E-Paper
‘Working to improve research ecosystem’: BHU conveys regret
Researchers from the Banaras Hindu University that conducted a study on the safety of Covaxin have conveyed their regret to the Indian Council of Medical Research (ICMR) for acknowledging the support of the apex biomedical research regulator without proper authorisation
Researchers from the Banaras Hindu University that conducted a study on the safety of Covaxin have conveyed their regret to the Indian Council of Medical Research (ICMR) for acknowledging the support of the apex biomedical research regulator without proper authorisation, people familiar with the matter said.
“The researchers have communicated their point to the ICMR representatives and a copy of the communication has been shared with the higher authorities at the university,” said an official, requesting anonymity.
BHU also issued a statement saying it was working to strengthen its research ecosystem. “The university has taken note of a study in connection with Covaxin after effects, involving some members of BHU’s Institute of Medical Sciences, and a series of reactions in that regard. We are also aware of the communication made by the ICMR to the concerned individuals. The Institute of Medical Sciences is looking into the matter,” the statement said.
“Additionally, the Institute of Medical Sciences is also working on further strengthening and improving its research ecosystem.”
ICMR on Monday distanced itself from the BHU study that raised concerns on the safety of Bharat Biotech’s Covid vaccine Covaxin, and threatened legal action against the study’s authors for acknowledging ICMR’s support for a poorly designed study without its consent.
ICMR chief Rajiv Bahl wrote to the researchers, criticizing the research paper entitled “Long-Term Safety Analysis of the BBVl52 Coronavirus Vaccine in Adolescents and Adults: Findings from a 1-Year Prospective Study in North India”.
“The Indian Council of Medical Research (ICMR) has been incorrectly and misleadingly acknowledged in the paper. ICMR is not associated with this study and has not provided any financial or technical support for the research. Further, you have acknowledged ICMR for research support without any prior approval of or intimation to ICMR, which is inappropriate and unacceptable,” Bahl said in the letter. “ICMR cannot be associated with this poorly designed study which purports to present a “safety analysis” of Covaxin”.
Nearly one-third of the 926 participants in the study who received Hyderabad-based vaccine manufacturer’s Covaxin reported “adverse events of special interest (AESI)”, the paper stated. The study, conducted by researchers from BHU from January 2022 to August 2023, claimed nearly 50% of study participants complained of infections during the follow-up period.
Serious AESI, which included strokes and the Guillain-Barre syndrome, were reported in 1% of individuals, noted the study, which looked at long-term safety of the Covaxin in adolescents and adults. The study involved 635 adolescents and 291 adults who received the Bharat Biotech’s vaccine.
