Hep b vaccine for newborns

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Hepatitis B Pediatric Vaccine

Hepatitis B is a serious disease caused by a virus. Hepatitis B causes inflammation of the liver, vomiting, and jaundice (yellowing of the skin or eyes). Hepatitis can lead to liver cancer, cirrhosis, or death.

Hepatitis B is a disease of the liver that is spread through blood or bodily fluids, sexual contact or sharing IV drug needles with an infected person, or during childbirth when a baby is born to a mother who is infected.

The hepatitis B pediatric vaccine is used to help prevent this disease in children and teenagers.

This vaccine works by exposing your child to a small amount of the virus, which causes the body to develop immunity to the disease. This vaccine will not treat an active infection that has already developed in the body.

Vaccination with hepatitis B pediatric vaccine is recommended for all children beginning at birth, especially children and adolescents who are at risk of getting hepatitis B. Risk factors include: being born to a mother who is a hepatitis carrier; being on dialysis or receiving blood transfusions; living in an institute for the mentally handicapped; traveling to high-risk areas; living with a person who has chronic hepatitis B infection; and being of Native Alaskan, Indochinese, Haitian, or Pacific Island descent.

Like any vaccine, the hepatitis B vaccine may not provide protection from disease in every person.

Hepatitis B pediatric vaccine should not be given to a child who is allergic to baker’s yeast.

This vaccine will not protect against hepatitis B if your child is already infected with the virus, even if he or she does not yet show symptoms.

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 baker’s yeast.

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

  • multiple sclerosis;
  • kidney disease (or if the child is on dialysis);
  • 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 (or if this was a reaction to a previous vaccine).

Your child can still receive a vaccine if he or she has a minor cold. In the case of a more severe illness with a fever or any type of infection, wait until the child gets better before receiving this vaccine.

It is not known whether this vaccine will harm an unborn baby. Tell the doctor if your child is pregnant or becomes pregnant while receiving the series of hepatitis B vaccines.

It is not known whether hepatitis B vaccine passes into breast milk or if it could harm a nursing baby. Tell the doctor if your child is breast-feeding a baby.

Hepatitis B pediatric vaccine

Generic Name: hepatitis B pediatric vaccine (HEP a TYE tis B pee dee AT rik VAX een)
Brand Name: Engerix-B Pediatric, Recombivax HB Pediatric/Adolescent, Recombivax HB

Medically reviewed by Drugs.com on Jul 9, 2019 – Written by Cerner Multum

  • Overview
  • Side Effects
  • Dosage
  • Interactions
  • Pregnancy
  • More

What is hepatitis B vaccine?

Hepatitis B is a serious disease caused by a virus. Hepatitis B causes inflammation of the liver, vomiting, and jaundice (yellowing of the skin or eyes). Hepatitis can lead to liver cancer, cirrhosis, or death.

Hepatitis B is a disease of the liver that is spread through blood or bodily fluids, sexual contact or sharing IV drug needles with an infected person, or during childbirth when a baby is born to a mother who is infected.

The hepatitis B pediatric vaccine is used to help prevent this disease in children and teenagers.

This vaccine works by exposing your child to a small amount of the virus, which causes the body to develop immunity to the disease. This vaccine will not treat an active infection that has already developed in the body.

Vaccination with hepatitis B pediatric vaccine is recommended for all children beginning at birth, especially children and adolescents who are at risk of getting hepatitis B. Risk factors include: being born to a mother who is a hepatitis carrier; being on dialysis or receiving blood transfusions; living in an institute for the mentally handicapped; traveling to high-risk areas; living with a person who has chronic hepatitis B infection; and being of Native Alaskan, Indochinese, Haitian, or Pacific Island descent.

Like any vaccine, the hepatitis B vaccine may not provide protection from disease in every person.

Important Information

Hepatitis B pediatric vaccine should not be given to a child who is allergic to baker’s yeast.

This vaccine will not protect against hepatitis B if your child is already infected with the virus, even if he or she does not yet show symptoms.

Before taking this medicine

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 baker’s yeast.

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

  • multiple sclerosis;

  • kidney disease (or if the child is on dialysis);

  • 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 (or if this was a reaction to a previous vaccine).

Your child can still receive a vaccine if he or she has a minor cold. In the case of a more severe illness with a fever or any type of infection, wait until the child gets better before receiving this vaccine.

It is not known whether this vaccine will harm an unborn baby. Tell the doctor if your child is pregnant or becomes pregnant while receiving the series of hepatitis B vaccines.

