IVI Watch [to 21 February 2015]
http://www.ivi.org/web/www/home
.
:: EuBiologics Acquires Licensure for New Cholera Vaccine
– First cholera vaccine made in Korea for use in developing world
– Global health partnership between EuBiologics and International Vaccine Institute to control cholera in poor countries
– Application for WHO approval underway

Seoul, South Korea [Undated] EuBiologics Co., Ltd. and the International Vaccine Institute (IVI) announced that the inactivated oral cholera vaccine (OCV) Euvichol obtained licensure for export from the South Korean Ministry of Food and Drug Safety on January 28, 2015, making this the first cholera vaccine produced in Korea and paving the way for vaccine approval by the World Health Organization (WHO). An application has already been submitted for obtaining WHO prequalification of Euvichol.

“After several years of hard work and effort, we are extremely pleased that Euvichol has been licensed since we are one step closer to WHO prequalification and ensuring access of the vaccine for the world’s poor,” said Mr. Yeong-Ok Baik, EuBiologics CEO, “We are thankful to IVI for their support in helping make this happen.”

Since 2010, EuBiologics and IVI have been collaborating on the development and production of a new inactivated oral cholera vaccine following technology transfer from IVI to EuBiologics. Their aim is to ensure a reliable global supply of safe, effective and affordable cholera vaccines to prevent and control endemic and epidemic cholera in the world’s poorest communities…

…In collaboration with partners in Vietnam, Sweden, the United States and South Korea, IVI reformulated the oral inactivated cholera vaccine and transferred the technology to Shantha Biotechnics (part of the Sanofi group), an Indian manufacturer. The vaccine Shanchol was licensed in India in 2009 and WHO-prequalified in 2011. In 2010, IVI transferred technology for the cholera vaccine to EuBiologics, which was unprecedented for a Korean company at the time. Euvichol will be the third internationally licensed vaccine against cholera (Shanchol and Dukoral produced by Crucell, part of Johnson & Johnson)…