The Indian Council for Medical Research (ICMR) evaluated the Banaras Hindu University (BHU) study on the long-term safety analysis of Covaxin in adults and adolescents and found major methodological problems, said Minister of State (MoS) for Health Prataprao Jadhav in the Rajya Sabha today, Tuesday, August 6.
In a written response, Jadhav stated that the study did not include an unvaccinated control arm to compare the frequencies of incidents between the vaccinated and unvaccinated groups, reports PTI.
"Hence, the reported events in the study cannot be linked or attributed to COVID-19 vaccination," added the minister.
The article "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 magazine.
In his written response, Jadhav elaborated on the "serious methodological flaws" identified by the ICMR, stating that the study did not provide background rates of observed events in the population, making it impossible to assess the change in the incidence of observed events in the post-vaccine period.
Additionally, no baseline information about the study participants was supplied.
The study's tool was found to be contradictory with the 'Adverse Events of Special Interest (AESI)' definition supplied in the paper's AESI citation, according to Jadhav, citing the ICMR.
"The method of data collection used in the study had a high risk of bias,” he said.
He added, “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 that for the study's conduct, the ICMR had not offered any sort of support and that the authors had overstated their research support.
He further denied that the ICMR had objected to the research report and urged the researchers to retract the work.
"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 a poorly designed study," Jadhav stated.
The ICMR has asked the scientific journal to remove the acknowledgement of 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.
