Rotavirus vaccine developed in India demonstrates strong efficacy
New Delhi, India—The Government of India’s Department of Biotechnology (DBT) announced positive results from a Phase III clinical trial of a rotavirus vaccine developed and manufactured in India. Data from the trial showed ROTAVAC® to have an excellent safety and efficacy profile. The clinical study demonstrates for the first time that the India-developed rotavirus vaccine ROTAVAC® is efficacious in preventing severe rotavirus diarrhoea in low-resource settings in India. ROTAVAC® significantly reduced severe rotavirus diarrhoea by more than half—56 percent 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. VijayRaghavan. “The clinical results indicate that the vaccine, if licensed, could save the lives of thousands of children each year in India.”