Swine-flu vaccine now being tested on humans
Last Updated: Friday, August 14, 2009 | 5:31 PM ET
CBC News
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The manufacturer of Canada's swine flu vaccine has started human testing, the company announced Friday.
GlaxoSmithKline PLC said it plans to test its vaccine in more than 9,000 people in Canada, the United States and Europe as part of 16 clinical trials.
The first results are expected early next month from tests in Germany on 128 people aged 16 to 60, spokeswoman Alexandra Harrison said.
Initial results will be submitted to regulators in North America and Europe, who will then decide whether to licence the vaccine.
In Canada and the U.S., Glaxo is testing vaccines with and without adjuvants — the additives that are used to stretch a vaccine's active ingredient and boost immune response to the serum.
Other Glaxo trials will test the vaccine in infants, children and the elderly and are scheduled to last about a year, but the vaccine is expected to be available before they end.
"We aim to get the first doses out in September," Harrison said. The plan is to fill major orders by the end of the year or early 2010.
The company plans to donate 50 million doses to the World Health Organization for use by poorer countries. Toward that end, Glaxo will set aside 20 per cent of the vaccine produced in Canada for people in the developing world.
GlaxoSmithKline, which has a contract with the federal government for the inoculations, has said the entire Canadian order will be produced at its factory in Quebec City.
Two other major drugmakers, Novartis AG and Sanofi-Aventis SA, began testing their swine flu vaccines earlier this month. In July, Australian pharmaceutical company CSL started testing its vaccine in Australia.
Study checks how many infected
Also on Friday, the Ontario government launched a website as part of a national study to determine how many people are already infected with the H1N1 pandemic virus and how many others are still vulnerable.
The serological study will also determine risk factors for infection.
The information has important implications for infection control, vaccination policies and future epidemiological research on the flu virus, the Ontario Agency for Health Protection and Promotion said.
The agency is looking for 3,000 volunteers who live in Ontario and are 18 years of age or older. Participants will fill out a questionnaire and then go to a local laboratory to give a blood sample and, in some cases, a saliva sample.
All volunteers will be given their test results. Having antibodies to the H1N1 swine flu virus may signal some protection against the virus and a lower likelihood of becoming infected again, the health protection agency said.
With files from The Associated PressShare Tools
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