Indication Extension For SB's Infanrix

SmithKline Beecham has received the first registration worldwide of a primary vaccination indication for Infanrix, its combined diphtheria, tetanus and acellular pertussis vaccine, in Germany. It has been available in Germany since May 1994 for the more limited indication of booster use after a primary course of whole-cell pertussis vaccine.

SB has submitted an application dossier to most European Union countries. DTP vaccines have been widely used since the 1940s, but the vaccine currently used is based on a whole-cell pertussis component and has been associated with a number of local and systemic side effects.

Despite recommendations by the German health authority, the STIKO, that pertussis vaccination should be given to all children, the take-up rate is running at around 60%, according to Heinz Schmitt of the Children's Hospital in Mainz. "Each year in Germany approximately 100,000 pertussis cases are seen in children," he said, adding that parents are wary of getting their children vaccinated due to the side-effect profile of the whole cell vaccine.