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.
I Am A Healthcare Worker Who Did Not Develop Hepatitis B Antibodies After Immunization What Should I Do
Two versions of hepatitis B vaccine are available. One, called Heplisav-B, contains a novel adjuvant that was not present in previous versions used by adults . Some people did not respond to the older version hepatitis B vaccine. In fact, in a group of adults younger than 40 years of age who received two doses of the older version vaccine 75 of 100 were protected. Following the third dose, this number increased to 90 of 100. However, people older than 40 years of age were less likely to respond to the vaccine with increasing age. On the other hand, 90 to 100 of 100 adults 18 years of age and older respond to Heplisav-B, which was approved for use in 2018.
About 5-10 of every 100 children and adults younger than 40 years of age do not respond to the third dose of the hepatitis B vaccine. Some of these people will be recommended to get vaccinated again. About 5 of 100 people will still not respond after getting all recommended doses of both series. Note that children younger than 18 years of age cannot get Heplisav-B.
If the people who do not respond to vaccination are determined not to have chronic hepatitis B, they will be reliant on taking precautions to reduce the chance of exposure and relying on those around them for protection. In other words, these people will be reliant on herd immunity.
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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Recommended Doses Of Hepatitis B Vaccine
Recommended doses of hepatitis B by vaccine type, age, formulation, dosage and schedule.
Download PDF version formatted for print: Recommended Doses of Hepatitis B Vaccine
Infants: birth, 1-4, 6-18 monthsOROlder children: 0, 1-2, 4-6 months
20 years & older
Infants: birth, 1-4, 6-18 monthsOROlder children: 0, 1-2, 4-6 months
0, 1, 4-6 months
* The schedule for hepatitis B is flexible, but minimal intervals and minimum ages need to be observed:
- There should be at least 4 weeks between doses 1 and 2, and at least 8 weeks between doses 2 and 3.
- The minimum interval for the overall series from dose 1 to final dose is 4 months .
- Infants, should receive the final dose of hepatitis B vaccine on or after 6 months of age, otherwise long term immunity may be impacted.
- Adults who are immunocompromised or on dialysis require a larger dose of hepatitis B vaccine.
- The Engerix-B dose required is 40mcg/2.0mL on a scheduled of 0, 1, 2, and 6 months.
- For Recombivax HB, a special formulation is available. The dose is 40mcg/1.0mL given on a schedule of 0, 1, and 6 months
6 weeks thru 6 years
Hep B as Engerix-B 10 mcg, DTaP as Infanrix, Polio
Give single antigen hep B dose at birth followed by Pediarix at: 2, 4, 6 months
Hep A as Havrix 720 El.U, Hep B as Engerix-B 20 mcg
0, day 7, day 21-30, 12 months
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
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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.
Who Should Get Hepatitis B Vaccine
All infants should get their first dose of hepatitis B vaccine within 24 hours of birth and will usually complete the series at 6 months of age.
All unvaccinated children and adolescents younger than 19 years of age should also get vaccinated.
All adults 19 through 59 years of age are recommended to get vaccinated.
Adults 60 years and older with risk factors should get vaccinated. Risk factors include:
- People whose sex partners have hepatitis B
- People who live with someone with hepatitis B
- Sexually active people who are not in a long-term relationship
- People getting evaluated or treated for a sexually transmitted infection
- Men who have sex with men
- People who share needles, syringes, or other drug-injection equipment
- Health care and public safety workers at risk for exposure to blood or body fluids
- People with chronic liver disease, who are on dialysis, have HIV infection, or hepatitis C infection
- People with diabetes
- Developmentally disabled persons in long-term care facilities
- People in prison or jail
- Travelers to areas with high rates of hepatitis B
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How Is This Vaccine Given
The vaccine is injected into a muscle. Your child will receive this injection in a doctor’s office or other clinic setting.
The hepatitis B pediatric vaccine is given in a series of shots beginning shortly after birth. The booster shots are sometimes given 1 to 2 months and 6 to 18 months after the first shot. If your child does not receive a birth dose, the vaccine series should begin as early as possible.
Your child’s individual booster schedule may be different from these guidelines. Follow the doctor’s instructions or the schedule recommended by your local health department.
