 Hello and welcome to NewsClick. Today, we have with us Professor Satyajit Rath. And we are going to discuss some of the issues that have been coming up regarding the vaccines. Satyajit, one issue that has come up regarding the vaccines is that it is private sector driven. The bars are lower than what it could be. And then we have no independent verification of the success or otherwise of the vaccine before they are pushed into large scale use. So how would you react to this kind of criticisms? And do you think that we could have done better? So absolutely. We've discussed some aspects of these issues in some of our previous conversations. Let me just reiterate a few of the crucial points of worry about vaccines. And let me give reference to very recent happenings. Firstly, we've been pointing out that the US FDA has said that 50% protective efficacy will be sort of acceptable for licensing a vaccine. Now we are told that the European regulatory authority might accept an even weaker threshold. They haven't come up with a number, but they've given some indication that they might be satisfied with an even weaker threshold. This makes two points. Not the point that this is unacceptably low. There is no such thing as an unacceptably low protective bar with a first generation vaccine. Most first generation vaccines will show modest efficacy and they'll improve over time. So that's not the problem. The problem is, firstly, that everybody seems to be doing a different threshold. This is going to get messier and messier. And everybody is doing their own vaccine trial in their own way. So let me give example again of all the huge numbers of claims we've had for treatments. And what came out last week as the result from the solidarity trial, which is coordinated by the WHO, that said much of antiviral medication does not really help a lot in severe illness. So a reasonable question from the public comments point of view is, why isn't there a common vaccine trial platform coordinated by the WHO in which all vaccine candidates can be plugged in, where transparency, uniformity and related issues will all be dealt with appropriately? So effectively, if everybody tests their own thing in their own way, the criteria is not common. What is efficacy and how efficacious each of them are? And I'll ask Lehmann's question here. We are getting two kinds of, again, noise or informed criticism, we're not sure which. One of which which says that vaccines should be such that people should not get infected at all. And that should be really the criteria. Other criteria is, well, even if they do get infected, that they don't show any severe symptoms, obviously, there is still protective action. And therefore, reducing the level of infection, so to say, is also a valid target. So how do you evaluate such claims? So that's a great point, because it's a point of concern currently. Here's the difficulty. We have a whole spectrum starting from very mild infections to very severe infections. But what we mean by mild and severe has two separate axes, if you like. One is the amount of virus. The other is the amount of symptom and sign of illness in the body. While they are correlated, these are not necessarily identical at all. For instance, you can have a very severe reaction of your own body to the infection, but not have a very severe viral load at that point. Precisely. In fact, we've discussed this in past months, where we pointed out that the severity of illness is almost entirely due to the body's response to virus. So there's always likely to be some gap between how much virus and how much bodily response. So we do want the vaccine primarily against disease. We do not say a vaccine against SARS-CoV-2. We say a vaccine against COVID-19. Okay. On the vaccine against the disease, because it's the disease and its mortality, or otherwise severe illness and related issues, that we are most worried about. That's a very valid point. Let me sort of reiterate that or I'll ask you to sort of elaborate that a bit. That the difference between SARS-Virus not being a SARS-CoV-2, but against the disease, means that even if you have reproduction of the virus in your body and you are able to fight it off and not show symptoms, that means that's okay because that didn't really cause an illness. But when you show symptoms, then you are saying that there is a quote-unquote COVID-19 disease. Is that the difference? So absolutely yes. But there is yet another twist to that story, which is we have an individual perspective and we have a community perspective. At the individual level, we want what you pointed out. We do not want to be severely sick, so long as I'm not particularly sick, so long as I don't even really notice that I'm infected, I don't care whether I'm infected or not at the individual level. But at the community level, I am because even if I'm transmitting for just a little while, that's significant in terms of the dynamics of spread of disease. So in both ways, vaccines matter. These two are not necessarily identical. And it's completely confusing at this point what the vaccines are being tested for and what they're not being tested for. So that criteria is not being common, means comparing vaccines or understanding what they're expected to do is also then confused at least for laypeople like us. So at the moment, I think that the bulk of the design of the vaccine simply says, is any illness caused by the vaccine protected against by the vaccine? So asymptomatic infections, none of the vaccine trials, as far as I can see, even look for. So they are not designed to