Seasonal influenza vaccines

Safety advisory

11 March 2011

9 November 2011 - The recommendations for the use in children of the seasonal influenza vaccines listed below apply to the 2011 influenza season. Recommendations for the use of seasonal influenza vaccines in children in 2012 are currently under consideration. A new statement will be published in early 2012.

During the 2010 influenza season an excess number of cases of febrile reactions and febrile convulsions were observed in paediatric populations following immunisation with one of the registered seasonal trivalent influenza vaccines.1 Consequently, the TGA imposed a condition on the registration of all 2011 seasonal influenza vaccines with a paediatric indication which were not supplied in Australia in 2010. Sponsors were required to undertake active surveillance of children from 6 months to 9 years of age, to ensure effective monitoring of paediatric populations in Australia previously unexposed to these vaccines.

Two sponsors were unable to meet this condition of registration. Although the safety of Agrippal and Fluarix has been demonstrated in the Northern Hemisphere 2010/2011 influenza season, the TGA does not have any safety data on the use of these vaccines in Australian children. Hence, the TGA recommends that these vaccines are not used in any child under the age of 9 years.

For children under the age of 9 years it is recommended that they be vaccinated with either Influvac or Vaxigrip. These two vaccines were not associated with increased rates of fever or febrile reactions in 2010.

CSL's vaccine Fluvax is not approved for use in children under the age of 5 years for the 2011 influenza season. Although CSL has an active surveillance system in place to actively monitor children aged 5-18 years, the Australian Technical Advisory Group on Immunisation (ATAGI) has advised that there is a strong preference for the use of either Vaxigrip or Influvac in children aged 5 years to less than 10 years. ATAGI advises that Fluvax may be used in children aged 5 years to less than 10 years when no timely alternative vaccine is available.2

The approved indication for each seasonal influenza vaccine and the recommendations for their use in children are found below.

Vaccine Sponsor Approved indication Recommendations for use in children
Fluvax CSL 5 years + Not approved for use inchildren under 5 years.
There is a strong preference that Vaxigrip or Influvac be used in children under the age of 10 years.*
Influvac Abbott 6 months + Use in children aged 6 months and above.
Vaxigrip Sanofi Pasteur 6 months + Use in children aged 6 months and above.
Intanza Sanofi Pasteur 18-59 years Do not use.
(approved for adults aged 18-59 years only).
Fluarix GSK 6 months + Not recommended in children under the age of 9 years.
Agrippal Novartis 6 months + Not recommended in children under the age of 9 years.

* CSL has an active surveillance system in place to actively monitor children aged 5-18 however ATAGI has advised that there is a strong preference for the use of Influvac or Vaxigrip in children aged less than 10 years.

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

All reports of adverse events or inadvertent administration can be reported to the TGA by using the online reporting form available from the TGA website, see 'Report a problem with a medicine'.

1 - Investigation into febrile reactions in young children following 2010 seasonal trivalent influenza vaccination, status report as at 2 July 2010 (updated 24 September 2010). Canberra: Therapeutic Goods Administration, 2010. (accessed 9 March 2011).

2 - Immunise Australia web statement