The Banarus Hindu University (BHU), in its recent publication with Drug Safety (a Springer Journal), reported long-term adverse events of special interest following the administration of COVAXIN.
COVAXIN: The Product
COVAXIN is a COVID-19 vaccine that was designed and developed by Bharat Biotech in collaboration with the Indian Council for Medical Research (ICMR). The vaccine boasts the greatest safety, given that its makers conducted trials on a record number of individuals.
COVAXIN, unlike its peers, is also a whole virion vaccine that confers resistance towards multiple epitopes and not just the spike protein. This confers the recipient with additional resistance to potential variants of the virus as well. A record number of individuals studied during clinical trials ensured that the vaccine was the safest on the market for COVID-19.
Naturally, this begs the questioning of findings from the BHU.
The BHU Study
ICMR’s scientists have identified flaws in a study from BHU in response to the latter’s acknowledgement of ICMR in their study. ICMR also distanced itself from the study by doing so.
The identified flaws in the BHU study are:
- Does not have control group of unvaccinated individuals to prove that side effects are indeed associated with vaccination
- Does not mention how frequently these adverse events were reported by the population to establish that they are associated with vaccination
- The study tool was not consistent with the definition of “Adverse events of special interest” that is globally accepted
- Responses from participants were recorded a year after vaccination without verification of clinical records or physician examination, increasing the scope for biased reporting.
Science isn’t a place for personal vendetta. It needs reasoning. It seems beyond clear that scientists at ICMR aren’t attacking findings from BHU simply because they collaborated with Bharat Biotech in making the vaccine. Their reasons for criticizing the study are indeed valid.
The criticism from ICMR scientists reflects how well thought-out COVAXIN was and only furthers its credibility.
Reference:
https://indianexpress.com/article/health-wellness/covaxin-side-effects-bhu-study-icmr-9340377
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