Scientific Tools And Resources
Interpretation of Hepatitis B Serologic Test Results
One page describes the four most common tests used in hepatitis B serologic testing and provides guidance to interpret different patterns of test results.
Screening and Referral Algorithm for Hepatitis B Virus Infection among Pregnant Women
This is a clinical algorithm for screening and referral of pregnant women who are HBsAg-positive.
N/A=not available
*This CPT code corresponds only to the HBsAg screening component additional CPT codes might be associated with other component tests.
Notes: CDC recommends healthcare providers use prenatal HBsAg tests for pregnant women, which allows for reporting of positive results along with pregnancy status to public health jurisdictions. Refer all HBsAg positive pregnant women to Perinatal Hepatitis B Prevention Program coordinators for case management of mother and infant: .
Laboratories reserve the right to add, modify, or stop performing tests at any time providers should review any test notifications from laboratories for changes.
How Do Inactivated Viral Vaccines Work
Inactivated viralvaccines are sterile biologic products that provide immunity against viral infections. Inactivated viral vaccines work by stimulating the bodys immune system to produce antibodies against specific types of viruses, and protect a person from becoming infected when exposed to these viruses.
In the case of SARS-CoV-2 coronavirus that causes respiratory illness and has led to the COVID-19 pandemic, vaccines do not entirely prevent infection but protect vaccinated individuals from serious illness and hospitalization from the disease.
Inactivated viral vaccines contain particles of proteins or genetic material from viruses. Inactivated viral vaccines may also contain substances that preserve and stabilize the vaccine, and enhance immune response. Some viral vaccines are delivered in inactivated harmless viruses such as human adenovirus.
Inactivated viral vaccines may be made from:
- Surface proteins of the viruses enable the virus to hold on to a human cell, enter inside and replicate.
- Modified RNA particles from the virus can enter host cells and induce the production of viral antigen, which stimulates an immune response from the body.
- Recombined DNA material from multiple strains and subtypes of viruses, killed to eliminate disease-causing capability.
Currently, inactivated viral vaccines approved by the FDA protect against viral infectious diseases that include:
- Coronavirus disease , caused by SARS-Cov-2 virus
Adults
How To Get Vaccinated Against Hepatitis B
All babies in the UK born on or after 1 August 2017 are given 3 doses of hepatitis B-containing vaccine as part of the NHS routine vaccination schedule.
These doses are given at 8, 12 and 16 weeks of age.
Babies at high risk of developing hepatitis B infection from infected mothers are given extra doses of the hepatitis B vaccine at birth, 4 weeks and 1 year of age.
If you think youre at risk and need the hepatitis B vaccine, ask your GP to vaccinate you, or visit any sexual health or genitourinary medicine clinic.
If your job places you at risk of hepatitis B infection, its your employers responsibility to arrange vaccination for you, rather than your GP. Contact your occupational health department.
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Indications For Recombivax Hb Indications For Recombivax Hb
RECOMBIVAX HB® is indicated for prevention of infection caused by all known subtypes of hepatitis B virus.
RECOMBIVAX HB is approved for use in individuals of all ages.
RECOMBIVAX HB Dialysis Formulation is approved for use in adult predialysis and dialysis patients 18 years of age and older.
RECOMBIVAX HB is indicated for prevention of infection caused by all known
RECOMBIVAX HB is indicated for prevention of infection caused by all known subtypes of hepatitis B virus.
RECOMBIVAX HB is approved for use in individuals of all ages.
What Other Drugs Interact With Hepatitis B Vaccine
If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.
- Severe Interactions of Hepatitis B Vaccine include:
This information does not contain all possible interactions or adverse effects. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns, or for more information about this medicine.
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Protecting Your Baby Against Hepatitis B Guide
This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. To view this licence, visit nationalarchives.gov.uk/doc/open-government-licence/version/3 or write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or email: .
Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned.
This publication is available at https://www.gov.uk/government/publications/protecting-your-baby-against-hepatitis-b-leaflet/protecting-your-baby-against-hepatitis-b-with-the-hepatitis-b-vaccine
Persons New To Canada
Health care providers who see persons newly arrived in Canada should review the immunization status and update immunization for these individuals, as necessary. In many countries outside of Canada, HB vaccine is in limited use.
All persons from a country that is endemic for HB should be assessed and vaccinated against HB if not immune and not infected. Individuals born in developing countries are more likely to be carriers of HB, necessitating vaccination of their sexual and household contacts based on review of their serologic test results. HB vaccine is recommended for all household contacts whose families have immigrated to Canada from areas in which there is a high prevalence of HB and who may be exposed to HB carriers through their extended families or when visiting their country of origin.
Children adopted from countries in which there is a high prevalence of HB infection should be screened for HBsAg and, if positive, household or close contacts in the adopting family should be immunized before adoption or as soon as possible thereafter. Adults going to pick-up children from these countries should be vaccinated before departure. Refer to Immunization of Persons New to Canada in Part 3 for additional information.
