ICMR distances itself from BHU study on Covaxin, calls it 'poorly designed'

Bharat Biotech had then rebuked the BHU study, saying that its indigenously developed Covid vaccine Covaxin has shown an 'excellent safety track record' in various studies

The Indian Council of Medical Research (ICMR) on Monday slammed a group of researchers from Banaras Hindu University (BHU) for “erroneously” associating the medical body with a recent study on effects of Covaxin, saying that it was a “poorly designed” study.

ICMR, which is the country’s apex body for formulation, coordination, and promotion of biomedical research, has asked the researchers to remove the acknowledgement of ICMR from the study and publish an apology, or face a legal and administrative action.

“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 the body, which is inappropriate and unacceptable,” a letter, addressed to the authors of the research paper and editor of the science journal in which it was carried, said.

The letter was written by Rajiv Bahl, director general, ICMR.

“We request you to retract this paper which implicitly makes conclusions about vaccine safety that are not supported by evidence,” the letter stated. 

The study

Earlier this month, a team of researchers at BHU had conducted a one-year follow-up study on Covaxin, manufactured by Hyderabad-based vaccines maker Bharat Biotech.

The study involved 635 adolescents and 291 adults, who received Covaxin. The participants were interviewed over phone about long-term adverse events of special interest (AESI) after one year of vaccination. 

According to the study, nearly one third of the individuals who received Covaxin were reported to have faced AESI, such as viral upper respiratory tract infections, menstrual abnormalities and Guillain-Barre Syndrome. 

Published in a peer reviewed journal Drug Safety of Springer Nature, the study comes in the wake of UK pharmaceutical giant AstraZeneca admitting its Covid vaccine can cause rare side-effects of blood clotting and lowering of platelet counts in UK court. 

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ICMR, meanwhile, has flagged poor methodology and critical flaws in the design of the study. 

Highlighting that the method of data collection in the study had a high risk of bias, Bahl pointed out that study participants were contacted telephonically one year after vaccination and their responses were recorded without any confirmation with clinical records or physical examination. 

In his letter, Bahl added the study has no control arm of unvaccinated individuals for comparing the rate of events between the vaccinated and the unvaccinated groups. “Hence, the reported events in the study cannot be linked or attributed to Covid-19 vaccinations,” the letter stated.  

He further said that the study did not provide a rate of observed events in the population, making it impossible to assess the change in incidence of observed events in the post vaccination period. 

BHU meanwhile said that it was looking into the matter.

“The university has taken note of the study in connection with after effects of Covaxin, involving some members of BHU’s Institute of Medical Sciences and a series of reactions in that regard,” the university said in a media statement.

The university also said that the individuals mentioned in the letter have communicated their responses to the ICMR.

“The Institute of Medical Sciences is working to strengthen and improve its research ecosystem”, BHU added in its statement.   

Bharat Biotech on the study

On its part, Bharat Biotech has said that its indigenously developed Covid vaccine Covaxin has shown an “excellent safety track record” in various studies.

The vaccine maker said that several studies have been carried out on the safety of Covaxin, and published in peer reviewed journals, demonstrating an excellent safety track record.

Bharat Biotech also pointed out lapses in the methodology of the study.
 

“For such a study in safety to be effective, informative and to avoid investigator bias, several data points are also required. For example, the AESI safety profile of the subjects prior to participation in the study; comparison of safety profile of non-vaccinated subjects during the course of the study; comparison of safety profile of subjects who received other vaccines during the course of the study; all study participants should be followed during the course of the study, instead of only a subset,” the firm said in its response.