The Indian Council of Medical Research distances itself from study on Covaxin side-effects

ICMR criticizes methodology of study by Banaras Hindu University professors

Overview of the study on Covaxin side-effects

The Indian Council of Medical Research, or ICMR, has distanced itself from a follow-up study by two Banaras Hindu University professors that said nearly a third of 926 individuals who received the India-made Covaxin COVID-19 vaccine reported serious side-effects. The study 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. Conducted between January 2022 and August 2023, the study also said 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.

ICMR’s criticism of the study

However, the ICMR faulted the study – ‘Long-Term Safety Analysis of BBVl52 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 to it “acknowledging” the medical body. ICMR Director-General Rajiv Bahl said the study had no control arm (of unvaccinated individuals) to compare rate of AESIs, or Adverse Events of Special Interest, and, therefore, the reported side-effects could not be linked or attributed to being administered Covaxin as COVID-19 vaccination.

What study authors and Bharat Biotech have to say

Among the points made, the researchers acknowledged that understanding the AESIs-vaccines link required a control arm of unvaccinated individuals to compare rates of reported serious side-effects. The authors 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. Bharat Biotech, the developers of Covaxin, have pointed to multiple alternate studies emphasising the drug’s “excellent safety track record”.

Impact on individuals in India

As an individual in India, the conflicting reports on the side-effects of Covaxin can lead to confusion and concern. It is important to stay informed about the latest updates and recommendations from health authorities to make informed decisions about vaccination.

Impact on the world

The controversy surrounding the study on Covaxin side-effects highlights the importance of rigorous methodology and transparency in reporting vaccine safety data. It also underscores the need for continuous monitoring and evaluation of vaccine safety to ensure public trust and confidence in vaccination programs worldwide.

Conclusion

In conclusion, the debate over the study on Covaxin side-effects underscores the complexities and challenges in assessing vaccine safety and efficacy. It is essential for researchers, health authorities, and vaccine manufacturers to work together to ensure accurate and reliable data on vaccine side-effects, and to address any discrepancies or concerns promptly to maintain public trust in vaccination efforts.