The Indian Council of Medical Research (ICMR) has distanced itself from the Banaras Hindu University (BHU) researchers for “incorrectly” associating it with an observational study on the side effects of the Covid-19 vaccine Covaxin. The ICMR said that the recently published research paper entitled Long-Term Safety Analysis of the BBVl52 Coronavirus Vaccine in Adolescents and Adults: Findings from a 1-Year Prospective Study in North India was poorly designed with critical flaws, and asked why it should not take legal and administrative action for these lapses.
In its letter to the researchers, the ICMR said the body has not provided any financial or technical support for the research. ICMR director general Rajiv Bahl called the paper “poorly designed” and said it “incorrectly and misleadingly” acknowledges financial or technical support from the ICMR.
“ICMR cannot be associated with this poorly designed study,” the director general’s letter says.
“We the authors would like to state that all communications received by us from ICMR are treated with utmost respect as confidential. We have already mailed the DG-ICMR with copy to the Director, IMS. We do not wish to make any other statements as we are scientists and do not like getting involved in unnecessary public controversies,” the authors of the paper informed The Hindu.
The BHU, in its press release on Monday, noted 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”.
“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,” the BHU said.
The ICMR has directed the BHU to immediately remove the “acknowledgement to ICMR” for the study and publish an erratum.
“We have also noticed that you have similarly acknowledged ICMR in similar previous papers without permission. Please explain why ICMR should not seek legal and administrative action against you,’’ it noted.
In its letter, the ICMR has listed out critical flaws with the study and says that it does not have a control group of unvaccinated individuals to prove that the side-effects are indeed associated with vaccination. Also it does not mention how frequently these adverse events were reported by the sample population to establish that they were associated with vaccination, the study tool was not consistent with the definition of “adverse events of special interest” that is globally accepted and lastly the responses of the participants were recorded one year after immunisation without verification of any clinical records or physician examination, increasing the chances of biased reporting.
