SUNDAY, MAY 20, 2018

Synflorix gains positive opinion from European agency

Synflorix™ gains CHMP positive opinion
Synflorix™ gains CHMP positive opinion | Courtesy of
GlaxoSmithKline’s Synflorix recently received a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency.

This allows Synflorix to have an expanded and updated label that will include data about the effectiveness of its protection. The vaccine is designed to protect people from invasive pneumococcal disease (IPD), acute otitis media (AOM), and pneumonia. These illnesses are all caused by the pneumococcus bacterium.

The vaccine’s effectiveness is thanks to serotypes that are part of the vaccine. The serotypes, specifically 19A, are effective for children between the ages of 6 weeks and 5 years old.

The positive review is established mostly on two post-marketing studies from Finland and Brazil. The data demonstrated a reduction in the invasive disease. The reduction was especially noticeable after the vaccine was introduced as part of the national immunization programs in Finland and Brazil. Introducing Synflorix caused an overall decrease in the nations’ pneumococcal disease rates.

"GSK welcomes this news,” Thomas Breuer, chief medical officer at GSK Biologicals, said. “Importantly, the label update affirms what has been observed in real-life settings, and provides clear information about the value Synflorix can provide in helping to protect children against IPD, pneumonia and AOM."

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GlaxoSmithKline - UK

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