Question on BHU’s study regarding Covaxin, ICMR said – the method of study is wrong, isolated itself

New Delhi : The Indian Council of Medical Research (ICMR) has rejected the study related to Covaxin conducted under the leadership of Banaras Hindu University (BHU). In this study it was claimed that Covaxin increased the rare risk of stroke and Guillain-Barré syndrome. ICMR has written a letter to the editor of the New Zealand-based Drug Safety Journal. It said it should withdraw the study on Covaxin side effects recently published by BHU authors as the name of the apex research body was ‘incorrectly and misleadingly’ cited in the paper.

The apex research body wrote in the letter that ICMR is not associated with this study. Also, no financial or technical assistance has been provided by them for the research. It further said that further, you have stated that ICMR has given support for the research without any prior approval or information, which is inappropriate and unacceptable. ICMR Director General Dr Rajiv Bahl said in the letter that the apex research body cannot be linked to this poorly conducted study, which aims to misrepresent the ‘safety analysis’ of Covaxin.

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Dr. Bahl has asked the authors of the study and the editor of the journal to remove ICMR’s information and publish a corrigendum. Dr. Bahl wrote that we have also seen that you have given the name of ICMR in similar previous papers without permission. He also sought clarification from the authors of the study as to why ICMR should not take legal and administrative action against them. He also highlighted the poor methodology and design of the study.

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Covaxin, the anti-COVID-19 vaccine, was developed by Bharat Biotech in collaboration with the Indian Council of Medical Research – National Institute of Virology. ICMR Director General highlighted that ICMR was accepted for research support without any prior approval or information. This is unfair and unacceptable. The study fails to control for a group of unvaccinated individuals. This makes it impossible to attribute the reported events to the Covaxin vaccine.