British drug maker GlaxoSmithKline (GSK) has received positive opinion from the European Medicines Agency (EMA's) Committee for Medicinal Products for Human Use (CHMP) for additional indication for Synflorix, a pediatric pneumococcal vaccine.
The additional indication is for the active immunization against pneumonia caused by Streptococcus pneumoniae in newborns and children from six weeks up to five years of age.
The company has submitted the application as a variation to the marketing authorization application to the EMA.
GSK Vaccines senior vice president and lead physician Thomas Breuer said 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.
"Vaccination is recognised by The World Health Organization to be the only public health measure likely to have any significant impact on the incidence of pneumococcal pneumonia," Breuer said.
"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."
Final decision from the European Commission is expected during the fourth quarter of 2013.
At present, Synflorix is approved in the EU and 90 other countries for active immunization against invasive disease and acute otitis media.
