ICMR Flags Methodological Flaws in Covaxin Safety Study

The ICMR criticized a study on Covaxin's long-term safety conducted by Banaras Hindu University, citing serious methodological flaws. The study lacked a control group and background rates of observed events, leading to unreliable conclusions. The ICMR disassociated itself from the study and requested the journal to retract it.

The Indian Council of Medical Research (ICMR) has criticized a recent study on the long-term safety of Covaxin, conducted by Banaras Hindu University, citing serious methodological flaws. The study, which reviewed the safety of the vaccine in adults and adolescents, was published in the Springer Nature journal in May.

According to Minister of State for Health Prataprao Jadhav, the study lacked a control group of unvaccinated individuals, making it impossible to compare the rate of events between vaccinated and unvaccinated groups. Additionally, the study did not provide baseline information or background rates of observed events in the population, making it difficult to assess any changes in incidence post-vaccination.

Jadhav also pointed out discrepancies in the data collection method, which involved telephonic interviews conducted a year after vaccination without any clinical confirmation. The minister clarified that ICMR had not provided any support for the study and demanded the scientific journal to remove its acknowledgement. Moreover, the ICMR requested the journal to retract the paper due to unsupported conclusions.