The Indian Council of Medical Research (ICMR) has disassociated itself from a Banaras Hindu University (BHU) study claiming Covaxin increases the rare risk of stroke and Guillain-Barre syndrome.

ICMR has demanded the study be retracted due to incorrect acknowledgment and lack of support, threatening potential legal action.

The BHU study found one-third of Covaxin recipients experienced adverse events, with infections being the most common, and serious events like stroke and Guillain-Barre syndrome reported in one percent of individuals.

ICMR criticized the study for being poorly designed with critical flaws such as issues with control groups, frequency of events reporting, study tools, and biased reporting.

BHU researchers are addressing ICMR's concerns, including the absence of a control group and inconsistent reporting of adverse events.

The study authors have been asked to remove ICMR's acknowledgment and publish an erratum.

Bharat Biotech emphasized the need for comprehensive data analysis to avoid bias in response to the criticism.

BHU is investigating the matter, and concerns about Covishield safety have also been raised recently.