Sunday, November 27, 2022

Hepatitis B Vaccine Dose For Newborns

How Is This Vaccine Given

Does HepB Vaccine Cause Defects?

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 your doctor’s instructions or the schedule recommended by your local health department.

Why Vaccinate Newborns For Hepatitis B

If you’re like many parents, you may wonder why doctors recommend vaccinating all children against hepatitis B. Although vaccinating infants of mothers who are infected with hepatitis B and delaying vaccinating others is one strategy for preventing hepatitis B in newborns, it’s not as effective as universal immunization.

In fact, health experts tried this approach first, immunizing select newborns when the hepatitis B vaccination first came out, and unfortunately, it wasn’t successful. Too many children were still getting sick from hepatitis B.

It wasn’t until after the universal immunization program for the hepatitis B vaccine began that the rate of new hepatitis B infections in children began to drop. That’s why medical professionals recommend vaccinating all newborns against hepatitis B.

In a universal immunization program, all newborns are immunized against the virus, even if their mothers test negative for hepatitis B infections.

Giving this birth dose of the vaccination helps prevent the disease from developing in babies who have mothers who have hepatitis B infections but never knew it. It also prevents a scenario in which the mother has a known hepatitis B infection, but the baby somehow misses the hepatitis B shot. This scenario can occur when a mother fails to report her hepatitis B infection to her doctor, forgets that she has the infection, or gets a false negative on her hepatitis B test.

Dosage Forms & Strengths


  • belimumab

    belimumab decreases effects of hepatitis b vaccine by immunosuppressive effects risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.

Serious – Use Alternative

Monitor Closely


  • chloroquine decreases effects of hepatitis b vaccine by pharmacodynamic antagonism. Minor/Significance Unknown.

  • ozanimod

    ozanimod decreases effects of hepatitis b vaccine by immunosuppressive effects risk of infection. Minor/Significance Unknown. No clinical data are available on the efficacy and safety of vaccinations in patients taking ozanimod. Vaccinations may be less effective if coadministered with ozanimod.

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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.

When To Delay Or Avoid Hepb Immunization

Why do newborns need the hepatitis B vaccine?

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 baker’s yeast

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Testing Your Baby For Infection

Each year, a very small number of babies may develop infection so your baby will be offered a blood test when they are 1 years old. This is to check that the course of vaccines have prevented them from developing hepatitis B.

There are 2 ways that this may be done and your GP, health visitor or practice nurse will advise you which test your baby will have:

  • A heel prick dried blood spot test where a sharp point is used to make a small prick in your babys heel and a few drops of blood are dropped onto a card which is sent off for testing.
  • Blood test taken from a vein in your babys arm or hand.
  • If they do have the infection, they will be referred to a specialist for treatment to reduce their risk of developingserious liver disease.

    If a young infant is infected, they are more likely to develop long lasting infection without any signs or symptoms of infection. Even if your baby has no signs or symptoms of infection they should still have the blood test.

    Infection can be prevented in 90% of cases if the first dose of vaccine is given at birth and the full course of vaccines is completed on time.

    How You Can Protect Your Baby

    Talk to your midwife and register your baby with a GP as soon as you can so that their vaccines can beordered. You can find a list of local GPs by town or postcode.

    Make sure that your baby:

    • has their vaccines at the right age from birth
    • completes the full course of vaccines
    • has a blood test for infection when they reach 1 year of age

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    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.

    Before Taking This Medicine

    Why Do Newborns Get the Hepatitis B Vaccine?

    Hepatitis B vaccine will not protect against infection with hepatitis A, C, and E, or other viruses that affect the liver. It may also not protect against hepatitis B if your child is already infected with the virus, even if he or she does not yet show symptoms.

    Your child should not receive this vaccine if he or she ever had a life-threatening allergic reaction to any vaccine containing hepatitis B. Hepatitis B pediatric vaccine should not be given to a child who is allergic to yeast.

    If your child has any of these other conditions, this vaccine may need to be postponed or not given at all:

    • kidney disease

    • a bleeding or blood clotting disorder such as hemophilia or easy bruising

    • an allergy to latex rubber or

    • a neurologic disorder or disease affecting the brain .

    Your child can still receive a vaccine if he or she has a minor cold. If the child has a more severe illness with a fever or any type of infection, your doctor may recommend waiting until the child gets better before receiving this vaccine.

    It is not known whether this vaccine will harm an unborn baby. However, if you are at a high risk for infection with hepatitis B during pregnancy, your doctor should determine whether you need this vaccine.

    It may not be safe to breastfeed while using hepatitis B pediatric vaccine. Ask your doctor about any risk.

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    Concurrent Administration Of Vaccines

    HB-containing vaccines may be administered concomitantly with other vaccines or with HBIg. Different injection sites and separate needles and syringes must be used for concurrent parenteral injections.

    Refer to Timing of Vaccine Administration in Part 1 for additional information about concurrent administration of vaccines.

    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.

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    Vaccinees In Original Clinical Trials

    During 19811984, several randomized controlled vaccine trials using a 3-dose series of plasma-derived hepatitis B vaccine were conducted in Taiwan with 972 neonates born to HBsAg-positive mothers. Eligible infants were enrolled from Taipei Municipal Women and Children’s Hospital, MacKay Memorial Hospital, and National Taiwan University Hospital, where all women seeking prenatal care were routinely screened for HBsAg by reverse passive hemagglutination with commercial kits . Trained project nurses gave both a written description and oral explanation of the study to each HBsAg-positive woman. Infants of parents who gave consent were enrolled in the trials if they were delivered in the hospital of recruitment, their birth weight was 3000 g, and their 1-min Apgar score was 9 .

