ICMR distances itself from BHU’s Covaxin study, cites critical methodological flaws

The Indian Council of Medical Research (ICMR), the country’s apex body for formulation, coordination, and promotion of biomedical research, has distanced itself from the ‘poorly designed study’ of the Banaras Hindu University (BHU) wherein it raised concerns on the safety of the Indian-developed Covid-19 vaccine, Covaxin. 

The research paper was titled “Long-Term Safety Analysis of the BBVl52 Coronavirus Vaccine in Adolescents and Adults: Findings from a l-Year Prospective Study in North India” and was published in the Drug Safety journal. 

The study claimed that over 30 per cent of individuals who took the jab encountered adverse events, including stroke, Guillain-Barre syndrome, a neurological disorder, and upper-respiratory problems. 

The article misleadingly and erroneously acknowledges the Indian Council of Medical Research (ICMR), the research facility’s Director General (DG), Dr Rajiv Bahl, said in a letter to the authors of the research paper. 

“ICMR is not associated with this study and has not provided any financial or technical support for the research. Further, you have acknowledged ICMR for research support without any prior approval of or intimation to ICMR, which is inappropriate and unacceptable,” he wrote.

Explaining the ‘critical flaws’ in the methodology, Dr Bahl 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 Iinked or artributed to Covid-19 vaccination,” he said. 

According to further clarification by ICMR, the study does not provide background rates of observed events in the population, making it impossible to assess the change in incidence of observed events in the post-vaccination period. Baseline information of study participants is missing.

• Also read: BHU Study on Covaxin: Wider data parameters needed to study AESI, says Bharat Biotech

It was also pointed out that the study tool used is inconsistent with ‘Adverse Events of Special Interest (AESI)‘. The method of data collection has a “high risk of bias”. 

“Study participants were contacted telephonically one year after vaccination and their responses were recorded without any confirmation with clinical records or by physician examination,” the DG of ICMR further mentioned. 

“ICMR cannot be associated with this poorly designed study,”  Dr Bahl wrote. 

The Editor of the journal has also been asked to “immediately” remove the acknowledgement to ICMR and publish an erratum. 

ICMR has also said it would explore legal and administrative action in case of failure to retract the acknowledgment or take corrective steps in addressing concerns raised by apex body. 

“The authors have been urged to immediately rectify the acknowledgment to ICMR and publish an erratum. Additionally, they are asked to address the methodological concerns raised,” a Health Ministry official said. 

• Also read: ICMR releases revised ‘Dietary Guidelines for Indians’, urges avoiding protein supplements

The Banaras Hindu University (BHU) also issued a statement said, it has “taken note of a study in connection with Covaxin after effects, 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,” the statement said. .

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