Disease & Vaccine Information

Hepatitis B Overview



Hepatitis B virus

Hepatitis B: The Disease

Hepatitis B (HBV) is a viral infection that infects the liver and requires direct contact with infected blood or other body fluids for transmission and most acute infections do not persist and become chronic.

Symptoms of hepatitis B generally appear in 90 days and last a few weeks, and about half of infected adults and children over the age of five will have symptoms, while many children under the age of five will not.  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).  Learn more about Hepatitis B disease …

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 beginning at 12 hours of age, with the last dose given before 18 months of age to prevent transmission by an infected mother to her newborn. The CDC also recommends hepatitis B vaccination for adults who are at higher risk of infection due to lifestyle choices or underlying health condition, possible exposure through infected blood, and travel to endemic countries. Learn more about Hepatitis B vaccine

Hepatitis B 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 do not persist but if the infection lasts 6 months or longer, it could lead to chronic liver disease, liver cancer and death. 
  • 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.   
  • 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.  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; Twinrix (combined with hepatitis A); and Pediarix (combined with diphtheria and tetanus toxoids, acellular pertussis adsorbed, and inactivated poliovirus).   The fifth, Comvax (combined with Haemophilus Influenza Type B (HIB) and Meningococcal Protein) is an approved vaccine but production of the vaccine was discontinued in December 2014.  The sixth is Heplisav-B, recombinant adjuvanted vaccine, and was recommended for use in adults by the CDC in 2018. 
  • The CDC recommends that all infants be vaccinated with three doses of hepatitis B vaccine beginning at 12 hours of age with the last dose given before 18 months of age to prevent transmission by an infected mother to her newborn.  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. 
  • 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.      Continue reading quick facts...

Learn More About Hepatitis B and Hepatitis B Vaccine

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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 virus

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 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.  

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.

 

 

Is Hepatitis B Contagious?

hepatitis b virus

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 chicken pox 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?

disease history

The U.S. and Western Europe have always had among the lowest rates of hepatitis B disease in the world, affecting less than one 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.   When, in 1991 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 2016, there were 3,218 reported cases of acute hepatitis B in the U.S. 

From 2000 through 2016 reported cases of acute hepatitis B in the U.S. is highest in adults aged 30-39 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 2016,

  • Of the 1,371 case reports that included information about injection-drug use, 472 cases (over 34 percent) indicated use of injection drugs;
  • Of the 663 case reports that included information about sexual contact, 28 cases (4.2 percent) indicated sexual contact with a person with confirmed or suspected hepatitis B;
  • Of the 104 case reports from males that included information about sexual preference/practices, 9 (8.7 percent) indicated sex with another man;
  • Of the 482 case reports that had information about number of sex partners, 143 (almost 30 percent) indicated individuals having more than 2 sex partners;
  • Of the 663 case reports that included information about household contact, 4 (0.6 percent) indicated household contact with a person with confirmed or suspected hepatitis B. 

Additionally, the CDC reports that of the 48 reporting states, 39 (81.25 percent) states have met Healthy People 2020 goal of reducing incidence of hepatitis B to <1.5 cases/100,000 population. 

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.

 

 

Can Hepatitis B Cause Injury and/or Death?

disease injury and 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.

During 2016, of the 1,651 acute hepatitis B cases containing information about death, 44 deaths were reported. 

There is no recommended medicine for the treatment of acute infections  and 95 percent of adults recover fully from acute hepatitis B infection and acquire life-long immunity.  Eating well, drinking plenty of fluids and avoiding alcohol and drugs assist in recovery. 

Of the approximately five percent who do not recover completely and become chronic carriers of the virus, only 20 to 30 percent will develop life threatening liver disease such as cirrhosis or liver cancer. ,   Chronic infection requires monitoring and avoidance of alcohol to avoid liver damage. 

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. 

Those who recover completely from hepatitis B infection acquire life-long immunity. Of those who do not recover completely, fewer than five percent become chronic carriers of the virus with only 20 to 30 percent developing liver cancer or cirrhosis. 

