India-developed rotavirus vaccine demonstrates strong efficacy

In a public-private partnership, the Indian government’s Department of Biotechnology (DBT) and Bharat Biotech announced positive results from a Phase III clinical trial of a rotavirus vaccine developed and manufactured in India. Data from the trial, presented at the International Symposium on Rotavirus Vaccines for India - The Evidence and the Promise, showed ROTAVAC to have an excellent safety and efficacy profile, is reported by EurekAlert.

The clinical study demonstrates for the first time that the India-developed rotavirus vaccine ROTAVAC is effective in preventing severe rotavirus diarrhea in low-resource settings in India. ROTAVAC significantly reduced severe rotavirus diarrhoea by more than half – 56% during the first year of life, with protection continuing into the second year of life. Moreover, the vaccine also showed impact against severe diarrhoea of any cause.

"This is an important scientific breakthrough against rotavirus infections, the most severe and lethal cause of childhood diarrhoea, responsible for approximately 100,000 deaths of small children in India each year," said DBT Secretary Dr K Vijay Raghavan, adding: "The clinical results indicate that the vaccine, if licensed, could save the lives of thousands of children each year in India."