Source Pravda.Ru

Glaxo seeks preliminary pandemic flu vaccine approval in Europe

Science

GlaxoSmithKline PLC said Friday it was seeking preliminary approval in Europe to market a vaccine against &to=http://english.pravda.ru/science/19/95/380/14373_vaccine.html' target=_blank>pandemic influenza, which experts fear may be triggered by bird flu.

Since no one can predict the exact form that 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.

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

The EMEA confirmed that it has 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 in order to obtain quick authorization for their pandemic vaccines.