receive hepatitis B vaccine.¹⁶

The hepatitis B Surface Antibody (anti-HBs) blood test can determine whether a person has immunity to Hepatitis B, however, this test is unable to differentiate between vaccine induced immunity or recovery from an acute infection.¹⁷

What is the history of Hepatitis B vaccine use in America?

The first vaccine against hepatitis B, Heptavax-B, (Merck Sharp & Dolme) licensed and approved by the FDA in November of 1981, was comprised of antigen from human serum harvested from several IV drug users and homosexual men.When the vaccine became available in 1982, the Advisory Committee on Immunization Practices (ACIP) recommended the vaccine for individuals who were at risk for contracting hepatitis B due to their lifestyles or their employment. The targeted population included IV drug users, homosexual males, individuals with multiple sex partners, newborn infants of hepatitis B positive mothers and health care workers and patients exposed to blood and blood products.

Concerns over the safety of using human serum in vaccines, due to potential contamination with human viruses, led to the introduction of a second hepatitis B vaccine by Merck Sharp & Dolme, Recombivax-HB, in 1986. This new type of vaccine, known as a recombinant vaccine, was the first vaccine created through genetic engineering. To develop this recombinant hepatitis B vaccine, the gene of the HBV protein envelope was inserted into yeast cells, eliminating the risk of viral contamination from using human serum to produce the vaccine.

Between 1982 and 1991, the hepatitis B vaccine was recommended for individuals considered at moderate to high risk for developing hepatitis B. These populations consisted of health-care professional exposed to blood and blood products, staff and patients of institutions for the developmentally delayed, staff and patients in hemodialysis units, infants born to hepatitis B positive mother, IV drug users, homosexual males and heterosexuals with multiple sex partners.

While hepatitis B vaccine uptake was slow but progressing in health care professionals, as well as those working and living in institutions and those administering and receiving hemodialysis, by 1987, there was little improvement in the rate of use among IV drug users, homosexual males or individuals with multiple sex partners.

By 1989, a second recombinant hepatitis B vaccine, Engerix-B (SmithKlineBeecham), was approved for use in the U.S. However, even though two vaccine manufacturers had produced two new hepatitis B vaccines that had been licensed by the FDA for use by children and adults, the vaccine was not being used.

In 1990, CDC officials expressed concerns that targeting high risk populations was an ineffective strategy because high risk populations did not understand the risk of hepatitis B or need for the vaccine; the vaccine’s cost was a barrier for those who couldn’t afford it; and there was no infrastructure with staffing to reach high risk populations by adequately identifying and vaccinating those most at risk. Further, vaccine education programs targeting IV drug users “failed to motivate them to receive three doses of vaccine.”

While acknowledging that “The sources of infection for most cases include intravenous drug abuse (28%), heterosexual contact with infected persons or multiple partners (22%), and homosexual activity (9%),” CDC officials also stated that, “Between 25% and 50% of children infected before 5 years of age become carriers, whereas only 6%-10% of acutely infected adults become carriers.”

Therefore, in 1990, the CDC recommended that a comprehensive strategy be developed to give hepatitis B vaccine to every child - “before they engage in behaviors or occupations that place them at risk of infection."

In 1991, the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control (CDC) recommended that all infants be injected with the first dose of hepatitis B vaccine at birth before being discharged from the hospital newborn nursery. This recommendation was also supported by the Committee on Infectious Diseases of the American Academy of Pediatrics (AAP), despite little knowledge about the health of an individual baby's immune and neurological systems at birth.

In advance of the 1991 ACIP recommendations, stories appeared in the media portraying Hepatitis B as a deadly disease that was rampant in the United States. News sources were reporting hepatitis B was spreading quickly and everyone was at risk of infection from over 1.5 million persons in the U.S. living with the disease.

These media reports generated by the CDC used hepatitis B disease statistics that were not anchored in documented fact, yet they are still used today to promote mass hepatitis B vaccination. Most of the inflated disease statistics originated with statements generated by officials at the CDC. In the 1991 ACIP recommendations calling for mass vaccination with hepatitis B vaccine published in the Morbidity and Mortality Weekly Report (MMWR), the CDC stated that there are an "estimated 1 million-1.25 million persons with chronic hepatitis B infection in the United States" and that, "each year approximately 4,000-5,000 of these persons die from chronic liver disease" and that, "an estimated 200,000-300,000 new [hepatitis B] infections occurred annually during the period 1980-1991."However, the CDC gives no scientific reference for this data other than the CDC.

