CHMP recommends EU label expansion of Synflorix vaccine for pneumococcal disease- Glaxo Smith Kline

The Committee for Medicinal Products for Human Use of the European Medicines Agency has issued a positive opinion for the expansion of the European label of Synflorix vaccine, from Glaxo Smith Kline. The updated label now includes effectiveness data for protection against invasive pneumococcal disease (IPD) and pneumonia and acute otitis media (AOM) caused by the pneumococcus bacterium. The effectiveness of the vaccine is due to an impact on pneumococcal disease caused by serotypes included in the vaccine in addition to an impact on serotype* 19A, in children aged 6 weeks up to 5 years of age, as confirmed by the EMA.

This positive opinion was based largely on two post-marketing studies carried out in Finland and Brazil. The data show a decrease in invasive disease caused by serotypes contained in the vaccine, as well as serotype 19A, following the introduction of Synflorix into the national immunisation programmes (NIPs) in these countries. Introduction of Synflorix into the Brazilian and Finnish NIPs also notably resulted in an overall decrease in pneumococcal disease in these countries.

Comment: Synflorix is indicated for active immunisation against IPD, such as meningitis and sepsis, in infants and children from 6 weeks up to 5 years of age. In a number of countries, Synflorix has additional indications, including community-acquired pneumonia, acute otitis media caused by Streptococcus pneumoniae (S. pneumoniae), and AOM caused by non-typable Haemophilus influenzae.