On Aug. 31, 2005, the inactivated, injectable influenza vaccine (Fluarix) by GlaxoSmithKline (GSK) was licensed. The vaccine was indicated for adults 18 years of age and older.  Fluarix is a split, trivalent, inactivated vaccine, manufactured from highly purified, egg-grown influenza viruses by GSK.

Fluarix underwent accelerated approval for use in adults by the U.S. FDA following a US-based, randomized, placebo-controlled trial that established its safety and immunogenicity in adults. The vaccine has been licensed in Europe since 1992 for all age groups.

Multiple registration trials in all age groups in Europe have demonstrated that the vaccine was safe and well tolerated and of immunogenicity standards that met the requirements of the European Committee for Medicinal Products for Human Use. There are no published clinical trials evaluating the effectiveness or efficacy of Fluarix against influenza and its complications.