CSL Inc. has stop distribution of its <"http://www.yourlawyer.com/practice_areas/defective_drugs">pediatric flu vaccine in Australia after some children who had received it suffered adverse reactions. CSL is one of the world’s largest influenza vaccine manufacturers.
According to a report in The Wall Street Journal, the injection at the center of the concern was a seasonal vaccine that immunized children against three influenza strains, including the swine flu.
Most of the adverse reactions were reported in Western Australia, where about 60 children suffered fevers and convulsions within 12 hours of being injected. Incidents were also reported in Queensland and South Australia.
According to Australian media reports, the country’s chief medical officer, Jim Bishop, said CSL had been contacted to determine which batches had been sent to Western Australia. Samples had been obtained to test for abnormalities. For now, the vaccine has been banned in Australia for children under five.
Bishop is describing the ban as a precautionary measure. “Until it can be established what factors are causing the apparent rise in fevers in some children I am writing to all immunization providers to advise them not to administer seasonal flu vaccine to all children under five,” he said.
Possible causes for the reactions could be a contaminant in the vaccine, or the circulation of a virus, which when combined with the vaccine, could cause the reported reactions.
The Australian is reporting that clinical tests were never carried out on this particular vaccine, which was a first-time combination of seasonal flu with Panvax, a vaccine against the H1N1 strain. Australia was the first country to use this type of vaccine, the report said. Panvax was tested on 400 children before its release last year, but the combined shot was not subjected to any clinical trials.
According to The Wall Street Journal, CSL said in a statement that it was working with health authorities to investigate the problem. “The company takes the safety and quality of its products seriously and will provide more information as soon as possible,” it said.