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23 April 2010
Due to a spike in the numbers of young children in Western Australia experiencing fever and convulsions following seasonal flu vaccinations, Australia's Chief Medical Officer, Professor Jim Bishop, is advising all GPs and immunisation providers to stop giving seasonal flu vaccine to children five years and under until a cause is established.
"This is a precautionary measure while the matter is being urgently investigated by health experts and the Therapeutic Goods Administration (TGA)," Professor Bishop said.
"Until it can be established what factors are causing the apparent rise in fevers in some children in WA, I am writing to all immunisation providers to advise them not to administer seasonal flu vaccine to all children 5 years of age and under until further notice."
Professor Bishop said the medicines regulator, the TGA, is investigating the WA data as a matter of urgency to determine whether the adverse reactions reported in WA relate to the vaccine, or whether factors related to the program delivery in WA are involved.
"The TGA has contacted CSL Ltd 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 in the batches of vaccine used in WA," Professor Bishop said.
"The TGA will be urgently reviewing data from WA Health about the adverse events and the vaccine distribution data to see if the rates of fever and convulsions are truly higher than expected. The TGA is convening an expert scientific advisory panel to review the information from WA, and is seeking additional information from the manufacturer, CSL Ltd, and from regulatory colleagues internationally.
"TGA will test batches of the vaccine used in WA for any abnormalities.
"The Department of Health and Ageing has sought advice from the Australian Technical Advisory Group on Immunisation. which is currently reviewing the available information on cases and the Department will be seeking its further advice. States and territories have been asked to report any adverse events related to seasonal influenza urgently to the Therapeutic Goods Administration. States and territories have also been asked to provide details on batch numbers and type of vaccine."
Professor Bishop said people over five years of age can continue to be vaccinated against seasonal influenza as per usual. Flu can be a serious disease especially in people who are in high risk categories including people aged 65 years and over; all Aboriginal and Torres Strait Islander people aged 15 years and over and pregnant women. The Commonwealth Government provides the seasonal flu vaccine free for these at risk groups.
Professor Bishop said that there do not appear to be implications for the swine flu vaccine Panvax®.
"It is safe to have the swine flu vaccine. The TGA’s assessment of clinical trials and the advice of its expert committees is that Panvax® is a safe, effective vaccine for prevention of the H1N1 influenza.
“It is expected that the dominant flu this winter season will be swine flu and the specific Panvax vaccine is available free for all Australians.”
Media contact: Kay McNiece, Dept of Health and Ageing, 0412 132 585