 Hello and welcome to NewsLeak. Today we have with us Dr. Satyajit Rath and we'll discuss even if the vaccines do become available and we'll discuss when it's likely to be available, how will it reach the people, whether it will at all reach the people who really need it. Satyajit, it does look like now by end of the year among all the vaccines which are on phase 3 trials now, some of them will act be available or at least get into manufacture. Now, is that likely as a scenario? Do you think by beginning of next year we'll see the availability of the vaccines at least to some people? So let's start with what shall we say, statutory disclaimer. The statutory disclaimer is that while all preliminary evidence for all the half a dozen plus vaccines that are now in phase 3 clinical trials, for all of them the preliminary evidence looks good, but that is no guarantee or even assurance that they will provide reliable reasonable term protection. That's a statutory disclaimer. This is a matter of trial and error. The proof of the pudding will be in the eating and the phase 3 clinical trial will show this. That said, the answer to your question is still with a spoonful of optimism, most likely yes. We will see more than one vaccine with a reasonable degree of protection, my guess is by the end of the year. And if we take WHO statement that the vaccine is not the silver bullet, of course silver bullet refers to as you know vampires and therefore there's a bat somewhere in the picture in the silver bullet imagery, but having taken that for granted. Shall we say that also that we do not know for how long the immunity would last? That is the other question mark that hangs over all of this. Right. So WHO's cautious optimism, which leads it to say that the vaccine is unlikely to be a silver bullet, refers to the way I phrased our statement just now to say reasonable degree of protection for a reasonable length of time. Two disclaimers, people may not have understood this, you're making two disclaimers here. Reasonable degree of protection or 100% protection, maybe 70% or 80% and other is we do not know for how long. These are the two disclaimers you have put. Yes. So and those are the uncertainties that the WHO silver bullet comment is referring to. Although I must confess that the first thing that struck me as well was that this was in the context of the bat species of the world. This was a particularly unfortunate use of imagery. But yes, that's what is in tech. Okay. So having got that out of the way, the question is of course that we have now a number of these vaccines entering trials. There are also two Russian vaccines which seem to be entering trials. There are two Chinese vaccines. There is two US ones, one Moderna, I think one Pfizer is also there. And then of course we have AstraZeneca, which is a tie up in India with the Sedum Institute. And Sedum Institute is also now proposing trials to be held in India with the AstraZeneca vaccine. Now all of this, the question and I will start with the selfish argument in terms of India. Is it likely to be available to India in the beginning of the year? Is that the likelihood? Let us take the most optimistic scenario for India and describe that. The most optimistic scenario for India would be the Chimpanzee adenovirus vaccine trial, which is in phase three trial in more than one location across the world now. To show results that are sufficiently striking for their DMSB, their data management and security board to say, oh, stop the trial. We're done. At that point, supposing for example that happens by October or November, by that point, if the Sedum Institute of India has actually managed to put together a reasonable stockpile of that vaccine, then what we might have is an actual vaccine rather than a vaccine candidate that is available in India and for which politically speaking, politically in the broadest sense, politically speaking, a public commitment has been made that half the stock will be immediately available for usage in India. And if that happens, now that's a whole series of optimistic assumptions. If that happens, then I would imagine that by the end of the year, we will begin to have particularly at risk groups beginning to be vaccinated. Okay. Now you have raised, I'm going to reduce all those disclaimers which you're so fond of putting so that we get some figures which we can talk about, which is that assuming that we have, by October, we have some proof November acceptance, December production. So beginning of January, this is your optimistic scenario, beginning of January, we start seeing vaccines being manufactured. Now the question, 50% of that being made available to India, that's the real question. And again, secondly, that Austrozenka has contracted with Sedum Institute. Now, while 50% may be available, but it doesn't mean the first match will be split 50-50. It could be, yes, it will be available, but the first dibs is for the UK who want 60 million to be given to UK first, and then the United States, which is I think given about 1.2 or 1.5 billion dollars to Austrozenka again, and then they get the second lot which could be 300 million, and after that you will get half, that means 360 million could be after the first 360 million are delivered. It's possible, isn't it? So absolutely, and a core issue in all of this is that we in the sense of public discourse only know what the protagonists in these commercial agreements are willing to tell us. We haven't seen the agreements. We haven't seen the consultative commitments that they've made to each other. So when the Sedum Institute of India with all good intentions and goodwill in the world says that they have a billion dose capacity, what the timeline for supplying this billion dose itself is quite unclear. Similarly, as you point out, what the priority of the 50-50 commitment to India versus overseas will be for each batch of vaccine as it comes out of production is entirely unclear. So it's quite possible as you point out that the first few batches may simply go overseas to meet to Austrozenka's core problem in all of this is that we have no idea of the detail and the devil is in the detail. And therefore, this is something to worry about quite seriously. So in these agreements, as you put it, the devil is really in the detail, and 50 is okay, but 50 when 50 or what are all