EMEA receives first pandemic flu vaccine application

The first application for a pandemic influenza vaccine has been submitted to the European Medicines Agency by GlaxoSmithKline Biologicals.

The application uses the 'core dossier' approach, a novel European approach that allows the evaluation and approval of an application based on a 'mock-up vaccine' before the outbreak of a pandemic. Once the actual virus strain has been identified at the time of an outbreak, a variation to the core dossier is submitted to incorporate that strain.

The EMEA has introduced a number of incentives to encourage companies to use the core dossier approach. These include fee waivers for the evaluation of core dossiers and for scientific advice. The Agency's scientific committee, the Committee for Medicinal Products for Human Use (CHMP), has also made a commitment to speed up its evaluation of applications.

Part of the EMEA pandemic influenza crisis management plan (currently out for consultation) is to establish efficient procedures for the assessment and authorisation of pandemic influenza vaccines via the centralised procedure and for surveillance of vaccines and antiviral medicines used in a potential pandemic.