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Why Should I Vaccinate My Newborn Child If I Know That I Am Not Infected With Hepatitis B Virus
Before the hepatitis B vaccine, every year in the United States about 18,000 children were infected with hepatitis B virus by the time they were 10 years old. This statistic is especially important because people are much more likely to develop liver cancer or cirrhosis if they are infected early in life, rather than later in life .
About 9,000 of the 18,000 children infected in the first 10 years of life caught the virus from their mother during birth. However, many young children didn’t catch the disease from their mother. They caught it from either another family member or someone else who came in contact with the child. Because hepatitis B can be transmitted by relatively casual contact with items contaminated with the blood of an infected person, and because many people who are infected with hepatitis B virus don’t know that they have it, it is virtually impossible to be “careful enough” to avoid this infection.
For these reasons, all young children are recommended to receive the hepatitis B vaccine. The best time to receive the first dose is right after birth. This will ensure that the child will be protected as early as possible from catching hepatitis B from people who dont know that they are infected with the virus.
Listen to Dr. Offit explain why newborns get the hepatitis B vaccine by watching this short video, part of the series Talking About Vaccines with Dr. Paul Offit.
Selected Safety Information For Recombivax Hb Selected Safety Information For Recombivax Hb
Do not administer RECOMBIVAX HB® to individuals with a history of severe allergic or hypersensitivity reactions after a previous dose of any hepatitis B-containing vaccine or to any component of RECOMBIVAX HB, including yeast.
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.
Apnea following intramuscular vaccination has been observed in some infants born prematurely. Decisions about when to administer an intramuscular vaccine, including RECOMBIVAX HB, to infants born prematurely should be based on consideration of the individual infants medical status and the potential benefits and possible risks of vaccination. For RECOMBIVAX HB, this assessment should include consideration of the mothers hepatitis B antigen status and high probability of maternal transmission of hepatitis B virus to infants born to mothers who are HBsAg positive if vaccination is delayed.
Hepatitis B vaccination should be delayed until 1 month of age or hospital discharge in infants weighing < 2000 g if the mother is documented to be HBsAg negative at the time of the infants birth. Infants weighing < 2000 g born to HBsAg positive or HBsAg unknown mothers should receive vaccine and hepatitis B immune globulin in accordance with ACIP recommendations if HBsAg status cannot be determined.
Vaccination with RECOMBIVAX HB may not protect all individuals.
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Us Children And Adult Hepatitis B Vaccine Schedules
*Please note that the first dose should be given as soon as possible. Additional doses require minimum time intervals between doses in order for the vaccine to be effective.
3-Dose Vaccine Series for Children and Adults
The hepatitis B vaccine is an injection that is generally given in the arm as a three-dose series on a 0, 1, and 6-month schedule. Alternative schedules may be considered, noting that a third dose at 6 months, meeting minimum intervals between doses, is needed for maximum, long-term protection. Completing the hepatitis B vaccine series, preferably beginning at birth, will ensure protection against hepatitis B, hepatitis delta and lower the lifetime risk of liver cancer. Greater than 90% of babies and up to 50% of young children who are not vaccinated and are infected with hepatitis B will have lifelong infection, which makes the birth dose essential to their protection.
There are four, 3-dose vaccine brands approved in the U.S.
- PreHevbrio PreHevbrio is only approved for adults age 18 and over.
2-Dose Vaccine Series
Babies And Hepatitis B Vaccination
Pregnant women have a routine blood test for hepatitis B as part of their antenatal care.
Babies born to mothers infected with hepatitis B need to be given a dose of the hepatitis B vaccine within 24 hours of their birth, followed by further doses at 4, 8, 12 and 16 weeks of age, plus a final dose when theyre 1 year old.
Babies of mothers identified by the blood test as particularly infectious might also be given an injection of HBIG at birth on top of the hepatitis B vaccination to give them rapid protection against infection.
All babies born to mothers infected with hepatitis B should be tested at 1 year of age to check if they have become infected with the virus.
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Rationale For The Birth Dose
Rationale for the birth dose
The rationale for the birth dose for all newborn infants is to prevent:1
- vertical transmission from a mother with chronic hepatitis B, recognising that there may be errors or delays in maternal testing, reporting, communication or appropriate response
- horizontal transmission to the infant in the first months of life from people with chronic hepatitis B who are household or other close contacts
Newborns should receive the birth dose as soon as they are medically stable, and preferably within 24 hours of birth, but the vaccine can be given within the first 7 days of life. Every effort should be made to give the vaccine before the baby is discharged from the obstetric hospital or delivery unit.
How Common Is Hepatitis B
One U.S. study following trends in hepatitis B infection over a three-year periodfound that 4.3% of the population had a past or present HBV infection.
