There is no Bacillus Calmette-Guerin (BCG) vaccine currently available which is registered for use in Australia. This fact sheet provides information on the alternative BCG vaccines in use in New South Wales TB Services.
Why are unregistered BCG vaccines being used?
The sole BCG product registered by the Therapeutic Goods Administration (TGA) for use in Australia manufactured by Sanofi Pasteur has been unavailable for several years. Two alternative BCG vaccines which are currently not registered for use in Australia are being offered under special prescribing arrangements to people who require BCG vaccine. The products are BCG-10 which has been manufactured by Biomed Lublin since 1955, and is registered in Poland, and BCG-SII, produced by the Serum Institute of India which has been classified as a World Health Organization (WHO) prequalified vaccine since 2003.
Are these products safe for me or my child?
The Australian Technical Advisory Group for Immunisation (ATAGI), Australia’s peak advisory group that assesses the information available for vaccines and provides advice to government and immunisation service providers, has advised that both BCG-10 vaccine and the BCG-SII vaccine are suitable for use and are likely to provide a similar level of protection against tuberculosis (TB) as other BCG products, including the TGA registered product.
The TGA has approved supply of BCG-10 vaccine based on evidence of manufacture under acceptable quality and safety conditions. The BCG-SII vaccine is classified as World Health Organization (WHO) prequalified; a process that includes independent laboratory testing, site audits of manufacturing facilities and ongoing reporting and monitoring requirements. ATAGI considers the WHO prequalification process to provide a considerable level of confidence regarding vaccine safety.
Both BCG-10 vaccine and BCG-SII vaccine appear to have similar safety profiles to the vaccine previously available in Australia based on the limited data available. The available evidence indicates that the rate of side effects should be no greater than that associated with other BCG products.
As ATAGI have deemed both products as suitable, NSW TB Services will source either BCG-10 or BCG-SII based on the product availability, clinic resources and demand in their local area.
For further information see the NSW Health BCG Vaccination: Information for Parents available on the NSW TB Program website
. If you have any further questions you can discuss these with your vaccine provider.