GlaxoSmithKline seeks approval for new Synflorix indication

GlaxoSmithKline has submitted a new regulatory application in Europe for its paediatric pneumococcal vaccine Synflorix.

The pharmaceutical giant is seeking approval for the vaccine to be used for active immunisation against pneumonia caused by Streptococcus pneumoniae in infants and children from six weeks up to five years of age.

It has submitted the application as a variation to the marketing authorisation application to the European Medicines Agency.

Synflorix is already approved in the European Union and 90 other countries for active immunisation against invasive disease and acute otitis media caused by Streptococcus pneumoniae in children within this age group.

Of the 90 nations, 67 already have the indication for pneumonia approved.

The vaccine contains inactivated extracts from ten of the most common types of Streptococcus pneumoniae bacteria, stimulating the immune system to produce antibodies.

It is usually administered via an injection into the thigh muscle for babies less than 12 months old and in the upper arm for older children.