A new study published in the International Journal of Risk and Safety in Medicine has raised concerns about Rotovac, a rotavirus vaccine developed by Bharat Biotech. According to the study, the vaccine, which is part of India’s government immunisation program, may lead to bowel complications in infants.
The research, conducted by Dr. Jacob Puliyel from the International Institute of Health Management Research in India and Brian Hooker from Children’s Health Defense, found a 1.6 times higher risk of intussusception in infants who received the vaccine.
Intussusception is a serious medical condition where one part of the intestine slides into another, potentially causing severe complications like bowel gangrene or even death if not treated promptly.
Dr. Puliyel stressed the importance of informing parents about this risk since the symptoms of intussusception can resemble those of dysentery. However, Bharat Biotech, the vaccine’s manufacturer, has dismissed the study’s findings.
Bharat Biotech argues that Rotovac’s safety has been thoroughly evaluated. They point to earlier research, including a 2020 analysis in the New England Journal of Medicine, which found no increased risk of intussusception beyond the usual background level in vaccinated infants. This analysis used a method called the self-controlled case series (SCCS), which compared the risk of intussusception within 21 days after vaccination to the background risk in the population.
The company also criticized the recent study’s methodology, claiming it deviated from established statistical plans, which makes its findings questionable. Bharat Biotech maintains that Rotovac is made from human rotavirus strains, not animal ones, which they say supports its safety.
In a statement, Bharat Biotech reiterated that the data used in the recent study is not new but a reanalysis of old data. They argue that this reanalysis was not conducted according to the original experimental design and statistical plan, making its conclusions unreliable.
“Rotovac is manufactured using human rotavirus strains and not from animal origin. Hence, the rate of intussusception is similar in vaccinated and non-vaccinated subjects,” the company stated, reaffirming the vaccine’s safety.
This ongoing debate highlights the importance of rigorous scientific evaluation and transparent communication to ensure public trust in vaccination programs.
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