Both Recombivax HB and Engerix-B vaccines originally contained the mercury preservative thimerosal, which is used to prevent bacterial contamination of inactivated vaccines, particularly vaccines packaged in multi-dose vials. The Food and Drug Administration (FDA) Modernization Act of 1997 called for FDA to review and assess the risk of all mercury-containing food and drugs. Subsequently, the American Academy of Pediatrics (AAP), the U.S. Public Health Service and vaccine manufacturers published a joint statement on July 9, 1999 calling for the removal of thimerosal from childhood vaccines. However, despite calling for removal of thimerosal from vaccines, including hepatitis B, “as soon as possible,” there was a recommendation that vaccination of children and adults continue using thimerosal-containing vaccines.

The FDA approved thimerosal-free Recombivax HB on August 27, 1999. Thimerosal-free Engerix-B was not approved until January 30, 2007. While the CDC recommended that newborns and infants up to the age of six months be vaccinated with the thimerosal-free version of the hepatitis B vaccine, they stated that high-risk infants and those over the age of six months should continue to receive thimerosal-containing vaccines.

The FDA approved HEPLISAV-B in 2017 for use in adults 18 years of age and older. The CDC’s ACIP voted to add notations to their adult vaccination schedule that would include usage of HEPLISAV-B.

In December of 2018, the FDA approved VAXELIS, a 6 in 1 (hexavalent) vaccine containing Haemophilus influenzae type b conjugate vaccine in combination with diphtheria and tetanus toxoid and acellular pertussis (DTaP), inactivated poliomyelis (IPV), and recombinant hepatitis B vaccine. Manufactured in a partnership between Sanofi Pasteur and Merck, VAXELIS combines the diphtheria and tetanus toxoids, acellular pertussis and inactivated poliomyelis antigens manufactured by Sanofi Pasteur with the Haemophilus influenzae type b conjugate and hepatitis B recombinant vaccines, manufactured by Merck. VAXELIS, approved for use in infants and children between 6 weeks and 4 years of age and recommended to be administered at 2, 4, and 6 months of age.

On November 30, 2021, the FDA approved PREHEVBRIO, a recombinant hepatitis B vaccine manufactured by VBI vaccines that targets the three known hepatitis B subtypes. The vaccine is approved as a 3-dose series in adults 18 years of age and older.

Recommendations for vaccination are made by federal health officials at the CDC, but legal requirements for admission to daycare and schools are made by health officials in health departments in each individual state. When federal health officials set the goal of achieving a 100 percent vaccination rate in the U.S. with new vaccines developed by drug companies and licensed by the FDA, they must persuade states to turn federal vaccine policies into state law.

During the past 70 years, many state legislatures have turned over the power to mandate vaccines to state health department officials, and rarely do state legislators take a vote to approve the mandating of a new vaccine, such as hepatitis B vaccine. Following the 1991 CDC recommendation for universal use of hepatitis B vaccine by all children, state health department officials began issuing mandates requiring children to show proof they have received three doses of hepatitis B vaccine in order to attend daycare or school.

By the end of 1997, 35 states had regulations on the books requiring children to get three doses of hepatitis B vaccine, yet only 15 states had passed laws requiring prenatal screening of pregnant mothers for hepatitis B infection. As of 2021, 48 states and Washington, D.C. required three doses of hepatitis B vaccine for school and/or daycare entry, while only 27 states required prenatal screening of pregnant mothers for hepatitis B infection.

In October 2018, the CDC published its annual vaccine report on vaccination rates of infants, children and adults and reported that 73.6 percent of all newborns receive their first dose of hepatitis B within the first three days of life, and meeting Healthy People 2020 goals with 91.4 percent of all children receive all three doses of the vaccine before the age of 36 months. In 2019, the CDC reported that 91.6 percent of adolescents ages 13-17 as having received all three doses of hepatitis B.

While vaccination rates for infants, children and adolescents was estimated at over 91 percent in 2018, 30 percent of adults had received all three doses of the hepatitis B vaccine. Adults aged 19 to 49, which are those considered to be most at risk for developing hepatitis B, have a vaccination rate of 40.3 percent.

How effective is Hepatitis B vaccine?

The CDC estimates that after completion of the three-dose series of hepatitis B vaccine, over 90 percent of individuals will develop antibodies. All vaccines only stimulate artificial, temporary immunity, and the length of immunity conferred by the hepatitis B vaccine and the future need for more "booster" doses later in life is still not clear. At this time, the CDC is not recommending booster doses for Hepatitis B, however, studies show that only 16 percent of individuals who were vaccinated at birth, one month and six months, as most infants are today, show antibodies after 18 years of age. In individuals who were administered the three-dose series after the age of one, 74 percent have persistent antibodies against Hepatitis B.

