New Delhi: The ICMR reviewed the study on the long-term safety analysis of the Covaxin in adults and adolescents by the Banaras Hindu University and observed that it had serious methodological flaws, Minister of State for Health Prataprao Jadhav told the Rajya Sabha on Tuesday. The study had no control arm of unvaccinated individuals for comparing the rates of events between the vaccinated and unvaccinated groups, Jadhav said in a written reply.
“Hence, the reported events in the study cannot be linked or attributed to COVID-19 vaccination,” he said.
The study titled “Long-Term Safety Analysis of the BBV152 Coronavirus Vaccine in Adolescents and Adults: Findings from a 1-Year Prospective Study in North India” was published in May in the Springer Nature journal.
Elaborating on the “serious methodological flaws” highlighted by the ICMR, Jadhav stated in the written reply that the study did not 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.
Also, no baseline information regarding the study participants were provided.
The tool used in the study was found to be inconsistent with the ‘Adverse Events of Special Interest (AESI)’ definition that was in the reference provided in the paper for AESI, Jadhav said citing ICMR.
“The method of data collection used in the study had a high risk of bias. It was observed that study participants were contacted telephonically one year after vaccination and their responses were recorded without any confirmation with clinical records or by physician examination,” Jadhav stated.
Jadhav informed that ICMR had not provided any form of support for the conduct of the study and the authors had unduly acknowledged it for the research support provided for the conduct of the study.
On whether ICMR has taken objection to the research paper and has asked the researchers to retract the study, Jadhav said that ICMR has not asked researchers to retract the study.
“Researchers have been asked to immediately remove acknowledgement to ICMR, as it had not provided any financial or technical support, and it cannot be associated with poorly designed study,” Jadhav stated.
The ICMR has asked the scientific journal to remove the acknowledgement to it and to retract the paper as conclusions made in the paper are not supported by evidence/data. It is expected that good journals only publish papers where conclusions are supported by the data presented in the paper, the minister said.