It is not known whether hepatitis B vaccine passes into breast milk or if it could harm a nursing baby. Tell the doctor if your child is breast-feeding a baby.

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 month and 6 months after the first shot. If your child has a high risk of hepatitis B infection, he or she may be given a booster 2 months after the first shot and then 12 to 24 months later.

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.

What happens if I miss a dose?

Contact your doctor if you miss a booster dose or if you get behind schedule. The next dose should be given as soon as possible. There is no need to start over.

Be sure your child receives all recommended doses of this vaccine. Your child may not be fully protected if he or she does not receive the full series.

What happens if I overdose?

An overdose of this vaccine is unlikely to occur.

What should I avoid before or after receiving this vaccine?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity.

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.

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.

Becoming infected with hepatitis B is much more dangerous to your child’s health than receiving this vaccine. However, like any medicine, this vaccine can cause side effects but the risk of serious side effects is extremely low.

Call your doctor at once if your child has:

  • high fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;

  • fussiness, irritability, crying for an hour or longer;

  • unusual muscle weakness;

  • changes in behavior; or

  • severe skin reaction–fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects include:

  • diarrhea, loss of appetite;

  • feeling weak or tired;

  • mild fussiness or crying;

  • low fever; or

  • runny nose.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.

Hepatitis B pediatric vaccine dosing information

Usual Pediatric Dose for Hepatitis B Prophylaxis:

What other drugs will affect hepatitis B vaccine?

Before your child receives this vaccine, tell the doctor about all other vaccines your child has recently received.

Other drugs may interact with hepatitis B vaccine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Copyright 1996-2018 Cerner Multum, Inc. Version: 5.01.

Medical Disclaimer

More about hepatitis b pediatric vaccine

  • Side Effects
  • During Pregnancy
  • Dosage Information
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  • En Español
  • Drug class: viral vaccines

Consumer resources

Other brands: Engerix-B Pediatric, Recombivax HB Pediatric/Adolescent

Related treatment guides

  • Hepatitis B Prevention

Your Child’s Immunizations: Hepatitis B Vaccine (HepB)

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Hepatitis B virus affects the liver. It can cause a mild illness with fever, nausea, vomiting, and jaundice.that last for a few weeks. Or it can cause a lifelong infection. Those who become lifelong carriers of the virus may develop long-term liver problems, such as cirrhosis (scarred and damaged liver) or cancer of the liver.

HepB Immunization Schedule

Hepatitis B vaccine (HepB) usually is given as a series of three injections:

  1. shortly after birth
  2. at 1–2 months of age
  3. at 6–18 months of age

If the mother of a newborn carries the hepatitis B virus in her blood, her baby must receive the vaccine within 12 hours after birth, along with another shot — hepatitis B immune globulin (HBIG) — to immediately provide protection against the virus. If a newborn’s mother shows no evidence of the virus in her blood, the baby can receive the HepB vaccine within 24 hours after birth.

Anyone can receive the vaccine series at any time if they missed it as a baby. This is especially important for people who are at higher risk of getting infected, such as health care and public safety workers, people with chronic liver or kidney disease, people with HIV infection, and people who inject drugs.

Why Is the HepB Vaccine Recommended?

The HepB injection usually creates long-term immunity. Infants who receive the HepB series should be protected from hepatitis B infection not only throughout their childhood but also into their adult years.

Eliminating the risk of infection also decreases risk for cirrhosis of the liver, chronic liver disease, and liver cancer.

Possible Risks of HepB Vaccine

There is a very small chance of an allergic reaction with any vaccine. Serious problems associated with receiving the vaccine are rare. Problems that do occur tend to be minor, such as mild fever and soreness or redness at the injection site.

When to Delay or Avoid HepB Immunization

As long as the mother does not have the virus in her blood, immunization will be delayed for babies who weigh less than 4 pounds, 7 ounces (2,000 grams) at birth. The first dose will be given 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 severe allergic reaction (anaphylaxis) after a previous dose of the vaccine or is allergic to baker’s yeast

Caring for Your Child After HepB Immunization

The vaccine may cause mild fever and soreness or redness in the area where the shot was given. Check with your doctor to see if you can give either acetaminophen or ibuprofen for pain or fever and to find out the appropriate dose. Very young infants should not be given either of these medicines.

When Should I Call the Doctor?

  • Call if you’re not sure of the recommended schedule for the HepB vaccine.
  • Call if you have concerns about your own hepatitis B carrier state.
  • Call if moderate or serious side effects appear after your child has received a HepB injection.