look for prevention of transmission. On the other hand, they are not even designed specifically to look for reduction in severe illness. So they are sort of in neither nor, it's not a totally rational design, but it is a design that is geared to give you results in as short a time as possible. So that's where you started from, that if we want a quick vaccine and we desperately need one at the moment, which can reduce the severity of the disease, cause much less people then to die. All of that is what our primary concern at the moment is. Transmission then will be fine-tuning the vaccine, say, and that's going to take longer. Do I sort of summarize what the intent at the moment is for the vaccine development? Yes, yes, but let me complicate this further for our audience. I apologize, but COVID-19 is complicated and we need to stop pretending, unlike governments the world over and particularly in India, that it is not complicated. It is complicated. So here is the difficulty. If our first generation vaccines are mildly protective and mildly inhibiting preventing transmission, how widely are we going to use them? How long are we going to wait for a second generation vaccine that will do better? Who are we going to give the first generation vaccine to? These are the sorts of ongoing complexities of public health policy that we need to be openly, seriously and transparently engaged in discussing and we don't seem to be. And that is where the big problem in most countries are, particularly in India, when we have an opaque body or bodies which are doing a certain set of things. We are hearing from the minister that, yes, we are going to do all of this. We're going to provide 20 to 25 crore people with vaccines by June. But we really have no idea what the success criteria is. Who are the people? How are they being selected for giving the vaccines? What is the cost of the vaccines? How will the supply chain be built and maintained except for much smaller number of people for which we have the necessary supply chain, basically from the polio vaccine oral drops. But again, there were oral drops. They were not, for instance, injectable. So that automatically reduces the number quite significantly. So all of this is completely opaque as of now and we have not got any answers and not has any committee come out and said, this is what you're planning or doing. Yes, but it doesn't surprise me because on the one hand, we have a government and related establishment, scientific establishment mechanism that's not telling us any of what you address. On the other hand, it is telling us fanciful supermodel stories about how India's national lockdown, which has been described, I suspect, accurately as draconian has saved some monumental numbers of lives. And this is based on really no good evidence whatsoever. Both of these, I think, are of a piece with governments and establishments simply beginning over these months to use the pandemic to put an uncritical positive spin on their performance rather than dealing substantively with their citizens. And not to say about declaring Bihar vaccine during the elections, but we leave that part out. Coming to what you have raised, and I think that's a very, very important issue, though I really hate to use the supermodel for a model unless we are talking about the ramps. And I suspect those who have produced a supermodel would have been better off doing that than what the mathematics they have presented to us. I'm going to talk about one particular element of this that while all public health bodies, experts, three bodies got together and said Indian lockdown had failed. And this is epidemiologists, public health experts who have spent lifetime in all of these issues. They said that Indian lockdown was draconian, but it failed. So we have that statement. And then we have three people. One of them is a control engineer, I would say my brethren, part of my larger brethren group, because I used to be one before I considered myself enough 30, 40 years of modeling was enough. So a control engineer, a computer science person and a military doctor. These are the three who have got together as somebody has written, I think is Gautam Menon has written that none of them have anything to do with epidemiology, or at least one of them had something to do with medicine. And they're produced to what is called a supermodel. Okay, now the criticism of the model is that a, it is the same genre of model, which can be used to say, give a two, three weeks prediction of some kind, but has not succeeded in predicting anything beyond that, mainly because you cannot predict how people interact with each other. And it's not true that this interactions can be modeled the way what our statistician mathematical friends say in these class of models. So they are basically models of predicting what would happen if you don't take action and be they're not meant to be for more than one, two week predictions. And I think Gautam Menon is on record on this, who's a computational biologist who's saying that they have changed parameters six times or eight times during the model, the parameter value, which has changed from 65 to something like some thousands. So the number, the ratio of the parameter change is something like one to 1000 or even larger. So all of this is, if you want, if you can do this, you can predict a square, but the what is it a square plus b square is equal to cc square. And therefore God exists, which was one time mathematical proof that was given for the existence of God. So isn't this pathetic that we have descended to this level