IVI announced the WHO prequalification of Shanchol™, described as an innovative cholera vaccine developed through IVI and produced by Shantha Biotechnics – part of the Sanofi group – in India where the vaccine has been licensed and sold since 2009. IVI said Shanchol™ is “ready to use in a single-dose vial and is administered orally, which facilitates its implementation in large-scale immunization programs.” Dr. Christian Loucq, IVI’s new Director General, said, “I am immensely pleased by the news that Shanchol™, a vaccine enabled by IVI, received WHO prequalification. This stamp of approval shows that public-private partnerships – such as those among IVI, Vabiotech, Shantha and Sanofi – are essential for successful vaccine development, particularly in developing vaccines against neglected diseases of the poor like cholera.”
IVI noted that WHO prequalification of Shanchol™ is “the latest achievement in IVI’s mission to develop and introduce innovative, safe, and effective vaccines to protect vulnerable populations in poor countries against deadly diseases including cholera.” IVI said that “with financial support from the Bill & Melinda Gates Foundation and the governments of Korea and Sweden, and technical support from scientists in Sweden, as well as at Vietnam’s National Institute of Hygiene and Epidemiology and production experts at Shantha, IVI enabled technology transfer from Vabiotech, a vaccine manufacturer in Vietnam, to Shantha for the production of cholera vaccine. IVI also established and transferred tests to ensure the vaccine was of the highest quality and enabled improvements in production to keep manufacturing costs as low as possible.”
The prequalification by WHO sets the stage for the next planned phase of the vaccine: “introducing Shanchol™ in settings where cholera remains a major public health problem, such as countries in Africa and South Asia where the disease is endemic. Dr. Loucq continued, “In light of the devastating cholera outbreaks in Haiti, Pakistan, Nepal and in several countries of Africa, there is a clear need for a solution to halt the countless deaths and suffering.”
vaccines and global health :: ethics and policy 