New Delhi: Days after two Banaras Hindu University (BHU) professors issued a follow-up study on the India-made Covaxin COVID-19 vaccine saying that nearly a third of 926 individuals, who received the vaccine reported serious side-effects, the Indian Council of Medical Research (ICMR), has distanced itself from the study reports, which shows concern over the safety and side-effects of the vaccine. The study, which was conducted between January 2022 and August 2023, claimed that around one per cent of respondents reported strokes and an autoimmune disorder called Guillain-Barre Syndrome, which causes weakness in nerves in the arms and legs.

Following the study report, the top medical body, ICMR faulted the study - 'Long-Term Safety Analysis of BBVl52 (Covaxin) Coronavirus Vaccine in Adolescents and Adults: Findings From a 1-Year Prospective Study in North India' published by Springer Nature - for poor methodology, and objected "acknowledging" the medical body.

ICMR urges to rectify acknowledgment to the top medical body and warns of legal action if not done

ICMR Director General (DG) Rajiv Bahl said the study had no control arm of unvaccinated individuals to compare rate of the Adverse Events of Special Interest (AESIs), and, therefore, the reported side-effects could not be linked or attributed to being administered Covaxin as COVID-19 vaccination.

Bahl, while talking about the list of critical observations, rejected the study saying that it does not provide background rates of observed events in the population, making it impossible to assess change in such incidences in the post-vaccination period.

What authors acknowledged?

The authors of the study acknowledged that understanding the AESIs-vaccines link required a control arm of unvaccinated individuals to compare rates of reported serious side-effects. They also said that in the absence of data on background rates of observed AESIs, no comments were possible on changes in incidence of observed events in post-vaccination periods.

In addition to it, the study also claimed that 50 per cent of the sample size complained of respiratory infections, and over 30 per cent reported assorted physical problems, ranging from skin and nervous system disorders to bone and muscle problems.

Specifically, between adolescents and adults respondents the study claimed 10.5 per cent reported new-onset skin and subcutaneous disorders and 10.2 per cent claimed nervous system concerns. Among female respondents, 4.6 per cent claimed menstrual disorders.

The researchers had stated that their findings were confined to Covaxin and should not be extrapolated to viral vector vaccines. They also said that the study primarily involved adolescents and the sample size of adults was relatively small, while the larger adult-based studies are needed to understand long-term safety of Covaxin (BBV152) in adults.

No technical or financial support was provided: ICMR Chief

Responding to the study report, the top medical body criticised the method of data collection, during which apparently study participants were contacted via telephone a year after vaccination and their responses were recorded without confirming them via medical records or examination by doctors.

ICMR DG Dr Bahl stressed that the ICMR is not associated with the study claiming side-effects from the India-developed vaccine, and had not provided any support, whether technical or financial, to the study authors.

Urging the study authors and publishers to remove the acknowledgement to the ICMR, the ICMR chief warned them of legal action if they failed to do so. He stated, "The authors are urged to rectify acknowledgment to ICMR and publish an erratum. Additionally, they are asked to address methodological concerns raised. Failure to do so may prompt ICMR to consider legal and administrative action."