Update on availability of BCG vaccine

4 July 2017 - Communicable Disease Control Branch

No BCG vaccine registered by the Australian Therapeutic Goods Administration (TGA) has been available for use in Australia since December 2015. It is not certain when a registered BCG vaccine will be available on a secure basis.

As a temporary alternative in 2017, a BCG vaccine product from the Serum Institute of India (SII), which is World Health Organisation (WHO) prequalified, http://www.who.int/immunization_standards/vaccine_quality/118_bcg/en/, has been obtained by the SA Health Immunisation Program. This BCG vaccine has been assessed by the Australian Technical Advisory Group on Immunisation (ATAGI) as suitable for use on quality and safety grounds, but it is not registered or approved for marketing by the TGA in Australia. Therefore its provision will be through special prescribing arrangements with the TGA and will require a specific process of informed consent by the patient or parent/guardian before vaccination can occur.

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Adult formulation Hepatitis B vaccine (Engerix®) shortage

26 June 2017 - Communicable Disease Control Branch

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.

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