BioCSL Fluvax - investigations into the cause of fevers in children under 5 years

12 June 2014

News room

During the 2010 influenza season bioCSL's Fluvax influenza vaccine was associated with a higher rate of fever and fever-related convulsions in children under 5 than other influenza vaccines. Information about TGA's response to this issue can be found at: Seasonal flu vaccine.

BioCSL has now published its research into the causes of these adverse events.

The BioCSL researchers found that the likely cause of higher rates of fever and fever-related convulsions was the introduction of new viral strains in that season's vaccine which generated a stronger immune response than seen previously. When processed using the BioCSL standard production method, the new strains also generated certain extra viral components that additionally stimulated the immune system. The researchers concluded that these factors combined to generate stronger immune responses in a sub-group of the population under 5 years of age that resulted in a higher rate of fever and fever-related convulsions in this group.

Advice and actions undertaken

The TGA has not approved Fluvax for use in children under the age of 5 years.

As fevers have been observed in children aged 5 to under 9 years after immunisation with bioCSL Fluvax, health professionals are advised that a decision to vaccinate a child in this age group with the 2014 bioCSL Fluvax vaccine should be based on careful consideration of potential benefits and risks in the individual child.

The following actions have been undertaken:

  • bioCSL Fluvax's Product Information has been changed to add a Black Box Warning against use in children under 5 and additional precautions in children aged 5 to 9
  • additional warning labels have been included on the packaging
  • a prominent warning label for vaccine refrigerators has been made available to remind health professionals against use of the vaccine in children under 5 years.

Information for consumers

When discussing vaccination with a health professional, consumers should be aware that bioCSL Fluvax should not be used in children under 5 years of age. There are other suitable vaccines available for this age group. Consumers should also be aware that bioCSL Fluvax should only be used in children aged 5 to 9 years after careful consideration of the potential benefits and risks in the individual.

The TGA requests that consumers report all adverse events associated with influenza vaccination in patients of any age.

For more information about bioCSL Fluvax, consumers should read the Consumer Medicine Information (CMI).

Information for health professionals

Health professionals are advised to be aware of the Indications, Contraindications and Precautions associated with bioCSL Fluvax, in particular that the product should not be used in children under 5 years of age and careful considerations of the benefit/risk profile should be undertaken when considering vaccinating children aged 5 to 9 years. These are listed in the Product Information (PI). There are other vaccines registered for use in children from the age of 6 months.

The TGA requests that health professionals report all adverse events associated with influenza vaccination in patients of any age.

Health professionals are also requested to report any inadvertent administration to a child of a vaccine not currently recommended for use in children regardless of whether the child has a reaction.

Reporting problems

Consumers and health professionals are encouraged to report problems with medicines or vaccines. 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 or vaccine.