BHU study on Covaxin side effects poorly designed, erroneously acknowledges ICMR: Dr Bahl

ICMR Director General criticizes study on Covaxin safety, clarifies ICMR not involved, urges removal of misleading acknowledgement.

The Indian Council of Medical Research (ICMR) Director General Dr Rajiv Bahl on Mayh 20 criticised a recently published study on the long-term safety analysis of the Covaxin in adults and adolescents for its poor methodology and design, and clarified the article misleadingly and erroneously "acknowledges" ICMR.

Dr Bahl said the study had 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 linked or attributed to COVID-19 vaccination.

The ICMR is not associated with the study and has not provided any financial or technical support for the research, Dr Bahl said.

The ICMR DG has written a letter to the authors of the paper and Editor of the journal to immediately remove the acknowledgement to ICMR and publish an erratum.

A research paper, titled 'Long-Term Safety Analysis of the BBVl52 Coronavirus Vaccine in Adolescents and Adults: Findings from a l-Year Prospective Study in North India' stated that nearly one-third of the 926 participants in the study who received Bharat Biotech's anti-COVID vaccine Covaxin reported 'adverse events of special interest,' or AESI.

Dr Bahl said that ICMR was acknowledged for research support without any prior approval of or intimation to ICMR, which is inappropriate and unacceptable. He stated that ICMR cannot be associated with this poorly designed study which purports to present a "safety analysis" of Covaxin due to several critical flaws.

He said the study does not even 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.