B/f Vaccine to be registered

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     http://www.odt.co.nz/article.

 Bird flu vaccine to be registered

 Wednesday, 31st January 2007 

Sydney: The first bird flu vaccine will be registered with the Therapeutic Goods Administration in Australia next month after drug maker CSL reported encouraging trial results. 

The manufacturer yesterday announced that new data from its pandemic influenza vaccine clinical trial programme proved it was safe and well tolerated. 

It also had determined the ideal dose of antigen needed to produce a strong immune response against the H5N1 bird flu virus, CSL spokeswoman Rachel David said. 

�What we have now is sufficient information to definitively put in a master file to the TGA to say we can make this product,� she said. 

�With the current strain we�re looking at, the Indonesian strain, we should be able to vaccinate the Australian population within six months.� 

Two other pharmaceutical companies, GlaxoSmithKline and Sanofi-Aventis, are also developing pandemic flu vaccines but CSL will be the first to file for registration in Australia. 

Results from phase-two trials in adults aged 18 to 65 showed the vaccine was safe, effective and well tolerated. 

The outcome of tests on infants, children and the elderly are yet to be released. 

�We know it will be effective in adults aged up to 65 and we know they�ll need two doses of 30 micrograms of antigen,� Dr David said. 

The federal government has contributed $A7.17 million ($NZ8.05 million) towards the Melbourne company�s pandemic vaccine development programme. 

CSL�s chief scientific officer Dr Andrew Cuthbertson said while results were encouraging thus far, further research was under way to ensure the maximum number of vaccine doses could be produced in the shortest possible time. 

�The ultimate goal of our research programme is to develop a pandemic vaccine which uses the lowest dose of antigen, which can offer cross-protection against similar but non-identical bird flu strains, and which lasts as long as possible,� Dr Cuthbertson said. 

At least 132 people have died worldwide since the virus reemerged in east Asia in 2003, with Indonesia and Vietnam worst hit. 

The infection is transmitted via bird to human contact and the World Health Organisation has said there is no evidence so far of human to human transmission. 

But experts fear it is possible the deadly H5N1 strain could mutate to a human flu strain, with the potential to kill millions of people. 

In Taiwan, government researchers announced on Monday that an experimental H5N1 vaccine for humans had produced antibodies in small animals. They hope to complete two clinical trials before the end of 2008. AAP

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	http://www.odt.co.nz/article. Bird flu vaccine to be registered Wednesday, 31st January 2007 Sydney: The first bird flu vaccine will be registered with the Therapeutic Goods Administration in Australia next month after drug maker CSL reported encouraging trial results. The manufacturer yesterday announced that new data from its pandemic influenza vaccine clinical trial programme proved it was safe and well tolerated. It also had determined the ideal dose of antigen needed to produce a strong immune response against the H5N1 bird flu virus, CSL spokeswoman Rachel David said. �What we have now is sufficient information to definitively put in a master file to the TGA to say we can make this product,� she said. �With the current strain we�re looking at, the Indonesian strain, we should be able to vaccinate the Australian population within six months.� Two other pharmaceutical companies, GlaxoSmithKline and Sanofi-Aventis, are also developing pandemic flu vaccines but CSL will be the first to file for registration in Australia. Results from phase-two trials in adults aged 18 to 65 showed the vaccine was safe, effective and well tolerated. The outcome of tests on infants, children and the elderly are yet to be released. �We know it will be effective in adults aged up to 65 and we know they�ll need two doses of 30 micrograms of antigen,� Dr David said. The federal government has contributed $A7.17 million ($NZ8.05 million) towards the Melbourne company�s pandemic vaccine development programme. CSL�s chief scientific officer Dr Andrew Cuthbertson said while results were encouraging thus far, further research was under way to ensure the maximum number of vaccine doses could be produced in the shortest possible time. �The ultimate goal of our research programme is to develop a pandemic vaccine which uses the lowest dose of antigen, which can offer cross-protection against similar but non-identical bird flu strains, and which lasts as long as possible,� Dr Cuthbertson said. At least 132 people have died worldwide since the virus reemerged in east Asia in 2003, with Indonesia and Vietnam worst hit. The infection is transmitted via bird to human contact and the World Health Organisation has said there is no evidence so far of human to human transmission. But experts fear it is possible the deadly H5N1 strain could mutate to a human flu strain, with the potential to kill millions of people. In Taiwan, government researchers announced on Monday that an experimental H5N1 vaccine for humans had produced antibodies in small animals. They hope to complete two clinical trials before the end of 2008. AAP