Reviewed by: Elana Pearl Ben-Joseph, MD Date reviewed: March 2019

Hepatitis B vaccine overview

Hepatitis B vaccination is routinely available as part of the NHS vaccination schedule. It’s offered to all babies at 8, 12 and 16 weeks of age.

It’s also offered to those thought to be at increased risk of hepatitis B or its complications.

The vaccine gives protection against the hepatitis B virus, which is a major cause of serious liver disease, including scarring of the liver (cirrhosis) and liver cancer.

Who should be vaccinated against hepatitis B?

All infants should be vaccinated to protect against hepatitis B infection.

This is because the infection can persist for many years in children and can eventually lead to complications, such as scarring of the liver or liver cancer.

Although the risk of hepatitis B is low in the UK, children and adults in high-risk groups are offered the vaccine.

Babies born to mothers with hepatitis B have been offered the hepatitis B vaccine from birth since the 1980s. During autumn 2017, this vaccine became available in the routine childhood vaccination schedule for all babies as part of the 6-in-1 vaccine.

You can get infected with hepatitis B if you have contact with an infected person’s blood or other body fluids. People who are at risk of getting hepatitis B or developing serious complications from it should consider being vaccinated. These groups include:

  • people who inject drugs or have a partner who injects drugs
  • people who change their sexual partners frequently
  • men who have sex with men
  • babies born to infected mothers
  • close family or sexual partners of someone with hepatitis B
  • anyone who receives regular blood transfusions or blood products, and their carers
  • people with any form of chronic liver disease
  • people with chronic kidney disease
  • people travelling to high-risk countries
  • male and female sex workers
  • people whose work puts them at risk of contact with blood or body fluids, such as nurses, prison staff, doctors, dentists and laboratory staff
  • prisoners
  • families adopting or fostering children from high-risk countries

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 additional 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 (GUM) clinic.

Find local sexual health services.

If your GP or nurse is unable to offer you the hepatitis B vaccine because of a temporary shortage in supply, you may need to wait longer for the vaccine. For more information, read What to do if you have to wait for a dose of hepatitis B vaccine (PDF, 159kb).

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.

What does hepatitis B immunisation involve?

Full protection involves having 3 injections of the hepatitis B vaccine at the recommended intervals.

Babies born to mothers with hepatitis B infection will be given 6 doses of hepatitis B-containing vaccine to ensure long-lasting protection.

If you’re a healthcare worker or you have kidney failure, you’ll have a follow-up appointment to see if you’ve responded to the vaccine.

If you’ve been vaccinated by your employer’s occupational health service you can request a blood test to see if you’ve responded to the vaccine.

Emergency hepatitis B vaccination

If you’ve been exposed to the hepatitis B virus and have not been vaccinated before, you should get immediate medical advice, as you may benefit from the hepatitis B vaccine.

In some situations, you may also need to have an injection of antibodies, called specific hepatitis B immunoglobulin (HBIG), along with the hepatitis B vaccine.

HBIG should ideally be given within 48 hours, but you can still have it up to a week after exposure.

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 they’re 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’ve become infected with the virus.

Hepatitis B vaccination in pregnancy

Hepatitis B infection in pregnant women may result in severe disease for the mother and chronic infection for the baby, so the hepatitis B vaccine is recommended for pregnant women who are in a high-risk category.

There’s no evidence of any risk from vaccinating pregnant or breastfeeding women against hepatitis B. And, as it’s an inactivated (dead) vaccine, the risk to the unborn baby is likely to be negligible (insignificant).

Hepatitis B vaccine on the NHS

A hepatitis B-containing vaccine is provided for all babies born in the UK on or after 1 August 2017. This is given as part of the 6-in-1 vaccine.

Hospitals, GP surgeries and sexual health or GUM clinics usually provide the hepatitis B vaccination free of charge for anyone at risk of infection.

GPs are not obliged to provide the hepatitis B vaccine on the NHS if you’re not thought to be at risk.

GPs may charge for the hepatitis B vaccine if you want it as a travel vaccine, or they may refer you to a travel clinic for a private vaccination. The current cost of the vaccine is around £50 a dose.

How safe is the hepatitis B vaccine?

The hepatitis B vaccine is very safe. Other than some redness and soreness at the site of the injection, side effects are rare. It’s an inactivated (dead) vaccine, so it cannot cause the infection itself.

Read more about vaccine safety and side effects.

