The Indian Council for Medical Research (ICMR) issued a letter to the researchers of Banaras Hindu University last week, countering their study on the side effects of India’s indigenous vaccine for COVID — Covaxin.
What did the BHU study conclude?
Adolescent girls and those with co-morbidities were at a higher risk of adverse events after receiving Bharat Biotech’s BBV152 (Covaxin) vaccine against COVID-19,
Findings from a one-year prospective study in North India’, also said that serious adverse events occurred in 1% of BBV152 recipients
Comorbidity - It describes the existence of more than one disease or condition within your body at the same time
What did ICMR object to?
Dr. Bahl said ICMR was not associated with the study and had not provided any financial or technical support.
He alleged that the authors had acknowledged ICMR for research support without prior approval or intimation to the institution, calling this “inappropriate and unacceptable.”
Poor Methodology: The Indian Council for Medical Research (ICMR) criticized the BHU (Banaras Hindu University) study for having significant flaws in its design and methodology
No Control Group: A major issue was the lack of an unvaccinated control group. This makes it impossible to definitively link the reported side effects to the Covaxin vaccine itself
Misleading Acknowledgement: The BHU study apparently acknowledged the ICMR's involvement, which the ICMR claims is misleading and incorrect
It's important to note that due to the methodological issues, the findings of the BHU study regarding Covaxin's side effects are inconclusive. There's no way to tell from the study if the side effects are linked to the vaccine
Why Examining Vaccine Safety is Crucial:
Public Trust: Rigorous examination of vaccine safety is essential to maintain public trust in vaccination programs.
Rare Side Effects: Even if a vaccine is generally safe, there's always a possibility of rare side effects. Studies with proper controls help identify and address these.
Continuous Monitoring: Vaccine safety is an ongoing process. Monitoring helps ensure the long-term safety of vaccines like Covaxin.
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