title: Hepatitis E virus: Current epidemiology and vaccine.
abstract: Hepatitis E virus infections have been continuously reported in Indian subcontinent, Africa, southeast and central Asia, posing great health threats to the public, especially to pregnant women. Hecolin® is the only licensed HEV vaccine developed by Xiamen Innovax Biotech Co., Ltd. Extensive characterizations on antigenicity, physicochemical properties, efficacy in clinical trials, and manufacturing capability have made Hecolin® a promising vaccine for HEV control. However, there are many obstacles in large scale application of Hecolin®. Efforts are needed to further evaluate safety and efficacy in HEV risk populations, and to complement HEV standards for quality control. Passing World Health Organization prequalification and licensing outside China are priorities as these are also hindering Hecolin® promotion. Multilateral cooperation among Chinese vaccine manufacturers, Chinese National Regulatory Authorization (NRA) and WHO will expedite the entrance of Hecolin® into international market, so that Hecolin® could play its due role in global hepatitis E control.
authors.affiliation: a National Institutes for Food and Drug Control , Beijing , PR China.
authors.forename: Xing
authors.initials: X
authors.lastname: Wu
authors.affiliation: a National Institutes for Food and Drug Control , Beijing , PR China.
authors.forename: Pan
authors.initials: P
authors.lastname: Chen
authors.affiliation: b R&D Department , Shanghai Institute of Biological Products Co., Ltd. , Shanghai , PR China.
authors.forename: Huijuan
authors.initials: H
authors.lastname: Lin
authors.affiliation: a National Institutes for Food and Drug Control , Beijing , PR China.
authors.forename: Xiaotian
authors.initials: X
authors.lastname: Hao
authors.affiliation: a National Institutes for Food and Drug Control , Beijing , PR China.
authors.forename: Zhenglun
authors.initials: Z
authors.lastname: Liang
mesh_terms: D000349:Africa; D001208:Asia; D002681:China; D017277:Drug Approval; D014943:Global Health; D016751:Hepatitis E / Q000453:epidemiology* / Q000517:prevention & control*; D016752:Hepatitis E virus / Q000276:immunology*; D006801:Humans; D014614:Vaccines, Synthetic / Q000009:adverse effects* / Q000276:immunology* / Q000592:standards; D014761:Viral Hepatitis Vaccines / Q000009:adverse effects* / Q000276:immunology* / Q000592:standards; D014944:World Health Organization
chemical_list: D014614:Vaccines, Synthetic; D014761:Viral Hepatitis Vaccines; C577000:hecolin
keywords: Hecolin®; Hepatitis E virus; epidemiology; quality control; vaccine