August 15, 2009

Swine Flu Vaccine Undergoes Testing

On Friday, GlaxoSmithKline PLC, the drugmaker of a new swine flu vaccine, said that it has started to test the vaccine in humans.

Glaxo said it is planning 16 clinical trials of its swine flu vaccine in over 9,000 people in Europe and North America.  The company expects to see results in September from its first trial in Germany.  The data will be shared with drug regulators so they will be able to decide whether to license the vaccine or not.

The U.S. and Europe both have fast-track approval systems for the swine flu vaccine, which will ensure the vaccine is available once the testing is complete.  The European Medicines Agency said H1N1 vaccines might be approved within five days.

Novartis AG and Sanofi-Aventis SA, two other major drugmakers, will begin testing their vaccines later this month.  Australian pharmaceutical company CSL started testing their vaccine in July.

According to spokeswoman Alexandra Harrison, Glaxo's first trial is being conducted in Germany among 128 people between the ages 16 to 60.

The company said that once the initial results are received, they will be sent to European and American regulatory authorities.  Glaxo said it is going to provide older data on a bird flu vaccine, on which the swine flu vaccine is based.

Glaxo is testing the vaccine in infants, children and the elderly.  The trials are expected to last for 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.

Glaxo is testing the vaccine in Europe with an adjuvant, which is a chemical compound used to stretch a vaccine's active ingredient and boost the body's immune response.

Glaxo is testing the vaccine in Canada and the United States 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 is still not well known. 

Glaxo has orders for 291 million doses of its swine flu vaccine around the world.  The U.S. has ordered $250 million worth of vaccine ingredients.

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

The swine flu has killed at least 1,462 people worldwide since it emerged in April.  The virus has been estimated to have infected millions.


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