"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
|Contact: Tae Kyung Byun|
International Vaccine Institute