BHU Study on Covaxin: ICMR Dismisses as Misleading and Demands Erratum!

A study claiming that Covaxin increases the rare risk of stroke and Guillain-Barre syndrome has been dismissed by the Indian Council of Medical Research (ICMR) as "misleading".

This study titled, “Long-Term Safety Analysis of the BBVl52 Coronavirus Vaccine in Adolescents and Adults: Findings from a 1-Year Prospective Study in North India” was conducted by Banaras Hindu University (BHU) and has been published in the journal Drug Safety ().

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‘As per World Health Organization (WHO) data, the total number of deaths directly or indirectly linked to the COVID-19 pandemic, from January 1, 2020, to December 31, 2021, was estimated to be around 14.9 million! #covaxin #misleading #stroke #medindia’

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The BHU has also faced criticism from the ICMR due to the inclusion of ICMR support incorrectly.

What is Covaxin?

Covaxin is a vaccine developed by Indian pharmaceutical company, Bharat Biotech, in partnership with the Indian Council of Medical Research, a government-funded biomedical research institute, and its subsidiary, the National Institute of Virology.

It is a vaccine against the coronavirus 2 (SARS-CoV-2). The coronavirus disease 2019 (COVID-19) pandemic not only brought illness and death but also presented a challenge to global public health, food systems, human dignity, and employment.

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Why ICMR Demands to Retract the Publication?

The Indian Council of Medical Research (ICMR) has labeled the study conducted by BHU as “misleading”, due to the significant flaws in its study design.

Furthermore, the Indian Council of Medical Research (ICMR) has communicated to the Editor of the Drug Safety Journal, a New Zealand-based journal, to retract the publication reporting the study on Covaxin side effects conducted by authors from BHU. This action was taken by ICMR as the prestigious research institution was "incorrectly and misleadingly acknowledged in the paper."

“The ICMR is not associated with this study and has not provided any financial or technical support for the research," the research institution wrote in the letter. "Further, you have acknowledged ICMR for research support without any prior approval of or intimation to lCMR, which is inappropriate and unacceptable," it added.

ICMR's Director General, Dr. Rajiv Bahl, stated in a letter that the prestigious research organization cannot be linked to the inadequately conducted study claiming to provide a "safety analysis" of Covaxin. Dr. Bahl has requested the authors of the study and the editor of the journal to eliminate any mention of ICMR and an erratum be published. He cautioned that failure to adhere could result in legal and administrative consequences.

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Dr. Bahl also wrote to ICMR, “We have also noticed that you have similarly acknowledged ICMR in similar previous papers without permission,". He also demanded an explanation from the study's authors as to why legal and administrative action should not be pursued by ICMR against them.

Reference:

Long-Term Safety Analysis of the BBV152 Coronavirus Vaccine in Adolescents and Adults: Findings from a 1-Year Prospective Study in North India - (https://pubmed.ncbi.nlm.nih.gov/38740691/)

Source-Medindia