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Swine flu vaccine available within weeks, makers say

By Steve Larkin
Wed Jul 22 19:19:50 EST 2009

ADELAIDE, July 22 AAP/AP - An Australian vaccine for swine flu could be available in weeks, with the world's first human trials now underway in Adelaide.

Australian bio-pharmaceutical companies CSL and Vaxine are confident their vaccines will protect against the potentially deadly influenza A(H1N1) virus.

Adelaide-based Vaxine reportedly began trials at the Flinders Medical Centre Monday with 300 subjects, and Melbourne's CSL will inject 240 people at the Royal Adelaide Hospital in its trial, which started on Wednesday.

Both companies say their trials are the first tests of a swine flu vaccine on humans and will later conduct further trials on children and those with chronic diseases.

CSL's research and development director Andrew Cuthbertson says he expects that initial results will allow distribution of its government-funded vaccine in October.

With more than 40 deaths so far recorded in Australia, the federal government has ordered 21 million doses of CSL's vaccine, should it be proven to work.

"As soon as I have confirmation that the vaccine is safe and effective, I will ensure it can be rolled out to the community," federal Health Minister Nicola Roxon told reporters in Melbourne on Wednesday.

The CSL adult trials, which will take six weeks to complete, are testing the appropriate dose of the vaccine.

"It will be available when the government decides how to roll it out," Dr Cuthbertson told reporters in Adelaide on Wednesday.

"There is a clear distinction between CSL's role, which is to do the research, develop the vaccine and make it in large amounts and make it available to government - and government will then decide what the roll-out will be.

"There may be a point where our government feels the threat justifies moving forward in deploying the vaccine."

While medical experts have warned against rushing vaccines through the trials, CSL spokeswoman Rachel David said there was "no additional safety risk in rolling out the vaccine" in September or October.

She said the vaccine was similar to the currently available seasonal flu vaccine - the only difference being the new vaccine contained one strain of flu - swine flu - while the seasonal flu vaccine contained three strains of influenza.

Dr Cuthbertson said CSL was "confident that the safety profile of this vaccine will be very similar to our normal seasonal vaccines".

"We will be supplying other countries but we would supply Australia with the vaccine, and then the rest of the world," he said.

It is understood the vaccine developed by Vaxine is unlike the egg-based inactivated virus vaccine being trialled by CSL.

Vaxine's research director Nikolai Petrovsky said his company's vaccine was a novel state-of-the-art protein production technology that did not contain typical viral contaminants.

"This revolutionary design means that vaccines can now be produced in record time, making this technology ideal for rapid vaccine production in pandemic situations," said Peter Cooper who, along with Professor Petrovsky, invented a key component of the new Vaxine vaccine.

Professor Petrovsky said it would be six to eight weeks before results would verify whether the Vaxine vaccine was effective.

"There is no guarantee any of these vaccines will work," he said.

"Swine flu is a very peculiar beast, it's a very different virus that we're dealing with. But we are hopeful."

Some 41 people have died with swine flu across Australia and 1,662 have been hospitalised since the pandemic was identified.

Dr Cuthbertson said swine flu had yet to mutate.

"So far, at least, it doesn't appear to have changed very much which, I guess from the point of view of preparing a vaccine, is a good thing.

"We are really in a constant battle in trying to stay ahead of the evolution of the virus, if you like, but we are very well prepared do to that.

"What we have developed, I'm pleased to say, is entirely appropriate for the current threat ... that is not to say it won't change in the future but I think so far the vaccine is quite appropriate for the current threat."