11 April 2009
By Kounteya Sinha
News Delhi, India
A double dose Oral Cholera Vaccine (OCV) that provides 70% protection against the diarrhoeal disease over two years could soon be used in India.
Developed by the International Vaccine Institute (IVI) in Seoul, which has transferred the production technology to an Indian pharma company, the vaccine has been found to be safe when tried in a phase II trial on 70,000 human subjects (aged 12 months and older) in Kolkata by the National Institute of Cholera and Enteric Diseases (NICED).
According to ICMR director general Dr V M Katoch, experts in India have decided to recommend using the vaccine in endemic districts and outbreak settings, to start with. “We have good scientific evidence that this vaccine works. We will therefore recommend its use starting in West Bengal and Orissa which are highly endemic states. Expansion to a national level will be guided by the results from its use in these areas,” Dr Katoch said.
A cost analysis, based on data from the Kolkata study, found that using this vaccine would be highly cost–effective – around $1 a dose.
Dr N K Ganguly, advisor to the Union health minister and former DG of ICMR, said, “After 38 years of drought in cholera vaccination, we finally have an affordable orally administered vaccine available now.”
According to Ganguly, the two–year–immunity limit that this vaccine offers would greatly benefit India where diarrhoeal diseases account for an estimated 600,000 deaths each year in children aged under 5 years.
India used to administer an injectible vaccine in the 1970s when cholera was a notifiable disease. However, in 1973, it's use was scrapped as it was only 30% effective and provided immunity only for eight months.
IVI's killed whole–cell vaccine was originally produced by Vietnam which has till now used 9 million doses of it. Since the vaccine did not require any buffer, it was easier to administer.
However, an analysis of the Vietnamese vaccine showed that to comply with WHO guidelines, the vaccine needed to be reformulated. IVI then worked on it to make it meet international good manufacturing standards.
The OCV was licensed on February 24, 2009 by the drugs controller general of India.
Dr John Clemens, director–general of IVI, said, “We will never get rid of cholera. In the past 10 years alone, there has been a 70% increase in cholera cases. Our vaccine is not an alternative but an additional tool alongside better water quality and improved sanitation.”
Dr Clemens added, “The only WHO–prequalified OCV to date is the double dose Swedish vaccine called Dukoral. It is very expensive–around $15 a dose – and needs to be co–administered with a relatively large volume of buffer solution. Our vaccine will provide protection against both the classical strain and the El Tol variety.”
Cholera continues to create havoc in India and in some cases leads to death within 24 hours when left untreated. In 2007, the Who recorded 177,963 cholera cases and 4,031 deaths worldwide. The true number of cholera–related deaths, however, is estimated to be as many as 120,000 each year.
Cholera is extremely virulent. Unlike other diarrhoeal diseases, it can kill healthy adults within hours.
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