IVI receives WHO prequalification for new oral cholera vaccine

International Vaccine InstituteNov 13 2011

Shanchol vaccine developed through IVI and produced by Shantha can be used to prevent and control cholera around the world

Shanchol-, a new oral cholera vaccine developed through the International Vaccine Institute (IVI), an international organization established by the United Nations and based in Seoul, recently received prequalification from the World Health Organization (WHO). Developed for use in developing countries to protect against life-threatening cholera, Shanchol- is ready to use in a single-dose vial and is administered orally, which facilitates its implementation in large-scale immunization programs. Shanchol- is produced by Shantha Biotechnics - part of the Sanofi group - in India where the vaccine has been licensed and sold since 2009.

"I am immensely pleased by the news that Shanchol-, a vaccine enabled by IVI, received WHO prequalification," said Dr. Christian Loucq, IVI's new Director General. "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."

Certification by WHO of Shanchol- represents a major milestone as it indicates that the vaccine meets WHO standards of quality, safety and efficacy, and allows the vaccine to be procured by UN agencies and other international organizations for use in countries around the world. It also accelerates international use of the vaccine since WHO prequalification eliminates the need for country-level market authorization in some countries, which can take years to obtain.

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. 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.

"This important milestone validates Vabiotech's efforts and technical capability in developing and promoting the manufacture of an affordable cholera vaccine for the world's poorest people," said Dr. Nguyen Thu Van, Director General of Vabiotech. "We are eager to see this vaccine rapidly deployed, especially in endemic areas, amid recent outbreaks of cholera in Africa, Asia and the Caribbean."

A Phase III clinical trial performed by IVI and colleagues at India's National Institute of Cholera and Enteric Diseases was launched at a field site in Kolkata to evaluate the vaccine in people from ages one year and up. The results showed the vaccine to be safe and protective against cholera for three years in all age groups. Licensed in India in 2009, Shanchol- was the first vaccine to be developed and licensed from the pipeline of vaccines being developed with support from the Bill & Melinda Gates Foundation

"Prequalification of the Shanchol- vaccine by WHO represents a validation of Shantha's quality processes and the safety and efficacy of the vaccine," said Dr. Harish Iyer, Chief Executive Officer of Shantha Biotechnics. "This approval also reinforces our commitment to work with partners to provide vaccines against infectious diseases affecting developing countries."

The prequalification by WHO sets the stage for IVI's next planned phase of the vaccine, which is introducing Shanchol- in countries where cholera remains a major public health problem, such as countries in Africa and South Asia where the disease is endemic. Recently IVI estimated that nearly 3 million cases requiring treatment and about 94,000 deaths are due to cholera in endemic countries. The large outbreak that erupted in Haiti in October 2010 demonstrates that the incidence and severity of the disease can shift dramatically over a short period of time. The Haitian health ministry reported that this outbreak had caused 194,095 cumulative cases and 3,819 deaths by January 16, 2011.

Also, West and Central Africa have recently been besieged by a major outbreak across the region. According to UNICEF, 85,000 cholera cases and 2,466 deaths have been reported this year so far, potentially making it one of the worst outbreaks in the region's history. Deploying Shanchol-, in conjunction with other preventive interventions and treatment, could play a key role in saving lives both in countries where the disease is endemic and in settings of natural disasters or humanitarian crises.

"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," said Dr. Loucq. "A vaccine like Shanchol- should positively impact public health efforts to control cholera in these countries. Now that Shanchol- is WHO prequalified, IVI is looking forward to working with governments and other organizations to introduce this vaccine and to make it widely available for use around the world."

"This demonstrates the power of vaccines to prevent epidemic diseases in people at risk," said Dr. Regina Rabinovich, Director of Infectious Diseases at the Bill & Melinda Gates Foundation. "We must continue to work together to ensure that everyone has access to affordable vaccines, no matter where they live."