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GSK pneumococcal vaccine to be reviewed by EMEA

GlaxoSmithKline has announced its pneumococcal paediatric vaccine Synflorix has been accepted for review by the European Medicines Agency.

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

The vaccine is designed to protect children against both invasive pneumococcal disease (IPD) and bacterial respiratory infections such as acute middle ear infections (otitis media).

Acute middle ear infections is one of the most frequent childhood diseases and the most frequent indication for prescribing of antibiotics.

GSK says it uses a breakthrough approach in pneumococcal vaccine technology with this vaccine. It has been designed with an active carrier protein to induce protection against non-typeable Haemophilus influenzae (NTHi) in addition to Streptococcus pneumoniae.

Jean Stèphenne, president of GSK Biologicals, said "We are very pleased with this important step towards the introduction of this vaccine, which is designed to offer a broad protection against pneumococcal disease and a dual pathogen protection against otitis media caused by Strep pneumoniae and non-typeable Haemophilus influenzae. If approved, this vaccine could further reduce the mortality due to invasive pneumococcal disease and also the significant morbidity associated with a more frequent disease in children, namely otitis media."

According to VacZine Analytics, a UK-based strategic research agency, GSK's pending new vaccine, (as well as Wyeth which is also looking into the next generation of pneumococcal vaccines) makes it incredibly difficult to enter the near-term market for pneumococcal vaccines despite its huge long-term potential.

For this reason other companies such as Sanofi- Pasteur and Novartis, have been experimenting with protein based-antigens that might provide universal coverage and avoid the complex and expensive protein-polysaccharide manufacturing process associated with current vaccines.

31st January 2008

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