Clinical data on Fluarix: an inactivated split seasonal influenza vaccine.

Influenza viruses cause annual winter epidemics in temperate regions, with significant morbidity, mortality and economical impact. Fluarix is a split, trivalent, inactivated vaccine, manufactured from highly purified, egg-grown influenza viruses by GlaxoSmithKline. In 2005, Fluarix underwent accelerated approval for use in adults by the US 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. Currently, Fluarix plays an important role in the diversification of the supply chain of influenza vaccine to the community. However, vaccines with improved immunogenicity in at-risk populations, such as the elderly, and with less reliance on growth in eggs, as well as the inherent demanding timelines, are needed to enhance the control of influenza.