India unveils new, affordable rotavirus vaccine

The Indian government has unveiled a low-cost rotavirus vaccine which it says could save the lives of thousands of children every year

The Indian government has unveiled a low-cost rotavirus vaccine which it says could save the lives of thousands of children every year.

Rotavac, which is India’s first indigenous vaccine, is administered orally to infants in a three-dose course at the ages of six, 10 and 14 weeks. Clinical trials have demonstrated strong efficacy and safety: 6,799 infants at three sites in India showed the vaccine reduced severe cases of diarrhea caused by rotavirus by 56 per cent during the first year of life. Rotavirus, which causes dehydration and severe diarrhea and is spread through contaminated hands and surfaces, currently kills around 100,000 children a year in India. The country accounts for 22 per cent of the estimated global deaths from rotavirus.

The new vaccine was developed under a public-private partnership between India’s Department of Biotechnology and Hyderabad-based pharmaceutical firm Bharat Biotech, with the support of the Bill & Melinda Gates Foundation and other international organisations. If Rotavac is approved by the Drugs Controller General of India (DCGI), Bharat Biotech says it can mass-produce tens of millions of doses at 54 rupees ($1) per dose. Currently international pharmaceutical companies GlaxoSmithKline and Merck produce similar vaccines, but each dose costs around 1,000 rupees.

“We are planning to file a dossier with the DCGI in July. We will come to the market after getting the requisite regulatory clearances,” said Krishna M Ella, chairman and managing director of Bharat Biotech. “If licensed… the vaccine will be a more affordable alternative to the rotavirus vaccines already in the market.”

One in four instances of moderate-to-severe diarrhoea in India is caused by rotavirus, according to a recent study. According to World Health Organisation estimates, diarrhea hospitalises between 457,000 and 884,000 children in India each year, while another 2 million require visits to the doctor.