 Hello and welcome to NewsClick. Today, though we have some good news regarding the vaccines, that there are a number of vaccines on the table in various stages of regulatory approval, yet what is the likely scenario for the Indian people? It's still a question because we don't really know the extent of the preparedness when the approvals will be given, on what basis the approvals will be given, and for what section of the population. And what are the stocks of vaccines which are going to be available by the end of the year? If we take at least 2021 as a target for vaccinating the entire population. Satyajit, let's start with the good news that we have discussed this earlier. We have about four vaccines now in various stages. Bharat Biotech is just starting his phase three trials. So I'm a little surprised that they have also moved for emergency usage. I thought that you do after you've got some preliminary results. So if that is valid, then we can talk about five vaccines, but at the moment we have four vaccines which is on the table. How do we read Bharat Biotech's application? Serum Institute application at least is backed by some preliminary figures. How do you take Bharat Biotech's application for emergency usage? So this is beginning to be interesting and it's beginning to be interesting as an emerging scenario that complicates the landscape between public health considerations on the one hand and capitalist money making on the other hand. Let's all keep in mind that what licensing we are currently discussing is not regular ordinary straightforward licensing, it's emergency use authorization and we've pointed this out repeatedly. Now, as soon as one emergency use authorization was provided by the UK regulatory authority to the BioNTech Pfizer, let us call it vaccine, what companies have begun to do is push the envelope. So currently in India, we have three different categories as far as I can see of companies applying for emergency use authorization. One is the straightforward mimic of the BioNTech Pfizer in UK, which means that you have preliminary evidence of efficacy from a phase three clinical trial and in the country in which you've done this, you're applying for an emergency use authorization. Here is the point. The Serum Institute Oxford AstraZeneca vaccine application in India comes closest to this. At the moment, there are no phase three trial based efficacy data in India that I'm aware of. But at least the Serum Institute of India, Oxford AstraZeneca candidate and application is based on efficacy data outside and phase one, phase two immunogenicity and safety data inside India. So that's one push of the envelope. And they have the phase three trials going on. They have ongoing phase three trials, but they do not have, those are not even the preliminary data that appear to be included in the application. And if that's correct, then this is, as I'm pointing out, one way of pushing the envelope further is second push of the envelope comes from the BioNTech Pfizer vaccine, which Pfizer has applied to the Indian regulatory authority for permission to import and distribute as emergency use authorization. Now remember, this is not simply there are no preliminary phase three trial data in India. There are no phase one, phase two data in India either. Okay. So that's a yet different push of the envelope. And a third kind of push of the envelope is the Bharat Biotech reported plan or application. I'm not quite sure which. That has, that's a vaccine candidate that has gone through phase one and phase two trials in India. But that has not gone through even preliminary phase three efficacy data in India or anywhere else. So you see what I'm saying that in three very different ways, three different private sector companies are pushing the regulatory envelope of emergency use authorization for vaccination. And you will recollect that a couple of months ago, these are the kinds of scenarios that we had begun to think about when we pointed out that multiple vaccine candidates are likely to start coming at the same time all from private sector sources beginning to show respectable efficacy and therefore every day of profit making will begin to matter. The Bharat Biotech is basically the Pune Institute of Biology. That's the ICMR lab that has developed the vaccine. But in this case, it would be rather strange that without any efficacy to be shown in the phase three trials that you ask for emergency usage. We don't know whether it's useful or not. And the problem with vaccines has always been if for instance it doesn't work, you also destroy the credibility of vaccines itself. Yes, of course you do. But here's the argument being made. Remember that this is why I keep bringing up the politics of the situation rather than simply the so-called value neutral science. There is no such thing. Because here's the argument being implicitly made. If I can get emergency use authorization for widespread huge distribution which means huge sales with an emergency use authorization that means that a full phase three clinical trial is really not needed. Number two, if a full phase three clinical trial is not needed in even the first country where efficacy is demonstrated then efficacy trials elsewhere can't be needed because all I have to do is show that the amount of antibody made is comparable between two countries. Then if in my country, the same amount of antibody is made then I can as in another country where efficacy is demonstrated then I can say because the antibody levels are similar, efficacy is bound to be similar. That's one more step. If that's said, then I can turn around and say, hey, this is a platform that's immunogenic. So we really don't, you know, this is a slow slope of digging away and trying to get your product into the market while the market is hot. You know, something like this, why I understand the capitalist ethics or lack of it here. What I'm unable to understand is the regulatory system because India's emergency usage itself is a very weak regulatory structure. It's not really very clearly defined and it also is true that this is relatively new in the world, that this kind of emergency usage really is 2010 onwards. This has been on the