Fluarix® Product Notification

GlaxoSmithKline Australia (GSK) in consultation with the Therapeutic Goods Administration (TGA) has issued a product notification to healthcare professionals for its influenza vaccine Fluarix (Inactivated Split Influenza Vaccine).

GSK and the TGA are advising healthcare professionals to visually inspect Fluarix pre-filled syringes for any foreign particulate matter and/or variation of physical aspects prior to administration. This reminder is In line with best practice for all injections and recommended in the Australian Immunisation Handbook.

Any healthcare professional who identifies a visible inclusion in the vaccine should withhold that injection and notify GSK Medical Information on 1800 033 109.

A TGA Product Notification provides precautionary information about a therapeutic product in a situation that is unlikely to involve significant adverse health consequences and which does not require a recall of the product.

This notification is being made following a single report to GSK Australia that a Fluarix vaccine failed to be completely administered due to a manufacturing defect where what appears to be a visible piece of glass-like material was found to be blocking the action of the syringe. No harm to the patient was reported.

Initial investigation by GSK suggests that this is an extremely rare incident as less than one complaint of this type per 10 million vaccines distributed over the past three years has occurred. There have been no other product quality complaints in Australia or other markets where this year’s Fluarix has been distributed.

As this is considered an extremely rare event and unlikely to impact patient safety the TGA has agreed that Fluarix vaccine should continue being used in accordance with similar inspection recommendations in the prescribing information.

Patient safety is the primary concern of GSK, and we continuously cooperate with regulatory authorities to maintain the highest standards of safety, quality and efficacy. Investigation into the root cause of this issue is currently underway.