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September 4, 2009

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China's 1-shot vaccine holds hope for world's H1N1 battle

THE answer may be at hand to a crucial question about vaccination for the advancing swine flu - one shot or two?
Chinese officials approved a vaccine yesterday that they say prevents the new flu in a single dose.
If they're right, it would be good news. Many health researchers fear it will take two shots to protect people, vastly complicating efforts to stem the spread of the illness.
The World Health Organization says it is encouraged after reviewing the test details from the vaccine by Beijing-based drug maker Sinovac Biotech Ltd.
The WHO said information provided by Sinovac showed that in studies, the vaccines were tested in three formulations of 15 micrograms per dose, and all gave antibody responses that satisfied regulatory criteria. That vaccine dose is the same amount the US is testing.
"We have no reason to doubt what Sinovac is reporting," said Melinda Henry, a WHO spokeswoman in Geneva. "Certainly if one dose proves sufficient to produce the desired immune response, this would be very encouraging in terms of augmenting the global supply of vaccine in the near future."
Swiss drug maker Novartis AG also said yesterday that one of its swine flu vaccines may work with just one dose, rather than two as previously expected.
In early results from human tests on one of its swine flu vaccine candidates, Novartis said one shot of its vaccine provided enough protection against the virus, as set out by criteria by US and European drug regulators.
However, experts said more results are needed from other vaccine makers to determine if one dose would be potent enough.
In about two weeks, the US expects to announce initial test results from its vaccine, which is the same type as one of the Chinese versions, said Dr Anthony Fauci of the US National Institutes of Health.
"From what I've seen and heard of the data, it looks encouraging," Fauci said of the clinical trials of Sinovac vaccine. "This is very good news. Let's hope the material that we're using has similar results."
China's State Food and Drug Administration said yesterday that it approved the vaccine by Sinovac, which completed testing last month. The vaccine is the first to be approved by the Chinese regulator and is set to be followed by at least one other vaccine this week, made by Hualan Biological Engineering Inc.
Another four vaccines were being reviewed, the regulator has said.
Both companies say their studies show one shot of vaccine is effective on people ages three to 60. More than 3,000 participated in the trials.
Sinovac says it has the capacity to produce up to 30 million doses of swine flu vaccine in a year, while Hualan said it can make 160 million doses.
Stockpiling vaccines is China's latest move to contain the spread of swine flu. Nearly 4,000 cases have been confirmed on the mainland - none fatal.


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