ICMR Identifies Methodological Flaws in BHU's Covaxin Study

New Delhi: The Indian Council of Medical Research (ICMR) reviewed a study on the long-term safety analysis of Covaxin in adults and adolescents conducted by Banaras Hindu University. Minister of State for Health Prataprao Jadhav informed the Rajya Sabha that the study had significant methodological flaws.

Key Issues Identified by ICMR
Lack of Control Arm: The study did not include a control arm of unvaccinated individuals, making it impossible to compare the rates of events between vaccinated and unvaccinated groups.
No Baseline Information: There was no background information on the study participants, which is essential to assess changes in the incidence of observed events post-vaccination.
Inconsistent Tools: The tools used for data collection were inconsistent with the 'Adverse Events of Special Interest (AESI)' definition referenced in the study.
High Risk of Bias: The method used for data collection had a high risk of bias. Participants were contacted telephonically one year after vaccination, and their responses were recorded without confirmation from clinical records or physician examination.
ICMR's Response
No Support Provided: The ICMR clarified that it did not provide any financial or technical support for the study and was unduly acknowledged.
Retraction Request: ICMR requested the scientific journal to remove the acknowledgment and retract the paper, as the conclusions were unsupported by the data.
Study Background
In a month of May, a study examining the long-term safety of the BBV152 coronavirus vaccine in adolescents and adults, titled "Findings from a 1-Year Prospective Study in North India," was published in the Springer Nature journal.

This review underscores the importance of robust methodological practices in vaccine safety studies to ensure reliable and valid conclusions.