The study published in the journal Drug Safety had said that a third of Covaxin recipients had suffered adverse events of special interest
Indian Council of Medical Research has written to the the Banaras Hindu University asking for the acknowledgement to the apex research body be removed in its publication of a the university’s recent study which reported that a third of Covaxin recipients suffered adverse reactions.
“The Indian Council of Medical Research (ICMR) has been incorrectly and misieadingly acknowledged in the paper. ICMR is not associated with this study and has not provided any financial or technical support for the research. Further, the authors have acknowledged ICMR for research support without any prior approval. ICMR cannot be associated with this poorly designed study which purports to present a “safety analysis” of Covaxin…” wrote ICMR director general Dr Rajiv Bahl in a letter dated May 18, 2024. The study was published in the journal Drug Safety.
In his letter, Dr Bahl identified some “critical flaws” in the study that makes the council loathe to be associated with it. He wrote that since the study had no control arm of unvaccinated individuals for comparing the rates of events between the vaccinated and unvaccinated groups the adverse events could not be attributed to COVID-19 vaccination. Neither does the study 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. The baseline information of study participants is missing.
He added: “The study tool used is inconsistent with ‘Adverse Events of Special Interest (AESI)’ as defined in the reference provided in the paper for AEST. 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.”
