Trial Of Oxford Vaccine By Aug In India: Aadar Poonawalla

The potential vaccine has now entered phase three. So first, I want to understand from you what are some of the key things that we should be watching out for once phase three is finally out. You know, if you talk to us about where we're at in the current timeline, how plans are coming along.

So we've committed more than $200 million that we've already started to spend on the opex and capex to make this product. And we have a capacity that we've borrowed from Serum Institute's existing capacity of other vaccines, to the tune of six to seven hundred million doses. And we'll scale that up next year to go close to a billion. So right now, we've committed more than $200 million to this candidate. If it doesn't work out, we'll have spent all that on the raw materials, partly some of the equipment. Because without doing that and committing fully right now, we would not be able to have any doses produced come end of this year. And that's very important because if we just wait for the trials to be concluded by October, November, we'll have no doses to give our country. And that's why we took this bold decision to bet and commit on this candidate very early on. We've got other four other candidates: Kenics, Novavax, and other partnerships as you know. But we're not producing anything else at risk. We're only doing this. And to answer your earlier question, yes, the trial I'm talking about starting in two weeks is in India on Indian patients, so that we have a phase two-by-three licensure trial done in India.

Well, not lower, but it does give you a very good sample size. You know, Oxford and AstraZeneca did it in a thousand patients. Canino, Moderna, and others have done a trial between 40 to 60 patients, which is a rather small phase one. But fine, I mean that's what they chose to do. So it does give us a better sense of the data and the safety. It doesn't necessarily give any indication of how well it's going to work out. And that's exactly why you're doing a phase three in thousands of patients.

Yeah, so realistically, and this is probably going to be a two-dose vaccine like most vaccines. Because if you look at all the other vaccines, pneumonia, rotavirus, measles, even the flu one which in fact you take every year, these vaccines are generally you take a primer and a second dose. So if we're talking about giving two doses to get that higher level and real good level of protection and long-term protection at that, then we're talking about at least two years before every Indian gets it, given our population size and demography. And the world will probably take four years before everyone's vaccinated because these volumes, getting them out, rolling them out is what we said. Early 2021 is when India is going to see large volumes rolling out, whether we succeed or others succeed in a lure of a product by the end of this year. So I don't think unfortunately the public at large is going to get large volumes till the middle of next year, end of next year. The doses will start getting rolled out by December, but as you rightly said, it'll take time to phase it and roll it out.

You look at flu, pneumonia, these diseases also exist today. Coronavirus is a little more infectious, no doubt, and is worse than flu of course, but it's not so bad that we can't live with it. So I think before any proper drug comes, and I know there have been a few drugs which have been given emergency licensure, but they're very expensive and I don't really know how well they really work. I'm sure they do a sort of fair to moderate job. I think that's the general consensus. So the point is that we all are going to have to live with this for the next two to three years. And I say this because till a really good vaccine or proper drug comes about, you can't expect to rush the science beyond what we're already doing today. We don't want to circumvent rules and laws, so we're all going by that as soon as we can. The regulators are helping us and supporting us, but nobody's flouting any rules or wants to circumvent any rules and laws because you don't want to rush the science. You don't want to play with people's lives that could be far worse than the disease itself. We've seen that in the past where certain drugs or vaccines were rushed to the market, there were serious complications. So we don't want to do that. Having said that, we need to just take our precautions and get on with our lives and work. There's no easy solution and early solution. Look, even if a vaccine gets licensed end of this year, early next year, we'll really never know till three to four years have passed to know if that vaccine is giving you that long-term protection. Only time can answer that. There's no way of analyzing or predicting whether this vaccine is going to give you that long-term immunity. Nobody can say that. No one can answer that for any vaccine. They can claim that they can predict it, but if you're wanting to be very frank and candid about it, till time passes, you can't answer that question. So we have to live with it. There's no easy fix or easy solution.

No, we're ensuring with the government that no citizen of India probably will have to pay for it because we're going to give it to the government and then they'll provide it free like they do so many other vaccines. And we'll ensure and plan with the government that the most vulnerable sections get it first: your healthcare workers, elderly people, immunocompromised, and then healthy individuals like you and I would probably get it last. So I think that's the responsible and ethical way of doing that. And as I said, the pricing would be, we said a thousand rupees, but it could be significantly less as the volumes pick up. It was just an indicative price because we said if a test is two and a half thousand rupees and you're going to probably do many tests in your lifetime, and you've got remdesivir and other drugs which go into tens of thousands of rupees as treatment, a thousand rupees with a two-dose vaccine, so it's 2,000 rupees for a full treatment is actually nothing. And we hope to bring that down significantly also as the volumes pick up. So I don't think affordability will have any impact or role to play for the accessibility. I think as long as the government and the vaccine producers work together to ensure that the product is given to the vulnerable sections, the price and the affordability will not play a role in this at all.

No, I mean, look, initially we want all vaccines to succeed because we want the best chance of success to deal with the disease. And different companies have taken different approaches. We've taken different approaches for our own in-house candidates. We're using live attenuated viruses. Bharat Biotech's gone for the killed vaccine, which is also a good approach. You've got Adus who's doing it in a different way. We've got other partnerships which are using different platform technologies. So we just hope that everything succeeds. I don't know how many ultimately will succeed, but let me tell you that after two years or so or three years, once we see and get more data from trials and other phase four studies, the World Health Community will probably conclude and converge toward some of the better vaccines, whatever they may be, whichever they may be. So those would be then further scaled out, scaled up later to give it to everyone else. So initially maybe there'll be a bunch of vaccines licensed, and then that number may reduce in terms of the off-take based on the data that they show. So that's how I think probably it's going to work out. That's how it's happened in the past for different diseases. Multiple vaccine manufacturers have attempted, made vaccines. Some have been better than others, and then the countries have chosen and decided what they feel with their health experts to be the best in their interest based on their demography. So that's what's going to happen in the next three to four years. But initially, I think there's going to be a lot of vaccines hopefully that will be licensed, and we're all wishing and hoping for that to happen.

I never like to make these predictions or anything. My hope and the science, and I mean what we're hoping, that this will be 60 to 70% chance of success is there. That's what I feel. There is never anything which is 100%, especially this early on. We're hoping, and this is what I've been told by the Oxford scientists that they have 60 to 70% chance they feel and believe that the vaccine will succeed. I can only go by that. I really can't make, and I hate making any predictions on success because anything can happen. We don't have enough data to predict anything at this stage. But this is the hope, this is what they have said. So I'll go by that, and then we'll just have to wait and see where we end up.