GlaxoSmithKline submits first pandemic flu vaccine to EMEA

The European Medicines Agency (EMEA) has said that it has received a pre-development application for a pandemic flu vaccine.

GlaxoSmithKline Biologicals sent the EMEA a “core dossier” proposal for the vaccine, which allows pharmaceutical firms to suggest a “mock-up” version of a drug before a pandemic occurs ? resubmitting to incorporate the flu strain once it has been identified.

The agency said that it had encouraged firms last year to use the approach through incentives such as fee waivers for scientific advice and dossier evaluation. Its scientific committee also promised to speed up evaluation and marketing authorisations for pandemic flu vaccines.

Meanwhile, Turkey has reported cases of bird flu in five more people, including one adult and two children found to have contracted the H5N1 bird flu virus near to the Turkish capital of Ankara.

But the World Health Organisation told Reuters that the new cases had not been confirmed by laboratory tests, and that only four people have been found to have died from the disease so far in the country. It is not thought that the virus has developed into the pandemic form.

Twenty-one patients have been taken into hospital in Istanbul. If tests on the individuals return positive, then it would be the most western point the disease has travelled.

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