FED: Flu vaccine maker rules out 'bad batch'

AAP General News (Australia)
04-27-2010
FED: Flu vaccine maker rules out 'bad batch'

By Danny Rose, Medical Writer

SYDNEY, April 27 AAP - The maker of the flu vaccine now implicated in a rash of child
sickness across Australia - and possibly one toddler's death - has ruled out a "bad batch"

is involved.

A spokesperson for Melbourne-based pharmaceutical company CSL says a check of available
batch numbers listed on adverse reaction reports had indicated no single batch could be
responsible.

West Australian health authorities have now received more than 250 reports of child
sickness linked to the vaccine.

GPs nationwide have been told to temporarily stop administering the vaccine to children
aged under five.

"CSL is continuing to work with the Therapeutic Goods Administration (TGA) and WA Health
to urgently investigate the adverse event reports," the CSL spokesperson told AAP on Tuesday.

"What we have been able to analyse so far indicates that it is not batch related ...

our evidence shows it was not a bad batch."

The spokesperson said CSL was now working to finalise numbers on how many doses of
its FLUVAX vaccine were sent to WA.

WA was the only state to offer a specific program offering the injections for free
to healthy children under five, which may account for its higher rate of adverse reactions
compared to other states.

The lack of a problematic batch indicates that other factors - such as practises at
immunisation clinics - are likely to be drawn into the TGA's investigation.

WA started its pediatric vaccination program on March 19, and related adverse reactions
among children have included vomiting and high fever leading to fits or convulsions.

A one-year-old girl remains in a serious but stable condition in Perth's Princess Margaret
Hospital after receiving the vaccine.

Queensland's coroner is also investigating the tragic case of toddler Ashley Jade Epapara,
a two-year-old who was found dead in her cot on April 9 just 12 hours after receiving
the seasonal flu vaccine.

All state and territories have been asked to provide data on other possible cases of
adverse reactions in children, though a TGA spokesperson said the problem appeared to
be centred on WA.

"To date, the pattern and rate of adverse reactions reported by WA have not been seen
in other states," the spokesperson told AAP.

"The TGA has contacted the vaccine suppliers to confirm which batches of vaccine were
used in WA, and is obtaining samples of the vaccine to test in its laboratories to determine
if there are any abnormalities."

The spokesperson said the investigation would take in the content of the vaccine as
well as "factors related to the program delivery in WA".

Seasonal flu vaccines are made available ahead of every Australian winter, and their
make-up is dictated by the World Health Organisation.

These vaccines are trivalent in that they offer protection against three influenza
virus strains expected to be in circulation.

This year's seasonal flu vaccine offers protection against the A(H1N1) swine flu, along
with an Influenza B strain and an A(H3N2) virus.

CSL is the major distributor and the only Australian-based maker of the vaccine though
versions can also be imported into Australia by rival pharmaceutical companies.

AAP dr/ht/apm

KEYWORD: FLU WRAP (WITH TIMELINE)

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