As 60-97.7 percent of individuals who receive a “booster” dose of hepatitis B respond rapidly with antibodies, the CDC believes that this is indicative of “immunological memory”and exposure to Hepatitis B should result in rapid antibody response and protection. However, according to the CDC, this 2013 conclusion is based on few studies and “might change as additional data become available”.

More recent research conduct after the CDC’s conclusion suggests that the effectiveness of the vaccine wanes over time and it is possible that additional booster doses will be recommended.

The package inserts for HEPLISAV-B, Recombivax-HB, Engerix-B, or PREHEVBRIO do not provide information on long-term effectiveness of the hepatitis B vaccine.

Can Hepatitis B vaccine cause injury & death?

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. Systemic reactions include fever, headache, and pain. 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). See Hepatitis B Quick Facts for current reports of hepatitis B containing vaccine reactions, hospitalizations, injuries and deaths made to VAERS and links to the manufacturers package inserts.

Some of the events reported during pre-licensure clinical trials by the manufacturers included:

Recombivax HB – tenderness, swelling, nodule formation, pharyngitis, upper respiratory infection, sweating, lightheadedness, chills, dyspepsia, vomiting, influenza, vertigo, paresthesia, myalgia, back, shoulder and neck pain, insomnia, earache, dysuria and hypotension.

In the clinical trials conducted by the manufacturer prior to vaccine licensure, Recombivax-HB hepatitis B vaccine was only evaluated for safety in 147 healthy infants and children for a total of 5 days after each vaccine dose was administered. No long-term safety data was reported for individuals who participated in the clinical trials conducted by the manufacturer before the FDA approved the vaccine for use in all newborn infants.

Engerix B – Dizziness, headache, upper respiratory infections, agitation, lymphadenopathy, agitation, insomnia, hypotension, diarrhea, nausea, vomiting, rash, sweating, back pain, myalgia, chills, influenza-like symptoms, irritability, malaise and weakness.

Clinical trials of Engerix B conducted by the manufacturer prior to FDA approval involved 5,071 healthy newborns, children, and adults without evidence of past hepatitis B infection. Adverse events in trial participants were monitored for only 4 days following each vaccine dose, and no long-term safety studies of trial participants were reportedly conducted by the vaccine manufacturer.

Twinrix - Upper respiratory tract infections, agitation, insomnia, dizziness, migraine, paresthesia, somnolence, syncope, vertigo, abdominal pain, vomiting, rash, sweating, urticaria, back pain, myalgia, influenza-like symptoms, irritability, weakness, lymphadenopathy, hypotension, hypertonia, tingling and photophobia.

Clinical trials of Twinrix conducted in the US involved 773 adults between 18 and 70 years of age who received either Twinrix, or Engerix-B hepatitis B vaccine and Havrix hepatitis A vaccine. No placebo-controlled study was conducted and trial participants were monitored for specific pre-determined adverse events for a total of 4 days post vaccination, and up to 31 days for unsolicited adverse events. No long-term safety studies were reportedly completed by the vaccine manufacturer.

Pediarix – fever, drowsiness, irritability, loss of appetite, pyrexia, gastroenteritis, culture-negative clinical sepsis, bronchiolitis, asthma, diabetes mellitus, chronic neutropenia, febrile and afebrile seizures, and death.

Clinical trials of Pediarix conducted in the US involved 673 infants who received the vaccine and 335 infants who were given separate doses of Infanrix (DTaP) vaccine, Engerix-B hepatitis B vaccine, and IPV (inactivated polio vaccine). Infants in both groups were also given the 7-valent pneumococcal conjugate vaccine (PCV7) and a Hib conjugate vaccine, both of which are no longer available in the US. Participants were monitored for specific adverse reactions for a total of 4 days after each dose administered at 2, 4, and 6 months, and a telephone follow-up was conducted at 1 month and 6 months after the third vaccine dose to solicit information on adverse events. No additional long-term studies for safety were reportedly conducted by the manufacturer after six months following completion of the 3-dose series clinical trial.

HEPLISAV-B – Fatigue, headache, malaise, fever, myalgia, Guillain-Barré syndrome (GBS), Grave’s disease, myocardial infarction (heart attack), hypothyroidism, vitiligo, herpes zoster (shingles), and death.

Clinical trials of HEPLISAV-B hepatitis B vaccine involved a total of 9,597 adults between 18 and 70 years of age involved in five separate studies, however, data from only three of the five studies was made available for review in the package insert. Participants in these three clinical studies received either 2 doses of HEPLISAV-B vaccine and a third dose of saline placebo, or 3 doses of ENGERIX-B hepatitis B vaccine. No placebo-controlled studies were completed.

