COMMUNICABLE DISEASE 
CONTROL BRANCH
- Attention all doctors - 
Date: 26/06/2017     Contact telephone number: 1300 232 272  (24 hours/7 days)

 

Adult formulation Hepatitis B vaccine (Engerix®) shortage

SA Health is aware of supply constraints of adult formulation hepatitis B vaccine due to a precautionary halt in the manufacturing process of the GlaxoSmithKline (GSK) Engerix-B® vaccine. Production has returned to normal, however it will take time to rebuild capacity. Seqirus vaccine, H-B-Vax II® – adult formulation, and hepatitis A and B combination vaccines can still be sourced.

The Engerix-B® and H-B-Vax II® vaccines are manufactured by different processes. Switching mid-course between monovalent hepatitis B vaccine brands is not routinely recommended, however, under the current circumstances it is acceptable. Switching mid-course between monovalent and combination vaccines is not recommended.

Persons under 20 years of age

  • Use combination vaccines or paediatric formulations of hepatitis B vaccine as detailed in the Australian Immunisation Handbook.

Persons 20 years of age and older
For patients who have already commenced a course of monovalent hepatitis B vaccine:

  • Use adult formulation hepatitis B vaccine if available.
  • If monovalent adult formulation hepatitis B vaccine is not available, use two doses of paediatric formulation 0.5ml H-B-Vax II® (i.e. total dosage of 1.0ml) as an alternative for one dose of adult formulation H-B-Vax II®, including for the purposes of a challenge dose.

For patients who have already commenced a course of combination hepatitis A and B vaccine (Twinrix®):

  • Continue the course using combination hepatitis A and B vaccine.

For patients commencing a primary schedule:

  • Use a three dose schedule of the combined hepatitis A and B vaccine at intervals of 0, 1 and 6 months

OR

  • Use a three dose schedule with two doses of paediatric formulation 0.5ml H-B-Vax II® at intervals of 0, 1 and 6 months.

Health professionals who are administering hepatitis B vaccine for an occupational health program and work under the Authority of the Vaccine Administration Code (the Code) are still able to administer the vaccine in accordance with the Code as published on the Health Care Worker immunisation requirements webpage.

Substituting 2 doses of paediatric hepatitis B vaccine 0.5ml H-B-Vax II® for 1 dose of adult hepatitis B vaccine can be used as an alternative during the supply shortage.

For those are administering vaccines under the Authority of Standing Medication Orders (SMOs), the SMO will be required to be updated indicating this interim clinical advice.


These recommendations only apply whilst monovalent hepatitis B vaccine is in short supply.

For further information see www.sahealth.sa.gov.au/immunisationprovider.

 

Dr Ann Koehler - Director, Communicable Disease Control Branch
For all enquiries, please contact the CDCB on 1300 232 272
Public – I3-A1

Download the official health alert here (PDF)
 

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