ICMR said study was poorly designed with no control arm of unvaccinated people for comparing events

Indian Council of Medical Sciences (ICMR) Director General Dr Rajiv Bahl said in a letter to BHU that the study was poorly designed with no control arm of unvaccinated individuals to compare the incidence of adverse events. This meant the reported events in the study could not be Iinked to covid-19 vaccination. 

Further, the participants were contacted telephonically one year after vaccination and their responses recorded without any confirmation with clinical records or by physician examination, he added.

The findings from a one-year prospective study in North India was published in SpringerLink Nature journal. The study claimed that nearly a third of the participants reported experiencing adverse events of special interest (AESI) after being vaccinated with Covaxin.

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The ICMR DG sought an explanation from BHU as ICMR was not associated with the study and asked why legal action should not be taken against the university. 

He also directed the researchers to immediately remove the study's acknowledgement to ICMR and publish an an erratum.

“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. Further, you have acknowledged ICMR for research support without any prior approval of or intimation to ICMR, which is inappropriate and unacceptable," said Bahl.

Study lacking

The apex medical research body noted that the study does not even 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.

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“The study tool used is inconsistent with 'Adverse Events of Special Interest (AESI)' as defined in the reference provided in the paper for AESI," he said.

Bahl said the method of data collection has a high risk of bias. 

“Study participants were contacted telephonically one year after vaccination and their responses recorded without any confirmation with clinical records or by physician examination," he said adding that even in the past BHU researchers have made similar acknowledgments to ICMR in previous papers without permission.

Sankha Shubhra Chakrabarti, one of the BHU researchers and an author of the study, refused to be drawn into the controversy, saying, “We the authors would like to state that all communications received by us from ICMR are treated with utmost respect as confidential. 

We have responded to them directly by mailing the DG-ICMR with a copy to the Director, IMS )Institute of Medical Sciences, BHU). We do not wish to make any other statements as we are scientists and do not like getting involved in unnecessary public controversies." 

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The health miniestry said, “The article misleadingly and erroneously acknowledges the ICMR. The Editor has been asked to retract the paper which implicitly makes conclusions on vaccine safety which are not supported by evidence."

Queries sent to Upinder Kaur, researcher and co-author of the study done by BHU, remained answered.

A BHU spokesperson said, “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. 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." 

Similar reports of serious after-effects have surfaced in the UK too, over the covid-19 vaccine developed by AstraZeneca. The British drugmaker has accepted that its covid-19 vaccine can show adverse reactions in rare cases. The vaccine that was used in India and other parts of the world world was manufactured by the Serum Institute of India.  It was known as Covishield in India.