‘Incorrect, Misleading’: ICMR Seeks Retraction Of BHU Study On Covaxin Side Effects, Warns Of Legal Action

The ICMR also said that the study tool used is inconsistent with ‘Adverse Events of Special Interest (AESI)’ as defined in the reference provided in the paper for AESI.

The Indian Council of Medical Research (ICMR) has hit back at the authors of the study spotlighting numerous side effects associated with the Covid-19 vaccine, Covaxin, calling it “incorrect, misleading and unacceptable”. Also, India’s premier medical research agency has asked the publisher to retract the study. The Banaras Hindu University (BHU) has said that is working on improving its research ecosystem.

From skin disorders, nervous system disorders, menstrual abnormalities, and malfunctioning of eyes to hypothyroidism – the study published by the researchers at the BHU claimed to have found several “special events” or side effects. The observational study titled ‘Long-Term Safety Analysis of the BBVl52 Coronavirus Vaccine in Adolescents and Adults: Findings from One Year Prospective Study in North India’ was published on the peer-reviewed platform, Springer, on May 13.

Covaxin is the first made-in-India Covid-19 vaccine, manufactured by Hyderabad-based Bharat Biotech, along with the ICMR. The study – by the lead authors Dr Upinder Kaur, assistant professor, department of pharmacology and Dr Sankha Shubhra Chakrabarti, head of department of geriatric medicine – thanks ICMR for “research support”.
However, the letter by the research agency denies any such support.

“The ICMR has been incorrectly and misleadingly acknowledged in the paper. ICMR is not associated with this study and has not provided any financial or technical support for the research,” said the letter written by Rajiv Bahl, secretary, director general, ICMR. “Further, you have acknowledged the ICMR for research support without any prior approval of or intimation to the ICMR, which is inappropriate and unacceptable.”

Moreover, the ICMR has also written a separate letter to Nitin Joshi, editor-in-chief, drug safety, Springer to “retract” the paper. “We request you to retract this paper which implicitly makes conclusions about vaccine safety that are not supported by evidence.”

The ICMR – in both letters – claimed that it cannot be associated with this “poorly designed study which purports to present a ‘safety analysis’ of Covaxin” and then the letter goes on to list several flaws. Bahl has asked the authors and publisher to remove the name of the ICMR “immediately” and publish a corrigendum.

Also, the ICMR has warned the authors of legal action. “We have also noticed that you have similarly acknowledged the ICMR in similar previous papers without permission. Please explain why ICMR should not seek legal and administrative action against you.”

MULTIPLE FLAWS IN THE STUDY: ICMR

The agency said that 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.”

Secondly, it said that the baseline information of study participants is missing. “The study does not even provide background rates of observed events in the population, making it impossible to assess the change in the incidence of observed events in the post-vaccination period.”

The ICMR also said that the study tool used is inconsistent with ‘Adverse Events of Special Interest (AESI)’ as defined in the reference provided in the paper for AESI.
It also added that 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.”

“We, therefore, ask you to immediately get the acknowledgement to ICMR removed and an erratum published.”

WORKING ON IMPROVING THE RESEARCH ECOSYSTEM: BHU
Meanwhile, the BHU has issued a release saying that “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”.

It said that the BHU is aware of the communication made by the ICMR to the individuals concerned and its 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.”