Why in news
Indian Council of Medical Research (ICMR) to strongly criticise the poor design of the long-term safety study of Covaxin by researchers from the Banaras Hindu University, Varanasi
Bharat Biotech too pointed out the major limitations in the Covaxin study
The study lacked a control arm and data on the background rates of observed adverse events
Importance of rigorous scientific research
Including a control arm is extremely important while studying vaccine safety.
Only such a study can provide meaningful and reliable information about the adverse effects of a vaccine.
Studying the safety of a vaccine in thousands of participants for periods lasting one to three years is vital.
Clinical evaluation of every adverse event is also paramount to rule out causality.
Finally, randomly assigning the participants either to an intervention arm or a control group is important to eliminate bias.
A phase-3 randomised, controlled trial involving a large number of participants is thus ideal for studying vaccine safety
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