What Is Hepatitis B
Hepatitis B is a contagious liver disease caused by the hepatitis B virus. When a person is first infected with the virus, he or she can develop an acute infection. Acute hepatitis B refers to the first 6 months after someone is infected with the hepatitis B virus. This infection can range from a very mild illness with few or no symptoms to a serious condition requiring hospitalization. Some people are able to fight the infection and clear the virus.
For others, the infection remains and is chronic, or lifelong. Chronic hepatitis B refers to the infection when it remains active instead of getting better after 6 months. Over time, the infection can cause serious health problems, and even liver cancer.
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.
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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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.
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
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Interchangeability And Dosing Schedule
- 2-dose HepB vaccine series only applies when both doses consist of HepB-CpG, administered at least 4 weeks apart.
- Series consisting of a combination of 1 dose of HepB-CpG and a vaccine from a different manufacturer should do the following:
- Adhere to the 3-dose schedule minimum intervals of 4 weeks between dose 1 and 2, 8 weeks between dose 2 and 3, and 16 weeks between dose 1 and 3. However, if HepB-CpG is substituted for dose 2 of HepB-alum, a provider has the option of administering the next dose of HepB-CpG a minimum of 4 weeks from the previous dose for a complete series.
Concerns About Immunisation Side Effects
If the side effect following immunisation is unexpected, persistent or severe, or if you are worried about yourself or your childs condition after a vaccination, see your doctor or immunisation nurse as soon as possible or go directly to a hospital.
It is important to seek medical advice if you are unwell, as this may be due to other illness, rather than because of the vaccination.
Immunisation side effects may be reported to SAEFVIC, the Victorian vaccine safety and reporting service. Discuss with your immunisation provider how to report adverse events in other states or territories.
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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
Protecting Your Baby Through Vaccination
Infants born to people with hepatitis B must receive accurate doses of hepatitis B vaccine and hepatitis B immune globulin to ensure complete protection. In order to protect these infants, medications should be given immediately after birth in the delivery room or within the first 12-24 hours of life*.
* See Testing and Treatment During Pregnancy section for details. Please note that testing of all pregnant people for hepatitis B is a global recommendation.
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Persons With Chronic Diseases
Refer to Immunization of Persons with Chronic Diseases in Part 3 for additional general information about vaccination of people with chronic diseases.
Chronic renal disease and patients on dialysis
People with chronic renal disease may respond sub-optimally to HB vaccine and experience more rapid decline of anti-HBs titres, and are therefore recommended immunization with a higher vaccine dose. Individuals undergoing chronic dialysis are also at increased risk for HB infection. In people with chronic renal disease anti-HBs titre should be evaluated annually and booster doses using a higher vaccine dose should be given as necessary.
People with conditions such as autism spectrum disorders or demyelinating disorders should receive all routinely recommended immunizations, including HB-containing vaccine.
Chronic liver disease
HB immunization is recommended for non-immune persons with chronic liver disease, including those infected with hepatitis C, because they are at risk of more severe disease if infection occurs. Vaccination should be completed early in the course of the disease, as the immune response to vaccine is suboptimal in advanced liver disease. Post-immunization serologic testing may be used to confirm vaccine response.
Non-malignant hematologic disorders
Persons with bleeding disorders and other people receiving repeated infusions of blood or blood products are considered to be at higher risk of contracting HB and should be offered HB vaccine.
Does The Hepatitis B Vaccine Have Side Effects
Some children will develop pain or soreness in the local area of the shot, and low-grade fever.
There is one extremely rare, but serious, side effect. About 1 out of every 600,000 doses of the hepatitis B vaccine will cause a severe allergic reaction, called anaphylaxis, with symptoms including swelling of the mouth, difficulty breathing, low blood pressure or shock. Anaphylaxis usually occurs within 15 minutes of receiving the vaccine. Although anaphylaxis can be treated, it is quite frightening. People should remain at the doctors office for about 15 minutes after getting the vaccine.
Although the hepatitis B vaccine is made in yeast cells, no one has ever been shown to be allergic to the yeast proteins contained in the hepatitis B vaccine .
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Advisory Committee On Immunization Practices Recommendations
In February 2018, ACIP approved recommendations for Heplisav-B vaccine as an option for previously unvaccinated or incompletely vaccinated persons, including:
- Adults 18 years of age and older who have a specific risk, or lack a risk factor but want protection. See ACIP Recommended Immunization Schedule for Adults for risk factors.
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Why Should My Baby Get The Hepatitis B Shot
- Protects your child from against hepatitis B, a potentially serious disease.
- Protects other people from the disease because children with hepatitis B usually dont have symptoms, but they may pass the disease to others without anyone knowing they were infected.
- Prevents your child from developing liver disease and cancer from hepatitis B.
- Keeps your child from missing school or child care and you from missing work.
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Use In Special Populations
There are no adequate and well-controlled studies designed to evaluate RECOMBIVAX HB in pregnant women. Available post-approval data do not suggest an increased risk of miscarriage or major birth defects in women who received RECOMBIVAX HB during pregnancy.
Data are not available to assess the effects of RECOMBIVAX HB on the breastfed infant or on milk productions/excretion. The developmental and health benefits of breastfeeding should be considered along with the mothers clinical need for RECOMBIVAX HB and any potential adverse effects on the breastfed child from RECOMBIVAX HB or from the underlying maternal condition.
How Is Reactivation With Hbv Defined
Reactivation is defined as the sudden increase or reappearance of HBV DNA. When the virus invades the cell, it forms a covalently closed circular DNA in the nucleus of infected cells referred to as hepatocytes. Because cccDNA is resistant to antiviral treatments, it is never removed from the cells. Therefore, even after recovery from a past infection, the cccDNA is present and may reactivate. It is not clearly understood why this may happen, but certain factors may increase the risk for reactivation.
To learn more about the core, click here.
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When To Delay Or Avoid Hepb Immunization
Doctors delay giving the vaccine to babies who weigh less than 4 pounds, 7 ounces at birth whose mothers do not have the virus in their blood. The baby will get the first dose at 1 month of age or when the baby is discharged from the hospital.
The vaccine is not recommended if your child:
- is currently sick, although simple colds or other minor illnesses should not prevent immunization
- had a serious allergic reaction after an earlier dose of the vaccine or is allergic to bakers yeast
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Prevention Of Perinatal Transmission Of Hepatitis B Infection
- All infants born to HBsAg-positive mothers should be administered hepatitis B immune globulin and the 1st dose of hepatitis B vaccine within 12 hours of birth, these infants should receive their 2nd dose of hepatitis B vaccine at 1 month of age
- Infants born to women with unknown HBsAg status should be administered the 1st dose of hepatitis B vaccine if results of HBsAg testing are not available within 12 hours of birth. If the mother is determined to be HBsAg positive, HBIG should be administered as soon as possible and no later than age 7 days.
- Standard of care is that all other infants should receive their first dose of hepatitis B vaccine no later than at the time of discharge from the birthing hospital
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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.
What If A Dose Was Given Too Early
A dose can be counted as valid as long as the minimum intervals are met, as described above for hepatitis B vaccine. Keep in mind the additional guidance that an infant should not receive the last dose in the series earlier than 24 weeks of age. In general, CDC allows a four-day grace period for vaccines, i.e., vaccine doses administered up to four days before the minimum interval or age can be counted as valid. If a dose was administered five or more days earlier than the recommended minimum interval between doses, it is not valid and should be repeated. The repeat dose should be spaced after the invalid dose by an interval at least equal to the recommended minimum interval.
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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.
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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