India’s COVID Vaccine Trials And Consent: Is There Truly Informed Consent?

No ‘Control Group’ In Vaccine Trials: Why This Is An Issue

Let’s approach it from another perspective. This is even more fundamental and even more instructive.

Randomised control trials are conducted by dividing the study population into two groups. One, that will receive the vaccine, and the other, that wouldn’t. I want to draw your attention to the people who wouldn’t.

If there is no approved treatment available in the market, then we just inject them with placebo (for example, normal saline). But — and here’s the catch, if there is a treatment available in the market, then the control population would get the approved treatment as control. Now, when these trials started, both, the one by Oxford and the one by Bharat Biotech, there was no preventive vaccine against COVID.

So, they were fair in treating the placebo group with nothing. But, the government decided to make the trial open label after the Oxford vaccine had been approved by a couple of countries.

However,…

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