Study links Bharat Biotech's Rotovac to increased risk of bowel issues in infants; company defends safety: Report

Responding to the findings, Bharat Biotech dismissed the study, stating the vaccine's safety had been rigorously evaluated

Bharat Biotech's Rotovac, an indigenous rotavirus vaccine included in the government's immunisation program, has been associated with an increased risk of intussusception in infants, Economic Times reported citing a study by the International Journal of Risk and Safety in Medicine.

Intussusception is a serious condition where the intestine telescopes into itself, potentially leading to bowel gangrene or even death without immediate treatment.

The study, co-authored by Jacob Puliyel, MD of the International Institute of Health Management Research, India, and Brian Hooker of Children's Health Defense, revealed a 1.6-fold increased risk of intussusception (a serious condition in which part of the intestine slides into an adjacent part of the intestine) among vaccinated infants, which was not previously detected in initial analyses. Puliyel emphasised the need for parents to be informed about this risk due to the vaccine's potential to mimic dysentery symptoms.

Responding to the findings, Bharat Biotech dismissed the study, stating the vaccine's safety had been rigorously evaluated, the ET report said. They referred to previous analyses, including one from the New England Journal of Medicine in 2020, which suggested no increased risk of intussusception beyond the background level in vaccinated infants.

The company reaffirmed Rotovac's safety, emphasising its manufacture from human rotavirus strains and not animal origins. They criticized the recent study's methodology, asserting it deviated from established statistical plans, thus questioning its validity.