tetano
Editor, Senior Moderator
This follows US concerns over Australian pharmaceutical giant CSL.
Australian Medical Association vice-president Steve Hambleton yesterday said GPs were still waiting for the Therapeutic Goods Administration to officially inform them about discolouration in multi-use vials of the Panvax vaccine.
"We would want them to provide further reassurances that we can maintain our confidence in the stockpile which is in many doctors' surgeries around the country," he said.
The Australian revealed yesterday that the TGA had waited until US authorities blew the whistle on vaccine production at CSL's Melbourne laboratory in April, before launching its own inquiry into discoloration of the nation's stockpile of swine flu a month later. The TGA told The Australian on Wednesday that the remaining 9.4 million doses of Panvax stockpiled by the federal government did not pose a safety risk. Testing has failed to reveal the cause of the discoloration.
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The US Food and Drug Administration has written to CSL criticising "deviations from current good manufacturing practice requirements", and singled out the presence of black particles in multi-dose vials of seasonal flu vaccine made for the American market.
At the time of the US inspection, the TGA had suspended use of CSL's seasonal flu vaccine for young children after it had triggered febrile convulsions at nine times the usual rate. The TGA has ruled out any link between problems with the paediatric flu shot and the discoloration in the swine flu vaccine.
A CSL spokeswoman yesterday said the TGA "did not find any safety issues" in an audit of CSL's laboratories last month.
The Gillard government yesterday handed CSL, a listed company, $30m of taxpayer funds for research and development.
More than 100 Australian children suffered febrile fits before the seasonal flu vaccine -- a combination of seasonal and swine flu strains -- was suspended for healthy under-fives in April.
http://www.theaustralian.com.au/new...wine-flu-vaccine/story-e6frg6n6-1225892954576
Australian Medical Association vice-president Steve Hambleton yesterday said GPs were still waiting for the Therapeutic Goods Administration to officially inform them about discolouration in multi-use vials of the Panvax vaccine.
"We would want them to provide further reassurances that we can maintain our confidence in the stockpile which is in many doctors' surgeries around the country," he said.
The Australian revealed yesterday that the TGA had waited until US authorities blew the whistle on vaccine production at CSL's Melbourne laboratory in April, before launching its own inquiry into discoloration of the nation's stockpile of swine flu a month later. The TGA told The Australian on Wednesday that the remaining 9.4 million doses of Panvax stockpiled by the federal government did not pose a safety risk. Testing has failed to reveal the cause of the discoloration.
Start of sidebar. Skip to end of sidebar.
End of sidebar. Return to start of sidebar.
The US Food and Drug Administration has written to CSL criticising "deviations from current good manufacturing practice requirements", and singled out the presence of black particles in multi-dose vials of seasonal flu vaccine made for the American market.
At the time of the US inspection, the TGA had suspended use of CSL's seasonal flu vaccine for young children after it had triggered febrile convulsions at nine times the usual rate. The TGA has ruled out any link between problems with the paediatric flu shot and the discoloration in the swine flu vaccine.
A CSL spokeswoman yesterday said the TGA "did not find any safety issues" in an audit of CSL's laboratories last month.
The Gillard government yesterday handed CSL, a listed company, $30m of taxpayer funds for research and development.
More than 100 Australian children suffered febrile fits before the seasonal flu vaccine -- a combination of seasonal and swine flu strains -- was suspended for healthy under-fives in April.
http://www.theaustralian.com.au/new...wine-flu-vaccine/story-e6frg6n6-1225892954576