GSK flu vaccine gets marketing go ahead in UK, Germany

Hannah Blake

pharmaphorum

GSK has announced the marketing authorization of its quadrivalent (four-strain) influenza vaccine in Germany and the UK. This is the first four-strain influenza vaccine to be approved in a European country for active immunisation of adults and children from three years of age for the prevention of influenza disease caused by the two influenza A virus subtypes and the two influenza B virus types contained in the vaccine.

Germany’s Paul Ehrlich Institut (PEI) was the first national regulatory authority in Europe to grant marketing authorization for this influenza vaccine, followed by the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK.

The new four-strain vaccine will be marketed as INFLUSPLIT™ TETRA in Germany and FLUARIX™ TETRA in the UK. They are both set to be launched in time for the 2013/14 flu season.

This vaccine was approved by the Food and Drug Administration for use in the United States back in December 2012. It will be marketed in the US as FLUARIX QUADRIVALENT.

GSK has also submitted license applications for this vaccine in Australia, Switzerland and Taiwan. Regulatory decisions for these countries are expected over the coming months.