[Research progress on immune efficacy, safety, vaccination intention and immunization strategy of domestic enterovirus 71 vaccine after its marketing].

Enterovirus 71 (EV71) is one of the main pathogens of hand, foot and mouth disease (HFMD) and the main pathogen of severe HFMD. In 2015, three EV71 vaccines were successively marketed in China as powerful prevention and control tools for HFMD caused by EV71. To understand the efficacy, immunogenicity, safety and quality stability of the domestic EV71 vaccine after entering into the market and analyze potential problems in its application, this article incorporates research regarding the immune effect, population effect, safety, quality testing and evaluation results, vaccination willingness and vaccination behavior survey to explore the vaccination strategies for the donll stic EV71 vaccine. EV71 vaccine has good immunogenicity, safety, protective efficacy, and good quality stability after entering into the market, however, only a few study focused on its safety when inoculating with other immunization planning vaccines simultaneously. Strengthen safety monitoring and discuss the safety of the EV71 vaccine especially when simultaneously inoculate with other immunization program vaccines are still necessary. Enterovirus evolution and recombination, whilst the probable impact of the EV71 vaccine can be the reason for future changes of HFMD epidemic strains, hence continuous monitoring of antigenic mutations and genetic evolution of enterovirus should be responded to. Encouraging the R&D of polyvalent vaccines against HFMD is also necessary. Parents' lack of HFMD and EV71 vaccine knowledge was common, therefore HFMD knowledge should be strengthened at the same time when introducing the EV71 vaccine to the public. Also, it should be emphasized that the EV71 vaccine can only prevent HFMD caused by EV71.肠道病毒71型（Enterovirus 71, EV71）是手足口病（Hand, foot and mouth disease, HFMD）主要病原体之一，也是重症手足口病的主要病原体。自2015年底起，我国在全球率先上市了3种EV71疫苗，为控制由EV71引起的手足口病提供了有力的防控手段。为了解国产EV71疫苗投入使用后免疫效果、安全性、质量稳定性情况，分析新疫苗上市后在应用中可能面临的问题，本文纳入了目前国产EV71疫苗的免疫效果、人群效应、安全性、质量检测、质量评价结果、人群接种意愿和接种行为调查等大量研究，以探讨EV71疫苗上市后手足口病流行的防控策略。国产EV71疫苗具有良好的免疫原性、安全性、保护效力，质量稳定性好，然而EV71疫苗与其他免疫规划疫苗同时接种的安全性研究较少，应继续加强EV71疫苗安全性监测工作，并探讨疫苗本身及与其他免疫规划疫苗同时接种的安全性。由于肠道病毒病原体的进化、重组等原因，及应用EV71疫苗带来的可能影响，手足口病的流行株可发生改变，应对肠道病毒的抗原变异和遗传进化持续监测；鼓励和推动多价手足口疫苗的研发亦有必要。家长对手足口病及EV71疫苗的认知普遍较为欠缺，在开展疫苗宣传时应同时加强家长对手足口病疾病本身知识的宣传，且应强调EV71疫苗只能预防由EV71引起的手足口病。.