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HBvaxPRO

Common name:

Hepatitis B, HepB

Protects against hepatitis B.

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Overview

Infants born to mothers who are hepatitis B positive are at a very high risk of developing chronic hepatitis B infection, which can result in liver failure and cancer later in life as well as infecting others. Therefore, hepatitis B vaccine is given to these newborn babies, at the same time as hepatitis B immunoglobulin (HBIG), to reduce the risk of having been infected with hepatitis B virus during the birth process. Hepatitis B vaccination plus HBIG protects infants from hepatitis B infection significantly better than immunoglobulin alone.

HBvaxPRO® 5mcg vaccine stock is reserved for administration to neonates.

Hepatitis B vaccine is delivered on the universal immunisation schedule as part of Infanrix-hexa vaccine delivered at 6 weeks, 3 months and 5 months. No further doses are required

Engerix®-B is currently the funded hepatitis B vaccine for: 

  • Hepatitis B catch-up immunisation for children and adolescents aged under 18 years, including adolescents aged 11–15 years following the two-dose schedule, with the second dose given 4–6 months after the first, and
  • Adolescents and adults aged 18 years or older who are on renal dialysis or who are liver or kidney transplant patients, and
  • Adults aged 18 years or older who meet other 'special groups' eligibility criteria.

Responses to vaccine

 HBvaxPRO (HepB)

Common Responses

  • Mild pain, redness and swelling around injection site
  • Nausea, vomiting, abdominal pain, or diarrhoea
  • Decreased appetite

Rare Responses

  • Hives
  • Itching
  • Temporary low platelet count
  • Muscle or joint pain
  • Abdominal pain and vomiting

As with any medicine, very rarely a severe allergic reaction (anaphylaxis) can occur following immunisation.

References

In Depth

Other brands: Engerix®-B 20mcg

Vaccine type: Subunit protein vaccine

Schedule and administration

HBvaxPRO® 5mcg vaccine stock is reserved for infants born to a mother who is hepatitis B surface antigen (HBsAg) positive.

  • HBvaxPRO 10mcg vaccine is out of stock.
  • HBvaxPRO® 40mcg vaccine is out of stock.
  • Please refer to the Engerix®-B vaccine webpage for
    • Hepatitis B catch-up immunisation for children and adolescents aged under 18 years, including adolescents aged 11–15 years following the two-dose schedule, with the second dose given 4–6 months after the first, and
    • Adolescents and adults aged 18 years or older who are on renal dialysis or who are liver or kidney transplant patients, and
    • Adults aged 18 years or older who meet other 'special groups' eligibility criteria.

Administration

  • The vaccine is administered by intramuscular injection in the vastus lateralis in infants.
  • Infants born to HBsAg positive mothers receive a single dose of HBvaxPRO 5mcg at or within 12 hours of delivery. These infants then receive three hepatitis B containing vaccines as per the National Immunisation Schedule.

Protecting at-risk newborns from hepatitis B

Infants born to mothers who are hepatitis B positive are at a very high risk of developing chronic hepatitis B infection, which can result in liver failure and cancer later in life as well as infecting others. Therefore, hepatitis B vaccine is given to newborn babies whose mothers are hepatitis B-positive, at the same time as hepatitis B immunoglobulin (HBIG), to reduce the risk of having been infected with hepatitis B virus during the birth process. Hepatitis B vaccination plus HBIG protects infants from hepatitis B infection significantly better than immunoglobulin alone.

Storage and preparation

  • Store as per cold chain between 2°C to 8°C.
  • HBvaxPRO does not contain preservative. 

Vaccine safety

  • Administration of HBvaxPRO should be postponed in infants suffering from a fever over 38°C. The presence of a minor infection is not a reason to delay immunisation.

Specialist advice should be sought for the following groups:

Those with bleeding disorders, such as haemophilia. The vaccine should be administered in accordance with the haematologist’s instructions. It may, in this situation only, be given subcutaneously. An increased incidence of local reactions including subcutaneous nodules has been observed with this method.

Vaccine effectiveness

Significantly fewer infants of HBsAg-positive mothers, who were given hepatitis B vaccine plus hepatitis B immunoglobulin at birth and completed their three dose primary hepatitis B vaccine course, acquired chronic hepatitis B infection when compared with historical controls who received only hepatitis B immunoglobulin at birth.

 

Last updated: Oct 2020