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.

 

 

Who is at Highest Risk for Getting Hepatitis B?

hepatitis b virus

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 people who have received blood transfusions using infected blood.  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. 

In 2016, there were 3,218 reported cases of acute hepatitis B in the U.S.  which included 32 reported cases of perinatal hepatitis B.  In December 2011, the ACIP recommended that all adults with diabetes, aged 19 to 59, be vaccinated with the hepatitis B vaccine. This recommendation was based on reports of 29 outbreaks of hepatitis B over a 15 year span in long-term care (LTC) facilities. Twenty-five of the 29 outbreaks were attributed to blood glucose monitoring devices. This recommendation was made for all adults with diabetes and not only those in LTC facilities, even though they appear to be at a greater risk due to lapses in infection control practices. 

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.

 

 

Who is at Highest Risk for Suffering Complications from Hepatitis B?

hepatitis b virus

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, individuals with pre-existing medical conditions, and pregnant women. 

Those most at risk for developing chronic hepatitis B include newborns and infants exposed to hepatitis B from their infected mothers, individuals with immune deficiencies and those receiving hemodialysis. 

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.

 

 

Can Hepatitis B be Prevented and are There Treatment Options?

hepatitis b virus destroyed

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. 

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 Hepatitis B Vaccine?

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.  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,  also contains the CpG 1018 adjuvant, not previously used in any vaccine licensed in the U.S.  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.  VAXELIS is expected to be available for use in the United States in 2020,  however, at this time the CDC’s Advisory Committee on Immunization Practice (ACIP) has not made any recommendation regarding the use of VAXELIS.

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. 

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.

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. 

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.

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.

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. 

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). 

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. 

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. 

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 milk production or breastfed infants. 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 are also no clinical data on this vaccines use in children and adults on hemodialysis.  

VAXELIS is manufactured in partnership by Sanofi Pasteur and Merck (MCM Vaccine Company) and contains Diphtheria and Tetanus Toxoids and Acellular Pertussi 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 VAXLEIS 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 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. 

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.  Currently, the CDC’s Advisory Committee on Immunization Practices has not made any recommendation regarding the use of VAXELIS. VAXELIS is expected to become available in the United States in 2020. 

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. 

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.  

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 Vaccine Use in America?

vaccine history

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 Immunization Practices Advisory Committee (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.

By 1990, CDC officials expressed concerns that targeting high risk populations was an ineffective strategy because high risk populations do not understand the risk of hepatitis B or need for the vaccine; the vaccine’s cost is a barrier for those who can’t afford it; and there is 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 made the recommendation 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 but are still used today to promote mass hepatitis B vaccination. Most of the inflated disease statistics originate with statements generated by officials at the Centers for Disease Control. In the 1991 ACIP Recommendations calling for mass vaccination with hepatitis B vaccine published in the Morbidity and Mortality Weekly Report, 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. 

More recently the FDA approved HEPLISAV-B in 2017 for use in adults 18 years of age and older. The CDC’s Advisory Committee on Immunization Practices voted to add notations to their adult vaccination schedule that would include usage of HEPLISAV-B. 

As well, 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.1 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, is expected to become available for use in the United States in 2020.1 The CDC’s Advisory Committee on Immunization Practices (ACIP), however, has not made any recommendations regarding the use of VAXELIS at this time.

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 2016, 47 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.  The CDC also reported 91.9 percent of adolescents ages 13-17 as having received all three doses of hepatitis B. 

While vaccination rates for infants, children and adolescents is estimated at over 91 percent, in 2013, just over 24 percent of adults had received all three doses of the hepatitis B vaccine. Adults aged 19 to 49, considered to be most at risk for developing hepatitis B, have a vaccination rate of 32 percent. 

In 2016, of the 1,651 acute hepatitis B cases containing information about death, 44 deaths were reported. 

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.

 

 

How Effective is Hepatitis B Vaccine?

vaccine effectiveness

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. 

