Glaxo in pandemic flu vaccine move

London-based GlaxoSmithKline said today it was seeking preliminary approval in Europe to market a vaccine against pandemic influenza, which experts fear may be triggered by bird flu.

Since no one can predict the exact form an eventual pandemic flu virus strain would take, the European Medicines Agency has established a “mockup” system that allows companies to start the approval process for core vaccines still under development.

“I can confirm that a mockup file of a pandemic influenza vaccine was submitted in December to the European authorities,” Glaxo spokesman David Mawdsley told Dow Jones Newswires.

Glaxo, Europe’s biggest drug maker, is the first vaccine company to make a submission under new European rules.

The EMEA confirmed it had received only one application under the system so far and that it had come from Glaxo.

The process will require companies to conduct clinical trials for safety and to establish the dosage and schedule for core “mockup” vaccines to obtain quick authorisation for their pandemic vaccines.

EMEA has identified five flu strains for use in the fast-tracking process of core vaccines.