Oxford's vaccine trials will be over by January in India: Poonawalla

Absolutely. Nice to talk to you, firstly. The trial in the UK is almost complete. They're talking about an emergency licensure there because there are some reports that hospitals there will receive the vaccine early because it is reducing a good response. The T-cell response, which is your CD4 and CD8 cells, which is what you need for long-term immunity, in addition to your antibodies, which are there anyway. The data is very good. As a result, if the UK goes into an emergency licensure, it will be up to the government of India to then decide and take a call after analyzing that data whether we follow suit in about a month as well. Having said that, our own trial in India will be completed by January. So now it will be up to the UK health authorities and the Indian health authorities to take a decision on how safe and efficacious this vaccine is. As you know, we've been stockpiling a lot of this product, so we'll have substantial volumes by December or January if they decide to license the vaccine by then to distribute.

That will depend entirely on the Drug Controller of India after he analyzes the data coming in from the UK and in India that we've got so far. If he thinks it makes sense and the health ministry officials and other ministries, who are all coordinated in this joint effort, decide that at risk, for a limited amount of people—whether it's the healthcare workers and the elderly, the vulnerable populations—we give a limited amount of vaccine to them, come December or January, that is possible. But again, after we look at that data which will be available in about two weeks' time from now from the UK.

Absolutely. You've articulated that perfectly. So we get a limited amount of supply out to the most vulnerable early on, and then we give the rest of the population once all the trials are fully completed. I think that would make the most logical sense. That's the way everyone is going to go.

January. Because we've already given the first dose to most of the patients in the trial, which is more than a thousand so far already. The total trial is for 1,600 patients in India. So once we give the second dose and then analyze their samples and monitor them for safety and efficacy, that's why I say January to be absolutely safe for India. But then again, we'll have to wait until all the data comes in from the UK to collate that together. Then the Indian drug controller will have enough data to decide which way to go and when to license the product.

Initially, nobody knew how that should happen. We also had a feeling that we should give it to the most vulnerable to begin with—the elderly, the healthcare workers, and other vulnerable pockets. Then we've heard that the center, the health ministry, will decide, and it's not the states individually or any company. We respect that decision. I think it's great that there'll be one nodal point that will decide how to do it in a fair and ethical manner, because they have all the data of where all the elderly or the healthcare workers would be most vulnerable. They should rightly distribute it as they deem fit. So we're going to just follow their lead and do as they ask us to with the initial supply. Maybe in a year or so, once there's enough supply, we go into the private market and other areas and sell it the way we want to as a commercial product.

Because we're talking at the moment at the highest levels at different ministries in the government, I won't comment exactly on the price, but it's going to be a very affordable price—a few hundred rupees. Again, for the bulk of it, the government will probably procure the vaccine and give it free to the people who can't afford to take it. But we'll also be selling a part of that quantity, as I said, after maybe six months or a year to the private market where people will pay for it. I don't think a few hundred rupees, considering tests today are costing more than 1,400 rupees, is a very high price. So we're going to price it very affordably so that the government can also buy enough of it, given the size of our population and the fact that it's going to be a two-dose vaccine. So we're going to price it the lowest in India, and then in other markets abroad, in other countries, we'll probably price it at a higher price.

Well, they've made it very clear in a lot of public responses that they have enough funds, the capability, and the will to do that. So that's very good news. We should all rest assured that the government is fully prepared, geared up both financially and logistically to handle that. They've made it very publicly clear with the different statements coming out from the government of India, and we're very grateful for that.

These early candidates, it's very clear like Novavax, AstraZeneca, Pfizer, Moderna—all of these vaccines will probably need two doses. The Oxford-AstraZeneca candidate will need two doses. Traditionally, most vaccines are two to three doses anyway. Even if you look at pneumonia, HPV, measles, pentavalent—all these vaccines you need a booster dose to give you that higher level, long-lasting protection so that you don't have to keep coming back and taking one every year. But having said that, it's too soon to comment on the COVID vaccines where we don't know how long even with the second dose you'll get that protection. Only time will tell after one or two years pass and we see whether people are actually protected against the disease, and then we'll know how long it's protecting for and when you need another jab. Perhaps the next generation of vaccines coming about, including ours in about a year's time or a year and a half—the live attenuated vaccines, the whole unit vaccines—will give definitely a better, more powerful response and a long-lasting response. But we can't wait for that. We have to take and vaccinate our populations in the interim with whatever is available and safe, at least to give you that 50-60% protection. And let me tell you, when we say 50-60% protection, even the rest of the people who may not get such a great response from the vaccine, the severity of the disease for them will be far less, so their chances of death and mortality will be substantially reduced. That's why even a vaccine which is 50 to 60% effective is going to be licensed all over the world.

Well, that's a very good point with perhaps the other candidates. That is a very valid point. But with the Oxford-AstraZeneca one, and that's one of the reasons why we backed it early on, is that the platform has been tested for safety and efficacy many, many times in thousands of people for many years, including the Ebola vaccine and other things. So the chimpanzee adenovirus is a very time-tested, safe, and efficacious platform. That's why, at least for this candidate to begin with, I have no concerns on safety. But of course, no one can be 100% sure, so I never want to make a definitive statement. But on the face of it, if you look at something that's been time-tested over a few years without having any severe side effects, one can assume that it's fairly safe. So that's why I'm fairly confident on that. Of course, no one can be 100% in anything, but that's where we are.

Absolutely. If you rewind to March or April of that period, I didn't even dream that we would have a vaccine ready so quickly, whether it's ours or anyone else's. But the way the regulation has been fast-tracked, of course without cutting corners, we've just gotten rid of a lot of the bureaucracy and gotten on with the actual science and the work, and that's what's cut short the time. Having said that, I didn't have access to this data and these results which are coming in from the UK even about a month ago. So that's why I'm very positive now, very confident now, especially also after having vaccinated more than a thousand Indians in India with this vaccine. So that's why, of course, I'm very hopeful, very confident now. It's just a matter of two or three months until we complete these formalities. And as you rightly said, come this time next year, at least our country is going to be in a very good position in terms of getting access to the vaccines and on our way to recovery.

Now talking to you, thank you.