Bharat Biotech’s Rotavirus vaccine can increase risk of bowel gangrene in babies

financialexpress.com:

A new study has revealed that Rotovac, an indigenous rotavirus vaccine by Bharat Biotech can lead to bowel complications. The findings of the study were published in the International Journal of Risk and Safety in Medicine.

According to the study, the vaccine which is a part of the government’s immunisation programme, has been associated with an increased risk of intussusception in infants.

Intussusception is a serious condition where one part of the intestine slides into the next, 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 among vaccinated infants, which was not previously detected in initial analyses.

According to a report by ET, Puliyel emphasised the need for parents to be informed about this risk due to the vaccine’s potential to mimic dysentery symptoms.

Meanwhile, Bharat Biotech dismissed the study and stated that the vaccine’s safety had been rigorously evaluated, the ET report said. The company 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. Reportedly, the drugmaker also criticised the recent study’s methodology, asserting it deviated from established statistical plans, thus questioning its validity.

In 2020, a New England Journal of Medicine analysis found there was no risk of intussusception