In Study 1, participants were monitored for specific pre-determined adverse events for seven days and unsolicited adverse events for 28 days following each dose. No additional adverse event data was collected on participants involved in this study after seven months following receipt of the first vaccine dose (one month after receipt of the third dose). Study 2 and Study 3 participants were also monitored for specific pre-determined adverse events for seven days and unsolicited adverse events for 28 days following each vaccine dose, however, Study 2 participants were monitored for 12 months following the first dose (5 months after dose 3), and Study 3 participants were monitored up to 13 months (6 months after dose 3). No long-term safety studies on clinical trial participants were reportedly conducted by the manufacturer past six months following completion of the 3-dose series clinical trials.

VAXELIS - fever, irritability, decreased appetite, pyrexia, respiratory syncytial virus bronchiolitis, bronchiolitis, bronchospasm, hypotonia, GI disorder, colitis, myoclonus, failure to thrive, hydrocephalus, constipation, injection site redness, pain, and swelling, dehydration, diarrhea, intussusception, Group A streptococcus bacteremia, Idiopathic thrombocytopenic purpura (ITP), febrile convulsion, and death.

Clinical trials of VAXELIS involved a total of 5,251 infants between the ages of 43 and 99 days at enrollment over a total of six studies. Two of the six studies were completed in the US and involved 3,392 infants who received VAXELIS, and 889 infants who were controls.

In one US study (Study 005), participants received either VAXELIS at 2, 4, and 6 months and DAPTACEL (DTaP) + PedvaxHIB (HIB) at 15 months, or PENTACEL (5 in one vaccine containing DTaP, HIB, and IPV) at 2, 4, and 6 months, RECOMBIVAX-HB hepatitis B vaccine at 2 and 6 months, and DAPTACEL + ActHIB (HIB) at 15 months. Additionally, all study participants in both groups received RotaTeq vaccine (rotavirus) at 2, 4, and 6 months and Prevnar 13 (pneumococcal conjugate vaccine) at 2, 4, 6, and 15 months.

In the second US study (Study 006), participants received either VAXELIS at 2, 4, and 6 months and PENTACEL at 15 months or PENTACEL at 2, 4, 6, and 15 months and RECOMBIVAX-HB hepatitis B vaccine at 2 and 6 months. As with Study 005, all clinical trial participants also received RotaTeq vaccine at 2, 4, and 6 months and Prevnar 13 at 2, 4, 6, and 15 months.

No placebo-controlled studies of VAXELIS were conducted, and study participants were evaluated for specific pre-determined adverse events by their parent/guardian for five days following receipt of a vaccine dose at 2, 4, and 6 months. Unsolicited adverse events following any vaccine dose were monitored for only 30 days after each administered dose. No long-term safety studies of clinical trial participants were reportedly conducted by the manufacturer after one month following completion of the vaccine clinical trial.

PREHEVBRIO – injection site pain and tenderness, myalgia, fatigue, headache, nausea, vomiting, diarrhea, fever, dizziness/vertigo, generalized itching, joint pain, hives, lymphadenopathy, and lymph node pain.

Clinical trials of PREHEVBRIO hepatitis B vaccine involved two studies of 4,443 participants who received at least one hepatitis B dose. Study participants received either 3 doses of PREHEVRIO hepatitis B vaccine or 3 doses of Engerix-B hepatitis B vaccine. No placebo-controlled studies were conducted. In both studies, participants were monitored for specific pre-determined adverse events for 7 days, and unsolicited adverse events for 28 days following each vaccine dose. Monitoring for serious adverse event continued until six months following receipt of the third vaccine dose. No long-term safety studies past six months following completion of the 3 dose vaccine series was reportedly completed by the manufacturer.

During the past three decades, there have been many published reports and studies linking hepatitis B vaccination to numerous chronic immune and neurological diseases in children and adults. These include lupus, arthritis, including polyarthritis and rheumatoid arthritis Guillain Barre Syndrome, demyelinating disorders such as optic neuritis, Bell’s palsy, transverse myelitis, demyelinating neuropathy and multiple sclerosis along with diabetes mellitus, chronic fatigue,vascular disorders and more.

