ICMR warns of legal action against BHU researchers for misleading study on Covaxin

The study claimed that 30 per cent of people who took the jab encountered adverse events, including stroke, Guillain-Barre Syndrome, neurological disorders, and upper respiratory problems.
Image used for representational purposes only.
Image used for representational purposes only.

NEW DELHI: The Indian Council of Medical Research (ICMR) on Monday junked a recently published BHU study on the long-term safety analysis of Covaxin in adults and adolescents for its poor methodology and design, and said the article “incorrectly and misleadingly acknowledged” ICMR in the paper.

The ICMR Director-General Dr Rajiv Bahl said the Banaras Hindu University (BHU) study is “poorly designed" and has critical flaws, and warned of legal action against the researchers for publishing the misleading paper over Covaxin safety.

The study claimed that 30 per cent of people who took the jab encountered adverse events, including stroke, Guillain-Barre Syndrome, an autoimmune disorder that causes weakness in nerves in the arms and legs, neurological disorders, and upper respiratory problems.

Dr Bahl in his letter to the authors of the study and editor of the journal said they should immediately remove the acknowledgment to ICMR and publish an erratum.

In a separate letter to the editor of the journal, that had published the paper, Dr Bahl said, “ICMR is not associated with this study and has not provided any financial or technical support for the research. Further, the authors have acknowledged ICMR for research support without any prior approval of or intimation to ICMR, which is inappropriate and unacceptable.”

Following ICMR criticism, the university in a statement said they are looking into the matter. “The university has taken note of a study in connection with Covaxin aftereffects, involving some members of BHU’s Institute of Medical Sciences, and a series of reactions in that regard. We are also aware of the communication made by the ICMR to the concerned individuals. The Institute of Medical Sciences is looking into the matter. The individuals have communicated their responses to the ICMR. Additionally, the Institute of Medical Sciences is also working on further strengthening and improving its research ecosystem.”

Prominent doctors and experts, including Dr Abby Philips, known as @theliverdr on Twitter, and Dr Rajeev Jayadevan, Co-Chairman of the National Indian Medical Association (IMA) COVID Task Force, have also criticized the study. Dr Jayadevan on X, formerly Twitter said, "A badly designed study claimed a high rate of "adverse effects" for Covaxin. The study methodology is so poor, it would not pass the scrutiny of any legitimate scientific journal."

Bahl in his letter to the researchers said the study has no control arm of unvaccinated individuals for comparing the rates of events between the vaccinated and unvaccinated groups.

Hence, the reported events in the study cannot be linked or attributed to Covid-19 vaccination, it said.

Dr Bahl, who is also secretary in the Department of Health Research under the Union Health ministry also said the study does not provide background rates of observed events in the population, making it impossible to assess change in such incidences in the post-vaccination period.

“The method of data collection has a high risk of bias. Study participants were contacted telephonically one year after vaccination and their responses recorded without any confirmation with clinical records or by physician examination,” the letter said.

The ICMR's reaction came amidst concern over rare side-effects for those who took the vaccine developed by AstraZeneca and Oxford University. It was manufactured and sold in India - as Covishield - by the Serum Institute of India. The British pharma giant has since then announced that they are withdrawing the vaccine globally due to a decline in demand.

Hyderabad-based Bharat Biotech, the developers and manufacturers of Covaxin, pointed to multiple alternate studies to emphasise that its vaccine has "excellent safety track record."

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