Estimates suggest that about 240 million people around the world have chronic hepatitis B. Up to 1.89 million people in the United States have a chronic HBV infection.
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What Are The Risks Of Not Getting The Vaccine
The main risk of the baby not getting the vaccine is that they may contract the hepatitis B virus.
Hepatitis B primarily attacks the liver, causing inflammation that can damage this organ over time. An acute infection lasts for less than 6 months and may cause no symptoms in some people.
Many acute infections resolve without treatment. If the infection persists for 6 months or more, doctors will refer to it as chronic. Chronic infections increase a persons risk of damage to the liver over time.
As this damage builds up, it can scar the liver, which is known as cirrhosis. This long-term damage may result in other complications, including liver cancer.
According to the WHO, about
Infants Are Recommended To Receive 4 Doses Of Hepatitis B Vaccine
Infants are recommended to receive 4 doses of hepatitis B vaccine:
- 1 dose of monovalent paediatric formulation hepatitis B vaccine at birth
- 3 doses of a paediatric hepatitis Bcontaining vaccine at 2, 4 and 6 months of age .
Infants can receive the dose scheduled at 2 months of age as early as 6 weeks of age. They should still receive their next scheduled doses at 4 months and 6 months of age.
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A Look At Each Vaccine: Hepatitis B Vaccine
View larger image The hepatitis B vaccine is given to prevent the severe liver disease that can develop when children or adults are infected with hepatitis B virus. The hepatitis B vaccine is given as a series of three shots. The first dose is given within 24 hours of birth. The second dose is given one to two months after the first dose, and the third dose is given between 6 months and 18 months of age. The vaccine is also recommended for those up to 60 years of age who have not previously received it and those 60 years and older who are at increased risk or who simply want the protection afforded by vaccination.
Us Infant Hepatitis B Vaccine Schedules
*Please note that the first dose should be given as soon as possible. Additional doses require minimum time intervals between doses in order for the vaccine to be effective.
3-Dose Vaccine Series for Infants
Since 1991, ALL medically stable infants with a birth weight of at least 2,000 g in the U.S. are recommended to receive the first dose of hepatitis B vaccine within 24 hours of birth. The additional 2 doses are given at 1 month and 6 months of age.
4-Dose Vaccine Combination Series for Infants
Combination vaccines, such as the pentavalent and hexavalent vaccines, include protection against 5 or 6 diseases, including hepatitis B. The first shot is usually given at 6 weeks of age, but in order to protect infants from hepatitis B beginning at birth, a monovalent or single dose of the hepatitis B vaccine is also recommended within 24 hours of birth. The hepatitis B vaccine series can then be completed with the pentavalent or hexavalent vaccine with the recommended schedule.
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What Are Warnings And Precautions For Hepatitis B Vaccine
Warnings
This medication contains the hepatitis b vaccine. Do not take Engerix B or Recombivax HB if you are allergic to the hepatitis b vaccine or any ingredients contained in this drug.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.
Contraindications
- See “What Are Side Effects Associated with Using Hepatitis B Vaccine?”
Long-Term Effects
- See “What Are Side Effects Associated with Using Hepatitis B Vaccine?”
Cautions
- Not protective against hepatitis A, C, or E
- Gluteal muscle injection is not recommended
- Heptavax B is no longer used in the US
Pregnancy and Lactation
- Use the hepatitis B vaccine during pregnancy with caution if the benefits outweigh the risks. Animal studies show risk and human studies are not available, or neither animal nor human studies were done.
- It is not known if the hepatitis B vaccine is excreted in breast milk. Consult your doctor before breastfeeding.
General Information About Vaccination Outside The Us
In developing countries, the pentavalent vaccine, a combination 5-in-one vaccine that protects against five diseases, diphtheria, pertussis, tetanus, Hib and hepatitis B, may be given to babies more than 6 weeks of age, and can be given up to 1 year of age. The first dose is given at 6 weeks, and the second and third doses are given at 10 and 14 weeks of age. The pentavalent vaccine may be made available free of charge with the support of GAVI, the vaccine alliance. Check the GAVI country hub to see the resources and immunizations that may be available:
For babies born to mothers with hepatitis B, waiting for the first dose of the pentavalent vaccine is too late and will NOT protect the baby from vertical or horizontal transmission of hepatitis B. Babies born to a mother with hepatitis B have a greater than 90% chance of developing chronic hepatitis B if they are not properly treated at birth.
WHO recommends the hepatitis B vaccine within 24 hours of birth for ALL babies. Plan ahead and inquire about the availability and cost of the monovalent , birth dose of the vaccine, as it is not a GAVI provided immunization. This is particularly important to women who are positive for hepatitis B.
If you are unsure of your hepatitis B status, please be sure your doctor tests you for hepatitis B!
*WHO does not recommend a birth dose of HBIG, which may not be available in all countries. Talk to your doctor if you have questions.
Page updated September 2022.
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