Guidance On Reporting Adverse Events Following Immunization
Vaccine providers are asked to report, through local public health officials, any serious or unexpected adverse event temporally related to vaccination. An unexpected AEFI is an event that is not listed in available product information but may be due to the immunization, or a change in the frequency of a known AEFI.
Refer to Reporting Adverse Events Following Immunization in Canada and Adverse events following immunization in Part 2 for additional information about AEFI reporting.
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.
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.
How Is The Hepatitis B Vaccine Made
People are protected against hepatitis B virus infection by making an immune response to a protein that sits on the surface of the virus. When hepatitis B virus grows in the liver, an excess amount of this surface protein is made. The hepatitis B vaccine is made by taking the part of the virus that makes surface protein and putting it into yeast cells. The yeast cells then produce many copies of the protein that are subsequently used to make the vaccine. When the surface protein is given to children in the vaccine, their immune systems make an immune response that provides protection against infection with the hepatitis B virus.
The first hepatitis B vaccine was made in the 1980s by taking blood from people infected with hepatitis B virus and separating or purifying the surface protein from the infectious virus. Because blood was used, there was a risk of contaminating the vaccine with other viruses that might be found in blood, such as HIV. Although contamination with HIV was a theoretical risk of the early, blood-derived hepatitis B vaccine, no one ever got HIV from the hepatitis B vaccine. That is because the blood used to make vaccine was submitted to a series of chemical treatments that inactivated any possible contaminating viruses. Today, there is no risk of contaminating the vaccine with other viruses because the surface protein is manufactured in the laboratory.
Facts About Hepatitis B
- Two billion people, or one in three, have been infected with hepatitis B worldwide. Of these, almost 300 million live with chronic hepatitis B. This means about 1 of every 26 people throughout the world are living with a chronic hepatitis B infection.
- Each year about 900,000 people die from hepatitis B worldwide, and about 2,000 of these deaths occur in the United States.
- Hepatitis B is transmitted through blood and is 100 times more infectious than HIV. An estimated one billion infectious viruses are in one-fifth of a teaspoon of blood of an infected person, so exposure to even a very small amount, such as on a shared toothbrush, can cause infection.
- Hepatitis B is sometimes referred to as the silent epidemic because most people who are infected do not experience any symptoms.
- Liver cancer accounted for about 5% of cancer deaths in the U.S. during 2020.
- Almost half of liver cancers are caused by chronic infection with hepatitis B.
- The World Health Organization recommends the inclusion of hepatitis B vaccine in immunization programs of all countries in 2019, more than 8 of 10 infants born throughout the world received three doses of hepatitis B vaccine.
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Dosage And Vaccination Schedule
Dosage varies according to age and type of vaccine used: follow manufacturer’s instructions.
Child: one dose = 5 to 10 micrograms
Adult: one dose = 10 to 20 micrograms
- Standard schedule
- Neonate and infant:
- One dose as soon as possible after birth then a 2nd dose at 6 weeks and a 3rd dose at 14 weeks
- One dose as soon as possible after birth then 3 doses administered 4 weeks apart with the 1st at 6 weeks, the 2nd at 10 weeks and the 3rd at 14 weeks
- Child, adolescent, adult: schedule 0-1-6
2 doses 4 weeks apart, then a 3rd dose 6 months after the 1st dose
- Accelerated schedule, when rapid protection is required in the event of post-exposure prophylaxis
3 doses administered during the same month on D0-D7-D21, then a 4th dose one year after the 1st dose
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
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For Adults And Children
This vaccine schedule involves three doses within 2 months, followed by a booster dose at 1 year.
The initial accelerated doses provide immediate protection from HBV, and the booster dose helps provide long-term protection.
Below is the accelerated vaccination schedule approved for both adults and children:
|2 months after the first dose||1 year after the first dose|
Common And Local Adverse Events
HB vaccine is well tolerated. Reactions are generally mild and transient, and include: irritability, headache, fatigue and injection site reactions in 10% or more of recipients.
There is no increase in adverse events when HAHB vaccine is compared with HA vaccine given alone or concomitantly with HB vaccine at a different injection site. When the adult formulation of HAHB vaccine is given to children in the 2 dose schedule, there is no increase in adverse events compared with those occurring after administration of the pediatric formulation of HAHB vaccine.
Reactions are usually mild and transient, and include fever, irritability, restlessness and injection site reactions .
Headache, diarrhea, fever, urticaria, angioedema and injection site reactions may occur.
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Who Should Receive Hepatitis B Vaccination
- All newborns before hospital discharge. Infants born to hepatitis B-positive women need hepatitis B vaccine and HBIG within 12 hours of birth.
- All children and adolescents not previously vaccinated.
- Children born in the U.S. to individuals born in a country with high hepatitis B endemicity.
