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European union regulatory developments for new vaccine adjuvants and delivery systems

机译:欧盟针对新型疫苗佐剂和递送系统的法规开发

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摘要

Interest in vaccine adjuvants and new delivery systems has grown rapidly over the past few years. New vaccine candidates have emerged, which, because of their poor immunogenicity, rely on adjuvants to improve their presentation and targeting and to potentiate their protective immune response. Better understandings of the mechanisms of action, together with logistic and economical considerations have resulted in an explosion of technologies. However, there have been few new registered products for human use, and antigens incorporated into immunostimulating reconstituted influenza virosomes have only relatively recently been licensed in European Union (EU) countries. Influenza vaccine, adjuvanted with water in oil emulsion containing squalene (adjuvant MF59C1) is now also approved.
机译:在过去的几年中,对疫苗佐剂和新的递送系统的兴趣迅速增长。已经出现了新的候选疫苗,由于其免疫原性差,它们依赖佐剂来改善其呈递和靶向性并增强其保护性免疫应答。对作用机理的更好理解以及后勤和经济方面的考虑导致了技术的爆炸式增长。但是,几乎没有新的人类注册产品,并且掺入免疫刺激性重组流感病毒体中的抗原直到最近才在欧盟(EU)国家获得许可。现在还批准了含有角鲨烯的油包水乳液佐剂的流感疫苗(佐剂MF59C1)。

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