    Serological Testing After Hepatitis B Vaccination

    All babies should be given Hepatitis B vaccine at birth

    It is recommended that levels of hepatitis B surface antigen in infants born to mothers with chronic hepatitis B are measured 312 months after they complete the primary vaccine course. Do not test the infant before 9 months of age, to avoid detecting anti-HBs

    Post-vaccination serological testing is recommended 48 weeks after completing the primary course for:

    • people at significant occupational risk, such as healthcare workers whose work involves frequent exposure to human tissue, blood or body fluids
    • people at risk of severe or complicated hepatitis B, such as people who are immunocompromised and people with pre-existing liver disease not related to hepatitis B
    • people who may respond poorly to hepatitis B vaccination, such as haemodialysis patients and people with bleeding disorders who received the vaccine subcutaneously
    • close contacts of people who are infected with hepatitis B virus, including sexual partners, household contacts and household-like contacts22

    If serological testing 48 weeks after the primary course shows levels of antibody to hepatitis B surface antigen of < 10 mIU per mL, check the person for acute or chronic hepatitis B virus infection by testing for serological markers, including antibodies to anti-HBs and hepatitis B core antigen.

    After the booster dose, check for anti-HBs

    A non-responder is a person who:

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    What Are The Possible Reactions After The Vaccine

    Vaccines are very safe. It is much safer for your child to get the vaccine than to get hepatitis B.

    Common reactions to the vaccine may include soreness, swelling or redness where the vaccine was given. Some children may experience fever, fussiness or fatigue.

    It is important to stay in the clinic for 15 minutes after getting any vaccine because there is an extremely rare possibility, less than 1 in a million, of a life-threatening allergic reaction called anaphylaxis. This may include hives, difficulty breathing, or swelling of the throat, tongue or lips. Should this reaction occur, your health care provider is prepared to treat it. Emergency treatment includes administration of epinephrine and transfer by ambulance to the nearest emergency department. If symptoms develop after you leave the clinic, call 9-1-1 or the local emergency number.

    It is important to always report serious or unexpected reactions to your health care provider.

    Babies That Need To Stay In Hospital

    If your baby needs to stay in hospital they should receive the second dose of vaccine when they reach 4 weeks old and then continue to follow the schedule below.

    Keep a record of your babys appointments and vaccination dates. These will also be recorded by your midwife, health visitor, practice nurse and GP in your babys Red Book . Bring your childsRed Book to every appointment.

    If you have questions you can speak to your midwife, health visitor, practice nurse or GP.

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    What Are The Side Effects

    The most common of the hepatitis B vaccine are mild and include:

    • Low fever or,
    • 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

    People With Other Medical Conditions

    ACP and CDC issue recommendations for hepatitis B screening, vaccination, and care

    People with chronic liver disease and/or hepatitis C are recommended to receive hepatitis B vaccine if they are not immune

    Hepatitis B vaccination is recommended for people with chronic liver disease and/or hepatitis C who are seronegative for hepatitis B. This is because they may have an increased risk of hepatitis B and/or severe liver disease after hepatitis B.11

    Adult-formulation hepatitis B vaccine should be given in a 3-dose schedule. See Table. Monovalent hepatitis B vaccines for adolescents and adults in Vaccines, dosage and administration.

    Levels of antibody to hepatitis B surface antigen should be checked after the vaccination course. See Serological testing after hepatitis B vaccination.

    The combination hepatitis A-hepatitis B vaccine may be appropriate for people with chronic liver disease and/or hepatitis C if they are not immune to either disease. This is because they have an increased risk of hepatitis B and/or severe liver disease after hepatitis A and B. This is usually given in 3 doses using Twinrix . See Table. Combination hepatitis A-hepatitis B vaccines in Vaccines, dosage and administration.

    Low-birthweight and preterm newborns do not respond as well to hepatitis Bcontaining vaccines as full-term infants.12-14

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    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.

    Moving To Another Country

    If you are moving abroad before your baby is one year old, please let your GP know and dont forget to register your baby with a new family doctor in your new country of residence.

    Take your babys Red Book with you and make sure your baby receives all of the doses of hepatitis B vaccines on time and has a blood test at 12 months old.

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    Accelerated 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.

    In some instances, it may be necessary to vaccinate within a short period of time to ensure protection before travel. There are accelerated schedules to provide the highest level of protection over a short period of time. Individuals who need an accelerated schedule must have a booster dose at 1 year to ensure long-term protection. Note that the 2-dose Heplisav-B vaccine will also ensure maximum protection over a 1-month period without the need for a booster dose at 1 year.

    4-Dose Vaccine Series for Children and Adults

    Engerix-B is a 3-dose vaccine that can be given on an accelerated, four-dose schedule, with 3 shots administered within 2 months, and a booster dose at 1 year to provide maximum long-term protection.

    4-Dose Combination Hepatitis A and B Vaccine Series

    Twinrix is a 4-dose vaccine that can be given on an accelerated schedule to provide protection against hepatitis A and B. Three doses are administered within 1 month, followed by a booster shot at 1 year. This is a common choice of vaccine for those travelling on short-notice outside the U.S. It is important to complete the booster dose at 1 year, to ensure long-term protection.

    2-Dose Vaccine Series

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