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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Who Should Not Receive The Hepatitis B Vaccine
Talk to your healthcare provider before getting the hepatitis B vaccine if:
- You have had a severe allergic reaction to the hepatitis B vaccine or any of its ingredients in the past.
- You have had an allergic reaction to yeast in the past.
- You are moderately or severely ill.
- You are currently taking immunosuppressive medications.
In addition, pregnant people should not receive the Heplisav-B or PreHevbrio vaccines until more safety information is available.
For Adults At High Risk Of Exposure
Adults who have not received the hepatitis B vaccine series should be immunized when they have an increased risk of exposure. Job, travel, health condition, or lifestyle all may increase a persons risk of contracting hepatitis B.
People who live or work where there is risk of exposure include:
- Health care and public safety workers who are likely to be exposed to blood or blood products.
- Clients and staff of institutions or residential settings with known or potential HBV carriers.
- People planning extended travel to China, Southeast Asia, Africa, and other areas where hepatitis B infection is high.
People who have health conditions that put them at high risk for exposure or a severe infection include:
- People who have a severe kidney disease that requires them to have their blood filtered through a machine .
- People who have chronic liver disease.
- People who have hemophilia and other conditions in which they need to have blood products on an ongoing basis.
- People who had a stem cell transplant.
People whose lifestyle puts them at high risk for exposure include:
- People who inject illegal drugs.
- Men who have sex with men.
- People who have had more than one sex partner in the past 6 months or who have a history of sexually transmitted infection.
- Household contacts and sex partners of hepatitis B carriers.
- Prison inmates.
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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 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.
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Hepatitis B Vaccine: Canadian Immunization Guide
For health professionals
Last partial content update : May 2022
The footnotes in and the accompanying text description for the figure have been revised to align with the corresponding figure in Protocole dimmunisation du Québec, 5e édition from which it was adapted.
Last complete chapter revision :
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 you’re 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, it’s your employer’s responsibility to arrange vaccination for you, rather than your GP. Contact your occupational health department.
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Who Should Receive The Hepatitis B Vaccine
For most people, the hepatitis B vaccine is safe and effective. About 90% of people who receive three vaccine doses are protected against hepatitis B for over 30 years.
The CDC’s Advisory Committee on Immunization Practices recommends the hepatitis B vaccine for the following groups:
- All babies, starting just after birth
- Children and adolescents under 19 years old
- Adults ages 1959 who have not previously completed vaccination
- Adults ages 60 and over with a high risk of contracting HBV
Adults ages 60 and over who do not have any hepatitis B risk factors can receive the hepatitis B vaccine, but it is optional.
Hepatitis B spreads when the bodily fluids of an infected person enter another person’s body. Sexual contact is one way it can be spread. A person with HBV can spread it to their baby during childbirth. Other ways in which HBV may be transmitted include:
- Sharing medical equipment, whether at home or in a hospital setting, with a person who has an HBV infection
- Sharing syringes with a person who has hepatitis B, such as during injection drug use or at-home piercing or tattooing
- Sharing personal items, such as razors or toothbrushes, with someone who has hepatitis B
- Coming into contact with the sores or blood of a person who has hepatitis B
This Vaccine Side Effects
Get emergency medical help if your child has signs of an allergic reaction:hives difficulty breathing swelling of the face, lips, tongue, or throat.
Your child should not receive a booster vaccine if he or she had a life-threatening allergic reaction after the first shot.
Your child may feel faint after receiving this vaccine. Some people have had seizure like reactions after receiving this vaccine. The doctor may want your child to remain under observation for a short time after the injection.
Keep track of any and all side effects your child has after receiving this vaccine. When the child receives a booster dose, you will need to tell the doctor if the previous shot caused any side effects.
breathing that stops during sleep
fever, chills, swollen glands.
fussiness, irritability, crying for an hour or longer
unusual muscle weakness
changes in behavior or
Common side effects of hepatitis B pediatric vaccine may include:
diarrhea, loss of appetite
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Why Do You Need A Hepatitis B Shot
Hepatitis B is a viral infection that cant be transferred person-to-person unless you have contact with an infected persons bodily fluids. Annual infection rates of HBV are going down in the United States thanks to vaccines. So you might be wondering if you or your child needs a shot to protect against hepatitis B.
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.