After 14 years of research and work, the world’s first hepatitis E vaccine is now available in China, with plans to introduce it to international markets in the future, according to a Xinhua news report Oct. 27.
The vaccine called Hecolin, was developed by Xiamen University and Xiamen Innovax Biotech Co. Ltd. and received approval by China’s State Food and Drug Administration (SFDA) in December 2011.
According to the company’s website, the Recombinant Hepatitis E Vaccine (Escherichia Coli) is suitable for susceptible population aged 16 and above. It is recommended for individuals exposed to high risk of hepatitis E virus infection, such as those engaged in animal husbandry, those engaged in catering, students, officers and soldiers, women of childbearing age, travelers to endemic areas, etc.
The vaccine hit the market after a two-year clinical trial involving 113,000 volunteers in east China’s Jiangsu Province.
A Nature.com report today says Hecolin cost about 500 million renminbi (US$80 million) to develop, much of which came from the Chinese government through the university. The vaccine will be sold to distributors in China at a cost of 110 renminbi ($18) per dose, and the company expects it to reach sales of 62 million renminbi in 2013.
The World Health Organization (WHO) says every year there are 20 million hepatitis E infections, over three million acute cases of hepatitis E, and 70,000 hepatitis E-related deaths.
The highest numbers of persons in a population who test positive for hepatitis E are observed in regions where low standards of sanitation increase the risk for transmission of the virus. Over 60% of all hepatitis E infections and 65% of all hepatitis E deaths occur in East and South Asia, where seroprevalence rates of 25% are common in some age groups. In Egypt, half the population aged above five years is serologically positive for the hepatitis E virus.
The hepatitis E virus is transmitted mainly through the fecal-oral route due to fecal contamination of drinking water. However, people can also contract the virus through contaminated food, transmission from animals to humans, blood transfusions and from pregnant women to their newborn.
Hepatitis E is usually self-limiting but may develop into fulminant hepatitis (acute liver failure).
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