A Phase 3 clinical trial in India of the rotavirus vaccine BRV-PV known as ROTASIL show the vaccine is safe and effective against severe rotavirus. Photo by Gabe Bienczycki/PATH
Sept. 26 (UPI) -- A Phase 3 clinical trial in India of the rotavirus vaccine BRV-PV known as ROTASIIL shows the vaccine is safe and effective against severe rotavirus.
Rotavirus is the most common and deadly cause of severe diarrhea with dehydration in infants and young children. In 2013, roughly 47,100 rotavirus deaths occurred in India with 22 percent of all rotavirus deaths occurring around the world. Rotavirus diarrhea represents the highest risk of dehydration, hospitalization and death.
ROTASIIL was shown in the trial to be effective at reducing severe rotavirus diarrhea by 39.5 percent during a two-year period.
Results of the trial, published today in Vaccine, found the vaccine's efficacy was nearly 55 percent against the most severe and life-threatening cases of rotavirus diarrhea.
"We are delighted with these results, which indicate that ROTASIIL could save the lives of tens of thousands of children each year in India and, potentially, around the world," Dr. Rajeev Dhere, executive director of the Serum Institute, said in a press release.
The study was conducted at six sites throughout India and consisted of 7,500 infants who received an oral vaccine in a three-course 6, 10 and 14 weeks of age.
As a result of the trial, the India government has ordered 3.8 million doses of ROTASIIL to use for its Universal Immunization Program, which serves 26 million children.
"This is great news for India," said Dr. David Kaslow, vice president for Essential Medicines at the international nonprofit PATH and global head of the Center for Vaccine Innovation and Access. "The results and successful licensure of this rotavirus vaccine is an exciting and encouraging milestone toward the public health goal of improving the supply of affordable rotavirus vaccines, both in India and worldwide."
