Seasonal flu vaccine: 2015 seasonal influenza vaccines for use in children

3 March 2015

From the age of 6 months

For the 2015 influenza season, the following trivalent and quadrivalent influenza vaccines will be registered and available for use in children from the age of 6 months:

  • BGP Products# - Influvac (trivalent)
  • GlaxoSmithKline - Fluarix (trivalent)
  • Novartis Vaccines and Diagnostics - Agrippal (trivalent)
  • Sanofi-Pasteur -
    • Vaxigrip Junior (6 to 35 months) (trivalent)
    • Vaxigrip (trivalent)
    • FluQuadri Junior (quadrivalent)

# Previously the pharmaceutical division of Abbott Australasia.

From the age of 3 years

For the 2015 influenza season, there are two quadrivalent influenza vaccines registered and available for use in children from the age of 3 years:

  • GlaxoSmithKline - Fluarix-Tetra
  • Sanofi-Pasteur - FluQuadri

From the age of 5 years

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

  • bioCSL - Fluvax

The bioCSL Fluvax vaccine 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 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 distributed by bioCSL and available to providers for use during the 2015 influenza season:

image of vaccine refrigerator warning sticker distributed by bioCSL

Vaccine strains for 2015

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 for the strains to be covered by the 2015 seasonal influenza vaccines. Details of the strains were announced on the TGA website on 14 October 2014.

Trivalent vaccines include two influenza A strains and one B strain. For 2015, one of the A strains is the H1N1 strain that has been in the seasonal vaccine since 2010. The other two strains have changed compared with the 2014 vaccines used in Australia and the 2014/15 vaccines used in the recent Northern Hemisphere winter.

The quadrivalent vaccines contain the same strains as the trivalent vaccines with the addition of a second influenza B strain.

In conjunction with the Office of Health Protection and state and territory health authorities, the TGA will continue to closely monitor adverse event reports during the 2015 influenza vaccination program.

The 2015 National Seasonal Influenza Immunisation Program will start on 20 April 2015, instead of the usual start date of 15 March. The 2015 Program start date has been put back due to a double strain change from the 2014 influenza vaccine which has led to manufacturing delays.

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.