Courtesy of Bloomberg News
Australia’s drug regulator widened an investigation into CSL Ltd.’s seasonal flu vaccine, the first to include the H1N1 pandemic strain, after the shot was linked to fevers and convulsions among children. The Therapeutic Goods Administration asked the nation’s eight states and territories to examine all reports of fevers among children under 5 years, even cases not directly involving vaccination, for evidence of a pattern that may help explain the incidents, Kay McNiece, a spokeswoman for the regulator, said in a telephone interview from Canberra today.
The regulator said April 23 that children aged 5 and younger should stop receiving CSL’s Fluvax and the company said it stopped distributing the product after complaints of seizures and fevers among children. Fifty-five children in Western Australia, 5 years and younger, have been identified with possible convulsions after receiving the shot and a further 196 had less serious reactions such as fever, vomiting and inflammation at the injection site, Western Australia’s health department said. Between 20,000 and 30,000 children in the age group have been vaccinated so far this year, the department estimates.
A study of Fluvax among 298 children aged between 6 months and 8 years published in the journal Influenza and Other Respiratory Viruses last year found that 3.4 percent suffered severe fever, and one child had convulsions. “The risk of whether or not children have a convulsion with a fever is usually age-related,” said Jodie McVernon, a senior research fellow at the University of Melbourne who participated in the research. “The younger you are, the more likely you are to have a fit with a fever, and it’s something that you grow out of.”