The premier research body has also directed BHU to immediately remove the “acknowledgement to ICMR” for the study and publish an erratum.
According to a recent research by a team of researchers at BHU, nearly a third of the 926 participants of an observational study on the side effects of Bharat Biotech’s Covid-19 vaccine, Covaxin, reported adverse events of special interest (AESI). The study covered a one-year period after the vaccine was administered.
In its letter to the researchers, ICMR said the research body is not associated with this “poorly designed” study and has not provided any financial or technical support for the research.
“You have acknowledged ICMR for research support without any prior approval of or intimation to ICMR, which is inappropriate and unacceptable,” ICMR’s director general said in the letter. “ICMR cannot be associated with this poorly designed study, which purports to present a safety analysis of Covaxin.”
ET has seen a copy of the letter dated May 18.The director general said the study has flaws like it 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 Iinked or attributed to Covid-19 vaccination,” the letter said.
The director general said the study does not 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”, the letter said.
According to ICMR, the study tool used is inconsistent with “adverse events of special interest” as defined in the reference provided in the paper for AESI.
“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,” the letter said.
“We have also noticed that you have similarly acknowledged ICMR in similar previous papers without permission. Please explain why ICMR should not seek Iegal and administrative action against you,” the letter said.
