Adult formulation Hepatitis B vaccine (Engerix®) shortage
26 June 2017
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.
These recommendations only apply whilst monovalent hepatitis B vaccine is in short supply.
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.
Patients who have already commenced a course of combination hepatitis A and B vaccine
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.
Patients commencing a primary schedule
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.
Administering vaccines for an occupational health program and work under the Authority of the Vaccine Administration Code
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.
Administering vaccines under the Authority of Standing Medication Orders (SMOs)
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.
For further information see the Immunisation for health professionals web page or contact Communicable Disease Control Branch (CDCB) on 1300 232 272.