 Hello and welcome to NewsClick. We're going to discuss with Dr Satyajit Rat, COVID-19 and its other implications in terms of science or what we are learning from the frontiers of medical sciences. Satyajit, today's discussion, let's start with the vaccine issue. Now, it seems that the vaccine is also becoming an electoral ploy in the US elections and Trump wants to sanction user vaccine before the election campaign really starts. Do you think that is a possibility and what are the implications of that if that happens? Well, let's look at it this way. There was a ploy to declare a vaccine on the 15th of August, 2020 and that clearly did not work. This is your talk of the Indian vaccine that Modi would announce from the ramparts of the red port vaccine. Thankfully, that did not pan out. Proper procedures are being followed so far. But certainly, following on from that as well as following on from their own previous efforts at short-circuiting due approval processes, the US administration has now declared the 3rd of November to be a potential target date and it's a little bit further away than the 15th of August. Phase 3 trials have already started. So, is it within the bounds of possibility that the data might come in time for a rapid but proper procedure to certify a vaccine? There is an outside chance. It's not a very good chance but the US FDA and its political masters as it turns out have now begun apparently making noises about preparing ground for a short circuit of due process. Okay. So, a short circuit of due process is already being discussed. So, that's exactly what an emergency use authorization is, which is apparently what is being discussed. Okay. The whole point about having an emergency use authorization is that due process of efficacy for approval has not been gone through in its entirety. This is the hydrochloroquine authorization or the plasma therapy authorization as well. Correct. So, the hydroxychloroquine was a... So, it's interesting that you bring it up because it's instructive for us to compare and contrast what's going on. So, hydroxychloroquine was authorized on two grounds. One, that it was safe because it's already in the market and being used. And two, with no data whatsoever of any rigorous kind, meaning no clinical trial data, that there were anecdotal stories that it might be useful. The emergency use authorization therefore depended on saying, hey, it's safe and it might work. Okay. So, at least it satisfied the safety requirement if not the efficacy requirement. Correct. Now, that's precisely what is apparently being discussed as the basis for an emergency use authorization for what I keep calling candidate vaccines. Okay. Again, it is said, they've already been shown to be safe because they've finished phase one and phase two trials. Those trial results have been published and therefore they're safe. Okay. Whether they work or not, they likely work because they generate neutralizing antibody responses. We'll get a little bit of phase three data that begins to show some differences that should be enough for an emergency use authorization. So, it's been argued that it is safe and therefore there is not so much of a risk. This is the argument. This is the basis. I haven't heard the actual FDA personnel being reported as having said anything in this much detail. Simply the more opaque noises about we are looking at possibilities. Okay. But this is likely to be the basis. What's interesting is for us to look at the difference between a drug and a vaccine in the context of emergency use authorization. Okay. You give drugs to sick people. That the drug has a long history of being safe. You are giving it to sick people. You're hoping that it'll make a difference. If it doesn't make a difference, you're hoping based on its safety profile that it will do no harm. It will have no adverse consequences. Now, at least the safety has been proven. Therefore, risk to sick people is one issue. But here you are giving safety based on phase one and phase two trials to healthy people and that to a much larger number. So, it's a little, you're right, but it's a little more complicated than that. And here's the complication. Remember what we said about the drug. We said that if it doesn't work, it won't do any harm. It will have no adverse consequences. So, let us ask, is that true of a vaccine that doesn't quite work? Now, this is not simply a matter of safety, because let us admit that phase one, phase two trials have been done and therefore the candidate vaccine is safe in terms of the adverse effects. I take the vaccine for the next 15 days or three weeks. I'm healthy and I have had, apart from a little local pain, apart from a little fever, I have had no ill effects. Is that going to change if it is given under an emergency use authorization? Not likely. But remember what a vaccine does. A vaccine generates an immune response. The immune response we hope will last for a substantial period of time. This is very unlike a drug. You want the drug to have an effect while the drug is in the body. That's it. The vaccine is designed to create a long-term downstream effect over time. Now, in this context, consider what might happen. Supposing, just supposing that all is well, the vaccine offers some measure of protection and that will say that the gamble has worked. But suppose alternatives. Number one, the one alternative is that