New Delhi: The department of biotechnology has invited applications from drug companies to license India’s first indigenously developed cholera vaccine.
Though a key large-scale trial is set to begin later this year, the government’s effort reflects its confidence in the efficacy orally administered drugs.
The vaccine is the result of a combined effort by several publicly funded labs, including the National Institute of Cholera and Enteric Diseases of the Indian Council of Medical Research (ICMR) and the Institute for Microbial Technology, Chandigarh, affiliated to the Council of Scientific and Industrial Research (CSIR).
Other institutions involved include the Indian Institute of Chemical Biology and the Society for Applied Studies, an independent research organization.
If effective, the vaccine could be a key shield against the most virulent strain of cholera that’s a major scourge of India’s poor and a drain on the national health budget.
Cholera is one of the key culprits behind diarrhoeal diseases in India, which account for an estimated 600,000 deaths each year in children aged under five years.
“We’ve invited applications from private companies and given a manufacturing contract to Shantha Biotechnics Ltd for further trial studies,” said M.K. Bhan, secretary, department of biotechnology. “In about six weeks we should have a better idea about interest from the private sector.”
According to the World Health Organization, cholera kills about 120,000 people globally every year. In the past 10 years alone, there has been a 70% increase worldwide in cases of the disease, which is rife in India and sometimes leads to death within 24 hours when left untreated.
India, the epicentre of six of the last seven cholera pandemics in the last century, had an average 3,700 cases a year between 1996 and 2005, based on the most recent data available. The true number of cholera-related deaths in the country is, however, under-reported as these cases are often attributed to other infections.
Though the mortality rate from cholera is low (less than 0.1%), it causes severe morbidity and affects the productivity of citizens, besides significantly adding to public health expenditure.
India has no immunization programme for cholera because the existing vaccines, mostly used today by western travellers, are prohibitively expensive and not licensed for use in the developing world.
Last April, Hyderabad-based Shantha Biotechnics, which is controlled by Sanofi-Aventis, launched an oral cholera vaccine developed by the International Vaccine Institute, Seoul, South Korea, which costs Rs295 in stores.
Government officials say the newly developed vaccine could be cheaper and it’s important that more than one company manufactures such drugs against the disease as part of effective public health policy.
“Only phase 3 trials will determine the efficacy and cost of this vaccine, but there should be more than one vaccine option for tackling cholera,” Bhan said. “That could facilitate public accessibility and distribution.”
The most salient feature of this vaccine is that it’s administered in a single dose and hence will be more effective in any outbreak, say scientists associated with it.
“We’ve seen that in containing an epidemic, single-dose vaccines are far more effective than regimented multiple doses,” said Dilip Mahalanabis of the Society for Applied Studies, Kolkata, and among the key scientists involved with the drug.
He also pointed out that the disease was not confined to just some pockets of the country.
“It’s a mistake to think that only Kolkata and West Bengal suffer from cholera. There are several other states that aren’t tracking this malaise. So a cheap, affordable vaccine is all the more important.”
The perception that cholera is dying out is incorrect, Balkrish Nair, director, National Institute of Cholera and Enteric Diseases, had said in a previous interview with Mint. “We do see epidemics and 2007 was particularly bad when India and many other countries saw a huge burden of cholera,” he had said.
While there’s been a decline in infections, the number of outbreaks has increased due to the collapse in the infrastructure that allows drinking water to mix with sewage as pipes laid next to each other deteriorate.
All the same, experts said the oral cholera vaccine was not a complete remedy by itself but an additional tool alongside better water quality and improved sanitation. “Cholera strains evolve rapidly. So there can’t be a better alternative than providing clean water, though without doubt, a cheap vaccine could be valuable during outbreaks,” said C.R. Pillai, ICMR emeritus professor.