of modeling to justify what the government has done? So let me, let me take this conversation, let me shift this conversation just a little bit. I'm going to leave the criticism of the calculations themselves to people who know something about this. But for me and our for our audience, let me point out the extraordinary nature of this paper that is published in the Indian Journal of Medical Research. Remember what this is? This is a paper that models the progression of the epidemic of the COVID-19 epidemic in India. So you expect two components in the methodology. You expect the paper to describe where they took the data from and what the data consisted of and you expect the paper to say what model was applied in sufficient detail that people can reproduce it. Correct? Right. This is what is expected as the methodology of the paper in any serious scientific paper. Absolutely. Right? Let me read to our you and our audience what the section that says materials and methods consists of. So on this background of what we expect the methodological section of a scientific paper of this sort to contain, let me read the first few lines of the materials and methods section of this paper in Indian Journal of Medical Research. A consultative committee was constituted by the Department of Science and Technology under the Ministry of Science and Technology, Government of India, to develop a supermodel consisting of mathematical predictions as related to the COVID-19 pandemic in India. During the deliberations of this committee, there were extensive discussions and literature review of the evolving pandemic and experience from other countries. Several mathematical models submitted to the committee for the spread of a pandemic were analyzed in detail and the gaps identified. I stopped here and so on and so forth. This is scientific methodology in the materials and methods section of a scientific paper. Now secondly, there is no mention of where these data came from in the paper, in the materials and methods section at all. So I have no idea what seriousness the three authors of this paper have put into writing a paper. I don't need to know the mathematics or the modeling, in other words, to see that this is an entirely unserious exercise in scientific terms. You know, I am sorry to sound also so dismissive, but the point is, if you, as you said, this is a scientific paper, we expect the data and we expect the methodology to be such that if somebody else wants to do it, they should be able to reproduce the results. Now, if it is to be, the reproduction means the parameters have to be changed over the period of time. This is what we used to call essentially curve fitting in a way that always the results you wanted is what you got by changing the parameters to suit what results you wanted. The point here is the sheer blatantness with which a public relations exercise is being caused off as a scientific effort. I think you put it absolutely correctly that this is at best a trying to justify whatever the government has done, claim credit where none is visible or at least visible in the way we want to see it. And it's been covered up by the supposed pedigree of the three people who actually are the authors of the paper. It's also interesting, the committee that had other members and some of them have credentials which would actually have epidemiology or other background, none of them are signatories to the paper except this one. So let me add to that another point of note. And that is traditionally in scientific papers, the corresponding author is the author with maximal responsibility for the paper. For this paper, the corresponding author is Dr. Madhuri Ganeshkar and her address for the purpose of the paper, for the purpose of the publication and I read for correspondence Dr. Madhuri Ganeshkar, Deputy Chief Integrated Defence Staff Medical, Headquarters Integrated Defence Staff, Ministry of Defence, Government of India, New Delhi 110011 India, email mkarnitkar15 at gmail.com. In effect, especially since there is no disclaimer about the views not being the views of the Government of India, this is the publicity document of the Government of India through the Defence Ministry. Well, I think we have to excuse the Defence Ministry from what Dr. Ganeshkar has done, possibly, but definitely this is as, this is really a public relations exercise for the Government masquerading as a scientific paper and I think this does not, we do not cover ourselves with glory as a nation for building science, scientific outlook and so on. If the Government of India essentially gives cover or encourages such an exercise and the Journal of, Indian Journal of Medicine, what is it called? Indian Journal of Medicine. It's part of this thing, our ICMR, is it? Yeah. Okay. And it doesn't cover itself with glory, particularly in the Indian Journal of Medical Research, which is under ICMR, publishes such papers. And I don't think any serious international journal would have carried such a paper. And we have had serious papers, for instance, based on the Cereological Service, which have been carried by international journeys, which obviously have shown a certain basic minimum quality for a paper of this kind. Satyajit, thank you for being with us, spending this time just really discussing issues which are not easy, trying to make it easy for the anchor and the audience for how difficult COVID-19 is going to be and how to handle COVID-19 vaccines, but perhaps it's going to be even more difficult. This is all the time we have today. Do keep watching NewsClick and do visit our website.