Abstract
The hepatitis E virus (HEV) is an important public health concern and a significant cause of enterically-transmitted viral hepatitis infections. HEV infection remains a serious threat to life, es-pecially in immunocompromised individuals and pregnant women. Globally, vaccines have had a massive impact on public health and saved millions of lives. Vaccination can reduce the healthcare expenditure, decrease the mortality rate, and increase life expectancy. The availability of commer-cially effective vaccines is the most effective means for the prevention of HEV. However, the devel-opment of classic inactive or attenuated HEV vaccines is not feasible due to the lack of an efficient cell culture system for HEV. In recent years, recombinant HEV vaccine approaches have been ex-plored. Many vaccine candidates have showed potential efficacy against HEV infection. Currently, the only licensed vaccine is Hecolin (R), a recombinant vaccine developed by Xiamen Innovax Biotech Co., Ltd. It is available in China. However, there are many hindrances when it comes to the across-the-board application of Hecolin (R) and other vaccines worldwide. Large-scale efforts are needed to further evaluate the efficacy and safety of Hecolin (R) in at-risk populations and to pass the World Health Organization prequalification for licensing outside of China.