Recombivax

SIDE EFFECTS

In healthy infants and children (up to 10 years of age), the most frequently reported systemic adverse reactions ( > 1% injections), in decreasing order of frequency, were irritability, fever, diarrhea, fatigue/weakness, diminished appetite, and rhinitis. In healthy adults, injection site reactions and systemic adverse reactions were reported following 17% and 15% of the injections, respectively.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect the rates observed in practice.

In three clinical studies, 434 doses of RECOMBIVAX HB, 5 mcg, were administered to 147 healthy infants and children (up to 10 years of age) who were monitored for 5 days after each dose. Injection site reactions and systemic adverse reactions were reported following 0.2% and 10.4% of the injections, respectively. The most frequently reported systemic adverse reactions ( > 1% injections), in decreasing order of frequency, were irritability, fever ( ≥ 101°F oral equivalent), diarrhea, fatigue/weakness, diminished appetite, and rhinitis.

In a study that compared the three-dose regimen (5 mcg) with the two-dose regimen (10 mcg) of RECOMBIVAX HB in adolescents, the overall frequency of adverse reactions was generally similar.

In a group of studies, 3258 doses of RECOMBIVAX HB, 10 mcg, were administered to 1252 healthy adults who were monitored for 5 days after each dose. Injection site reactions and systemic adverse reactions were reported following 17% and 15% of the injections, respectively. The following adverse reactions were reported:

Incidence Equal To or Greater Than 1% of Injections

General Disorders And Administration Site Conditions

Injection site reactions consisting principally of soreness, and including pain, tenderness, pruritus, erythema, ecchymosis, swelling, warmth, nodule formation.

The most frequent systemic complaints include fatigue/weakness; headache; fever ( ≥ 100°F); malaise.

Gastrointestinal Disorders

Nausea; diarrhea

Respiratory, Thoracic And Mediastinal Disorders

Pharyngitis; upper respiratory infection

Incidence Less Than 1% of Injections

General Disorders And Administration Site Conditions

Sweating; achiness; sensation of warmth; lightheadedness; chills; flushing

Vomiting; abdominal pains/cramps; dyspepsia; diminished appetite

Rhinitis; influenza; cough

Nervous System Disorders

Vertigo/dizziness; paresthesia 5

Skin And Subcutaneous Tissue Disorders

Pruritus; rash (non-specified); angioedema; urticaria

Musculoskeletal And Connective Tissue Disorders

Arthralgia including monoarticular; myalgia; back pain; neck pain; shoulder pain; neck stiffness

Blood And Lymphatic Disorders

Lymphadenopathy

Psychiatric Disorders

Insomnia/disturbed sleep

Ear And Labyrinth Disorders

Earache

Renal And Urinary Disorders

Dysuria

Cardiac Disorders

Hypotension

Post-Marketing Experience

The following additional adverse reactions have been reported with use of the marketed vaccine. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to a vaccine exposure.

Immune System Disorders

Hypersensitivity reactions including anaphylactic/anaphylactoid reactions, bronchospasm, and urticaria have been reported within the first few hours after vaccination. An apparent hypersensitivity syndrome (serum-sickness-like) of delayed onset has been reported days to weeks after vaccination, including: arthralgia/arthritis (usually transient), fever, and dermatologic reactions such as urticaria, erythema multiforme, ecchymoses and erythema nodosum . Autoimmune diseases including systemic lupus erythematosus (SLE), lupus-like syndrome, vasculitis, and polyarteritis nodosa have also been reported.

Elevation of liver enzymes; constipation

Guillain-Barré syndrome; multiple sclerosis; exacerbation of multiple sclerosis; myelitis including transverse myelitis; seizure; febrile seizure; peripheral neuropathy including Bell’s Palsy; radiculopathy; herpes zoster; migraine; muscle weakness; hypesthesia; encephalitis

Skin and Subcutaneous Disorders

Stevens-Johnson syndrome; alopecia; petechiae; eczema

Musculoskeletal and Connective Tissue Disorders

Arthritis

Pain in extremity

Blood and Lymphatic System Disorders

Increased erythrocyte sedimentation rate; thrombocytopenia

Irritability; agitation; somnolence

Eye Disorders

Optic neuritis; tinnitus; conjunctivitis; visual disturbances; uveitis

Syncope; tachycardia

The following adverse reaction has been reported with another Hepatitis B Vaccine (Recombinant) but not with RECOMBIVAX HB: keratitis.

Read the entire FDA prescribing information for Recombivax (Hepatitis B Vaccine (Recombinant))

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