 Hello and welcome to Newsclick. We have with us Dr. Satyajit Rath and we have the issue that has recently come to light, which we have discussed regarding co-vaccine trials itself. Satyajit, when the approvals were given to co-vaccine, it was sent in basically what's called clinical trial mode, but now what we are looking at is mass vaccination. If we look at what's happening today, it's clear that these are full-fledged vaccination drive the government is doing. AstraZeneca has about two-thirds, one-third of it right now is co-vaccine and this is not being done in so-called clinical trial mode. This is really the vaccination drive. At the same time, we're also told that the volunteers are being asked to sign a form, giving informed consent for clinical trials. Our clinical trials generally are double-blind, etc., etc. So none of that is happening. So how do you see this amalgam of vaccination come clinical trials come informed consent that is currently taking place? So there are two cardinal issues involved in this that should be of concern to all of us. The first is the absolute lack of transparency and information availability on the part of the regulatory authorities, meaning on the part of the government. Regulatory authorities have not clarified what they've been by approval in clinical trial. How they want the clinical trial mode to be operated, what sort of data, what sort of consent process, what sort of analytical approaches, nothing has been clarified. In fact, Bharat Biotech pointed out that they didn't quite understand it either and we have heard nothing subsequently about whether they have now understood it or not. First, second, the vaccine is being purchased by the government and implemented, which means that the government is responsible for its administration. Yet, consent forms are being required from the individuals being given this vaccine and the consent forms identify Bharat Biotech as the agency involved and responsible particularly for treatment of adverse effects and so on and so forth. So the entire landscape of co-vaccine administration is a regulatory mess. Added to this is the problem of at least implicit coercion because this is keep in mind a vaccination campaign that's currently focused on healthcare workers primarily in the public or semi-public sectors. What they are being offered is a vaccine. And if they are that small minority at the moment, since vaccine supplies are very small for co-vaccine, if they are being offered co-vaccine, they don't have the option to say, I don't want this, I want that. As far as we, the rest of us can tell, they seem to be given the option you either take the vaccine that's being given to you or you don't get a vaccine. And that because co-vaccine is in clinical trial mode, it appears to be a violation of freedom of choice. You know, the second part of it is that the government when it said that it is going to give a mixture of the two, it never made clear who was going to get what, what was the basis of any of this. So this seems to be appears to be arbitrary, except for the fact that this is really being tried in the government hospitals. This co-vaccine seems to be targeting the government hospitals, while others, maybe also some other public hospitals are also out of it. But this then doesn't seem to be any of the co-vaccine trials at least in Delhi, which are targeting private hospitals. This seems to be entirely government hospitals. So therefore, it seems the pressure on the health workers in this government hospitals is actually greater. Absolutely, yes. And keep in mind that the signals coming about co-vaccine have been so complicated and so undirectional as to create almost legitimate vaccine anxieties. And I'm saying this despite my concern that we may be feeding vaccine anxieties. The government on the one hand puts out through its spokespeople statements that the vaccine is efficacious, yet there is no evidence even today, even of the preliminary kind about its efficacy. The people who are receiving it are being told that they are being given it for protection, yet they are being told that they are being given it in clinical trial mode where protective efficacy is being tested for. This is a regulatory and public relations mess of governments, of great dimensions. It's very interesting that you're saying this because the informed consent form they're signing makes clear that phase one, phase two trials have been conducted. The efficacy, this is a part of the efficacy trial. So there have been no efficacy trials in data on the basis of which it has been cleared. Again, confirm, not that it needed really confirmation, but there is no data on clinical trial efficacy. That's the phase three trials efficacy, that's very much there. The second is harsh abundance is both are equally effective. Now, how does he know that the AstraZeneca vaccine and co-vaccine biotech biotech co-vaccine because one has efficacy data one doesn't. So is it a matter of faith? Absolutely, it is a matter of faith and we are being asked to take this on faith as a matter of vaccine nationalism and I'm saddened by the necessity to bring this issue up, but that's where we have learned it. We have nationalized the AstraZeneca Oxford vaccine by calling it the Serum Institute Indian vaccine as well. But in essence, it is a Subramaniam Swamy's outsized influence on social media, which seemed to have precipitated this violation or bypassing shall be seen of all the norms that the