BHU Study On Covaxin Is "Poorly Designed": ICMR Director
The Indian Council of Medical Research (ICMR) on Monday criticised Banaras Hindu University”s (BHU) study on covaxin and called it “poorly designed.” A team of researchers at BHU conducted a one-year follow-up study (January 2022 to August 2023) on the long-term safety analysis of Bharat Biotech’s Covaxin in adults and adolescents.
The research paper was titled “Long-Term Safety Analysis of the BBVl52 Coronavirus Vaccine in Adolescents and Adults: Findings from a 1-Year Prospective Study in North India”. As per the study, nearly one-third of the participants experienced “adverse events of special interest” (AESI) after receiving the vaccine.
ICMR Director General Dr. Rajiv Bahl responded to the study by writing a letter to the authors of the paper and editor of the journal. In the letter, the director asked them to immediately remove the acknowledgement to ICMR and publish an erratum.
“BHU study on side effects of Covaxin erroneously acknowledges ICMR. ICRM cannot be associated with this poorly designed which purports to present a “safety analysis” of Covaxin,” the Times of India reports, as Dr Bahl is saying.
Baseline information about participants in the study is missing, the director said. The method of data collection has a high risk of bias, he added.
Dr Bahl observed that participants were contacted through telephone one year after vaccination, and their responses were documented without any confirmation with clinical records or by physician examination.
The study follows UK pharmaceutical AstraZeneca“s submission in a UK court that its COVID vaccine can cause rare side effects, including fatal blood clotting disorder and a reduction in platelet count.
