The Indian Council of Medical Sciences (ICMR) has threatened legal action against Banaras Hindu University (BHU) over a study that suggested Bharat Biotech Ltd’s COVID-19 vaccine, Covaxin, had adverse side-effects in up to a third of recipients.
ICMR Director General, Dr. Rajiv Bahl, criticised the study for its design, which lacked a control arm of unvaccinated individuals for comparison. He argued that without this, the reported events could not be definitively linked to the COVID-19 vaccination.
The study, published in the SpringerLink Nature journal, was based on a one-year prospective study in North India. It claimed that nearly a third of the participants experienced adverse events of special interest (AESI) after receiving Covaxin.
Dr. Bahl has demanded an explanation from BHU, stating that the ICMR was not associated with the study and questioning why legal action should not be taken against the university. He also instructed the researchers to remove the study’s acknowledgement to ICMR and publish an erratum.
“The study does not even 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,” Dr. Bahl said. He also pointed out that the method of data collection, which involved contacting participants telephonically one year after vaccination, had a high risk of bias.
One of the BHU researchers and an author of the study, Sankha Shubhra Chakrabarti, declined to comment on the controversy, stating that all communications from the ICMR were treated as confidential.
The Health Ministry has also weighed in on the issue, stating that the article misleadingly and erroneously acknowledges the ICMR and has asked the editor to retract the paper.
Meanwhile, a BHU spokesperson said that the university has taken note of the study and the reactions to it and that the Institute of Medical Sciences is looking into the matter.
This controversy comes as similar reports of serious after-effects have surfaced in the UK over the COVID-19 vaccine developed by AstraZeneca. The British drugmaker has accepted that its COVID-19 vaccine can show adverse reactions in rare cases. The vaccine, known as Covishield in India, was used in India and other parts of the world and was manufactured by the Serum Institute of India.
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