On 16th June, Bharat Biotech firmly rejected the claims made in a report by the Economic Times that suggested the company’s indigenous rotavirus vaccine, Rotavac, potentially increases the risk of intussusception in infants. In a post on X (formerly Twitter), the company said that the ET report was misleading and emphasised it lacked parts of the statement issued by the company to ET in response to queries about the recent study.
Bharat Biotech Fact Check in Public Interest! pic.twitter.com/tH9oOEFLEX
— Bharat Biotech (@BharatBiotech) June 16, 2024
The ET report was based on a “study” published in the International Journal of Risk and Safety in Medicine titled ‘Self-controlled risk interval study of rotavirus vaccine safety: Findings and implications’ authored by Dr Jacob Puliyel and Brian Hooker.
Bharat Biotech pointed out that ET skipped the information provided in the statement about a PIL filed by Dr Puliyel in the Delhi High Court that was dismissed stating the petition was “misconceived and motivated with private interest”.
In the alleged “study”, Dr Puliyel claimed that Rotavac increased the risk of intussusception. It is a serious condition where part of the intestine slides into an adjacent part. It may lead to severe complications including bowel gangrene and death. The study claimed that the vaccine increases the risk of the disease by 1.6-fold among infants. The authors argued that the risk was overlooked in earlier analyses of the vaccine.
Rotavac safe, author’s claims are misleading, says Bharat Biotech
Responding to the allegations, Bharat Biotech said, “Rotavac has been evaluated in tens of thousands of subjects for safety. It was developed over 40 years ago, with data extensively published in high-impact peer-reviewed journals such as NEJM and The Lancet. The risk of intussusception was similar to that of the background rate in the general population.”
The company further added that the article in ET was based on a reanalysis of the old data that deviated from the original experimental design and statistical plan. The company said such analysis renders the findings insignificant.
The company emphasised that “Rotavac is manufactured using human rotavirus strains, not of animal origin; hence, the rate of intussusception is similar in vaccinated and non-vaccinated subjects.”
Emphasising on the fact that ET did not mention the PIL dismissed by Delhi High Court, Bharat Biotech said, “Furthermore, The Economic Times has omitted an important part of our statement, depriving the readers of this crucial information: Dr. Jacob Puliyel filed a Writ Petition (allegedly PIL), being WP(C.) No. 6913 of 2015 before the Hon’ble High Court of Delhi, seeking segregated data of ‘Rotovac vaccine’ wherein the Hon’ble High Court of Delhi vide order dated 14.10.2015, while dismissing the writ petition had castigated Dr. Puliyel by stating that writ petition is misconceived and motivated with private interest.”
In 2015, Dr Puliyel filed a Public Interest Litigation (PIL) in the Delhi High Court seeking the release of segregated clinical trial data for Rotavac. Prashant Bhushan, a known anti-vaccine fear monger, represented Dr Puliyel in the court. The petition was dismissed by the court noting that the vaccine was approved based on comprehensive data reviewed by both national and international bodies which included the National Technical Advisory Group on Immunization (NTAGI) and the World Health Organization (WHO). The High Court further pointed out that Dr Puliyel, who himself was a member of NTAGI and the vaccine was introduced in the National Immunisation Programme on NTAGI’s recommendation.
While pointing out the discrepancies in the report by ET, Bharat Biotech urged the publication to publish a complete statement.
