The Government of India’s Department of Biotechnology and Bharat Biotech announced today the positive results from a Phase III clinical trial of a rotavirus vaccine, ROTAVAC®, developed and manufactured in India. Data from the trial showed ROTAVAC® significantly reduced severe rotavirus diarrhea by more than half—56 percent during the first year of life, with protection continuing into the second year of life. The vaccine was also found to protect against severe diarrhea of any cause. This is comparable to the efficacy in low-resource settings of the two currently available rotavirus vaccines.
Once licensed, Bharat Biotech has promised to make the drug available for US$1.00 per dose (or approximately INR 54 per dose), making it a more affordable alternative to the rotavirus vaccines currently on the market.
The burden of rotavirus is higher in India than any other country–rotavirus kills nearly 100,000 Indian children under age five each year, and sickens hundreds of thousands more. An affordable, effective vaccine, if introduced into the nation’s immunization program, will have a tremendous impact improving child health and saving children’s lives.
Statement on ROTAVAC® from Dr. Mathuram Santosham, co-chair of the ROTA Council:
“As someone who has conducted several Phase III trials as well as serving on several Data Safety Monitoring Boards, I am very impressed with the quality of the 116E Phase III trial. This trial meets the highest standards for ethics and patient care and has been conducted in compliance with international standards for Good Clinical Practices. The trial design included a strong safety net to identify and treat illnesses, especially gastroenteritis, among study infants as quickly as possible. All of the infants enrolled in the trial have received high-quality medical and emergency care, and the surveillance system for collecting cases of diarrhea is meticulous.”
Dr. Mathuram Santosham, a professor in the Departments of International Health and Pediatrics at Johns Hopkins University, was the Acting Chair of the Data Safety Monitoring Board for the ROTAVAC® Phase III efficacy trial.