anvil. Countries have done it and so on. But the risk in vaccines, because vaccines is not what you give to people who are sick. You know, who already, therefore, you're going to medicate, may need something which is not working, nothing else is working, but you're giving it to people who are actually healthy. Therefore the bar of safety should be much higher for the vaccine than for any other medicine. And this is not something which seems to be appearing on the radar of either the regulatory system right now in India or in the media because media is completely oblivious treating all these as very civil cases. So let me make two points in response. One of agreement and one of disagreement. The agreement is, of course, what you're saying is correct. We haven't as yet seen in the media an extensive and nuanced discussion of these issues at all. And that's a great disservice. But let me record a point of disagreement. And that is, or rather than disagreement, a caveat. And that is that there has been no shortcut so far of safety evaluations for any of these vaccine candidates. The only current shortcut for safety evaluations that we've seen even attempted is the Pfizer application to the Indian Regulatory Authority to license the BioNTech Pfizer vaccine for India without a safety and immunogenicity trial in India. And there's currently no indication about whether the Indian Regulator is going to approve this or not because that would mean a major step of relaxation even for the Indian Regulator. What you're saying is the phase one, two trials would cover safety at least. And therefore we don't really have to bother about that part, we're only looking at efficacy. So it may not be harmful, but it may not provide efficacy. So the worst case scenario. My argument was really, I guess I should have stated it much more openly, is that losing credibility of the vaccine of a particular vaccine may mean losing credibility of vaccines per se. And that is the bigger public health threat than the emerges. Again, yes and no, formally yes. But honestly, the numbers that are slowly creeping up make me think that pretty much all of these vaccine candidates are going to show reasonable protection over the short term. And if that is correct, then pretty much everybody who takes the vaccine is going to see some measure of protection. So why should we have phase three trials at all? So the full phase three trial is required for two additional reasons. And this is really the distinction that's important to make. They're not required at this point for reassuring individuals that the vaccine is safe and reasonably efficacious. They are important for two additional reasons that are critical for public health and policy. And those two issues are number one, exactly how efficacious and exactly how long does protection last as questions that need to be answered in order to plan vaccination campaigns. And the subsidiary point of are there extremely rare very long-term coverage adverse effects? And again, those are important in terms of policy making because they would identify people who are particular very small groups that are particularly at risk. So there's a distinction at this point between whether individuals should be reassured that vaccines that come into the public space are safe and reasonably efficacious. The answer is yes, they are. And whether the data are adequate to plan public health policy on which at the moment is not the case. Okay Saty, it's coming to what you said earlier that pushing the envelope of the vaccine emergency use authorization, we are going on directions which are not very healthy. Is there a safety risk to some of this emergency use vaccine authorization? Are the efficacy results proven enough for all of them? Particularly in the bar in the biotech which is no law not at the moment on the phase three track. So how would you see this emergency use authorization if it comes through? So let me specify the three different ways of pushing the envelope beyond the initial emergency use authorization condition that we've discussed. If somebody says that I have shown safety and immunogenicity in India and I have shown for the same vaccine protective efficacy elsewhere which is as emergency use authorization that I think after the case ascension that I think may not be unreasonable. But there are two other examples that we discussed that are deeply worrisome. One is not having phase one phase two trial data in country, not even having phase one, phase two trial data in country and yet asking for an emergency use authorization because- Biotech Pfizer vaccine. What if safety and immunogenicity are a little bit off? This is one concern. The second concern is to ask for an emergency use authorization for a vaccine and a vaccine platform which has not been shown to be efficacious even in preliminary data in any phase three clinical trial anywhere in the world so far and saying give us emergency use authorization. And I would flag both of these as extremely serious concerns. They are serious concerns in terms of establishing vaccine credibility. They are serious substantive concerns and they have the potential to be serious difficulties for public health policy for moving forward. So at the moment based on what the current regulations are both Pfizer-BioNTech or the Bharat Biotech vaccines should not be considered because there is really even by our regulatory standards which are as we said not too well defined and these are relatively recent regulatory issues that have come up emergency authorization even by those standards what it seems that the Bharat Biotech and the Pfizer-BioNTech vaccines should really not be entity. So would you be surprised if they are granted permission? I must confess that I would be surprised if they are granted permission. At this stage the way I understand and laid out their situations are I would be surprised. I'm going to have a very quick question on another vaccine which has made headlines in India recently the NOVA vaccine platform and the specific vaccine in question where it has been said India has booked 1 billion doses so we have really booked 1.6 billion doses one of the highest in the world and so on. This has been a big