Fluarix - influenza vaccine

Product alert

6 March 2013

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.

Information for consumers

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.

Reporting problems

Consumers and health professionals are encouraged to report problems with medicines, vaccines or medical devices. Your report will contribute to the TGA's monitoring of these products.

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.