In the comprehensive report evaluating scientific evidence, Adverse Effects of Vaccines: Evidence and Causality, published in 2012 by the Institute of Medicine, 27 reported vaccine adverse events following the hepatitis B vaccine were evaluated by a physician committee. These adverse events included multiple sclerosis, arthritis, Guillain Barre Syndrome, diabetes mellitus, optic neuritis, transverse myelitis and more. In 26 of the 27 hepatitis B vaccine-related adverse events evaluated, the IOM committee concluded that there was inadequate evidence to support or reject a causal relationship between the hepatitis B vaccine and the reported adverse event, primarily because there was either an absence of methodologically sound published studies or too few quality studies to make a determination. The IOM committee, however, concluded that the scientific evidence “convincingly supports” a causal relationship between anaphylaxis and hepatitis B in yeast-sensitive individuals.

A 2010 study published in the Journal of Toxicology and Environmental Health found that male neonates had a threefold greater chance of being diagnosed with autism compared to boys never vaccinated or vaccinated after the first month of life.

A 2015 study, which reviewed case studies and research on numerous autoimmune disorders following the hepatitis B vaccine, concluded that there is a link between hepatitis B vaccine and development of vasculitis, chronic arthritis, lupus, MS, myelitis, and thrombocytopenia/pancytopenia. While the study examined a relationship between hepatitis B vaccine and other conditions, such as neuropathy, myasthenia gravis, chronic fatigue syndrome, autoimmune skin conditions and more, study authors determined that further research was required before conclusions could be drawn.

Using the MedAlerts search engine, as of June 30, 2023, there have been more than 104,109 adverse events reported to the federal Vaccine Adverse Events Reporting System (VAERS) in connection with Hepatitis B and Hepatitis B containing vaccines. Nearly 56 percent (57,705) of serious Hepatitis B vaccine-related adverse events occurred in children under three years old, with over 70 percent (1,716) of deaths occurring in children under three years of age. Of the vaccine-related adverse events reported to VAERS there were 2,344 related deaths, 16,008 hospitalizations, and 3,707 related disabilities. 73,816 of the adverse events were associated with Hepatitis B vaccine alone (not combined with other vaccines).

Even though the National Childhood Vaccine Injury Act of 1986 legally required pediatricians and other vaccine providers to report serious health problems following vaccination to federal health agencies (VAERS), many doctors and other medical workers giving vaccines to children and adults fail to report vaccine-related health problem to VAERS. There is evidence that only between 1 and 10 percent of serious health problems that occur after use of prescription drugs or vaccines in the U.S. are ever reported to federal health officials who are responsible for regulating the safety of drugs and vaccines and issue national vaccine policy recommendations.

As of August 1, 2023, there have been 1,014 claims filed so far in the federal Vaccine Injury Compensation Program (VICP) for 102 deaths and 912 injuries that occurred after hepatitis B vaccination. Of that number, the U.S. Court of Claims administering the VICP has compensated 382 children and adults, who have filed vaccine injury claims following vaccination with a hepatitis B or hepatitis B combination vaccine.

Who is at highest risk for complications from Hepatitis B vaccine?

There is a gap in medical knowledge in terms of doctors being able to predict who will have an adverse reaction to hepatitis B vaccination, and who will not.

Persons at highest risk for complications from hepatitis B vaccine are those with contraindications and/or precautions to the vaccine. These include persons who are allergic to any ingredient found in the vaccine, including a hypersensitivity to yeast. Persons who receive a hepatitis B vaccine while ill may also be at an increased risk of developing complications.¹

Who should not get Hepatitis B vaccine?

According to the CDC anyone who has ever had a life-threatening allergic reaction to a previous dose of hepatitis B vaccine should not get another dose. Anyone with a severe allergy to any part of the vaccine, including yeast, should not receive the vaccine. People who are moderately or severely ill at the time the vaccine is scheduled should wait until they recover before getting hepatitis B vaccine.

Twinrix (Hepatitis A and Hepatitis B combination vaccine) should not be administered to anyone younger than 18 years of age. Pediarix (Diphtheria and Tetanus Toxoids and Acellular Pertussis, Hepatitis B and Inactivated Poliovirus combination vaccine) should not be administered to anyone younger than six weeks or older than six years of age.VAXELIS (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine) should not be administered to anyone younger than six weeks or older than four years of age.

Also, information about contraindications (reasons why a person should not get a vaccine) to hepatitis B vaccine are contained in the manufacturer’s product information package insert that accompanies vials of vaccine provided to doctors and other medical personnel administering the vaccine. Links to the vaccine package inserts can be found on the hepatitis B Quick Facts page.

Recombivax-HB should not be administered to anyone with a history of allergic or hypersensitivity reaction to any component of the vaccine, including yeast. The vial stopper and syringe plunger stopper and tip cap contain latex, which can cause allergic reactions. Caution should be used in administering this vaccine to any premature infant due to the risk of apnea. As well, this vaccine should be delayed at least 1 month (or until hospital discharge) for infants weighing less than 2,000 g (4.4 lbs) if the mother is known to be hepatitis B negative. There are no adequate and well-controlled studies designed to evaluate Recombivax-HB in pregnant women. It is also unknown whether the vaccine is excreted in human milk and caution should be used when administering to nursing mothers.

