2012 seasonal influenza vaccines for use in children
Updated safety advisory
6 February 2012
In 2012 there are four different influenza vaccines registered for use in children from the age of 6 months:
- Agrippal (Novartis)
- Fluarix (GSK)
- Influvac (Abbott)*
- Vaxigrip (Sanofi Pasteur)*
*These vaccines also have a paediatric ("Junior") presentation registered for use in children aged 6 to 35 months.
In addition to the vaccines mentioned above, another influenza vaccine is approved for use in children from the age of 5 years:
- Fluvax (CSL)
Febrile events have been observed in children aged 5 to 9 years following immunisation with Fluvax. Therefore, in this age group, a decision to vaccinate with the 2012 Fluvax vaccine should be based on careful consideration of potential benefits and risks in the individual.
During the 2010 influenza season an excess number of febrile reactions and febrile convulsions occurred in children under 5 years of age following immunisation with one of the registered seasonal trivalent influenza vaccines, Fluvax.
Consequently, in 2011 the TGA recommended that only Influvac and Vaxigrip vaccines be used in children under the age of 5 years. These vaccines had been used in Australian children in 2010 and had not been shown to be associated with an increased rate of fever or febrile reactions.
In 2011 the TGA recommended against the use of two vaccines, Agrippal and Fluarix, in children under the age of 9 years. These vaccines had not been supplied in Australia in 2010 and the sponsors had been unable to establish active surveillance to monitor the safety of their vaccines in this age group.
The TGA now considers that Agrippal and Fluarix may be used in children from the age of 6 months. This is because the sponsors of Agrippal and Fluarix have submitted additional data to the TGA to support the safety of their vaccines in children. The data submitted included the experience with their vaccines in the:
- 2011 Southern Hemisphere winter and
- 2011/2012 Northern Hemisphere winter.
Following evaluation, the TGA has found these data raise no safety concerns related to fever or febrile convulsions in children who received either vaccine.
There has been no change to the strains in the vaccine to affect the safety profile of the vaccines in 2012.
The investigation into the cause of the increase in febrile convulsions with Fluvax is continuing. Fluvax is not approved by the TGA for use in children under the age of 5 years and should only be used in children aged 5 to 9 years based on a careful consideration of the potential benefits and risks in the individual child.
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 personal advice about an individual's medical condition. Consumers are strongly encouraged to talk with a health professional if they are concerned about a possible adverse reaction to any vaccine.
- 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.
- Seasonal Influenza Vaccines – Safety Advisory 11 March 2011
Content last updated: Monday, 6 February 2012
Web page last updated: Monday, 25 June 2012