 Hello and welcome to NewsClick. Today we have with us Dr. Satyajit Rat and we'll be discussing the vaccination program which is supposed to be unfurled very soon. Satyajit, the government of India has said that it is doing various dry runs. They're going to start the vaccination program of the health workers followed by the frontline workers and then those who have co-morbidities and above 55. Now, if we take the first two, the health workers and the frontline workers, that's probably about three and a half crores, so we don't really have final figures on this. And the health line workers are probably at least about one and a half crores if we take all the hospital to dispensaries to the hospital staff, including the people who really run the hospital, keeping clean, give people food and everything. So you're really talking of a large number, but if you look at the number of vaccine doses the government has placed its order on, it's 11 million. Now, there seems to be a huge gap, 11 million is about 55 lakh of people against frontline plus hospital workers of three and a half crores. So how do you see this panning up? Do you think that this order is meant as a first shot and they will then start looking at alternatives or is it something else that we are missing in this picture? So I think this is a number of, shall we say, rate limiting points that are likely to be in operation. Firstly, despite all the brave words about dry runs and the Coven app and so on and so forth, I suspect, with some sympathy, that the government really is apprehensive about just how the vaccination program will actually roll out on the ground. The numbers are not going to be so high in the initial phases. And even then, it's going to be a massive exercise and I think what the government is hoping is that in the first couple of, in the first few weeks, glitches will become apparent and will become apparent at a rate at which the government can at least run about and find to God fixes for them. And I suspect that that's part of the reason why the orders are being spaced out a little bit, taking advantage on the other side of the fact that this is currently what's being made available at the price by the Serum Institute in all likelihood. Although, again, we don't know for sure what the discussions are about pricing and the schedule of supply. And add to this mix the other uncertainty, which is that the ICMR, Bharat Biotech Hyderabad based vaccine candidate Covaxin, which has been given a different kind of emergency authorization by the regulatory agency without any even preliminary efficacy data from anywhere in the world. I think government is hoping that those data will come out and therefore they can then begin to use whatever small stocks Bharat Biotech has available. So I think that there are jugglings and trade-offs going on where the government can be seen to have initiated a vaccination program, but is not going into it at a speed at which problems will become major public relations disasters. We're talking really about what, for instance, has happened in the United States, where a lot of the vaccines are sort of waiting in the refrigeration units and not being actually going in for giving people shots. So there's been a huge criticism of the failures on that front. And considering that we also have states, we've also have distributed mechanism for giving the vaccines. It's not a centralized military operation that the government would like to believe it is, that you are going to run into some of the same issues. Absolutely. So let me make two allied points here. One is a great deal of the vaccination dry runs appear to be based around the Covin app. The app is only as good as the connectivity of healthcare workers in far flung rural India. So it's quite unclear what percentage of the potential first phase recipients are going to run into major difficulties. It's quite unclear how efficiently four weeks later, people are going to come back for revaccinations. So there are many uncertainties in all of this. One example that you give of the uncertainties leading to credibility disasters for governments is of course the United States where supplies are getting bottlenecked. Another in a very different way is the United Kingdom, where the authorities started with arbitrarily expanding the timing of the second dose of the vaccine from four weeks to up to 12 weeks without any good evidence. Or more correctly, without strong evidence. There is sort of kind of preliminary evidence, but not really strong robust evidence on the one hand. On the other hand, throwing all adherence to even preliminary evidence out of the window. There seems to be now conversation about mixing vaccines in the United Kingdom. And that again is reminiscent of the Indian regulatory authorities opaque, rapidity of approving paratbiotics application for emergency use of the co-vaccine candidate. So governments across the world are responding in ways that are as much about saving face and avoiding blame to the extent possible as about actually dealing with the pandemic. So to put it slightly differently, they're not dealing as a public health issue, but as a political issue, a logistical and political issue and saving face could become a very expensive saving of face. If the pandemic lingers on because of the missteps we take in the vaccination doesn't really take place properly, we half vaccinate the people like is possible in the United Kingdom now as you were saying. And the share logistical nightmare of being able to space and give a second shot within the period which is reasonable maybe four to six weeks, but certainly anything longer than that. As you said already the data is very thin. So this is these are all the reasons you think government of