Glaxo said it plans to conduct 16 clinical trials of its swine flu vaccine in more than 9,000 people in Europe and North America. It expects to have early results in September from its first trial in Germany. The data will be shared with drug regulators so they can make an early decision whether to license the vaccine.
Both Europe and the United States have fast-track approval systems for the swine flu vaccine, to ensure that the vaccine is available as soon as possible
- and before complete safety tests are finished. The European Medicines Agency has said swine flu vaccines could be approved within five days.
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 their vaccine in Australia.
Glaxo's first trial is being conducted in Germany among 128 people aged 16 to 60, according to spokeswoman Alexandra Harrison.
The company said once it has initial results, these will be submitted to European and American regulatory authorities. Glaxo said it also would provide older data on a bird flu vaccine, on which the swine flu vaccine is based.
Other Glaxo trials will test the vaccine in infants, children and the elderly. The trials are scheduled to last about a year, although Harrison said the vaccine is expected to be on the market much sooner.
"We aim to get the first doses out in September," Harrison said, with major orders fulfilled by the end of the year or early 2010.
In Europe, Glaxo is testing vaccines with an adjuvant, a chemical compound used to stretch a vaccine's active ingredient and boost the body's immune response.
