'Poor methodology': ICMR dissociates itself from Covaxin safety study
ICMR accused the authors of the study of erroneously adding acknowledgment of ICMR's support on findings.
The Indian Council of Medical Research (ICMR), India's premier medical research body, has asked the authors of a study on the Covaxin vaccine to remove ICMR's acknowledgement. The study was published by the Banaras Hindu University (BHU).
ICMR accused the authors of the study of erroneously adding acknowledgment of ICMR's support on its findings. The medical body also pointed out serious methodological flaws in the study.
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.
ICMR chief Rajiv Bahl, reported ANI, has written a letter to the authors of the paper and the journal, Springer Nature, to remove the acknowledgment to ICMR and publish an erratum.
Covaxin was one of the two vaccines used by the Government of India to vaccinate millions of Indians. It was developed by Bharat Biotech in collaboration with ICMR.
The officer said the study has published ICMR's acknowledgment without seeking prior approval or informing the medical research body.
Bahl noted that the tool used for the study was 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, he added.
Also read: 1 in 3 Covaxin takers reported adverse events, BHU study claims
He said the ICMR has not provided any financial or technical support for the research.
He also asked the authors to remove the acknowledgment to ICMR and publish an erratum. It said failure to do so may attract legal and administrative action.
"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," he said.
ICMR had played a huge role in fighting the coronavirus pandemic.
With inputs from PTI, ANI
