It's important to go to the official sources media-if you really value the health of your little ones at least find credible and complete information as below from bothe the TGA and The Commonwealth Chief Medical Officer
Western Australian reports of adverse reactions to 2010 seasonal flu vaccine in children
23 April 2010 Therpeutic Goods Administration
The Therapeutic Goods Administration (TGA) is investigating reports of an increase in adverse events to the seasonal flu vaccine in Western Australia (WA), where all children 6 months to 5 years have been offered a free seasonal flu vaccination.
The pattern and rate of adverse reactions reported by WA have not been seen in other states, and the TGA will test batches of the vaccine used in WA for any abnormalities.
Other states and territories seasonal flu vaccination programs have focused on individuals in high risk categories.
The TGA is investigating the WA data to determine whether the adverse reactions reported in WA relate to the vaccine, or the WA program delivery.
However, until it can be established what is causing the rise in adverse events in some children in WA, Australia's Chief Medical Officer, Professor Jim Bishop, is writing to all immunisation providers to advise them not to administer seasonal flu vaccinations to all children 5 years of age and under until further notice.
What the TGA is doing
The TGA has contacted the manufacturer, 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.
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.
The TGA is urgently 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.
What parents and caregivers should do
If you have concerns because your child has received the seasonal flu vaccination please contact your doctor. Reported adverse reactions include fever, vomiting and febrile convulsions.
Whether there are any implications for swine flu vaccine
At this stage there do not appear to be implications for the swine flu vaccine Panvax®. Professor Bishop's advice relates only to the seasonal flu vaccination program for children 5 years of age and under.
It is safe to have the Panvax® H1N1 vaccine, even if you are already immune to the virus, just as it is safe to get a seasonal influenza vaccination if you've already had seasonal flu.
The TGA's assessment and the advice of its expert committees is that Panvax® and Panvax H1N1 Junior® are safe, effective vaccine for prevention of the H1N1 influenza.
Swine flu vaccination as alternative to seasonal flu vaccine
Panvax® H1N1 vaccine only protects you against the pandemic (H1N1) 2009 influenza virus. People can still be infected by seasonal influenza viruses circulating in the community. To reduce the risk of influenza during Australia's winter months people should still get the seasonal flu vaccine, particularly if they are in a high risk seasonal flu group. High risk categories include:
- People aged 65 years and over;
- Aboriginal and Torres Strait Islander people aged 15 years and over; and
- Pregnant women.
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CHIEF MEDICAL OFFICER
Professor Jim Bishop AO
MD MMed MBBS FRACP FRCPA
Commonwealth Chief Medical Officer
MEDIA STATEMENT
23rd April 2010
Seasonal Flu Vaccine and young children
Due to a spike in the numbers of young children in Western Australia experiencing feverand 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, 0412 132 585




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Whether it is safe or accurate to extrapolate the results from animal studies onto humans is questionable.

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