The International Vaccine Institute (IVI) said its new low-cost killed whole-cell (WC) oral cholera vaccine was found to be protective against clinically significant cholera in an endemic setting in a large-scale field trial conducted in nearly 70,000 residents of Kolkata, India. The new vaccine was found to be safe, and was effective in young children as well as older persons. IVI developed the vaccine “by modifying an inexpensive vaccine produced in Vietnam and said the new vaccine was licensed early this year in India. This major study was conducted by the IVI in collaboration with the National Institute of Cholera and Enteric Diseases (NICED) in Kolkata, India. Based in Seoul, Korea, the IVI is a nonprofit international organization devoted exclusively to development and deployment of new vaccines primarily for people in developing countries.
IVI Director-General Dr. John Clemens said, “This interim analysis shows that the modified vaccine is safe and efficacious, providing nearly 70 percent protection against clinically significant cholera for at least two years after vaccination.” IVI noted that an internationally licensed, killed whole-cell vaccine containing the recombinant cholera toxin B subunit (rBS-WC) is currently available. IVI said that due to the high cost and requirement of buffer for administration of rBS-WC, it is not feasible for use in developing countries. In contrast, the new IVI vaccine does not require any buffer, making it easier to administer, and is cheaper to produce, making mass vaccination campaigns more feasible, IVI said. In order for the new vaccine to be purchased by United Nations organizations such as UNICEF, the IVI said it transferred its production technology to the vaccine manufacturer, Shantha Biotechnics, in India, where the national regulatory authority is approved by the WHO. Shantha obtained licensure for this vaccine (Shanchol) on February 24, 2009 from the Indian national regulatory authority, paving the way for the expanded use of the vaccine.
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