Engerix-B should not be administered to anyone with a history of an allergic or hypersensitivity reaction to any component of the vaccine, including yeast. The tip cap of prefilled syringes contain latex, which can cause allergic reactions. Caution should be used in administering this vaccine to a premature infant due to the risk of apnea. As well, this vaccine should be delayed at least 1 month (or until hospital discharge) for infants weighing less than 2,000 g (4.4 lbs) if the mother is known to be hepatitis B negative here are no adequate and well-controlled studies designed to evaluate Engerix-B. It is also unknown whether the vaccine is excreted in human milk and caution should be used when administering to nursing mothers.

Twinrix (Hepatitis A & Hepatitis B) should not be administered to anyone who has ever had a severe (life-threatening) allergic reaction to a previous dose of hepatitis A or hepatitis B vaccine. Anyone who has a severe (life threatening) allergy to any vaccine component, including yeast and Neomycin, should not get the vaccine. The tip caps of the prefilled syringes contain latex and may cause allergic reactions in sensitive individuals. There are no adequate and well-controlled studies designed to evaluate Twinrix. Caution is advised when considering administration of Twinrix to nursing mothers, as it is unknown whether the vaccine is excreted in human milk. Twinrix should be given with caution to persons with bleeding disorders, such as hemophilia or thrombocytopenia, and to persons on anticoagulant therapy. Twinrix should not be given to anyone under 18 years of age.

Pediarix (DTaP, Hepatitis B, Inactivated Polio) should not be given to anyone who has had a severe reaction to a previous dose of diphtheria toxoid, tetanus toxoid, pertussis antigen, poliovirus or hepatitis B vaccine or a component of the vaccine, including yeast and neomycin or polymyxin B antibiotics. The tip caps of the prefilled syringes contain latex, which may cause an allergic reaction. Infants and children who developed encephalopathy (example - coma, seizures, and decreased level of consciousness) within seven days of a pertussis-containing vaccine should not receive Pediatrix. Also, any infant or child who developed a progressive neurological disorder, such as progressive encephalopathy, uncontrolled epilepsy and infantile spasms should not be given Pediarix. The manufacturer warns that if a fever of 105.7 F (40.5 C), collapse or shock-like state (hypotonic-hyporesponsive episode), persistent, inconsolable crying lasting three hours or more occurred within 48 hours, or if seizures (with or without fever) occurred within three days of a previous pertussis-containing vaccine, there should be careful consideration of the potential benefits and risks of giving Pediatrix. If Guillain-Barre syndrome occurred within six weeks of receiving a tetanus toxoid containing vaccine, careful consideration of the potential benefits and risks should be taken before administering Pediarix. Pediarix should not be given to anyone under the age of six weeks or over the age of six.

HEPLISAV-B (adjuvanted recombinant vaccine) should not be given to adults with a history of severe allergic reactions to any previous hepatitis B vaccine, or any component of HEPLISAV-B, including yeast. HEPLISAV-B is approved for use in persons 18 years and older. Persons under 18 years should not receive HEPLISAV-B.

VAXELIS (DTaP, inactivated polio, HIB conjugate, recombinant Hepatitis B) should not be administered to anyone with a history of a severe allergic reaction to a previous dose of VAXELIS, any ingredient found in VAXELIS, or any other tetanus toxoid, diphtheria toxoid, pertussis-containing vaccine, hepatitis B vaccine, inactivated poliovirus vaccine, or H. influenzae type b vaccine. VAXELIS should not be given to anyone who has suffered encephalopathy within seven days of a previous pertussis-containing vaccine with no other identifiable cause. Anyone with a history of progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy should not receive VAXELIS until a treatment regimen has been established and the condition has stabilized. Careful consideration should be given to the benefits and risks of VAXELIS before administering the vaccine to someone with a history of fever at or above 105 degrees F, a hypotonic-hyporesponsive episode, or persistent, inconsolable crying lasting more than three hours within 48 hours after a pertussis-containing vaccine, or who has suffered seizures within three days after a previous pertussis-containing vaccine. A causal relationship between tetanus toxoid and both brachial neuritis and Guillain-Barré syndrome has been determined by the Institute of Medicine (IOM). If Guillain-Barré syndrome occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, the risk for Guillain-Barré syndrome may be increased following VAXELIS. Apnea in infants born prematurely has been associated with the administration of intramuscular injections, including VAXELIS. Administration of this vaccine should only be considered after careful assessment of the infant’s health status, along with the potential risks and benefits of vaccination. VAXELIS is approved for use in infants and children 6 weeks through 4 years of age, prior to their fifth birthday. Infants younger than 6 weeks of age, and children 5 years of age and older should not receive VAXELIS.