India is going slow. So let us do smaller numbers but be sure of doing it rather than have more numbers and then fall flat. Add to this. Yes, but add to this yet another consideration. Let us keep in mind what the serum Institute of India appears to have indicated, namely that its price for the first 11 million doses to the government of India is 200 rupees a dose plus GST. But that it expects to sell the vaccine in the open market for 1000 rupees plus GST per dose. That's a five fold difference. Now, I gather from the media that the serum Institute to chief executive officer has commented that they are waiting to get approval from the government of India for open market states. Add to this. Let us remind our viewers that Pfizer made an application for approval for emergency use approval of its vaccine to the Indian regulatory authority this so far has not been approved because neither phase one nor phase two nor phase three data are available from within the India for that for the bio and tick Pfizer vaccine, but given that that vaccine needs minus 70 degrees storage. It was never going to be a practical component of a large scale public health care vaccination campaign response in India anyway. So what was the driver for the application. And a reasonable interpretation is that the driver was in metropolitan India for the urban upper class. The Pfizer vaccine would have been a straightforward sale. Absolutely. And let's face it, that there is enough segment of population in India, which can afford the Pfizer vaccine. And what you have already reminded our viewers a number of times in the past that all of these are for profit. And therefore, it's quite possible that serum Institute will deliver private and the public effort in different quantities. And if the government is not careful enough to block a certain number of files, certain number of quantities in advance. And that's what said I'm a student is also said, if you don't place orders early enough, what can we do, we would have other commitments and obviously the commitments is indicated are for the for profit private market as well, because vaccine should really not cost all that much, particularly when you produce in such large quantities, but that's another story, maybe for another day. So what you're saying is also that we are getting now into the market issue, but just taking a sidewise step on that. There are also other vaccines now slowly emerging in the market. There's the Somalia vaccine, which Reddy's Institute has already also started trials in India. Also, the Chinese to vaccine Sinovac and Sino farm, both seem to have very similar data though the details of the data not public, but whatever we learned from the Brazilians from other places. And also in the range of 75 to 85 in that range details aside so we're really talking about what you said earlier. This, this, this virus seems to be a wimpy one, and almost most vaccines seem to be working on it. So given that there are other vaccines available what about the Russian vaccine is there any step that you can see in that in terms of trials. And that's an interesting point. Again, if the, if the regular if the Indian regulators response to the Pfizer application to the reported Pfizer application, the reported response to the reported Pfizer application since we really don't know how to perform the horses mouth in any transparent fashion. But if that is correct, then Pfizer's application has was not successful presumably because there are, there aren't even phase one phase two data in country. In the next few days, then the fact that an Indian company is actually doing phase one phase two data for the Pfizer vaccine for the Malia Institute vaccine indicates that as soon as those data are in hand within another month or two. The vaccine will be in a position to be licensed exactly the same way as the Oxford AstraZeneca serum Institute vaccine is add to this, a vaccine that we are all overlooking, which is an Indian private sector vaccine which is the Zyda scheduler vaccine, which is a DNA based vaccine, which is also in clinical trials. Again, the media have not addressed the progress of the Zyda scheduler vaccines I just get a lot does not seem to have made any effort to foreground and publicize their progress. But that's yet another vaccine on the radar. So there's a whole range of vaccines on the radar. Novavax already has Indian agreements and their vaccine is in phase three clinical trials internationally again within the next month or two. We are likely to see preliminary data. I cannot emphasize this enough. All approvals we are seeing so far show perfectly good, complete, reliable phase one and phase two data, phase three data are placed only on preliminary evidence. Efficacy. So that's the other part because there's a lot of, I will say vaccine suspicion that is it safe that this is really the phase three trials and efficacy data, and this is not so much. It is really not about safety, safety. Yes, if something comes up, it's a byproduct of it, but the primary purpose is efficacy and almost all vaccines that are in phase three trials seem to show at least the 50% bar is being crossed by almost all of them. We haven't heard about the failure as yet. Yes, although in the British Medical Journal, Dr. Peter Doshi has had some thoughts to offer on that with regard to the bio and tech Pfizer and the NIH Moderna vaccines and where the trial data he points out are very narrowly identified and that raises questions about whether the efficacy numbers are in fact what the efficacy numbers are, but details of that sort aside, yes, that's all agreed with. This is a major reason why the criticisms for example, of the opaque and the hurried emergency use peculiar unspecified approval that