regulator themselves have specified earlier. And while the regulators are quite within their authority to make exceptions, making an unexplained exception and creating an uncharted pathway for its implementation is a ridiculous form of governance. You know, this also means that while you give this informed consent, you're also giving away some of your legal rights. So, while there have been uninformed consent on Tuskegee trials and so on, we don't have informed consent of this kind, which is something that which leaves you without a vaccine. This is, I don't seem to recall any such instance, maybe they did take such instances earlier, but I don't seem to recall any such instances earlier, but you've got informed consent under coercive conditions. Frankly, clinical trials in India, our friends in public health activism will tell us, has seen many such examples of drug trials and related issues in India. Our soft implementation to be euphemistic about it of regulatory regimes makes all sorts of violations possible. One of the sad part is that in a high profile public sector pandemic response situation, we seem to be behaving in exactly the same poor fashion. Part of government public relations exercise, having failed to control the epidemic, now to take kudos for the vaccination, because they also seem to believe that the numbers are going down so they can claim the vaccine is what now control the numbers and therefore this is, you know, the government is to be congratulated on this biggest exercise of vaccination in the world, etc, etc, etc. But again, coming back to numbers, numbers as of now, of the people to be vaccinated, it seemed to be rather thin. Compared to the three and a half crores that they're talking about what we have with what we seem to have, they were seems to have been procured for the health line frontline workers is only about 1.5 crores so still some distance to go even on that score. It's also interesting the residents doctors Association, who have obviously better knowledge of these things than most of the hospital frontline workers in Ramana or lawyer hospital one of the bigger hospitals in Delhi, with the government has refused to vaccinate themselves with this particular vaccine and raises vaccine anxiety in the larger sections of the people, and this is has been also one of the COVID back hospitals in Delhi. So this is also cause for concern if this. Let me let me underline something. And I think that it's important for for us all to see this in perspective. If I were getting a shot of co vaccine offered to me today under clinical trial mode, I would take it. It's safe. It's likely to be effective at the individual level there really isn't a risk. The concerns that are being expressed are at the level of poor to terrible regulatory governance and the lack of provision of true choice. This does not mean that the vaccine is an actual individual danger at all. It's a larger issue than that. It's a policy issue. It's a public behavior norms issue. It's not an issue of putting individuals directly and substantively at risk. So being forced is the key problem. Apart from the fact that this clinical trial mode is completely misnomer because clinical trial does not mean vaccinating large numbers in this particular way. One can imagine all sorts of clinical trials, not clarifying not providing information, not making an explicit and proper framework for the implementation of your decisions is a regulatory failure. At the same time, the efficacy trials are going on parallel. Precisely. So this is clearly a part of vaccination while calling it emergency use on the clinical trial mode seems to be a fig leaf if you will, to hide the fact that you really make it a part of your vaccination program. And without giving people choice, as you said, and I agree with you that if today I who have been listening to you, therefore I'm probably biased. If I'm offered a choice of this vaccine right now against waiting for it said two months down the line, I would also take it. But, but that's your influence. I don't know whether that's a scientific objective decision or not. But the point is, we are not talking about that this vaccine is harmful, we are not talking about that this vaccine should not be taken, we should wait for something that none of those are issues. Yes, it seems to have an antibody reaction, which is good. It seems to be safe safety trials have been conducted with both these two boxes being ticked. Yes, it is a choice if offered that a lot of people would take is being forced into this without choice. And what you call the regulatory obfuscation that exists with ministers, Minister of Health saying that this both have been found to be equally with equal efficacy for which no data has really been offered. So this is what to at best we can say this is a kind of truth which needs really a microscope to see for where did he get the data for saying it is equally efficacious. So let me use your let me use your imagery and point out that of course this is a fig leaf. The trouble with the fig leaf is not so much that it's a fig leaf, but that it is so ill designed a fig leaf that it does not hide what it is supposed to be hiding. Well, I think that gets us into very dangerous territory. We'll stop at that. Thank you very much Satyajit for clarifying this issue for us and we wait for the government to give us better understanding of what the hell they are doing. 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