ICMR Slams BHU Study On Covaxin’s Side Effects: ‘Poor Design, Misleading’

OB Bureau

New Delhi: The Indian Council of Medical Research (ICMR) has slammed Banaras Hindu University (BHU) for releasing a paper on long-term side effects of Covaxin.

ICMR Director General Dr Rajiv Bahl called out the poor methodology and design of the BHU study, and clarified that the article misleadingly “acknowledges” ICMR.

Bahl has written to the authors and editor of the journal in which it was published about incorrectly mentioning ICMR, even though the country’s apex medical research body did not offer any financial or technical support for the paper.

The reported events in the study cannot be attributed to the COVID vaccine as the study lacks a group of unvaccinated persons, which is crucial for comparing rates of adverse events between vaccinated and unvaccinated groups.

The study reported that one of three persons who had taken Bharat Biotech’s indigenous Covaxin experienced adverse events of special interest (AESI).

“The authors have been urged to immediately rectify the acknowledgement to ICMR and publish an erratum. Additionally, they are asked to address the methodological concerns raised. Failure to do so may prompt ICMR to consider legal and administrative action,” Bahl said.

He went on to highlight a number of critical flaws in the study, like failure to provide background rates of observed events in the population, lack of baseline information of study participants.

The study tool used in the study was inconsistent with the definition of AESI provided in the reference, and the data collection method highly prone to bias, according to ICMR.

OB Bureau

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