New Delhi: Bharat Biotech’s indigenous rotavirus vaccine Rotovac Being used in government vaccination program increases the risk Absorb Intussusception in infants is a condition in which the intestine becomes trapped in on itself and can lead to intestinal gangrene or death if not treated promptly, a new study finds.

This study has been published in the International Journal of Risk and Safety in Medicine. Bharat Biotech has rejected the findings of this study and claimed that the safety of the vaccine has been evaluated.

The study was co-authored by Jacob Puliyel, MD, and Brian Hooker, chief scientific officer, International Institute of Health Management Research, India. ChildrenA study by Health Defence found a 1.6-fold increase in the risk of intussusception in those who were vaccinated, which was overlooked in an earlier analysis.

“Additionally, vaccinated infants had a lower average age at developing intussusception, putting them at risk for serious harm, including death,” it said.

Puliyel told ET that those who are getting the vaccine should be told that there is a risk as they may mistake it for dysentery and take it lightly. “This is a terrible risk because it is a surgical emergency and must be treated. So, parents should be informed,” he said.

In 2020, an analysis in the New England Journal of Medicine found that there was no increased risk of intussusception from Rotavac, a live attenuated rotavirus vaccine. A statistical method called a self-controlled case series (SCCS) determined that the risk of intussusception in the high-risk window (21 days after any dose of vaccine) was equal to the background risk.

The company said the data was not new but a re-analysis of old data that “did not conform to the experimental design and statistical plan. Hence, it cannot be interpreted in a meaningful manner to merit serious consideration.”

“Rotovac is manufactured using human rotavirus strains and not those of animal origin. Therefore, the rate of intussusception is similar in vaccinated and non-vaccinated subjects,” the company said in a statement.