Processing Magazine

Glaxo seeks preliminary bird flu vaccine approval

January 10, 2006

GlaxoSmithKline PLC said it is seeking preliminary approval in Europe to market a vaccine against pandemic influenza, which experts fear may be triggered by bird flu, the Associated Press reports. 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. 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. EMEA has identified five flu strains for use in the fast-tracking process of core vaccines.