GlaxoSmithKline plc (GSK) has submitted a regulatory application in the European Union (EU) seeking approval of an additional indication for Synflorix, a paediatric pneumococcal vaccine, for the active immunisation against pneumonia caused by Streptococcus pneumoniae in infants and children from 6 weeks up to 5 years of age.
The application was submitted as a variation to the Marketing Authorisation Application to the European Medicines Agency.
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. Of these 90 countries, 67 already have the indication for pneumonia approved. Synflorix is not approved for use in the US.
The most common adverse reactions observed after primary vaccination with Synflorix in infants were redness at the injection site and irritability.