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Synflorix approved in EU

GSK has received authorisation from the European Commission for its paediatric pneumococcal vaccine, Synflorix

GlaxoSmithKline (GSK) has received European Commission authorisation for its paediatric pneumococcal vaccine, Synflorix.

The new vaccine can be used to immunise children between six weeks and two years old against potentially life-threatening diseases such as meningitis and bacteraemic pneumonia, as well as middle ear infections.

Middle ear infections are the main reason for children under three visiting a physician and often lead to children being fitted with grommets, one of the most common surgical procedures in Europe.

"Childhood pneumococcal infections such as meningitis and pneumonia devastate families across Europe and throughout the world. The burden of these conditions – in terms of individual suffering, emotional impact and associated public health costs – is considerable", said Jean Stéphenne, president and general manager, GSK Biologicals.

GSK said Synflorix, which includes 10 serotypes, has the potential to prevent more invasive pneumococcal diseases than Prevnar, Wyeth's 7-valent vaccine, which offers protection aginst three additional pneumococcal strains.

In the US however, Wyeth has submitted a Biologic License Application (BLA) to the Food and Drug Administration (FDA) for Prevnar 13, a 13-valent vaccine. Speaking about the BLA ,Dr Emilio Emini, executive vice president, vaccine research and development at Wyeth said: "We are pleased that, with this milestone, we are now one step closer, to bringing Prevnar 13 to infants and children."

Synflorix is already approved for use in children between six weeks and two years old in Canada and Australia. GSK has also applied for prequalification (PQ) for the drug from the World Health Organisation (WHO) – a WHO programme facilitating access to medicines in less-affluent countries.

1st April 2009

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