Seasonal flu vaccine: 2014 seasonal influenza vaccines for use in children

12 March 2014

From the age of 6 months

For the 2014 influenza season, there are four different influenza vaccines registered for use in children from the age of 6 months:

  • Abbott Australasia - Influvac*
  • GlaxoSmithKline - Fluarix
  • Novartis Vaccines and Diagnostics - Agrippal
  • Sanofi-Pasteur - Vaxigrip*

* These vaccines also have a paediatric ('junior') presentation registered for use in children aged 6 to 35 months.

From the age of 5 years

In addition to the vaccines mentioned above, another influenza vaccine is approved for use in children from the age of 5 years:

  • bioCSL - Fluvax

bioCSL Fluvax is not approved by the TGA for use in children under the age of 5 years because of an increased risk of fever and febrile convulsions.

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

The Product Information for bioCSL Fluvax contains the following black box warning:

WARNING: This season's vaccine is indicated for use only in persons aged 5 years and over. It must not be used in children under 5 years (see Contraindications). It should only be used in children aged 5 to under 9 years based on careful consideration of potential risks and benefits in the individual (see Precautions).

In addition to the black box warning, bioCSL Fluvax will have the following warnings on all sides of the packaging:

image of bioCSL Fluvax packaging warning: Do not use in children under 5 years

The following vaccine refrigerator warning sticker will also be available for use during the 2014 influenza season:

image of bioCSL Fluvax vaccine refrigerator sticker

From the age of 9 years

For the 2014 influenza season, the following five influenza vaccines can be used in children from the age of 9 years:

  • Abbott Australasia - Influvac
  • bioCSL - Fluvax
  • GlaxoSmithKline - Fluarix
  • Novartis Vaccines and Diagnostics - Agrippal
  • Sanofi-Pasteur - Vaxigrip

Vaccine strains for 2014

Following a review of the strains of influenza that were circulating in the Southern Hemisphere, the Australian Influenza Vaccine Committee (AIVC) recommended that the TGA should adopt the September WHO recommendations. These recommendations have resulted in changes to two of the strains in the 2014 vaccine compared with the 2013 vaccine. Details of the strains were announced on the TGA website on 11 October 2013.

The influenza strains in the 2014 vaccines are the same as the strains in the influenza vaccines used in the recent Northern Hemisphere winter. The TGA is reviewing data from the Northern Hemisphere to ensure there have been no unexpected adverse events related to the strains in these vaccines.

The TGA, in conjunction with the States and Territories, will be monitoring adverse event reports in Australia once the influenza vaccination program commences. Additionally, an independent organisation will be contracted to closely monitor adverse events in children under 5 years of age.

Background

During the 2010 influenza season, an excess number of febrile reactions and febrile convulsions occurred in children under the age of 5 years of age after immunisation with bioCSL Fluvax.

There have been no excess rates of febrile reactions for the four vaccines that have been approved for use from 6 months of age for the upcoming influenza season.

Reporting of adverse events following influenza vaccine

Health professionals and consumers are encouraged to report all adverse events associated with influenza vaccination in patients of any age to the TGA or through the current arrangements in their State or Territory.

All reports contribute to the TGA's ongoing monitoring of the safety of influenza vaccines.

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 vaccine or medicine.