the Indian regulator has given to its in house ICMR biotech vaccine that criticism is not intended on the part of any of the critics to say that the vaccine is unsafe. It's not even intended to say that the vaccine probably won't work because as we've said here, similar vaccines elsewhere, the Chinese one in this particular case have work. The question is about the integrity and the transparency of processes of governance of processes of official regulation. And what we have also said earlier, it's a credibility of the regulatory system which is very important, because if that fails, and for instance we find it didn't work properly as intended and so on, then reviving the faith in the regulatory institution is going to be much harder. So therefore, it is very important that this, this regulatory process at least the viability, the credibility of that process should not be disturbed. Coming back to the last question I had with you, you know, there is also, there have been various claims on the Bharat biotech vaccine that because it's a whole virus inactivated vaccine, it will work on the variants as well. Now, is there anything to say that the whole virus inactivated by vaccine works better for variants than other vaccines is anything. No, there is currently no evidence to say that inactivated whole virus vaccines will work better on variants than the spike protein specific vaccines at all. This is not the other way either. It's not that they are worse, it's not that they are better. At the moment, we really don't know. But speaking about variants, there's an interesting point that we should be noting, which is Pfizer has pointed out over these past few days that it has tested the most dramatic change mutation in the spike protein of the virus in the so-called UK variant. We really shouldn't be calling them this. And I like what the South Africans have done, they've called it N501, YV1 or V2, which is a smaller mouthful than VUI 2020-1201, which is what the British have called their variant. Can we make an appeal to them to give these variants simple but not geographical names that we can use the rest of us? Anyway, let us call it the so-called UK variant. The so-called UK variant mutation has been tested by Pfizer on serum from vaccinees and that serum works to neutralize viruses with that mutation. This is good news. It's small good news because keep in mind that the so-called South African variant has a number of mutations in the spike protein. All of them together, as far as I know, have not yet been tested. There are a couple of reports that are also both promising and cautionary in that many individual mutations seem not to be broadly escaping vaccine efficacy, but there is a cautionary note because there is an occasional amino acid in the sequence of the spike protein at position 484, for example, where mutations of at least certain kinds seem to cause trouble for at least some antibodies from some people to neutralize. So clearly, what we should be reassured by is that we don't as yet have a huge vaccine escape outbreak going on already. What we should be cautious about is that this is not the end. It's quite likely that as vaccination spreads, variants of the virus that are not easily and well-neutralizable by the vaccine will become more and more prominent and depending on the severity of illness that they cause, we might or might not need to develop next-generation vaccines against them. So it is a part of the larger biological war. So to say, I know you don't like these terms, but the evolutionary war between the microbes and us, which is not going to end in this year of 2021. But we will probably have a much better year with the vaccines than we had in 2020. At least that is the front hope that people with co-vormity like me have. Yes. It is quite true that I am disinclined to use the imagery of war in most situations and certainly not in this one. So I offer you an alternative image that's familiar in India of a crowded public transport bus onto which or a crowded unreserved railway train bogey into which yet more people come in and they say, yeah, just a little. Essentially, that's the given take between an incoming virus and us. How do we come to a new balance of coexistence? Equilibrium you say, but I don't think you would have the same equilibrium demand for smallpox. Or for Ebola virus, absolutely. Keep in mind that this is something we've been saying repeatedly about this pandemic for months, that if this was Ebola, we would be in a very different and a horrendously worse place. And the social response, the medical response would be very different or would need to be very different. But let's not, you know, inflict a horror story in our imagination. There are some of them on Netflix already going around. So I think we leave it to the Netflix and other such streaming platforms to talk about such possibilities. Question is, good news as yet on the vaccine front, nothing to worry about as yet on the vaccine front, cautious optimism. And the same time, it is a public health issue. And if we deal with it, like a law and order issue as an administrative issue, then we can run into problems. And the fact that the government has been extremely opaque. This can lead to problems of different kinds that people don't know what they have to do. They believe they're just objects. And if an open market release takes place, we can also see stampede for vaccines and causing other kinds of issues. So as I said, cautious optimism as Dr. Rath has shared with us, but fingers crossed on how the rest of the procedure to deliver and vaccinate the people take this. Thank you Satyajit for being with us clarifying some of these issues, and we'll come back again next week for this and other topics to discuss.