unknown unknowns in this particular case, so we really don't know. And the point simply is that there are commitments which are commercial commitments that Austrozenka has made being in supported by UK, they have taken money and Oxford facilities for this. And therefore, there is a stake that UK has in the vaccine and they have taken a lot of money from the United States as well. So having done that, there is a commitment obviously, this is nothing is for charity. So there is a commitment of quid pro quo and that is of course delivery of the actual produced vaccine. And if Serum Institute is as the largest generic vaccine producer in the world as a tie up with Austrozenka, they have to probably look at the fine print of Austrozenka's contract and of course, what is their contract with them, both of which are unknown at the moment. So it is not clear that just because the vaccine is there, it is successful and it is being manufactured in India that we shall therefore start seeing the vaccines delivered to our markets immediately. And of course, we have 1.3 billion people and that's hell of a lot of vaccine doses we are talking about. So question to you Satyajit and you have been also as much into the intellectual property discussions as anybody else in the science movement and the health movement to both of which you belong to both of these. The question is, is there under the patent act, don't you have provisions to get around this because the section 92 says we can actually break any patent for a health emergency or an epidemic and everybody recognizes we have both of these on our hands at the moment, WHO has called it a pandemic, the government of India has called it a disaster management act, disaster. So both ways it is satisfied. The question is, do we having the legal instrument, do we have the scientific and technical infrastructure to actually execute this and break if necessary, AstraZeneca's patent or whatever the property rights may be and manufacture it using public sector instruments that are there? So sadly, the answer is going to be that in principle, all of this is possible in practice in all likelihood eating is not going to happen. So let me unpack that. In the first place, all of these vaccine candidates that we are talking about at the moment are vaccine candidates that depend on a very specifically configured and designed vaccine delivery system. So copying that, manufacturing that are in manufacturing terms cutting edge technologies. In terms of laboratory science, they're not cutting edge technologies, but in manufacturing terms, they're cutting edge technologies. So the real question becomes, who has the capacity to do this and who will actually do it? So does Indian public sector science and technology have the capacity to rebuild these sequences, for example, of the Oxford vaccine vector or the modern RNA? Absolutely, yes. But the trouble is that they only have the capacity to do it at the lab scale. So which biopharmaceutical manufacturers have the capacity to do this at the manufacturing scheme? And the answer to that is that there's only a small handful of private sector manufacturers who can do this. Will they do this? The chances are no, because they will face downstream ostracism of all sorts from these original ITR holder companies, with whom all sudden none they have to be in business for a long time to come. So do I expect that the private sector will take up the challenge even if the government actually wrecks formally by legal notification the patent rights? And my guess is that the private sector manufacturers who will be willing will not have the manufacturing technological ability, and those who have the ability will not be willing. So what remains is the public sector. So the real question to ask is, does the public sector have this capacity? And the answer to that is, we don't know. We have no idea what the current capacities of both moribund and non moribund public sector manufacturing enterprises are in the country. It's astonishing to me that over these past few months, when it has become more and more apparent that public sector manufacturing is likely to be a major factor in a policy response to COVID-19 as a pandemic, the government has made absolutely not one peak about the state of the public sector manufacture. What you are saying is absolutely spot on that this government as well as the earlier governments have believed that the public sector is no longer critical to India's economy or India's technological development, which earlier was not the issue. And also that the public sector, public health are intrinsically linked in this particular ways is also not something that they seem to have recognized till we got the pandemic. Now, you were in Haffigan Institute earlier, once upon a time in your student days. I think after your postdoc also, postdoc also sometime. So Haffigan Institute had started essentially for playing vaccines. This is what it really was set up to do in the 20s and did it in the 30s. At the time, we did not even have the antibiotics and the sulphurs, sulphur drugs which stopped playing later. So this is where the vaccine Haffigan Institute was mass producing vaccine in the 30s, if my memory serves to be correct. And they seem to have given it up when other public sector units came up and they said, we'll do the research but not the vaccine production itself. But at that time, we have built in the public sector also the vaccine production capability. So what happened to all of that? So a small digression since you brought up my 35, 40 year old years back connection to the Haffigan Institute, a small digression about the Haffigan Institute as a public sector manufacturing capacity. So in the first place, while we all refer to it as the Haffigan Institute capacity, since about 1977, the Haffigan Institute formally has not been the manufacturing public sector organization at all. The Haffigan Institute is simply a state level science and technology institute, research institute. Because in 77, the entire composite enterprise was bifurcated and the public sector manufacturing unit was spun off separately as Haffigan, precisely as Haffigan biopharmaceutical corporation, not pharmaceutical, biopharmaceutical and in the early years of the Haffigan biopharmaceutical corporation, it continued to build its already well