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.
In Canada and the United States, Glaxo is testing vaccines both with and without adjuvants. Neither country has ever licensed any flu medications that contain the compound.
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.
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.
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.
The safety of adjuvant-boosted flu vaccines on pregnant women and children - two of the groups thought to be most at risk from swine flu - has yet to be determined conclusively.
Saturday, August 15, 2009
Excerpts from this Aug 15, 2009 story from the AP:
Posted by Meryl Nass, M.D. at 8:41 AM