Indian rotavirus vaccine concern over intussusception is unfounded, say researchers

Researchers testing an Indian rotavirus vaccine have said that concerns linking it to an increased risk of intussusceptions are unfounded. They were responding to an online campaign that has called for them to release raw data on the rates of intussusception seen during the trial.1

Gagandeep Kang, professor of gastrointestinal sciences at Christian Medical College, Vellore, who worked on the trial, said that the trial data cannot be used to estimate the risk of intussusception from the vaccine as the campaigners have argued. “This was not a study powered to detect rare events. If you want to find the rate of intussusception, you need to evaluate the vaccine in hundreds of thousands of children,” she told The BMJ.

Kang’s group conducted the trial in 6800 children to measure the efficacy of the Indian rotavirus vaccine, Rotavac, which was developed by the Hyderabad based company Bharat Biotech and tested with funding from India’s Department of Biotechnology. During the two year trial Kang’s team also collected data on intussusception, a rare side effect in which the intestine folds into itself, …