Flucelvax (Optaflu) for seasonal influenza
Flucelvax (Optaflu) for seasonal influenza
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DOI：
10.1586/14760584.2015.1039520
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发表时间：
2015-06-01
影响因子：
6.2
通讯作者：
Montomoli, Emanuele
中科院分区：
文献类型：
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作者：
Manini, Ilaria;Domnich, Alexander;Montomoli, Emanuele
传统的基于鸡蛋的季节性流感疫苗制造技术有几个缺点，包括缺乏灵活性、对鸡蛋供应的依赖、污染风险、某些分离株缺乏生长以及威胁疫苗匹配的鸡蛋适应性病毒突变。为了克服这些限制，人们设计了细胞培养疫苗，包括三价灭活疫苗 Flucelvax((R))/Optaflu((R))（分别是美国/欧盟的品牌名称）。 Flucelvax/Optaflu 已获得监管部门的广泛批准，目前已在多个国家实施。非临床研究缓解了对致癌性和对狗过敏的人使用的假设性担忧。大量的临床数据表明，Flucelvax/Optaflu在免疫原性、安全性和耐受性方面不逊色于鸡蛋疫苗，并且满足美国和欧洲的强制性要求。尽管 Flucelvax/Optaflu 目前仅适用于成人和老年人，但儿科数据表明其具有良好的免疫原性和安全性。本文提供了 Flucelvax/Optaflu 的临床开发、季节性试验和可用的上市后监测数据的最新信息。
Conventional egg-based manufacturing technology for seasonal influenza vaccines has several drawbacks, including its inflexibility, reliance on egg supplies, risk of contamination, absence of growth of some isolates and egg-adaptive viral mutations that threaten vaccine matching. To overcome these limitations, cell culture-derived vaccines have been designed, including the trivalent inactivated vaccine Flucelvax((R))/Optaflu((R)) (brand names in the US/EU, respectively). Flucelvax/Optaflu has gained wide regulatory approval and is currently implemented in several countries. Non-clinical studies have assuaged hypothetical concerns regarding oncogenicity and use in persons allergic to dogs. Ample clinical data suggest the non-inferiority of Flucelvax/Optaflu to egg-based vaccines in terms of immunogenicity, safety and tolerability, and it has fulfilled American and European mandatory requirements. Although Flucelvax/Optaflu is currently indicated only for adults and the elderly, pediatric data indicate its good immunogenicity and safety. This paper provides an update on the clinical development of Flucelvax/Optaflu, its seasonal trials and available post-marketing surveillance data.