hype that has been there in the media in this week. Now what I understand is yes we seem to have booked something of AstraZeneca Serum Institute will probably give a significant part of its production to Indian government. We can understand that. Gamalaya we have got 100 billion which will come to this laboratory. We have some data on that. The NOVA vaccine again hasn't done any phase three trials. It's supposed to start phase three trials now and so where is the question of booking 1 billion dosage come from except as a verbal assurance maybe a wish if it is successful then we might buy something from you kind of promise and best. So these are not commercial contacts of any seriousness from what I can see. These are really wishes at the moment because the vaccine has not been proven again in the phase three trial. So this is a very strange kind of commodities mind that's a very strange kind of market really. Future's market is really future's market basically. Yes you're right that's more accurate. Future's market and so here's the issue. The NOVA vaccine platform is actually the more appropriate one for generating antibodies as compared to the BioNTech Pfizer, the Oxford AstraZeneca or the Moderna or the Malia platforms. On phase one phase two data in terms of the levels and quality of antibodies generated the NOVA vaccine to candidate results are promising. They are if anything better than all the others. That doesn't necessarily prove protective efficacy. You've got to show it. And the NOVA vaccine phase three clinical trial is just starting. So it's going to be two, three months before it comes through. So basically we're doing a little speculative future spent. The point of course is what has been committed? What is involved in all these booking, blocking, buying agreements is entirely unclear. Are prices agreed upon? Are supply volumes and schedules agreed upon? What precisely do these booking agreements consist of? I have not seen any reportage. I went to the NOVAx press releases and they have said they have an agreement with the Serum Institute to manufacture I think one billion or two billion doses in 2021. Now again, as you know, these are speculative figures because it'll depend on when the pastry trials results will come, how much time they will get and so on. But it seems that Serum Institute has shown a lot of interest in it and they have tied up an agreement and that has boosted NOVAx share price quite a bit because Serum Institute going with NOVAx for scaling up the manufacture itself is a big step. And this again proves our earlier discussion that India's generic platforms starting with what happened earlier with antibiotics and all other platforms too, even the biologics and the vaccine platforms have played a very important role. And that's why India today has some protection. Of course, this is really a different discussion on intellectual property and so on for a different day. But that one billion or two billion doses is the basis of the claim that we will get one billion if the manufacture two billion doses. By the way, Serum Institute has not said it will manufacture it necessarily in India. They have other companies or other places outside India also where manufacturers can take place. So we stop that Serum Institute commitment automatically becomes half of that becomes India's as people seem to be thinking. So I think there's a bit of smoke and mirrors here apart from the futures market also involved that everybody is quiet about it. India is taking a credit that we've got 1.6 million doses booked, but at the end of it, we don't really know what that means. And I'm very, very skeptical. There is anything in writing or any such commitment which exists at this point. So let me just add one more example to what you've described as the uncertainty. And that is the Serum Institute of India has committed, we all keep saying the Oxford AstraZeneca vaccine to India. And we are assuming that therefore it will go to the government of India. But the chief executive officer of the Serum Institute of India has also been quoted as saying that that vaccine will be available in the market in by March or April. So now I wonder how much of it is going to be sold at whatever the open market prices will be that they will determine for private consumption and how much of it will be supplied to the government to provide as a public health vaccination campaign. Well, the figures, again, all of this is up in the air, is 500 for the market and 250 for the government because they'll make bulk purchase. The figures we are hearing, but it may be half of that, it may be double that, we really don't know, unless we have seen something in black and white, we can't comment. And the government is very cagey. Serum Institute had said they will make 100 million doses in advance of the emergency use authorization. But what we now know, they have only 40 million doses in store. So a lot of this claims, we have to see when it comes to actual things on the ground. So we really don't know where we are all of this. But yes, interesting times, but what is also very surprising is that while whatever you can say about UK's emergency use authorization, jumping the gun and so on, claiming they have the best regulatory system because they have done it the fastest. But the fact prevails, this nationalism of this kind that is taking place, India government seems to be the most reticent about who the emergency use is for, what are the plans, what are the health workers, we have raised the time and again. And what their vaccine commitments are, what is it they have got commitments for, all of this is really up in the air. We hope at some point, the prime minister in his weekly, monthly, fortnightly talks, monkey bath, will also share this information with us. But at the moment, we seem to be in the dark about all of these issues. Thank you Satyajit for being with us, explaining some of the more difficult technical aspects of these issues, which pertains to public health. As you keep on saying, vaccine capitalism, not only vaccine nationalism, but vaccine capitalism. With that, we thank you all viewers for joining with us. Do keep watching, do click and do visit our website.