GSK's Synflorix gets additional indication in Europe

5 December 2013

The European Commission has granted marketing authorization for an additional indication for UK pharma giant GlaxoSmithKline’s (LSE: GSK) pneumococcal vaccine Synflorix for the immunization against pneumonia caused by Streptococcus pneumoniae in children from six weeks up to five years of age.

This approval was based on results from a Phase III double-blind, randomized, controlled trial named COMPAS. This efficacy study for a latest-generation pneumococcal conjugate vaccine (PCV) was conducted in 63 centres in South America, involving 24,000 children.

“GSK welcomes this approval for an additional Synflorix indication in Europe,” said Thomas Breuer, senior vice president and lead physician at GSK Vaccines, noting that “pneumonia continues to kill more children under five than AIDs, malaria and measles combined and affects both the developed and the developing world.

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