India’s COVID Vaccine Rollout: Is There Truly ‘Informed’ Consent?

What's the problem with Covaxin (a vaccine designed by Bharat Biotech and approved in a hurry, without any data from the vaccine’s Phase 3 trial, by the Indian government), if people are giving their ‘informed consent’ before they receive it?

More than a question, this is often a rebuttal, an excuse, a ‘cover-up’.

But, most importantly it is an instructive argument, even though it's wrong.

Is informed consent just a ritualised briefing of someone on the details of the medicine/ intervention that they would be subjected to? Or is it actually an educated choice that is offered to someone, without fear of penalty and without fear to their own life?

If it's the latter, then what the government is seeking is not ‘informed consent’.

If You Refuse To Take Covaxin, Can You Come Back Later For A Vaccine Of Your Choice?

According to the government, only one of the vaccines (out of the two, the Oxford designed and approved Covishield or the Bharat Biotech designed Covaxin) will be offered at any of the centres in order to avoid providing recipients the option to choose one vaccine over the other. So, to the government, the two vaccines are equal.

They draw an equivalence, albeit unfounded, as only one of them, that is, Covishield, comes with Phase 3 data.

This lack of choice would have been justified perhaps, if there had been no other vaccine in the market. But, there is.

Now, suppose you walk into a centre that dishes out Covaxin, the vaccine that is on trial. And you refuse to take it. Yes, this is you refusing consent to being a part of the trial, but this is also you being potentially ‘penalised’ for refusing a half-baked vaccine.

Have you been assured that at a later time, you might get a chance to take the vaccine of your choice? No. Do we know how long we’d have to wait? No.

There is no news of when the other vaccine would arrive and when you might get another stab at it. You are being penalised, because it's the State that controls what vaccine you will get.

Remember, these are not available in the market yet. So, you are completely at their mercy. Wouldn't it have been much simpler for the government to have mixed things up? 50 percent Covaxin and 50 percent Covishield at every centre? And if then people chose Covaxin, that would have been informed consent. They wouldn't do it, because they know that people would have a preference. And yet, they call it ‘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.

This is the clincher. If they change the trial protocols, then it’s a new trial. And ethically, they would have had to use the Oxford vaccine as the control group.

However, devastatingly, the government decided to do away with the control group altogether. It's now called ‘open label’, which means that there is just one group that will always be given the vaccine (with informed consent, of course, wink, wink).

If It’s ‘Open Label’ & That’s The Only ‘Choice’, How Is It A ‘Trial’ Anymore?

Open label trials are inferior trials. If you have nothing to compare to and match with, the data would mean very little, especially if one were looking for side effects.

Second, I think it’s unfair for any company/ country to run open label trials in the presence of an approved drug in the market for that disease, and especially without giving the people a chance to choose, because then the vaccine is an imposition.

If it's open-label and that's the only choice, then how is it a trial anymore?

For many people, it will be the only vaccine they can get their hands on, and sadly, they'll take it.

Third, open label trials cannot become an excuse for the government to short-circuit an equivalence between drugs/vaccines that have been subject to rigorous testing and the ones that have not — no matter how indigenous the innovation.

For us to be innovative, the need is for better funding — and not governmental ‘sleight of hand’.

Open labels without choice, have made the two vaccines equal. At least for the moment, they are not.

Given what's happened, the vaccine is no longer on trial — the people are.

(Dr Dharamveer Tatwavedi, a clinician, is a Doctoral Research Student at the University of Oxford and his area of research is cancer modelling and drug discovery. He tweets @Dharam_tat. This is an opinion piece. The views expressed above are the author’s own. The Quint neither endorses nor is responsible for them.)