ICMR junks BHU's Covaxin Safety study, criticizes it for Poor Methodology and Design

New Delhi: The apex research regulator, the Indian Council of Medical Research (ICMR) has distanced itself from the study, published by the Banaras Hindu University, on the Covaxin side effects and called it ''poorly designed''.

Banaras Hindu University study said that after one year of vaccination, approximately one-third of the participants of Covaxin have been facing adverse events including stroke, Guillain-Barre syndrome, a neurological disorder and upper respiratory problems.

The study titled "Long-Term Safety Analysis of the BBVl52 Coronavirus Vaccine in Adolescents and Adults: Findings from a 1-Year Prospective Study in North India" by Kaur et al., was published in the journal Drug Safety.

Director General, ICMR, Rajiv Bahl, has written a letter to the authors of the paper and editor of the journal Springer Nature to immediately remove the acknowledgement to ICMR and publish an erratum. He also flagged the poor methodology and design of the study, news agency ANI reported.

The DG, ICMR highlighted that ICMR was acknowledged for research support without any prior approval of or intimation to ICMR, which is inappropriate and unacceptable.

The study fails to include a control group of unvaccinated individuals, making it impossible to attribute reported events to the Covaxin vaccine.

Additionally, there is no provision for background rates of observed events, preventing an assessment of changes in incidence post-vaccination. Baseline information of the participants is also missing. The tool used for the study is not aligned with the 'Adverse Events of Special Interest (AESI)' standards referenced in the paper. Data collection was conducted via telephone a year after vaccination without verification through clinical records or physician examination, introducing significant bias.

Bahl also noted that similar acknowledgements to ICMR have been made in previous papers without permission, raising concerns about the authors' practices.

The authors have been urged to immediately rectify the acknowledgment to ICMR and publish an erratum. Additionally, they are asked to address the methodological concerns raised. Failure to do so may prompt ICMR to consider legal and administrative action.

The editor has been asked to retract the paper, which implicitly makes conclusions on vaccine safety that are not supported by evidence.

According to an ANI report, Meanwhile, earlier this month, amid reports over potential rare side effects of the AstraZeneca-Oxford COVID-19 vaccine, Bharat Biotech, which developed the Covaxin, said in a statement that the vaccine was developed with a "single-minded focus on safety first."

It stated that Covaxin was the "only Covid vaccine" in government of India's COVID-19 immunisation program to have conducted efficacy trials in India.

Also Read: "Safety Is Primary Focus For All Our Vaccines": Covaxin-Developer Bharat Biotech