GlaxoSmithKline (GSK) has received positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommending an additional indication for Synflorix, a paediatric pneumococcal conjugate vaccine, for immunisation against pneumonia caused by Streptococcus pneumoniae in infants and children from six weeks up to five years of age.
The application was submitted as a variation to the Marketing Authorisation Application to the European Medicines Agency.
“Pneumonia continues to be one of the leading global killers of children under five years of age, with an estimated three million cases of pneumonia in Europe alone,” said Thomas Breuer, senior vice president and lead physician of GSK Vaccines. “Vaccination is recognised by The World Health Organisation to be the only public health measure likely to have any significant impact on the incidence of pneumococcal pneumonia. Today’s CHMP positive opinion takes us a step closer to offering greater protection to children against this disease. We look forward to the final decision of the European Commission and hope to make Synflorix available to more children in Europe.”
A CHMP positive opinion is one of the final steps before marketing authorisation is granted by the European Commission, but does not always result in marketing authorisation. A final decision by the European Commission is anticipated during the fourth quarter of 2013.
Synflorix is currently approved in the EU and 90 other countries for active immunisation against invasive disease and acute otitis media caused by Streptococcus pneumoniae in infants and children from six weeks up to five years of age. Around 40 countries and regions have chosen Synflorix in their universal mass vaccination programmes and 67 countries already have the indication for pneumonia approved. Synflorix is not approved for use in the US.
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