 Hello and welcome to NewsClick. Today we have with us Dr. Satyajit Rat in our usual discussions on COVID-19 and what the prospects are. Satyajit, today let's focus on the vaccine. And we have the Director of Ames who is also on the Task Force of the Ministry of Health on COVID-19 issues. Now he has said the vaccine is not likely to be available to the common person before 2022. Now this goes against the grain of what the Minister of Health, Dr. Harshavandan, has been saying, who said by middle of 2021 will have 22 or 25 crore people who will have been vaccinated. Now that's a very large number and we had raised this issue. Are we actually in a position to put in the infrastructure required to do this at a large scale that Dr. Harshavandan talked about? So Dr. Guleria seems to have disagreed with at least tacitly with what the Health Minister said. So part of the difference is that all said and done, Dr. Randip Guleria is the head of at least a nominally autonomous organization and is therefore a little more likely to tell the unvarnished truth than a government minister no matter how well-intentioned they may be. So clearly the fact of the matter is that despite recent enthusiasm over the past two days, we still don't have any definitive vaccines, what we still have are vaccine candidates. So there's going to be a fair amount of time taken for the approvals process. Keep in mind that the approvals process is country specific. The approvals process of the CDSCO which is the regulatory authority of the government of India will have its own take on it, will have to take its own time for approvals when applications are made to it. All of this is going to take a fair amount of time. I'm aware that we're all jumping up and down thinking that the Serum Institute of India which is emerging as an unlikely savior in the eyes of many people in the country is promising X, Y and Z numbers of vaccine doses of more than one vaccine candidate in fairly short order. What we don't know is what the scheduling of those doses would be like, which vaccines would be available in what numbers at what times, what would be the storage requirements of those vaccines and whether the 27,000 cold storage points across the country in public health centers, primary health centers, mainly, that were used for cold storage of the Pulse Polio campaigns are still reliable, functional, repairable and have appropriately skilled and trained personnel to be administering the vaccine. Keep in mind that the Pulse Polio campaign was oral vaccines giving drops to babies is a very different thing from pulling out a dose into a syringe and then sticking a sterile needle into somebody's arm or hip. So none of this is particularly clear as yet. So my expectations are, I must confess, more towards Professor Guleria's stated estimates rather than the far more optimistic estimates that the minister has provided, although I wish the minister were right. Particularly since we do not have a clear picture of who is doing what, what the plans are, there is a lack of clarity and a lack of transparency, if you will, of how the government proposes to do this because this involves the state governments, the central government, the vaccine provider, all of them to work together in order for successful delivery of the vaccine and that picture is not clear at all. Particularly as you said, we don't know which vaccine and which vaccine manufacture. That brings me to the next point, which we have been postponing for some time. What is the immunogenicity or the efficacy of the vaccines, which are now in various stages of clinical trials and the Pfizer one has made a lot of noise the last few days. I'm sure the Pfizer's stock prices have risen significantly and strangely enough, the oil prices have also risen significantly. The back of the Pfizer claims about how the vaccine has been highly efficacious, 90% efficacy and so on. But before we go into the Pfizer vaccine, the efficacy part of it, one thing is that we must also understand the three vaccine families that we are talking about right now. One is of course the Rinovirus vector vaccines, which are the Malia vaccine, the AstraZeneca vaccines and so on. So this is one set of vaccines that we are talking about. Also the whole inactivated virus vaccines, which India is also manufacturing. But apart from that, you have the protein vaccines subunit of all protein vaccines and you have the mRNA vaccines. mRNA is the only one that requires ultra cold chain minus 72 minus 80 degrees. Now do you think that, and this is the Pfizer vaccine at the moment, also the Moderna vaccine, do you think it actually is something that we can even think of in countries like us, us and also in large parts of the world, considering even Mayo Clinic has said they don't have the facility for ultra cold chain for the Moderna vaccine or the Pfizer vaccine. So clearly the RNA vaccines which require this ultra cold storage, which include as you point out the Moderna and the BioNTech, which Pfizer is only the money bag for, but is. So the vaccine company that Trump wanted to buy, if you remember, the Germans are very unhappy about, finally Pfizer stepped in and said, hey, we will manage them, don't worry. Correct. So the RNA vaccine storage issue, I am personally aware of at least a dozen groups across the world, including in India, who are desperately trying to test small modifications that allow them to be stored at more and more practical temperatures. So you are saying this is an impractical temperature for most countries. It's certainly an impractical temperature. It's an impractical temperature for the US, even though very brave noises are being made by the federal government in the US, at least in the Trump administration. One has no idea of how a Biden administration will look at this, especially since Vivek Modi's co-chairing the Biden and COVID task force with a much more realistic grasp of the public health situation. I don't think that that's practicable on a large scale. Is it practicable for well-off people to get an RNA vaccine with this kind of a cold chain, suddenly? Pretty much anything can be bought if you have enough money for it. So yes, but is this a public health answer and response? The likelihood is no. One technological response to that reality has been that a large number of groups, and I'm certain that this includes Pfizer and BioNTech and Moderna and so on and so forth, are trying to tinker with this stability issue. I've heard encouraging lab rumors about stability at much higher temperatures, meaning closer and closer to zero degrees. So my expectation is that over the next few months, those issues will also come into play. Now, keep in mind that it depends on how much the tinkering is. If the tinkering is too much, then it needs to go through an approval process all over again. So none of this is easy and straightforward. But clearly, the RNA vaccines have a major scale hurdle of implementation because of the temperature issue. There's just no avoiding that. So they might be easier to scale up in terms of production, and that's what we had discussed earlier. But in terms of the delivery mechanism and the cold chain that is involved, this is actually a much harder task. And as you said, even if the U.S. has problems, let's