New Delhi: Indian researchers on Tuesday claimed to have brought an indigenous vaccine against rotavirus – a pathogen that causes diarrhoea and kills thousands of children each year – close to commercialisation at one-twentieth the price of similar commercial vaccines made by multinational pharmaceutical companies.
While two common vaccines against rotavirus made by GSK and Merck cost around Rs 900 per dose, Hyderabad-based Bharat Biotech plans to sell the Indian product at Rs 54 (one dollar) per dose. Children need three dosages at sixth, tenth and 14th weeks of their lives.
Developed after 28 years of research, the indigenous vaccine against rotavirus shows promise in clinical trials. The last part of the trial (phase–III) demonstrates 60 per cent efficacy and lesser number of deaths. The two commercial vaccines too have similar efficacy in India.
Diarrhoea is the third leading killer of children in India, accounting for 13 per cent of all deaths in children below five years and kills an estimated 3,00,000 children each year, almost half of which are caused by rotavirus.
Rotavirus is the leading cause of severe diarrhoea causing 4,57,000 to 8,84,000 hospitalisations, two million outpatient visits and 1,22,000-1,53,000 deaths.
A Global Enteric Multicentre Study – published in the “Lancet” on Tuesday – showed one in five children in the developing countries of Asia and Africa below two years of age suffered from moderate-to-severe diarrhoea each year, which not only increased their risk of death 8.5 times more, but also led to stunted growth over a two-month follow-up period.
Conducted on 6,799 infants (aged six to seven weeks at the time of enrolment) at Delhi, Pune and Vellore, the phase-III clinical trial showed 55-60 per cent efficacy. The maximum efficacy was seen in the first year when the babies are most vulnerable.
Mortality rate drops
Though the study was not designed to check drop in mortality, a sharp 20 per cent reduction in mortality was found in the group receiving the vaccine, said former department of biotechnology secretary M K Bhan who discovered the vaccine strain at All India Institute of Medical Sciences way back in 1985. “Instead of 140 deaths we got only 37 deaths,” said Gagandeep Kang from Chistrian Medical College in Vellore who was one of the 400-odd researchers associated with the project.
“This is significant in public health as 25 per cent of all diarrhoeal admissions will be prevented. The case fatality rate was seven per thousand, which is seven times less than what was expected. It is a mono-valent vaccine but will offer cross protection from other strains,” Bhan said.
Bharat Biotech would submit its dossier seeking marketing approval to the Drugs Controller General of India in July, said Krishna M Ella, chairman and managing director of the company that invested close to Rs 60 crore in the project. The clinical trials cost between Rs 80-100 crore, which were provided by the government.
