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Australia approves locally made bird flu vaccine
Jun 17, 08 FDA ApprovalsAustralia said on Tuesday it had approved the first locally made vaccine to protect humans from future bird flu, giving the nod to Panvax manufactured by CSL.
“The vaccine, Panvax, protects humans against the H5N1 influenza virus, which has been responsible for outbreaks of bird flu in Asia, the Middle East, Europe and Africa,” Health Minister Nicola Roxon said in a statement.
Experts fear the H5N1 virus, which has led to the slaughter of many poultry populations worldwide, could mutate into a form easily spread among people and spark a pandemic. The virus has killed 241 people in a dozen countries since 2003.
Roxon said Panvax would provide Australians with safe, effective coverage against being infected by a human strain of avian influenza, and was developed with government backing.
Three randomized, double-blind clinical studies were conducted to assess the safety of the vaccine in adults aged 18-64, and older adults aged 65 years and over, she said.
The vaccine is administered in two doses and had been approved by Australia’s drug regulator, the Therapeutic Goods Administration, Roxon said.
Panvax can only be used once an influenza pandemic has been officially declared by the World Health Organization.
“There wouldn’t be any benefit to people having the vaccine now if a pandemic hasn’t been declared,” CSL Biotherapies General Manager Mary Sontrop said.
She said CSL had a number of virus strains ready for production and was one of a number of manufacturers around the world working on a vaccine.
“Our pandemic vaccine is based on the same process as our seasonal influenza vaccine so really, in essence, it is a matter of just changing the strains,” Sontrop said.
At least 16 companies are working on vaccines against H5N1. No one knows if they will work against whatever strain might eventually cause a pandemic.
Hong Kong last week began culling live poultry after H5N1 was found in markets and spread throughout the island’s poultry population.
CSL shares were off 1.25 percent at A$38.70 on Tuesday in a broader market up 0.7 percent.
CANBERRA (Reuters)
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