The Director General of the Indian Council of Medical Research (ICMR), Dr. Rajiv Bahl, has raised serious concerns about a recent study on Covaxin’s long-term safety. The study, which analyzed adverse events in adults and adolescents, has been criticized for its poor methodology and design, with Dr. Bahl clarifying that the ICMR was misleadingly acknowledged in the publication.
Dr. Bahl pointed out several critical flaws in the study, including the absence of a control group of unvaccinated individuals, which is essential for comparing event rates between vaccinated and unvaccinated groups. Without this comparison, the study’s reported events cannot be reliably linked to the Covid-19 vaccination.
Furthermore, the ICMR DG emphasized that the ICMR did not support the study financially or technically. He has formally requested the authors and the journal editor to remove the ICMR acknowledgment and issue an erratum.
Dr. Bahl also highlighted additional issues: the study failed to provide background rates of observed events in the population, lacked baseline information of participants, and used a study tool inconsistent with the defined AESI criteria. Moreover, the data collection method—conducting telephonic interviews a year after vaccination without clinical verification—introduced a high risk of bias.
