WHO Strategic Advisory Group of Experts on Immunization Assessed Hecolin® as a Promising Vaccine

In the meeting of Strategic Advisory Group of Experts (SAGE) on immunization on 21–23 October 2014 in Geneva, Switzerland, the SAGE Hepatitis E Working Group report to SAGE information on the Hepatitis E virus (HEV) vaccine Hecolin?. SAGE assessed the Hepatitis E vaccine as a promising vaccine showing high efficacy against Hepatitis E disease in healthy subjects aged 16–65 years in China. In particular, SAGE emphasized that the use of the vaccine during outbreaks of Hepatitis E should be considered.

Background information: Every year an estimated 20 million HEV infections occur globally resulting in more than 3 million clinical cases and 70 000 deaths. Most cases occur in developing countries where in addition to sporadic cases many small and occasional large scale outbreaks also occur. Hepatitis E case-fatality is highest among pregnant women, and can reach 20% when disease occurs in the third trimester of pregnancy. Outbreaks are frequent in Asia and Africa and result in high morbidity and mortality, particularly when occurring in displaced persons camps. Current understanding of HEV transmission indicates that effective prevention and control depend on ensuring safe drinking water, adequate sanitation and proper personal and environmental hygiene. However, in settings where Hepatitis E outbreaks occur, it is difficult to mount adequate prevention measures in a timely manner, mainly due to rapid transmission of HEV and the long incubation period (15–60 days).

The only currently licensed Hepatitis E vaccine, Hecolin?, is a recombinant vaccine which contains virus-like particles prepared using a recombinant Escherichia coli expression system. The vaccine is approved for use in China in those aged 16–65 years. Hecolin? is well tolerated and has been demonstrated to have a good safety profile in this age range.

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