Since 2004, when the first synthetic glycoconjugate vaccine against the pneumonia and meningitis causing bacterium Haemophilus influenza type b (Hib) approved for human use in Cuba was reported, 34 million doses of the synthetic vaccine have been already distributed in several countries under the commercial name of Quimi-Hib. However, despite the success of this product, no other synthetic glycoconjugate vaccine has been licensed in the following 13 years. As well as avoiding the need to handle pathogens, synthetic glycoconjugates offer clear advantages in terms of product characterization and the possibility to understand the parameters influencing immunogenicity. Nevertheless, large scale application of synthetic sugars has been perceived as challenging because of manufacturing costs and process complexity compared to natural polysaccharides.

中文翻译：

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推进均质抗菌糖缀合物疫苗

自2004年以来，第一款针对引起肺炎嗜血杆菌流感的肺炎和脑膜炎的合成糖缀合物疫苗据报道，古巴已批准将其用于人类的b型（Hib）型，已经在几个国家以商品名Quimi-Hib分发了3400万剂这种合成疫苗。然而，尽管该产品成功，但在随后的13年中没有其他合成的糖缀合物疫苗获得许可。除了避免处理病原体外，合成糖缀合物在产品表征和了解影响免疫原性参数的可能性方面也具有明显的优势。然而，由于与天然多糖相比的制造成本和工艺复杂性，合成糖的大规模应用已被认为具有挑战性。