2013年12月6日訊 /生物谷BIOON/ --葛蘭素史克（GSK）12月5日宣布，肺炎球菌共軛疫苗Synflorix額外適應症獲歐盟委員會（EC）批准，用於6周至5歲的嬰幼兒的接種，激活其體內的主動免疫，預防肺炎鏈球菌（Streptococcus pneumoniae）引發的肺炎。
Synflorix額外適應症的獲批，是基於一項雙盲、隨機、對照III期研究（COMPAS）的數據，該研究在南美63個中心開展，涉及24000例兒童。
目前，Synflorix已獲歐盟在內90個國家批准，用於嬰幼兒（6周至5歲）的主動免疫，預防肺炎鏈球菌（Streptococcus pneumoniae）引發的入侵性肺炎球菌疾病(IPD)及急性中耳炎(AOM)。約40個國家和地區已選擇Synflorix用於其大規模疫苗接種計劃，67個國家已批准Synflorix用於預防嬰幼兒肺炎。但在美國，Synflorix還未獲準上市。
Synflorix是一種10價疫苗，與目前市場上的7價疫苗相比，Synflorix包含的其他3種血清型(1、5與7F型)，使其能預防更多的IPD。歐洲部分地區5歲以下兒童感染IPD的病歷中，約90%是由本品所包含的這10種血清型肺炎球菌引起的。此外，Synflorix還能預防肺炎鏈球菌引起的急性中耳炎。（生物谷Bioon.com）
英文原文：Synflorix™ receives European marketing authorisation for additional pneumonia indication
GlaxoSmithKline (GSK) today announced that the European Commission (EC) has granted marketing authorisation for an additional indication for Synflorix™ for the immunisation against pneumonia caused by Streptococcus pneumoniae in children from six weeks up to five years of age.
This approval was based on results from a phase III double-blind, randomised, controlled trial named COMPAS. This efficacy study for a latest-generation pneumococcal conjugate vaccine (PCV) was conducted in 63 centres in South America, involving 24,000 children.
「GSK welcomes this approval for an additional Synflorix indication in Europe,」 said Thomas Breuer, Senior Vice-President and Lead Physician, GSK Vaccines. 「Pneumonia continues to kill more children under five than AIDs, malaria and measles combined and affects both the developed and the developing world. There are three million cases of pneumonia in children under five in Europe each year. With this new indication, we are confident that Synflorix will contribute to a significant reduction in cases of pneumonia caused by Streptococcus pneumoniae.」
About Synflorix
Synflorix is currently approved in the EU and 90 other countries for active immunisation against invasive disease and acute otitis media caused by Streptococcus pneumoniae in infants and children from six weeks up to five years of age. Around 40 countries have chosen Synflorix in their universal mass vaccination programmes and 67 countries already have an approved indication for pneumonia. Synflorix is not approved for use in the U.S.