Since November 2016, there has been an ongoing international shortage of adult formulation hepatitis B vaccines, initially affecting the private market.
 
In Australia we have previously been supplied with two brands of adult hepatitis B vaccine. Engerix-B® and H-B-Vax II®.  A precautionary manufacturing halt of the production of Engerix-B® from November 2016 resulted in increased demand for H-B-Vax II® and subsequent shortage of this product. The paediatric formulations of these products remain available.
 
Please refer to the Therapeutic Goods Administration Medicines Shortage Information pagefor up to date information. 
 

NSW Health and other states and territories are restricting distribution of adult hepatitis B vaccine

To date, this shortage has not affected the availability of adult formulation hepatitis B vaccine for government programs. However, supply of the vaccine under the National Immunisation Program has now become constrained. As a precautionary measure, NSW Health is restricting the distribution of free adult hepatitis B vaccine to ensure it is available for those at highest risk of contracting the disease, including household and sexual contacts of acute and chronic hepatitis B cases, and injecting drug users. (for eligibility, please see Additional Commonwealth and NSW-funded free vaccines).
 
General practitioners and other immunisation providers are therefore being asked to assess their patient’s risk of exposure to hepatitis B before recommending vaccination and to review the vaccination records of patients seeking hepatitis B vaccination thoroughly before ordering hepatitis B vaccine on their behalf. Childhood records can be checked on the Australian Immunisation Register (AIR) and high school records can be checked by phoning public health units 1300 066 055.
 
Most young people aged 18 to 26 would have been offered hepatitis B vaccine through the childhood immunisation program which commenced in 2000, or through the NSW high school catch-up program 2004-2013.
 
There is no need to repeat previous doses of hepatitis B vaccine. That is, provided minimum vaccination intervals are adhered to, there are no maximum vaccination intervals. For example, if your 21 year old patient has dose 1 hepatitis B vaccine documented at 18 years of age, and dose 2 at least three months later, then they only need one more dose of vaccine to complete the course.
 

Recommendations

The Australian Technical Advisory Group on Immunisation (ATAGI) has released updated (February 2018) clinical advice for vaccination providers on the use of hepatitis B vaccines during supply shortages.
 
Vaccination options include:
  • those <20 years of age can receive 3 doses of paediatric hepatitis B vaccine, or
  • those ≥20 years of age can receive Twinrix vaccine (combined hepatitis A and B vaccine), or
  • a double dose of H-B-VAX II (paediatric), Engerix (paediatric) or Twinrix Junior is also considered a valid adult dose, or
  • complete the vaccine course with the same vaccine brand if available or use the alternative brand (H-B-VAX II or Engerix, whichever is available) to complete the course.
Schedules should be administered as per the Table 4.5.1: Recommended schedules for use of monovalent hepatitis B and hepatitis B combination vaccines in the hepatitis B chapter in The Australian Immunisation Handbook (10th edition).
 

Ordering adult hepatitis B vaccine

Immunisation providers should ring their local public health unit on 1300 066 055 to order adult formulation hepatitis B vaccine for identified eligible patients.
 

More information

Frequently asked questions (FAQs) about the adult formulation hepatitis B vaccine shortage.
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Page Updated: Thursday 10 May 2018
Page Owner: Immunisation