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Bharat Bio’s Rotavirus vaccine Rotovac may be unsafe for children: Study

June 16,2024

New Delhi: Bharat Biotech’s indigenous rotavirus vaccine Rotovac used in the government’s immunisation programme increases the risk of intussusception in infants, a new study found. Intussusception is a condition where the intestine telescopes into itself and can lead to gangrene of the bowel or death if not treated immediately.

The study has been published in the International Journal of Risk and Safety in Medicine. Bharat Biotech has dismissed the findings claiming the vaccine has been evaluated for safety.

The study, co-authored by Jacob Puliyel, MD of the International Institute of Health Management Research, India, and Brian Hooker, chief scientific officer, Children’s Health Defense, found that there was a 1.6-fold increase in the risk of intussusception in the vaccinated, which was missed in the earlier analysis.

“Additionally, the mean age of developing intussusception was lower in the vaccinated babies, putting them at risk of serious harm, including death,” it said.

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

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

The company said that the data is not new, but it is reanalysis of old data that was “out of line with the experimental design and statistical plan. Hence, it cannot be interpreted in a meaningful manner to merit serious consideration,” it further said.

“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 said in a statement.

Source: Pharma

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