Joint Australian Technical Advisory Group on Immunisation (ATAGI) and Therapeutic Goods Administration (TGA) Seasonal Influenza Vaccine Safety Ad Hoc Working Group:

Review of data on the safety of seasonal influenza vaccines, in adults and children > 10 years

17 February 2012

In Australia, the Commonwealth Department of Health of Ageing (DoHA) has released a review of data on the safety of seasonal influenza vaccines in adolescents and adults. The review was undertaken by a joint technical working group at the request of DoHA in light of the unexpected febrile reactions associated with Fluvax^® vaccine in children in 2010. 

Unfortunately some media outlets in Australia have selectively reported data from the appendices in the safety review and in doing so have misrepresented the body of evidence reviewed by the working group. 

The working group were unable to make definitive statements about the risk difference for adverse events between different brands of influenza vaccines because of the variable quality and significant limitations of the most recent available data. However, the working group did find the possibility of a modest increased risk for non-serious adverse events (predominantly injection site reactions) in Fluvax recipients aged 10 years and over (mostly in 2010 where there appears to be evidence of stimulated reporting). However, the adverse events associated with Fluvax vaccine in this age group were found to be acceptable and consistent with the clinical studies that underpinned the registration of the vaccine in Australia, the US and other markets. 

Most importantly, it was concluded that the overall risk-benefit profile of Fluvax vaccine in adolescents and adults remains positive and that it continues to be suitable for use under the National Immunisation Program. 

The full report from the joint technical working group can be found at www.immunise.health.gov.au 


Media Contact:
Sharon McHale
Senior Director Public Affairs
Phone: +61 409 978 314
Email:sharon.mchale@csl.com.au