Health professionals and consumers are advised that GlaxoSmithKline Australia (GSK), in consultation with the TGA, has issued a precautionary product notification for its influenza vaccine, Fluarix.
The TGA has received a report that one dose of Fluarix vaccine failed to be completely administered because of a manufacturing defect, in which what appeared to be a piece of glass-like material blocked the action of the syringe.
No harm to the patient was reported.
This manufacturing defect is an extremely rare event (occurring at a rate of less than one report in 10 million doses distributed worldwide). In the unlikely event it happens again, it is similarly unlikely to pose a significant safety risk to the patient.
Further investigation into the cause of the problem is being undertaken.
The TGA has agreed that the Fluarix vaccine currently being distributed can continue to be used, but has advised health professionals to visually inspect the pre-filled syringes prior to administration.
If you have any questions or concerns about Fluarix, or any other influenza vaccine, please contact your health professional.
Information for health professionals
Health professionals should visually inspect all Fluarix pre-filled vaccine syringes for foreign particulate matter and/or any other variation of physical aspects prior to administration, as advised in the Product Information. If there is any visible inclusion in the vaccine, do not administer it.
The TGA reminds health professionals to 'inspect before you inject'. As specified in the Australian Immunisation Handbook, all vaccine should be checked visually prior to administration.
GSK is writing to all GP clinics and hospital pharmacies, as well as local immunisation centres where applicable, providing information and advice about this issue.
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine, vaccine or medical device.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.