Update on availability of BCG vaccine
Tuesday, 4 July 2017
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.
BCG Vaccination Policy
In South Australia, in accordance with national policy, BCG vaccination is primarily used in children under 5 years to limit their risk of developing severe forms of TB disease, and in those health care workers (HCW) working in areas where drug resistant TB is prevalent. For Australians this generally applies to those travelling to high TB burden countries for extended periods.
BCG Vaccination Request
In the current situation, the South Australian TB Service at the Chest Clinic will be the only authorised prescriber of the BCG vaccine. An appointment will be required.
A request for BCG vaccination can be made:
- by phoning 8222 4867
- emailingRAH.ThoracicMedicine@sa.gov.au the Chest Clinic so that a BCG request form can be forwarded to the person requiring vaccination.
Once a request is received the Chest Clinic will contact the person to make an appointment. More information on BCG vaccination is available at the link above and at http://www.rah.sa.gov.au/thoracic/diagnostic/BCGVaccine.php .
Alternative to BCG vaccination
An alternative recommendation to BCG vaccination is:
- All those under 5 years travelling to high TB burden countries for extended (3 months or more) or frequent visits should be tested for acquired TB infection with a follow-up tuberculin skin test (TST) at 8-12 weeks after returning.
- In those with evidence of recent TB infection, preventive treatment should be offered to minimise the risk of progression to active TB.
- HCWs travelling to MDRTB endemic areas should be made aware of the risk.
For further advice please contact the South Australian TB Services at the RAH Chest Clinic on 8222 4867.Patient services are provided free of charge.