PREHEVBRIO should not be administered to anyone who has had a severe allergic reaction to a previous dose of hepatitis B vaccine or to any component of PREHEVBRIO. PREHEVBRIO is approved for use in person 18 years and older. PREHEVBRIO should not be administered to persons under the age of 18 years.

What questions should I ask my doctor about Hepatitis B vaccine?

NVIC’s If You Vaccinate, Ask 8! webpage and downloadable brochure suggests asking eight questions before you make a vaccination decision for yourself, or for your child. If you review these questions before your appointment, you will be better prepared to ask your doctor questions. Also make sure that the nurse or doctor gives you the relevant Vaccine Information Statement (VIS) for the vaccine or vaccines you are considering well ahead of time to allow you to carefully review it before you or your child are vaccinated. Copies of VIS for each vaccine are also available on the CDC's website and there is a link to the VIS for the Hepatitis B vaccine on NVIC's Hepatitis B Quick Facts page.

It is also a good idea to read the vaccine manufacturer product insert that can be obtained from your doctor or public health clinic. Federal law requires drug companies marketing vaccines to include certain kinds of vaccine benefit, risk and use information in product information inserts that may not be available in the VIS or other information published by government health agencies. Vaccine package inserts for hepatitis B and hepatitis B combination vaccine are located on the NVIC’s Quick Facts page.

Other questions that may be useful to discuss with your doctor before getting the hepatitis B vaccine are:

If other vaccines in addition to hepatitis B vaccine are scheduled for my child at this office visit, am I allowed to modify the schedule so fewer vaccines are given at once?
What should I do if my child has a high fever or appears very ill after vaccination?
What kinds of serious vaccine reaction symptoms should I call to report after hepatitis B vaccination?
If the hepatitis B vaccine doesn’t protect my child, do I have any other options for preventing hepatitis B infection?

Under the National Childhood Vaccine Injury Act of 1986, doctors and all vaccine providers administering routinely recommended childhood vaccines are legally required to give you vaccine benefit and risk information before vaccination; record serious health problems following vaccination in the permanent medical record; keep a permanent record of all vaccines given, including the manufacturer’s name and lot number; and report serious health problems, injuries and deaths that follow vaccination to VAERS. It is important to remember that not all vaccines recommended for adults are covered by the 1986 Act.

Remember, if you choose to vaccinate, always keep a written record of exactly which shots/vaccines you or your child have received, including the manufacturer’s name and vaccine lot number. Write down and describe in detail any serious health problems that develop after vaccination, and keep vaccination records in a file you can access easily.

It also is important to be able to recognize a vaccine reaction and seek immediate medical attention if the reaction appears serious, as well as know how to make a vaccine reaction report to federal health officials at the Vaccine Adverse Reporting System (VAERS). NVIC’s Report Vaccine Reactions—It’s the Law webpage can help you file a vaccine reaction report yourself to VAERS if your doctor fails or refuses to make a report

Selected NVIC Statements & Commentaries Related to Hepatitis B or Hepatitis B Vaccine

NVIC Press Releases

Thimerosal and Newborn Hepatitis B Vaccine Recommendation- July 8, 1999
Hepatitis B Vaccine Congressional Hearing- May 19, 1999
Hepatitis B Vaccine Reaction Reports Outnumber Disease Reports - January 27, 1999

NVIC Articles

Hepatitis B: Discrimination and Vaccine Damage - by Barbara Loe Fisher, March 2008
Special Report - Hepatitis B Vaccine: The Untold Story, NVIC Vaccine Reaction, September 1999
France Suspends School-Based Vaccination Program(NVIC), 1999

The Vaccine Reaction

TVR Staff Indian Study Reveals Birth Dose of Hepatitis B Vaccine Unnecessary The Vaccine Reaction Feb. 6, 2018.
TVR Staff Hepatitis B Vaccine Global Market to Grow Over Next Decade The Vaccine Reaction Jan. 17, 2017.
Parpia R FDA Licenses New Hepatitis B Vaccine Despite Big Safety Concerns The Vaccine Reaction Aug. 3, 2018.
Piper-Terry M How Toxic Are Vitamin K and Hepatitis B Injections? The Vaccine Reaction Mar. 29, 2016.
Raines K FDA Approves 6 in 1 Combo Vaccine for Babies The Vaccine Reaction Jan. 3, 2019.
TVR Staff Two Infants in India Die Following Pentavalent Vaccination The Vaccine Reaction Mar. 15, 2018.
Fisher BL, LaVigne P Do You Know What’s In Your Vaccines? The Vaccine Reaction June 15, 2015.
McGovern C. Vaccination May Increase Risk of Rare Psychiatric Childhood Disorders, Study Finds The Vaccine Reaction Feb. 13, 2017.

