The curiosity and keen observation shown by a single doctor at the All-India Institute of Medical Sciences in New Delhi in 1985, combined with unprecedented team work by people from 13 institutions, both in India and abroad, would soon start annually saving the lives of thousands of children aged less than five years from a mass killer — rotavirus diarrhoea. In India, the disease annually kills over 100,000 children below the age of one, making the country account for a quarter of all global deaths caused by rotavirus diarrhoea. The majority of instances of the disease caused by the virus occurs during the first two years of age. According to results published recently in The Lancet, a Phase III trial of an indigenously developed rotavirus vaccine 116E carried out in three centres was found to be safe; it had 56.4 per cent efficacy in preventing severe rotavirus gastroenteritis in infants during their first year of life. Though the efficacy of the vaccine is only modest, it is superior to currently available ones. In the case of high-burden countries like India, even the modest efficacy of the vaccine would go a long way in reducing the number of deaths. The efficacy would further shoot up when widespread immunity is achieved through sustained vaccination of a majority of infants. Hence, there is a real possibility of the number of deaths dropping sharply in a few years after the introduction of the vaccine. It can also bring about a major reduction in the number of instances of hospitalisation in those aged below five, within two years of its introduction.
The vaccine, which would be made available to the government at not more than $1 a dose, is expected to be licensed shortly. It is imperative that the government quickly includes it in the national immunisation programme. The fact that three doses can be co-administered with other vaccines during the routine immunisation schedule makes it all the more attractive. While it is true that improving sanitation and hygiene levels is insufficient to rein in rotavirus diarrhoea, there is a compelling need to improve social infrastructure in order to control other pathogen-caused diseases like cholera. Besides the direct benefits from the vaccine, the isolation of the human neo-natal rotavirus strain and the conduct of clinical trials in India have given the science of vaccine development a much-needed boost. Though it has taken nearly 30 years to reach this stage, the development of this vaccine proves that Indian companies can take to completion clinical trials of novel drug candidates. In fact, the government should adopt the same model to develop drugs for other neglected tropical diseases that primarily affect people living in poverty in the developing countries.