'Rectify Acknowledgement, Publish Erratum': ICMR Slams Study On Side-Effects Of Covaxin, Demands Apology

The Indian Council of Medical Research (ICMR), has denounced a follow-up study by two Banaras Hindu University (BHU) professors that said nearly a third of 926 people who received the India-made Covaxin COVID-19 vaccine reported serious side effects.

The study, conducted between January 2022 and August 2023, claimed that around one per cent of people who received the said vaccine reported strokes and an autoimmune disorder called Guillain-Barre Syndrome.

The study further stated 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.

The study – ‘Long-Term Safety Analysis of BBVl52 Coronavirus Vaccine in Adolescents and Adults: Findings From a 1-Year Prospective Study in North India’ was published by Springer Nature.

ICMR, however, flagged the study for poor methodology and objected to it “acknowledging” the medical body, an NDTV report said.

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

Bahl also highlighted that the study does not provide background rates of observed events in the population, making it impossible to assess change in such incidences post-vaccination.

The ICMR head stressed that the medical body is not associated with the said study and had not provided any technical or financial support to the authors, who, along with publishers, have been urged to remove the acknowledgement to the ICMR.

“The authors are urged to rectify acknowledgement to ICMR and publish an erratum. Additionally, they are asked to address methodological concerns raised,” the ICMR chief was quoted by NDTV as saying.

“Failure to do so may prompt ICMR to consider legal and administrative action,” he added.

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