GSK sees Synflorix receive EMEA review

GlaxoSmithKline (GSK) has confirmed that its pneumococcal paediatric vaccine Synflorix has been accepted for review by the European Medicines Agency (EMEA).

The vaccine is indicated to protect children against invasive pneumococcal disease (IPD) and bacterial respiratory infections like acute middle ear infections.

GSK has illustrated that it used a new approach in pneumococcal vaccine technology to produce the candidate vaccine, using an active carrier protein to induce protection.

Jean Stephenne, president of GSK Biologicals, welcomed the decision by the EMEA, describing it as an “important step” towards the introduction of the vaccine.

He went on to highlight its unique development which brought broad protection against pneumococcal disease and a dual pathogen protection against otitis media.

“This approach is a continuation of our heritage to develop vaccines which address multiple pathogens with a single vaccine,” Mr Stephenne confirmed.

The vaccine also offers the potential for expanded protection against S. pneumoniae serotypes, beyond those covered by the current paediatric vaccination, including three serotypes (1, 5, 7F) associated with severe pneumococcal disease in children younger than five years of age.

Also this week, GSK and the Medical Research Council have announced the launch of a jointly funded programme that will look to identify new therapeutic targets and biomarkers from genetic association studies.