Glaxo starts testing its swine flu vaccine

Drugmaker GlaxoSmithKline PLC said Friday it has started testing its swine flu vaccine in humans.

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.

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.

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.

Glaxo has orders from countries worldwide for 291 million doses of swine flu vaccine. The United States has also ordered $250 million worth of vaccine ingredients.

Glaxo says it will donate 50 million doses of swine flu vaccine to the World Health Organization for use in poorer countries. The company also plans to set aside 20 percent of its Canadian production for the same purpose.

Since swine flu emerged in April, it has killed at least 1,462 people worldwide and is estimated to have infected millions.