Embarking on a journey of investigation, Banaras Hindu University (BHU) finds itself on the receiving end of a stern warning from the Indian Council of Medical Research (ICMR) concerning a recent publication delving into the “safety analysis” of Covaxin. The ICMR, wielding the power of legal and administrative action, demands the issuance of an erratum to rectify the erroneous inclusion of the medical research body in the study.
In a missive brimming with conviction, Dr. Rajiv Bahl, Director General of the ICMR, penned a letter to Prof. Sankhwar, the director of the Institute of Medical Science at BHU. Dr. Bahl expressed dismay over the improper acknowledgment of the ICMR in a paper titled ‘Long-Term Safety Analysis of the BBV152 Coronavirus Vaccine in Adolescents and Adults: Findings from a 1-Year Prospective Study in North India.’
Accusing both researchers, Dr. Upinder Kaur, Assistant Professor, and Dr. Sankha Shubhra Chakrabarti, Head of the Department of Geriatric Medicine at BHU, of falsely crediting the ICMR for research support without prior approval or notification, Dr. Bahl deemed such actions inappropriate and intolerable.
“Immediate removal of the acknowledgment to ICMR and publication of an erratum are demanded. Furthermore, we have observed similar unauthorized acknowledgments of ICMR in previous papers authored by you. Clarification on why ICMR should refrain from pursuing legal and administrative action against you is required,” stated Dr. Bahl emphatically in the communication.
Dr. Bahl vehemently asserted that the ICMR cannot be associated with a study of such poor design masquerading as a “safety analysis” of Covaxin. Critically, the absence of a control arm comprising unvaccinated individuals for comparative analysis renders the reported events in the study inconclusive in their linkage or attribution to Covid-19 vaccination.
Moreover, the study fails to furnish background rates of observed events in the population, rendering assessment of the incidence change in the post-vaccination period unattainable. Baseline information of study participants remains conspicuously absent.
“The method of data collection employed deviates from the ‘Adverse Events of Special Interest (AESI)’ framework as delineated in the referenced paper for AESI. Furthermore, the data collection method bears a significant risk of bias. Contacting study participants telephonically one year post-vaccination and recording their responses without clinical record confirmation or physician examination adds to this bias,” Dr. Bahl expounded.
In a parallel move, the ICMR dispatched a commensurate missive to Nitin Joshi, editor of the New Zealand-based ‘Drug Safety Journal,’ for disseminating the study.
Dr. Bahl, in his letter to Joshi, implored for the retraction of the paper, which draws implicit conclusions about vaccine safety lacking evidential support.
In response to the unfolding saga, the Union Health Ministry voiced concerns regarding the safety of the Covaxin vaccine post the publication of a research paper authored by Kaur in the Drug Safety journal.
“The article erroneously acknowledges the ICMR. The association of ICMR with this study is fallacious, as it has not extended any financial or technical support to the research,” the Health Ministry declared.
Conducting a one-year follow-up study, researchers at BHU disclosed that nearly one-third of the 926 individuals inoculated with Bharat Biotech’s Covaxin reported ‘adverse events of special interest’ or AESI.
AESI, an occurrence manifesting post-immunization with the potential for causal association with a vaccine product, surfaced prominently in the study. Nonetheless, Bharat Biotech, the manufacturer of Covaxin, issued a statement in response to the study, asserting the execution of several safety studies on Covaxin’s efficacy, documented in peer-reviewed journals, attesting to its sterling safety record.