- All individuals at risk of hepatitis B infection:
- Sex partners of hepatitis B-positive persons
- Sexually active persons who are not in a long-term, mutually monogamous relationship
- Persons seeking evaluation or treatment for a sexually-transmitted disease
- Men who have sex with men
- Persons who inject drugs
- Household contacts of hepatitis B-positive persons
- Persons born in countries where hepatitis B infection is endemic should be tested and vaccinated if susceptible
- International travelers to regions with high or intermediate rates of endemic hepatitis B infection
- Health care and public safety workers that may be exposed to blood or blood-contaminated body fluids
- Residents and staff of facilities for developmentally disabled persons, corrections facilities, and other facilities that serve adults at risk for hepatitis B infection
- Persons with end-stage renal disease, including pre-dialysis, hemodialysis, peritoneal dialysis, and home dialysis patients
- Persons with chronic liver disease
- Persons to age 60 years with diabetes
- Persons with HIV infection
- All other persons seeking protection from hepatitis B infection.
Why Is The Hepb Vaccine Recommended
People who dont know they’re infected can spread the hepatitis B virus. So it cant be avoided just by being careful. That’s why health experts recommend that all babies get the vaccine right from birth.
The HepB injection usually creates long-term immunity. Most infants who get the HepB series are protected from hepatitis B infection beyond childhood, into their adult years.
Eliminating the risk of infection also decreases risk for cirrhosis of the liver, chronic liver disease, and liver cancer.
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Hepatitis B Vaccination Schedule For Children And Infants
The Centers for Disease Control and Prevention recommends that babies and children receive three 0.5 milliliter doses of either Engerix-B or Recombivax HB, starting just after birth.
The current recommended hepatitis B vaccine schedule for children and infants is as follows:
|Hepatitis B Vaccination Schedule for Infants and Children|
|Hepatitis B Vaccine Dose|
|3||618 months old|
If your child is undergoing hemodialysis, your healthcare provider may recommend that they receive additional doses of the HBV vaccine.
What Are The Side Effects
The most common of the hepatitis B vaccine are mild and include:
- Sore arm from the shot.
Prepare for your child’s vaccine visit and learn about how you can:
- Research vaccines and ready your child before the visit
- Comfort your child during the appointment
- Care for your child after the shot
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More Information On Side Effects
Reactions listed under âpossible side effectsâ or âadverse eventsâ on vaccine product information sheets may not all be directly linked to the vaccine. See Vaccine side effects and adverse reactions for more information on why this is the case.
If you are concerned about any reactions that occur after vaccination, consult your doctor. In the UK you can report suspected vaccine side effects to the Medicines and Healthcare products Regulatory Agency through the Yellow Card Scheme
Screen For Contraindications And Precautions
- Do not administer Heplisav-B to individuals with a history of severe allergic reaction after a previous dose of any hepatitis B vaccine or to any component of Heplisav-B, including yeast.
- Consult the package insert for precautions, warnings, and contraindications and Hepatitis B Vaccine Safety for additional information and possible side effects.
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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.
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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How Do You Catch Hepatitis B Virus
Blood from a person infected with hepatitis B virus is heavily contaminated with the virus. As a result, contact with blood is the most likely way to catch hepatitis B. Even casual contact with the blood of someone who is infected can cause infection.
Healthcare workers are at high risk of catching the disease, as are intravenous drug users and newborns of mothers infected with the virus. Sexual contact can also expose people to infection. The virus is also present in low levels in saliva.
Who Should Get The Hbv Vaccine
The Centers for Disease Control and Prevention recommends that all children and adults up to age 59 should receive the hepatitis B vaccine.
Infants should get their first hepatitis B vaccine within 24 hours of birth and complete their doses by age 6 to 18 months.
All unvaccinated children and adults through age 59 should receive the vaccine. Also, unvaccinated adults over the age 60 who are at risk of hepatitis B should get the vaccine.
Adults over age 60 who are not at risk of hepatitis B may also choose to get the shot.
Several types of the HBV vaccine are also safe to administer to pregnant women.
- people who have had more than one sex partner in the last 6 months
- men who have sex with men
- people seeking treatment for a sexually transmitted infection
- people whose partners or household members have hepatitis B
- people who inject drugs
- people who live or work in care facilities
- people who are on dialysis
- travelers to countries where hepatitis B is common
- people with chronic liver disease, HIV, or hepatitis C
- people who are in jail or prison
People who have diabetes should talk with a healthcare professional about their risk for contracting hepatitis B.
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The Duration Of Protection And The Need For Booster Doses
In vaccine efficacy studies, immunocompetent children and adults who developed anti-HBs concentrations of 10 mIU/mL or higher after vaccination had complete protection against both acute disease and chronic infection for decades , even if subsequently, over time, anti-HBs concentrations declined to less than 10 mIU/mL . Indeed, the protective efficacy of hepatitis B vaccination is related to the induction of anti-HBs antibodies, but it also involves the induction of memory B and T cells. Ongoing surveillance of vaccinees is required to clarify whether hepatitis B vaccination can confer longer, or even lifelong, protection . Based on currently available scientific evidence, different advisory groups do not recommend routine booster doses of hepatitis B vaccine in immunologically competent persons who have received a full primary course, because the majority of previously vaccinated people with an anti-HBs antibody concentration of 10 mIU/mL or less mount an anamnestic response when they receive a booster dose or are exposed to HBV, indicating that they remained protected by memory B and T cells .
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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