forget about most of the world. Now we come to the other vaccine, which has also been a certain amount of noise, Novavax vaccine, which the CEPI GABI platform, which is the one which WHO is working with, which is trying to make a number of vaccines compete with each other and then deliver at the low price this to most of the developing countries. This is what the WHO Vaccine Alliance program is. The Novavax vaccine is one of the Covax vaccines that have been identified. Serum Institute has said they will manufacture a billion or two billion doses. Now the immunogenicity reports initially indicated this also had strong immunogenicity, that means strong immune responses in the body. So how would you rate that? Of course, we don't have the figures that Pfizer has produced for the BioNTech Pfizer vaccine. So first, let's keep in mind that the BioNTech Pfizer data that have come only as a Pfizer press release so far and nothing else, are an extremely preliminary look. And to be fair, the press release says that this is an extremely preliminary look and therefore one is very tempted to think that the press release is primarily directed at the stock price and at building public pressure for approval rather than as a serious scientific statement. But be that as it may be, the reality is that experience with the RNA, DNA, viral vector platforms versus the protein formulation platforms has by and large been that the protein formulations tend to give higher levels of antibodies. So number one, number two, most generic manufacturing companies such as the Serum Institute of India are far more comfortable with protein based formulation technologies at the manufacturing level. Number three, it has been apparent and if one looks at all the phase one, phase two published peer reviewed reports of COVID-19 vaccine candidates, it's very clear that the side effects, adverse events of RNA and or viral vector vaccines are somewhat more than those for a protein vaccine. They're not serious but they are there. Pain, fever, related issues tend to be apparently a little bit more frequent with RNA and viral vector vaccine candidates than with protein vaccines. Put all of this together with the fact therefore that even at with all this in mind, if the BioNTech Pfizer vaccine is working pretty well, then I think it's a reasonable expectation that most other vaccines will work. Most other vaccine candidates will work pretty well. Certainly the protein vaccine candidates will work pretty well. Those are also manufacturing technologies that although a little finicky here are actually more familiar for the industry. In fact, the institute has said they can produce 1 billion to 2 billion doses a year. That's a very large number. Of course, Serum Institute is the largest general vaccine manufacturer in the world. Absolutely, yes. So there is that issue. Added to that is the fact that unlike say the Pfizer vaccine, the Pfizer CEO, the Pfizer Vice President have made it very clear that they are not part of any global public health effort. That for them this is a commercial opportunity. They will treat it as a commercial and company value opportunity and not as a public health opportunity. On the other hand, Novavax has always worked with CEPI and with the other multilateral global alliances in the interests of public health. And protein vaccines we are familiar with. All our childhood immunization program vaccines are protein vaccines. We know how to store them. We know how to give them with all of this. My guess is that while we are going to see a mix of vaccines eventually coming next calendar year slowly, uncertainly, unevenly into the market. The fact that the front runners so far, speculatively, where the viral vectors, which were the Oxford AstraZeneca vaccine and the RNA vaccines, which were the Moderna and the BioNTIC Pfizer, the major countries of the global North have pre-booked many of these. That's my expectation therefore is that for countries of the global South, the immediately following vaccines such as the AstraZeneca, such as some of the Chinese vaccines, not the AstraZeneca, the Novavax and the Chinese vaccines, those may turn out to be the realistically accessible doses. And I must confess amused and impressed that the Zero Institute of India is quite extensively hedging its bets by taking on vaccine manufacturing for a whole range of those vaccines. It's good business. I'm not at all unsympathetic. And it's a good thing for India. In fact, it's a good thing for India if many such more vaccine manufacturing companies begin to do this in the country. One of them is Reddy's Laboratory with Gamalya. They have an agreement. Gamalya is also one of those which are the virus vector vaccines. We have to see what happens to that. But what you said about the Zero Institute that I would like to respond to that, it's also interesting because the Novavax vaccine was relatively an unknown vaccine. It's a small company. It has never successfully done vaccines. All that has been there. It's also the key person in that is also the Indian biologist, Dita Patel, I think that's a name, like Shyamla Harris, if you remember. Who's Gamalya Harris? Shyamla Harris, mother. Gamalha Harris's mother. Who was? Gamalha Gopala. Gamalha Gopala. Where is the Harris? No? Always Shyamla Gopala. Okay. Let me correct myself in this for this. So if you remember that the one of the key persons in this Novavax vaccine development is an Indian biologist who is of course in the United States, like Shyamla Gopala and Gamalha Harris's mother. And this is a debt that the first world has not paid to the global south because this is where trained biologists do migrate to the first world countries for various reasons, not naming them. But that's really the intellectual and physical debt that the global north incurs. So when they talk about, oh, we are doing this and we are doing that, they really tend to forget about this. But said an institute must be said that the fact that chose the small company with uncertain pedigree, which of course is also one of the war speed candidates. This is one of the six or seven war speed candidates the US is funding. But they decided to team up with them, as you said, also shows their business acumen. And the fact that of course, this is also part of the Novavax facility might have also influenced that. With all this vaccine candidate's picture may be clearer soon. But fundamentally, we still have to look at how to deliver the vaccine, where it can be delivered, by whom it can be delivered, all those issues will still stay. But it is clear the Pfizer and the Moderna vaccines are not for us. That part of it is clear at the moment. And also if you look at it, 2021, it's very far cry for bulk of the Indian population. It may only happen with the small, maybe fraction of health workers being able to be addressed by whatever is being done. I think the government needs to come clean on this, tell the people what they're planning, what kind of systems are being built up, so that vaccine, if and when it is available, can be delivered to the people. Thank you very much, Satyajit, for being with us, answering some of the questions which we have and I'm sure what the people also have. 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