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beast
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Novartis starts vaccine tests - swine flu
« Aug 12, 2009    01:01:37 AM »
Novartis starts vaccine tests

LONDON - SWISS drugmaker Novartis has begun injecting its swine flu vaccine into people in the company's first human tests, a spokesman said.

The vaccine is being tested in a yearlong trial of 6,000 people of all ages in Britain, Germany and the United States, Novartis spokesman Eric Althoff told The Associated Press on Wednesday, adding that the vaccine will likely be on the market before the trial finishes.

A person in Britain became the first to get the swine flu vaccine about 10 days ago, he said.

Sanofi-Pasteur, which makes about 40 per cent of the world's flu vaccines, expects to start testing its swine flu vaccine within days in the US and Europe, according to spokesman Benoit Rungeard.

Since swine flu was declared to be a pandemic, or global outbreak, by the World Health Organization in June, pharmaceuticals have been racing to get their vaccines ready. Last month, Australian drugmaker CSL became the first vaccine maker to start testing its vaccine in humans in Australia.

'We initiated clinical trials about 10 days ago,' Mr Althoff said.

Half of Novartis' vaccines being tested are grown in chicken eggs, the traditional way of making flu vaccines, while the other half use a new cell-based technology.

The trial will test the vaccine's safety and whether one or two shots are necessary. 'Our assumption is that two doses will be required,' Mr Althoff said.

The vaccines being tested in Europe have an adjuvant, an ingredient used to boost the body's immune response. In the US, Mr Althoff said Novartis will be testing both vaccines with and without adjuvants.

WHO recommends that countries use vaccines with adjuvants, to stretch the global supply of swine flu vaccine. Flu vaccines in Europe often contain adjuvants. However there are no licensed flu vaccines with adjuvants in the United States.

Once Novartis AG has preliminary data from the trial, they will submit that to drug regulators including the European Medicines Agency. European and US regulators have a fast-track process for approving swine flu vaccine, to ensure it is available before the flu season starts in the fall, when swine flu is expected to surge. -- AP


Source: http://www.straitstimes.com/Breaking%2BNews/Tech%2Band%2BScience/Story/STIStory_413275.html
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