Oral cholera vaccine Shanchol from Shantha for India

Shanchol, an oral vaccine for cholera from Shantha Biotechnics has been launched in India. Shanchol vaccine would be commercially available in the country from June.

Shanchol vaccine is recommended for children above one year and in two doses. Shanchol would be priced at Rs 300 (6 US dollars) a dose in India.

The other WHO approved oral cholera vaccine available is Dukoral, a Swedish vaccine, which costs about Rs 2000 ($40).

Earlier story on the OCV vaccine Shanchol

Shantha Biotech has spent a million dollars to set up facilities to Shanchol. Shantha plans to make 5 million doses of Shanchol initially.

Shanchol is first among more than a dozen vaccine projects that the Bill Gates Foundation is supporting, which has reached commercial scale, Mr K.I. Varaprasad Reddy, managing director of Shantha, said.

Shanchol is easy to administer, cheaper and provides more coverage. The vaccine has been developed in collaboration with the International Vaccine Institute (IVI), the VA Biotech of Vietnam and funding from Bill and Melinda Gates Foundation, Mr Varaprasad Reddy said.

Mr Reddy said, Shantha Biotechnics is receiving enquiries from Bangladesh and Zimbabwe for the supply of ‘bivalent oral cholera vaccine.’ Shanchol supplies are to be routed through the Gates Foundation. The WHO pre-qualification would be obtained in a couple of months.

The Drugs Controller General of India has already licensed the new oral cholera vaccine.

The oral cholera vaccine Shanchol 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.

Shanchol 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.

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 Shanchol 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. Dukarol is very expensive — around Rs 1250 a dose — and needs to be co-administered with a relatively large volume of buffer solution.

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

Shantha Biotechnics is part of the Merieux Alliance Group. The French healthcare company Merieux Alliance  has picked up about 60 per cent stake Shantha Biotechnics Ltd to strengthen its India presence.

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.