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Bharat Biotech responds to study that Rotavirus vaccine increases risk of gastrointestinal problems in infants – Health News

A recent study has revealed that Rotovac, an indigenous rotavirus vaccine developed by Bharat Biotech can cause gastrointestinal problems. The study findings were published in the International Journal of Risk and Safety in Medicine. According to research, the vaccine, which is part of the government’s vaccination program, is associated with an increased risk of stillbirth.

Intussusception is a serious condition in which one part of the intestine descends into the next, which can lead to gangrene or death without immediate treatment.

This study, published on June 11, 2024, was written by Jacob Puliyel, MD of the International Institute of Health. Management Research, Indiaand Brian Hooker of Children’s Health, revealed a 1.6-fold increased risk of intussusception among vaccinated infants, which was undetected in earlier studies.

According to an Economic Times report, Puliyel stressed the need for parents to be informed of this risk due to the vaccine’s ability to mimic the symptoms of diarrhoea.

Meanwhile, Bharat Biotech has rejected this study and said that the safety of the vaccine has been rigorously evaluated. The company has commented on previous reviews, including one from New England Journal of Medicine in 2020, which suggested that there is no increased risk of intussusception than post-vaccination conditions in vaccinated infants.

The company has confirmed the safety of Rotovac, emphasizing its production from the human strain of rotavirus and not animal origin. It is reported that the drug manufacturer also criticized the method of the latest study, asserting that it deviated from the established statistical plans, thus questioning its validity.

In 2020, a review in the New England Journal of Medicine found that there is no risk of complications from Rotavac, a rotavirus vaccine that has been weakened. A statistical method called “self-controlled case series” (SCCS) observed that the risk of intussusception in the high-risk window (21 days after any dose of vaccine) can be compared and back injury.

The company said that the data is not new, but a re-analysis of old data “that was not consistent with the experimental design and statistical design. Therefore, it cannot be rationally interpreted to be worthy of consideration in depth,” it continues.

“Rotovac is made using human strains of rotavirus and not from animals. Thus, the rate of intussusception is the same in vaccinated and unvaccinated subjects,” the company said in a statement.

Meanwhile, Bharat Biotech has pointed out that the ET report has omitted the information provided in the statement on the PIL filed by Dr. Puliyel in the Delhi High Court. which was dismissed saying the petition was “false and motivated by personal interests”.

Bharat Biotech said, “Furthermore, The Economic Times has left out an important part of our statement, depriving readers of this important information: Dr. Jacob Puliyel filed a Writ Petition (referred to as PIL), which is WP (C.) No. 6913 of 2015 before the High Court of Delhi, seeking separate details of ‘Rotovac vaccine’ in which the High Court of Delhi passed an order dated 14.10.2015 , while rejecting the written petition accused Dr. Puliyel of saying that the written petition was wrong and motivated by personal interests.

In 2015, Dr Puliyel had filed a Public Interest Litigation (PIL) in the Delhi High Court seeking the release of separate clinical trial data for Rotavac. The court rejected the appeal that the vaccine was approved based on the full data reviewed by national and international organizations that included the National Advisory Group on Immunization (NTAGI) and the World Health Organization (WHO). .

The High Court also pointed out that Dr. Puliyel, who was a member of NTAGI and the vaccine was introduced in the National Immunization Program with the recommendation of NTAGI.

(Disclaimer: Story and headline updated after receiving Bharat Biotech’s statement via email)

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