there will be an immune response. The phase two trial has said that there will be immune responses. So, when it's given under an emergency use authorization, there will be an immune response, but that immune response won't protect. Now, it's caused no harm because you say the people who are vaccinated with this emergency authorized vaccine are no worse off than people who are not vaccinated. Not quite. And that's where the difference becomes prominent. In the first place, we know, for example, in India, we are very familiar with the idea that a pre-existing immune response to dengue virus can actually enhance these caused by dengue virus. This is not at all to say that I think that's what's going to happen. This is simply to point out that in the immortal phrase, stuff happens. I mean, there's a stronger word than that, but we'll leave it out. But if that is a possibility, then what we would be dealing with is an adverse effect that is generated by an emergency authorized vaccine use in healthy people over a reasonably long term. Now, let's also break it down a bit. What you're saying is I get the vaccine and it doesn't really give me protection against the infection. I get the infection. Now the reaction of the body actually makes the infection far worse. Is that the lag? This is what seems to happen in the second dengue infection. The second one becomes much more. What is thought to happen in the dengue example? Kind of a cytokine reaction? Well, let's not even get into how it happens, because in all likelihood, how it happens in dengue is not going to be exactly how it happens in other instances. But the fact is, is this a possibility? Yes. Has it been ruled out? No. No. What would rule it out? Has such a case happened in the past with the vaccines, for instance? Not to my knowledge, but that's because in the past, no vaccine has been authorized through a short circuit. Remember, we said if there's protection, well and good. If there is just no protection, then it's okay. It's no worse. Whereas in the unlikely event that there is exacerbated diseases, we're being troubled. But that's unlikely. You say the most likely thing is that it won't protect after all. But that's not all. Even though it doesn't protect, it will have generated an immune response. Now my body is experienced with a SARS-CoV-2 vaccine and has generated a response in a direction that is apparently not protected. Okay. This might make me resistant to the effect of an actual vaccine. Okay. Okay. So if I get... Now that I have my body has experienced with some components of a candidate vaccine and has, for whatever reason, ended up making a response that's not protected. That's background. Now on top of this, I get a vaccine, even a vaccine that actually works. But my body may have very different ideas about how to respond in the light of its own previous experience. So it will react in that direction much more strongly and therefore the actual protective reaction may not take place. And while we do not have really, apart from Dengue, too many examples of exacerbated infection, do we have examples of redirected immune responses based on previous experience in truck loops, in experimental systems, in human systems? There are any number of examples where a previous experience with an infection modifies the direction of response to a subsequent immunization. So let me summarize it for our viewers. So one risk we carry is a Dengue-like response where the second infection, in this case, not from the vaccine, but from the virus itself, could provide a much more serious reaction in the body. So that is one. That's a risk. But you were saying, maybe it's not such a big risk, but certainly the more known and established risk is that instead of the body's immune system reacting, which it would normally do, because of the vaccine, it may direct itself in a different way. And that may actually make me more open to infections than would have occurred otherwise. Have I summarized this for my viewers? Yes, except that it's more that a vaccine that works may not work in these people. And added to that, a vaccine that works in other people will not work in this. It may not work in these people. Remove the protection, possible future protection by giving a not properly tested vaccine. Now let's take this further from science into actual public policy, because somebody will say, yes, but these are all possibilities in the Phase 3 clinical trial. Yes, but the Phase 3 clinical trial, this is precisely the reason why those trials are stringently designed, observed, supervised, and reported. Whereas authorizing use in the community is a whole different thing altogether. You don't even know who's gotten it, who's not. You're not really keeping stringent track. And in terms of public policy, what you're effectively doing is you're saying emergency use authorization, people can take the vaccine. And the result is people who take the vaccine don't think of it as a candidate vaccine with themselves as volunteers in a clinical trial. They think of themselves as taking a proven vaccine. And therefore their behavior changes. And under those circumstances, unlike in a Phase 3 clinical trial here, the chances are that if it doesn't protect, then people who think that they are protected but are not protected will eventually become themselves focuses of infection and spread. Let me add Satyajit to what