Neither HEPLISAV-B,  Recombivax-HB,  nor Engerix-B  product inserts provide information on long-term effectiveness of the hepatitis B vaccine.

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.

 

 

Can Hepatitis B Vaccine Cause Injury and Death?

vaccine injury and 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. 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). See Hepatitis B Quick Facts for current reports of hepatitis b containing vaccine reactions, hospitalizations, injuries and deaths made to VAERS.

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. 
  • 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. 
  • 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. 
  • 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. 
  • 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. 
  • 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. 

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.  

As of January 1, 2023, there have been 1,001 claims filed so far in the federal Vaccine Injury Compensation Program (VICP) for 101 deaths and 900 injuries that occurred after hepatitis B vaccination. Of that number, the U.S. Court of Claims administering the VICP has compensated 374 children and adults, who have filed vaccine injury claims following vaccination with a hepatitis B or hepatitis B combination vaccine. 

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.

 

 

Who is at Highest Risk for Complications from Hepatitis B Vaccine?

vaccine complications

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

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.

 

 

Who Should not get Hepatitis B Vaccine?

who should not get this 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 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. 

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.

  • According to Merck, 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. It is unknown whether Recombivax-HB can cause fetal harm or affect reproduction and should only be administered to a pregnant woman if clearly needed. It is also unknown whether the vaccine is excreted in human milk and caution should be used when administering to nursing mothers. 
  • According to GlaxoSmithKline, 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. It is unknown whether Engerix-B can cause fetal harm or affect reproduction and should only be administered to a pregnant woman if clearly needed. It is also unknown whether the vaccine is excreted in human milk and caution should be used when administering to nursing mothers. 
  • According to GlaxoSmithKline, 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. TwinRix is a pregnancy category C biological and it is unknown whether the vaccine can cause fetal harm or affect reproduction capacity. 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. 
  • According to GlaxoSmithKline, 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. 
  • According to Dynavax, HEPLISAV-B (adjuvanted recombinate 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, inclusive of yeast. 
  • According to the MCM Vaccine Company, 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 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 relation 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. 

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 Questions Should I Ask My Doctor About Hepatitis B Vaccine?

questions for doctors

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 “Quick Facts” at the top of this 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.

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.

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.

 

 

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

NVIC Hepatitis B Video Playlist

View the collection of video resources within the player below for more information on hepatitis b and the hepatitis b vaccine.

 
To view the entire video collection, click the hamburger menu in the upper left corner of the video player above. This will expand a full list of videos. You may also open the video player in full screen mode for optimal display.

 

NVIC Press Releases

NVIC Articles

The Vaccine Reaction

 

 

Selected Medical Literature and Resources Links

Media

 Testimonies

Additional Information & Resources

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.

 

 

Hepatitis B Quick Facts

hepatitis b virus

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 do not persist but if the infection lasts 6 months or longer, it could lead to chronic liver disease, liver cancer and death.  
  • 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. , 
  • 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. 
  • 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. , 
  • 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.  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.  In 2016, there were 3,218 acute cases of hepatitis B reported in the U.S.   

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.  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,  also contains the CpG 1018 adjuvant, not previously used in any vaccine licensed in the U.S.  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.  VAXELIS is expected to be available for use in the United States in 2020,  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.  
  • 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. , , 
  • 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.  
  • Using the MedAlerts search engine, as of December 31, 2022, there have been more than 101,696 adverse events reported to the federal Vaccine Adverse Events Reporting System (VAERS) in connection with Hepatitis B and Hepatitis B containing vaccines. Approximately 50 percent of those serious Hepatitis B vaccine-related adverse events occurred in children under 3 years old, with approximately 1,704 deaths occurring in children under three years of age. Of the vaccine-related adverse events reported to VAERS there were 2,323 related deaths, 15,574 hospitalizations, and 3,679 related disabilities. 22,905 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 January 1, 2023, there had been 1,001 claims filed in the federal Vaccine Injury Compensation Program (VICP) for injuries and deaths following hepatitis B containing vaccinations, including 101 deaths and 900 serious injuries. 

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.

 

 

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