Recommendation on Flu Vaccine for Children under 5

Professor Jim Bishop AO

MD MMed MBBS FRACP FRCPA

Commonwealth Chief Medical Officer

MEDIA STATEMENT

1 June 2010

SEASONAL FLU VACCINE REMAINS SUSPENDED FOR

YOUNG CHILDREN WITHOUT RISK FACTORS

After consideration of the results to date of a comprehensive investigation into the safety of the seasonal flu vaccine for young children, I have advised, that as a precaution, the suspension of seasonal flu vaccination should continue for healthy children under five years of age.

Since the first reports of a higher than usual occurrence of fever with convulsions in young children following seasonal flu vaccination in WA in April, investigations nationally have confirmed that a small number of children aged under five across the country have experienced fever with convulsions in the 24 hours after vaccination with the 2010 seasonal influenza vaccine. These reactions have been associated mainly with Fluvax, manufactured by CSL.

The investigation conducted by the Therapeutic Goods Administration (TGA), in association with the Australian Technical Advisory Group on Immunisation (ATAGI) and the National Centre for Immunisation Research and Surveillance has identified no apparent clinical, biological or epidemiological factors that would explain the higher than expected observed rates of fever with convulsions. Laboratory testing of the vaccine by the TGA and an audit of the CSL manufacturing plant have also revealed no abnormalities to explain this event. However this investigation is continuing.

Nevertheless, to date, epidemiological analyses point to a rate of febrile convulsions in children aged under five years following 2010 seasonal influenza vaccination of about 9 per 1000 children vaccinated, while the expected rate would be less than 1 per 1000.

While I am recommending that healthy children aged under five years not be vaccinated with seasonal flu vaccine this year, where a child aged under five has medical risk factors that would cause serious health effects for the child if they got the flu, parents should discuss with their doctor whether, on clinical evaluation of the risks and benefits, a seasonal flu vaccination would be the best option.

More information is available on the Immunise Australia Hotline at 1800 671 811.

Media contact: Kay McNiece, 0412 132 585

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