established strength in vaccine manufacture by actual on-site manufacture of polio vaccine, for example. But as we come into the 90s, if we look back in common with the disdain and the ignoring of public sector manufacturing, particularly in the drugs and vaccines sector, the Haffigan biopharmaceutical corporation was similarly starved of technological upgrades both in their human resources and in their manufacturing resources. So that in common with many other public sector vaccine manufacturers, the Haffigan biopharmaceutical corporation has also regressed from being capable of a vaccine manufactured from scratch to being essentially a repackager by buying bulk from outside and repackaging doses. Now, I speak as an outsider. Today, my 35-year-old association doesn't give me any special information, but it's part of public knowledge that this is what we've done to the Central Vaccine Institute in Kasoli, the King's Institute, Haffigan Biopharmaceutical Corporation, and in the broader pharma sector to the Indian Drugs and Pharmaceuticals Limited, and of course, to the Sun Antimimics. So across the board, we have systematically starved our public sector biopharma manufacturing capacity of human as well as technological upgrades that would keep them competitive for manufacture from scratch. And as a result today, I'm not sure that they have the capacity. Now, let me bring up one interesting public sector manufacturing possibility. The Government of India, I don't know, 15 years, 20 years ago, something like that, built a company, public sector company called Bibco, Bharat Immunological and Biological or something like that, Bibco. Its works are located near Delhi, I think, in or near Gulanchai. This is a public sector company under the Ministry of Science and Technology. It's recently set up. I am astonished. Do they have the capacity? Can they build capacity? Can they be part of our strategic tactical approach to providing drugs, biologics and vaccines for India during the COVID-19 pandemic? None of us seems to have asked this. Most astonishingly, we have an opposition that doesn't seem to have asked this at all. So these are the kind of questions at least the people's science movements need to ask in the country or the people's health movements need to ask in the country. So I'm glad that we're having this discussion. But one clarification just for our viewers, that when you talk about the biopharmaceuticals, you're really talking about both vaccines, which are one of the oldest modern medicine repertoire that we have, as well as the biologics, which are the latest in what we will call as the weapons we have against microbes. So vaccines, the oldest, and in this sense, the biologicals, the latest, both come under the biopharmaceutical as distinct from the chemical pharmaceutical sector. This is a distinction which may not be known to most of the viewers. Absolutely, yes. As a matter of fact, let me give the more sort of shallow entertaining add-on to that. The first Nobel Prize in Physiology and Medicine ever went for something called Serum Therapy to Emil von Behring, which is the equivalent of the plasma therapy that everybody is talking about. So clearly, a biologic and or vaccine related product. And one of the more recent Nobel Prizes in Cancer Immunotherapy has also been about biologics that modulate immune responses. So absolutely, you put it very well. And that is indeed the biopharma sector ambit. So if we conclude with this, that we have the scientific and technical capability. The question is, do we have the political will as the government of India and as the people of India, not going to put it only on the government of India, to also now say, if not now, then when? That if we do not pull our socks as they put it bluntly, rather weak phrase, I'm afraid. But if we don't do it right now and do this on a scale, which it requires to be done, we're talking about not millions, you're talking of really 1.3 billion. And if WHO's caution is to be taken for granted, or yours for that matters, that we don't know the duration, we may require it every year or every two years. So this is really a mammoth task just for India alone, not doing what we did during the AIDS epidemic where it became virtually the pharmacy of the world, because all said and done, 7.5 billion people were not at risk, unlike the COVID-19 case. So therefore, this was really a much smaller task than what we face today. But it is interesting that the government of India is, I think you've said this earlier, willing to bank upon the goodwill and the dynamism, if that is what we should be talking about of Indian capital and its philanthropy to provide the people with the medicines and the vaccine it requires. It doesn't seem to have anything else except given permission and talking the good talk. That's where it seems to be. But beyond the talk, we don't see much that seems to be happening, at least visibly. So let me quote our 1000-year-old master of the Pithi statement in what question we should be asking the government. This is what Kabir said. So that is the question that has up to date a 1000-year-old question as that. Either the vaccine or the possibility of a Yamapuri, though the only thing is this is not a mortal disease as you have said earlier. Let's not scare the people too much. Getting COVID-19 is not an individual risk as a social risk, because even if the percentage of figures are say one or two percent that they appear for us a small risk for society, it's a huge number. And that's where the Yamapuri threat comes out. So the Yamapuri threat comes up to simply take your point further, not because, as you say, COVID-19 is an individually high-risk disease. But because if we don't keep spread under control, the disaster visited upon our socioeconomic life is going to start killing people who do not have COVID-19. And for the government not to have a policy to address these effectively horrifying possibilities is a responsible invest. Thank you very much, Satyajit, for being with us, taking us through rather difficult technological terrain. And it's not a simple issue when you talk about vaccines, biopharmaceuticals, and of course, the larger social, political economic issues. This is all the time we have for NewsClick today. Do keep watching NewsClick. Do visit our website and also our YouTube channel.