Synflorix major label extension gains CHMP positive opinion
The organizations based their positive opinions on two post-marketing studies, which took place in Finland and Brazil. This data demonstrated that there was a significant decline in the invasive disease because of the immunogenicity generated by the vaccines that contained serotypes.
The modified label now includes data about the effectiveness of the vaccine against invasive pneumococcal disease (IPD), acute otitis media (AOM) and pneumonia. All of these illnesses are caused by one bacteria, the pneumococcus bacterium.
Experts attribute the success of this vaccine to the fact that is contains serotypes, including serotype 19A, which are able to be administered to children between the ages of 6 weeks old and 5 years old. This has been confirmed by the EMA.
"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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