Effectiveness of Oral Cholera Vaccine Proven for First Time in a “Real” Cholera-Endemic Setting
- Results published in the authoritative British medical journal The Lancet of a major large-scale study in Dhaka, Bangladesh showed that the vaccine had protection of 53%
- Vaccine, when combined with other anti-cholera measures, had protection of 58%
- Vaccine was developed by the International Vaccine Institute through a public-private partnership with India, Vietnam, Sweden, Korean and the United States
SEOUL, REPUBLIC OF KOREA – The oral cholera vaccine (OCV), Shanchol, which was developed by the International Vaccine Institute (IVI) was demonstrated to be effective in preventing cholera in a cholera-endemic region through a pivotal clinical study. It was the first large-scale study to show the effectiveness of the OCV in a real-life setting when the vaccine was delivered through the government public health system.
The findings were published in The Lancet on July 8. The study, which involved 270,000 participants in Dhaka, Bangladesh, showed the OCV (Shanchol) had a protection of 53% when people were vaccinated alone and of 58% when they were vaccinated in addition to preventive interventions such as hand-washing. Surprisingly, the vaccine worked better than supplying participants with chlorine for their water or soap for hand-washing, which are traditional preventive measures against cholera.
Shanchol was specifically developed for use in developing countries through a public-private partnership led by IVI with partners from India, Vietnam, and Sweden, and with support from the Bill & Melinda Gates Foundation, and the governments of Kore and Sweden. It was prequalified by the World Health Organization (WHO) in September, 2011.
Since its introduction on the market, IVI has delivered the vaccine to countries affected by cholera such as India, Ethiopia, and Malawi. The OCV was used for an emergency cholera vaccination campaign in Nsanje District in southern Malawi in response to concerns over a rapidly spreading cholera outbreak from April to May this year. The campaign was conducted by IVI in collaboration with partners such as WHO and Malawi’s Ministry of Health and with support from Kia Motors and the Korean Ministry of Foreign Affairs. In addition, IVI conducted a cholera vaccination campaign in Oromia Region, Ethiopia in early 2015 in collaboration with the Ethiopian Public Health Institute (EPHI) and LG Electronics.
"The study results adds to the growing body of evidence that vaccination can effectively prevent cholera in both endemic and epidemic situations,” said Dr. Jerome Kim, IVI’s Director General. “The oral cholera vaccine has successfully controlled the spread of cholera in countries such as Haiti, South Sudan, Guinea and Malawi; therefore this study scientifically confirms what we already know - the oral cholera vaccine works and it is a powerful public health tool to control cholera when used in conjunction with other interventions.”
He also said, “IVI will continue its efforts in preventing cholera and other neglected diseases through the discovery, development and delivery of effective vaccines and strengthening of our relationships with partners.”
Currently, there is only one manufacturer for the OCV (Shanchol is produced by Shantha Biotechnics of India, an affiliate of the Sanofi Group). To ensure a sufficient supply of the OCV for the global public market, IVI has been collaborating with a Korean vaccine manufacturer, EuBiologics Co., Ltd. (EuBiologics). IVI has been working with EuBiologics since 2010 on technology transfer and clinical development of their OCV (Euvichol). In January this year, export licensure was obtained for Euvichol from the Korean Ministry of Food & Drug Safety and it is expected to be WHO prequalified in 2016. Euvichol is projected to be even lower in price than Shanchol ($3.70 for two doses).
In addition, IVI has been partnering with Incepta Vaccine Ltd. of Bangladesh since 2014 to supply OCV for the domestic market since cholera is highly endemic in Bangladesh. Technology transfer was completed’ and IVI is currently providing support to Incepta on the clinical development.
Cholera is a potentially fatal infectious disease that causes acute watery diarrhea. If not properly treated, it can result in death within hours from infection. It is spread through contaminated food or water and often occurs in impoverished settings where there is overcrowding, lack of clean water, and limited sanitation and hygiene. According to the WHO, approximately 3-5 million cases and 100,000 deaths occur each year from cholera in developing countries.
The International Vaccine Institute (IVI) is the world’s only international organization devoted exclusively to discovering, developing and delivering new and improved vaccines to protect the world’s poorest people, especially children in developing countries. Established in 1997, IVI operates as an independent international organization under a treaty signed by 35 countries and the World Health Organization. The Institute conducts research at its headquarters in Seoul, Republic of Korea and in more than 20 countries of Asia, Africa and Latin America on vaccines against enteric and diarrheal infections, as well as dengue fever. For more information, please visit www.ivi.int.
Public Awareness/Advocacy Officer, IVI
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