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First HEV vaccine approved

China's Ministry of Science and Technology approved the first vaccine against the hepatitis E virus (HEV). The HEV 239 vaccine developed and manufactured by Xiamen Innovax Biotech in Xiamen, China, is distributed under the brand name Hecolin. China's regulator, the State Food and Drug Administration, based approval on clinical data from over 100,000 healthy participants from Jiangsu Province, aged 16–65 years. None of the participants developed HEV over a 12-month follow-up compared with 15 cases among the placebo group given a hepatitis B vaccine. (Lancet 376, 895–902, 2010), resulting in a 95.5% efficacy over 19 months. HEV is endemic in Central and Southeast Asia, North and West Africa, and Mexico, with disease outbreaks resulting from contaminated food or water. The World Health Organization estimates there are about 14 million symptomatic cases worldwide resulting in 300,000 deaths and 5,200 stillbirths annually. Rakesh Aggarwal from the Sanjay Gandhi Postgraduate Institute of Medical Sciences in Lucknow, India, points to long-term efficacy and cost as potential concerns. Steven Gao, general manager at Innovax in Xiamen, says that efficacy four years after initial vaccination remains “very high,” though no results are published. Innovax plans to launch Hecolin on the Chinese market later this year with worldwide distribution partnerships to follow.


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Proffitt, A. First HEV vaccine approved. Nat Biotechnol 30, 300 (2012).

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