[脊髓灰质炎疫苗和脊髓灰质炎病毒的生物风险管理]。

Uirusu Pub Date : 2018-01-01 DOI:10.2222/jsv.68.31
Yuichi Someya, Hiroyuki Shimizu
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引用次数: 0

摘要

日本是第一个将Sabin减毒株衍生的灭活脊髓灰质炎疫苗(用于生产口服脊髓灰质炎疫苗)引入常规免疫规划的国家。Sabin衍生灭活疫苗的开发基于以下事实:与野生脊髓灰质炎病毒相比,Sabin毒株的神经毒性较小,生产设施也更安全。同样令人信服的是,在大鼠免疫原性试验中,Sabin菌株更安全地用于评估灭活疫苗的效力。然而,在目前脊髓灰质炎病毒即将被根除的情况下,需要生产疫苗和/或对疫苗进行质量控制的设施,以满足世卫组织根据《2013-2018年消灭脊髓灰质炎和终局战略计划》制定的生物风险管理要求。目前,应将包括Sabin 2株在内的2型脊髓灰质炎病毒控制在符合世卫组织生物风险管理要求的设施中。预计各设施将在仔细评估病毒传播给人员、环境和设施周围社区的风险的基础上,充分考虑病毒传播的风险,并建立生物风险管理机制。因此,处理和储存传染性脊髓灰质炎病毒的设施必须按照世卫组织生物风险管理要求被认证为脊髓灰质炎病毒必需设施。
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[Polio vaccines and biorisk management of polioviruses].
Japan is the first country where inactivated polio vaccines derived from Sabin attenuated strains, which are used to manufacture oral polio vaccines, were introduced in routine immunization program. The Sabin-derived inactivated vaccine has been developed based on the fact that Sabin strains are less neurovirulent and manufactured at safer productionfacilities than wild polioviruses. It is also convincing that Sabin strains are more safely used for evaluating the efficacy of inactivated vaccines in rat immunogenicity tests. However, in the current situation where polioviruses are close to being eradicated, the facilities that manufacture vaccines and/or conduct quality control of them are needed to meet the biorisk management requirements established by WHO, which are based on the Polio Eradication & Endgame Strategic Plan 2013-2018. At present, type 2 polioviruses including Sabin 2 strain should be contained in the facilities which meet the WHO biorisk management requirements. The respective facilities are expected to give full consideration based on a careful risk assessment of viral transmission not only to personnel, but also to the environment and the community around the facilities, and the establishment of biorisk management will be needed. Thus, the facilities handling and storing infectious polioviruses must be certified as poliovirus-essential facilities following the WHO biorisk management requirements.
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