title: Enterovirus 71: a whole virion inactivated enterovirus 71 vaccine.
abstract: Enterovirus A71 (EV71) is the predominant causative agent of hand, foot, and mouth disease (HFMD), which is often associated with severe cases and even deaths. EV71-associated epidemics have emerged as a serious threat to public health, particularly in the Asia-Pacific region.
  
  
  
  We searched PubMed using the terms 'enterovirus 71', 'hand, foot, and mouth disease', and 'vaccine', with no date or language restrictions for all publications before April 27, 2016. Among various vaccine candidates, the alum-adjuvant inactivated EV71 vaccines are most promising. Three alum-adjuvant inactivated EV71 vaccines developed by mainland China showed high efficacy, good immunogenicity persistence and acceptable safety profiles in clinical trials. Recently, two of these EV71 vaccines have been approved for marketing in China and the other one is undergoing the review process of licensure. In this manuscript, we summarized previous study results as well as discussed the regulatory affairs and post-market surveillances issues. Expert commentary: The marketing of EV71 vaccines is a milestone in the controlling of HFMD. International clinical trials are needed to further assess the efficacy and cross-immunogenicity. Establishing a sensitive pathogen monitoring system would be essential to monitor the variation of genotypes and control HFMD epidemics.
authors.affiliation: a School of Public Health , Southeast University , Nanjing , PR China.
authors.forename: Yang
authors.initials: Y
authors.lastname: Zhou
authors.affiliation: b Department of Vaccine Clinical Evaluation , Jiangsu Provincial Center for Disease Control and Prevention , Nanjing , PR China.|c College of Pharmacy , Third Military Medical University & National Engineering Research Center for Immunological Products , Chongqing , PR China.
authors.forename: Jing-Xin
authors.initials: JX
authors.lastname: Li
authors.affiliation: d School of Public Health , Nanjing Medical University , Nanjing , PR China.
authors.forename: Peng-Fei
authors.initials: PF
authors.lastname: Jin
authors.affiliation: a School of Public Health , Southeast University , Nanjing , PR China.
authors.forename: Yu-Xiao
authors.initials: YX
authors.lastname: Wang
authors.affiliation: b Department of Vaccine Clinical Evaluation , Jiangsu Provincial Center for Disease Control and Prevention , Nanjing , PR China.
authors.forename: Feng-Cai
authors.initials: FC
authors.lastname: Zhu
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage; D000534:Alum Compounds / Q000008:administration & dosage; D001208:Asia; D002681:China; D002986:Clinical Trials as Topic; D017277:Drug Approval; D029821:Enterovirus A, Human / Q000276:immunology*; D006232:Hand, Foot and Mouth Disease / Q000453:epidemiology / Q000517:prevention & control*; D006801:Humans; D015164:Vaccines, Inactivated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D014765:Viral Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*
chemical_list: D000276:Adjuvants, Immunologic; D000534:Alum Compounds; D015164:Vaccines, Inactivated; D014765:Viral Vaccines; C041524:aluminum sulfate
keywords: Enterovirus A71 vaccine; and mouth disease; clinical trial; cross-immunity; efficacy; foot; hand; immunogenicity; safety; surrogate of protection