British firm GSK reports successful clinical trial of bird flu vaccine at Ghent University Hospital.

26 July 2006

BRUSSELS — British pharmaceutical firm GlaxoSmithKline (GSK) hopes to release a mass-produced vaccine against bird flu next year following successful clinical trials at the Ghent University.

GSK said the vaccine against the dangerous H5N1 strain of the bird flu virus proved effective in 80 percent of patients during trials at the Centre for Vaccinology at the Ghent University Hospital.

The trial showed that 80 percent of the 400 healthy Belgian patients (aged between 18 and 60) who were given a small dose of the vaccine had a strong immune reaction.

"These excellent clinical trial results represent a significant breakthrough in the development of our pandemic flu vaccine," GSK chief executive JP Garnier said.

"This is the first time such a low dose of H5N1 antigen has been able to stimulate this level of strong immune response."

GSK is planning in coming months to apply for permission from health authorities to produce a vaccine against a flu pandemic. It expects a positive response by the end of this year.

The firm is also testing another vaccine in Germany, of which a preparatory request for approval from the European Agency for the Evaluation of Medicinal Products (EMEA) has already been lodged.

The firm could then quickly obtain permission for the production of the vaccine if clinical tests are convincing, news agency Belga reported on Wednesday.

The international federation of the pharmaceutical industry said in May that worldwide, work is being carried on more than 30 prototype vaccines.

A prototype being developed by the French laboratory Sanofi-Pasteur appears to offer protection against the virus, but only with a very large dose.

A lack of production capacity means a vaccine that works with a small dose still needed to be found.

Since 2003, some 133 people have died from the bird flu virus.

[Copyright Expatica News 2006]

Subject: Belgian news