Selected Medical Literature and Resources Links

Testimonies

5/18/1999 Congressional Hearing, Barbara Loe Fisher
8/3/1999 Congressional Hearing, Dr. Howard Urnovitz
2/17/1999 Advisory Committee on Immunization Practices (CDC),Michael Belkin
2/18/1999 Advisory Committee on Immunization Practices (CDC),Michael Belkin
3/26/1998 Illinois Board of Health,Barbara Loe Fisher

Additional Information & Resources

Hepatitis B Quick Facts

Quick Facts

Hepatitis B

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 June 30, 2023, there have been more than 104,109 adverse events reported to the federal Vaccine Adverse Events Reporting System (VAERS) in connection with hepatitis B containing vaccines. Nearly 56 percent (57,705) of reported serious hepatitis B vaccine-related adverse events occurred in children under 3 years old, with over 70 percent (1,716) of deaths occurring in children under three years of age. Out of the reports in VAERS there were 2,344 related deaths, 16,008 hospitalizations, and 3,707 related disabilities.
As of August 1, 2023, there had been 1,014 claims filed in the federal Vaccine Injury Compensation Program (VICP) for injuries and deaths following hepatitis B containing vaccinations, including 102 deaths and 912 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)

Hepatitis B Disease and Vaccine Facts

People at high risk for getting hepatitis B disease (which is transmitted by coming into direct contact with an infected person's body fluids) are IV drug users, prostitutes, prisoners, sexually promiscuous persons and babies born to infected mothers. (1)
90-95% of all hepatitis B cases recover completely after 3 to 4 weeks of nausea, fatigue, headache, arthritis, jaundice and tender liver. (2)
Up to 17 percent of all hepatitis B vaccinations are followed by reports of fatigue and weakness, headache, arthritis and fever of more than 100 F.. (3) The vaccine can cause death, according to a 1994 Institute of Medicine report. (4)
According to Merck and Company: "The duration of the protective effect of [the vaccine] in healthy vacinees is unknown at present and the need for booster doses is not yet defined."
In 1996, there were 10,637 cases of hepatitis B reported in the U.S. and the CDC stated that "Hepatitis B continues to decline in most states, primarily because of a decrease in the number of cases among injecting drug users and, to a lesser extent, among both homosexual and heterosexuals of both sexes." (5)
In 1996, 279 cases of hepatitis B disease were reported to have occurred in the U.S. in children under 14 years old. (5)
An historic report in 1994 published by the Institute of Medicine, National Academy of Sciences, reviewed the medical literature for evidence that vaccines, including hepatitis B vaccine, can cause a variety of immune and neurological health problems. An independent committee of physician experts concluded that there were no case controlled observational studies or controlled clinical trials conducted on hepatitis B vaccine either before or after licensure to scientifically evaluate persistent reports that hepatitis B vaccine can cause sudden infant death syndrome; Guillain-Barre syndrome (GBS) and other central demyelinating diseases including transverse myelitis, optic neuritis, and multiple sclerosis; and immune system dysfunction including chronic arthritis.

The IOM report concluded: "The lack of adequate data regarding many of the adverse events under study was of major concern to the committee...the committee encountered many gaps and limitations in knowledge bearing directly or indirectly on the safety of vaccines. These include inadequate understanding of the biologic mechanisms underlying adverse events following natural infection or immunization, insufficient or inconsistent information from case reports and case series, inadequate size or length of follow-up of many population-based epidemiologic studies...." (5)

There are more than 200 vaccines being created by federal health agencies and drug companies, including Hepatitis C, D and E; Herpes simplex types 1 and 2; gonorrhea; rotavirus (diarrhea); Group A and B streptococcus; meningitis A, B and C; and HIV for AIDS. (6)

(1) CDC Prevention Guidelines: A Guide to Action (1997); (2) Harrison's Principles of Internal Medicine (1994); (3) Merck & Co. Hepatitis B Vaccine product insert (1993); (4) Adverse Events Associated with Childhood Vaccines (1994; (5) Adverse Events Associated with Childhood Vaccines (1994); (6) The Jordan Report (DHHS-1995).