Hepatitis E is an emerging global disease caused by hepatitis E virus (HEV) infection. While in developing countries the infection was primarily due to poor sanitary conditions through intake of contaminated water or undercooked meats of infected animals, increasing cases of chronic hepatitis E resulting in rapidly progressive liver cirrhosis and end-stage liver disease have been reported in organ transplant patients or in immune compromised patients in developed countries. Fortunately, hepatitis E is now a vaccine preventable disease with a HEV239 based vaccine licensed for human use. Much work is needed to enable its use outside China. This review recounted the development process of the vaccine, outlined the critical quality attributes of the vaccine antigen and, most importantly, listed the populations at risk for HEV infection and the subsequent disease. These at risk populations could benefit the most from the vaccination if the vaccine is widely adopted.
Keywords: Hepatitis E virus; antigenic determinants; capsid protein; critical product attributes; neutralizing epitopes; prophylactic vaccine; vaccination.