Oral cholera vaccine in India for Rs 50 ($ 1)

The new double-dose oral vaccine in India offers protection against cholera for 2 years.

A new low-cost oral cholera vaccine against cholera will soon be made available in India.

The double dose oral cholera vaccine (OCV) can provides 70% protection against the diarrhoeal disease over two years.

The oral cholera vaccine has been jointly developed by the International Vaccine Institute (IVI), Soul and Vietnamese manufacturer VaBiotech.

The IVI has transferred the production technology to Shantha Biotechnics Ltd, Hyderabad, India on 24 Feb 2009.

The oral cholera vaccine meets international good manufacturing practice standards (GMP) as well as World Health Organisation standards of production.

The Drugs Controller General of India, the apex body which regulates the quality of drugs sold in India, has already licensed the new oral cholera vaccine.

The oral cholera vaccine has been approved India based on the results of in a phase II trial on 70,000 human subjects (aged 12 months and older) conducted in Kolkata by the National Institute of Cholera and Enteric Diseases (NICED).

The Kolkata trials found the oral cholera vaccine to provide over 60 percent protection and no decline in protection over two years, John D Clemens, director general of IVI, said.

Half of those in the sample size were given the new vaccine while the others were given placebos.

The vaccine can be delivered orally through a syringe. Its cost comes down to nearly Rs 50 or a dollar per dose. It has been found to be effective in all age groups.

“After 38 years of drought in cholera vaccination and cholera outbreaks no way abating, it is very heartening to know that there is an affordable orally administered vaccine available now,” said Dr. N K Ganguly, advisor, translational health science and technology institute and economic advisor to health minister said.

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.

All the data generated from the studies on the vaccine will be submitted to the government so it can decide on how to use this vaccine — whether in the universal immunisation programme or as part of other vaccination programmes, he added.

India used to administer an injectible vaccine in the 1970s when cholera was a notifiable disease. However, in 1973, its use was scrapped as it was only 30% effective and provided immunity only for eight months.

The Union Health Secretary V M Katoch said the health ministry has been recommended to first introduce it in a guided manner in cholera endemic areas of West Bengal and Orissa. It could be expanded to other areas, as well, Katoch, who also heads the Indian Council of Medical Research (ICMR), added.

The oral cholera vaccine would be recommended as a supplement to conventional tools like safe drinking water and sanitation in the battle against cholera and not its replacement to prevent cholera, he pointed out.

The oral cholera vaccine is very innovative as it incorporated all the important genes required to make it very selective and more effective without harming the intestines in any way. It is designed to prevent even severe infections caused by various mutants of the cholera virus.

IVI’s has used 9 million doses its killed whole-cell vaccine, till now. Since the vaccine did not require any buffer, it was easier to administer.

The only WHO-prequalified oral cholera vaccine to date is the double dose Swedish vaccine called Dukoral. It is very expensive — around Rs 1250 a dose — and needs to be co-administered with a relatively large volume of buffer solution.

Cholera kills about 120,000 people globally every year. In the past 10 years alone, there has been a 70% increase in cholera cases. 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.

However, the oral cholera vaccine is not an alternative but an additional tool alongside better water quality and improved sanitation, experts reminded.

With the new vaccine having global applications, India could become one of its four to five manufacturing hubs, experts said.