Fears Grow As Toddlers Hospitalised From Untrialed Flu Vaccine
April 24, 2010
Debbie Guest and Natasha Bita
CLINICAL tests were never carried out on the latest seasonal flu vaccine – a first-time combination of seasonal flu with the feared swine flu H1N1 – that has left a baby girl fighting for her life in a Perth hospital and sparked fits, fevers and vomiting in up to 60 toddlers across the country.
Health officials were last night trying to determine what had caused the reactions in the children, mostly in Western Australia.
The country’s chief medical officer, Jim Bishop, yesterday ordered doctors in all states to stop giving the flu vaccine to children under five.
Professor Bishop said non-swine flu strains in the vaccine may have caused the reactions.
For the first time in the world, the flu shot rolled out in Australia last month combined two strains of seasonal flu, as well as H1N1.
Professor Bishop said the Panvax vaccine – the swine flu jab – was “safe”, but said the combined flu shot had been suspended for young children as a “precautionary measure” pending investigation by the Therapeutic Goods Administration, which approved its use last month.
Panvax was tested on 400 children before its release last year, but the combined shot was not subjected to any clinical trials.
CSL, which manufactures both vaccines, has stopped distributing children’s doses nationally “to reduce the risk of inadvertent administration in this age group”.
One angry West Australian mother, who only wanted to be identified as Sharon, said if officials had acted earlier, the one-year-old girl in critical condition in hospital may never have become sick.
Sharon had three of her four children vaccinated two weeks ago and all three needed hospitalisation after suffering from fevers, vomiting and fits. She said it was a frightening experience after her three-year-old, Alivia, turned purple and began shaking. One of her one-year-old twins, Lateesha, later started convulsing.
Peter Richmond, associate professor at the University of Western Australia’s school of pediatrics and child health, said the vaccine was not subjected to trials.
“As with each year’s seasonal influenza vaccine, this year’s seasonal influenza vaccine isn’t subject to specific trials in children before it’s used,” he said.
He added that three trials of different combinations of seasonal flu vaccines had been conducted in children and no concerns had been raised.
Professor Robert Booy, the director of clinical research at the National Centre for Immunisation Research and Surveillance – who helped supervise the swine flu trials – said the combination of flu strains could not be the cause of the problems.
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