you've said. If such an adverse case happens, meaning a failure of a magnitude, which is likely to occur if you do emergency use authorization of the vaccine, and it fails, then given the anti-vaccine campaign in the United States, which is apparently about 15 to 20% of people there don't believe in vaccine itself. And unfortunately, with the Facebook, we heard about the BJP being an ally of Facebook in India. But we know that Facebook has allied with the anti-vaxxers, not because it believes in anti-vaccination philosophy, but because that is the virality of Facebook's algorithm, that they have got huge numbers in the US today who do not believe in vaccines. And social media is a big spreader of this thesis. And unfortunately, I have come across this campaign now in India as well. So this anti-vaccine or anti-vaxxer campaign, as it has been called, is also going to gain a huge traction from this, and they in fact threaten all our vaccine programs in the future. Just no question about it. You're absolutely right that the irrational anti-vaccine perspective is going to gain ground from an emergency use authorization of a vaccine. In fact, even if the vaccine works, because the propaganda is going to be unproven, untried vaccines are being thrust down people's throats. So, I think that that possibility is even broader. It's particularly a problem because remember that this is a pandemic vaccine, which means that when we get effective vaccines in the plural, as I keep hoping, what we are going to need to do is immunize the population of the world in as short a time as possible. We should have structured plans about how to immunize them. Emergency use authorization does not lend itself to planning for vaccination implementation campaigns. It becomes much more chaotic. It leads itself to panic planning. Exactly. This is complicated even further by the fact that pretty much all of these vaccine candidates that are being tested are not single dose vaccines. Yes. Pretty much all of them will need at least two doses, perhaps more, but at least two doses. Now, more than one dose of a vaccine needs extremely careful, systematic, detailed planning for implementation, even when it's year by year immunization of children in the country. When you're trying to immunize the population of the world in structured, carefully targeted, and prioritized global basis, which is how we should be doing it across the world, two doses actually hugely amplify the operational difficulties involved. Satyajit, it's also clear that we are moving into magic remedies in the realm of at least policy, that we think there's a magic bullet which will be authorized by Mr. Trump just as he forced the FDA to authorize hydrochloroquine and thinking that that's a magic bullet. Now, of course, it's not that he's alone in this. There is also the Russian vaccine which we have criticized earlier, but at least they had said first of somewhere in January that it will be available for mass use. But here we are talking of really November, which is third of November, which is much earlier than that. But more than that, it does appear that the world over 15th of August, India's case was the earlier one that we criticized here, that we are really not talking of public health policy. We are really talking of magical remedies in this sense, that it will come from somewhere, this is in the silver bullet, it will solve all our problems, life will again become Machidori. We're not thinking that this is a watershed moment and it might need to change our policies and our behavior for at least the foreseeable future. It's completely consistent, what we are seeing masquerading as public policy across the world is completely consistent with the logic of rapacious capitalism. There is no disaster that you cannot turn a profit from. Disaster capitalism as Naomi Klein put it, so this is disaster capitalism on the basis of a pandemic. And it's how the states of the world are responding in public policy from the perspective of what is effectively the spirit of disaster capitalism. That's an interesting point to keep in mind that disaster capitalism, like all capitalism, is willing to turn a quick penny and is not really bothered about the long-term consequence of what happens. And this is exactly now the case, when you want to turn a quick buck, but also think politically a quick buck, that political capital. That's what I meant when I said the spirit of disaster capitalism is masquerading as public policy of right-wing governments. Thanks Satyajit for being with us talking about the vaccine issue, which I think increasingly is going to be the focus of our discussions in the future. Because it also brings together complicated science and we have already argued that immune systems are complicated and therefore vaccines are obviously also complicated and also public health policies and what we need to do. Unfortunately, the first brain of the pandemic has been the public health policies and we're really looking for solutions which are somehow politically going to satisfy the bosses. But unfortunately, viruses don't seem to understand this and that's going to be our problem. And the people, how they respond is going to decide what's going to happen in the future. Thank you very much for being with us and our viewers. Thank you for being with us and do keep watching NewsClick videos and also visit our website.