Health authorities are alarmed that some children under age five, including at least four in WA, have been given a flu vaccine banned for use in them because of an increased risk of seizures.

While there have been no reports of adverse reactions, the Federal Health Department has warned doctors and other vaccine providers they are legally liable if they give the bioCSL vaccine Fluvax to young children and they suffer ill effects.

The department revealed yesterday that since April 20 there have been nine confirmed cases, four in WA, of children under five being given Fluvax.

One was the cases was in a remote community.

Fluvax triggered a spate of bad reactions in children in 2010 and left 11-month-old Perth girl Saba Button severely disabled.

Her parents sued the manufacturer and the State Government for millions of dollars in damages.

It resulted in Australia’s flu vaccine program for young children being shut for three months and that product being banned for use in under 5s.

The Health Department contacted the Royal Australian College of GPs this week, calling on doctors to be vigilant in monitoring the use of Fluvax, which carries a black box warning that it should not be used in young children.

The college said Australia’s chief medical officer Chris Baggoley had made it clear that even one case of a child under five being given Fluvax was “totally unacceptable”.

Professor Baggoley warned that giving the vaccine to young children was an “off-label” use that exposed clinicians to a legal risk and the Government would not accept liability for any consequences.

A department spokeswoman said that as well as the vaccine not being registered for use in children under five, the Australian Technical Advisory Group on Immunisation did not recommend it for five to nine-year-olds because of an increased risk of reactions in that age group.

The Commonwealth had intentionally delayed the start of its national flu vaccination program this year to prevent Fluvax being given to young children by mistake while the manufacturing of overseas brands suitable for younger ages was delayed.

Australian Medical Association WA president Michael Gannon said while the risks were very low if young children were given the vaccine, no one could afford to take that gamble.

“The guidelines are very clear, and it’s not as if there are no alternatives for young children, so these reports are of great concern,” Dr Gannon said.

“Any doctor, nurse or pharmacist who gives a vaccine is duty-bound to check the product is age-appropriate.”

RACGP president Frank Jones said the overwhelming majority of GPs had been safely administering the flu vaccine to children.


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