Oxford COVID vaccine likely to hit Indian market by early 2021: Serum Institute's CEO Poonawalla

Well, we've got five different candidates. As you know, we've been big on the AstraZeneca Oxford candidate because it's far ahead in the trials. It's already proven well previously as a technology platform for the Ebola vaccine. And look, now after the phase one results that were recently published by The Lancet, you've got a good T cell response, good IgG response, and also, more importantly, the safety is very good. Now, the phase three will determine if the vaccine is actually going to work and protect you against COVID-19. And we're very hopeful. In fact, we put in more than $200 million of our own opex and capex, dedicating capacity and raw materials so that we can start manufacturing by the end of August, so that we can have hundreds of millions of doses right by the end of the year. And we wouldn't have done that if we weren't very hopeful.

See, that's a good question. We will only know after phase three is completed to answer that question. But look, mostly vaccines are typically two doses or three doses. You need to prime and then you need to boost. And yes, some individuals, or most individuals, get a good response with one dose, but there's always a smaller population in every country and every demography that needs a second dose to give you that higher level of protection beyond 70, 80, 90%. And that's what was here in the trial: 90% showed neutralizing antibodies with one dose, and the balance 10% needed a bit more.

No, the vaccine, just to correct you, it was a 1000 patient study roughly. About 500 people received the vaccine, 500 did not, so it was placebo-controlled. So if you compare the trial done by other companies, which is only 50-60 patients in their phase one like CanSino, Moderna, and all, we've done a 1000 patient study. This is, as I said, and what you rightly also said, is no indication beyond safety and that there is an immune response coming from the vaccine, which is great news. But whether it will work and protect against the disease, we will only know after phase three is completed, roughly in October or November.

They are also planning to do further studies in the older population. That is already on. And we are also in India, when we start our trial, will go to the vulnerable and elderly population and do a mixture, so we get data that it is working and protecting the most vulnerable, which is the elderly and immunocompromised sections.

This is a very severe disease which does attack your lungs and your respiratory system, so there are going to be long-term effects and long-term issues that might come about because of the damage your lungs and your body have taken when you got the disease and how severely you were attacked. So you are going to have that. In fact, people are saying that you could even contract and get infected again with the disease in six months or a year, even though you've recovered fully. So it doesn't mean that — and this is where we hope the vaccine will give you that long-term protection, which right now seems to be unlikely with the disease. If you recover from the disease, you can still get it again and have all these other complications like you mentioned. We're hoping that with the vaccine, you get a really good immune response in your body that can deal with the disease in a way that you don't have all these other issues. But look, again, that is something time will tell. We'll have to vaccinate people, observe them for one, two, three years, and see how their bodies are, how they recur, how they deal with infections and the disease, and then you really know that a vaccine, whether it's one dose or two doses, is giving you that proper protection without any of these other issues.

So we've chosen five different ones, as I mentioned. You've got Codagenix in the US, live attenuated virus, very good, very powerful, will have long-term protection, that's the hope. You've got Novavax, again a US company, you've heard of Novavax, they are also advanced in their studies, probably a month or two behind AstraZeneca. So we've chosen what we felt, based on the science, would give us the best result. Some of them are behind in the clinics, so every three to four months, Serum hopes to launch one of their in-house or partnership vaccines, AstraZeneca being the first and most promising at the moment. And so that's where we are. That's how we're here today. And look, we may even add one or two more partnerships because we have multiple manufacturing capabilities and capacities. So we want to commit to the world during this pandemic crisis so that we don't care which vaccine works. We hope everything works, and then we'll pick the best ones to serve humanity.

Of course, maybe a month or two before that, yes. And I'll tell you, this is only subject to the trial succeeding, otherwise you'll have made the vaccine and then you have to throw it away because it's not safe or efficacious in humans and protecting against the disease. So the timeline is more or less accurate: first quarter of 2021, subject to the phase three trials working and the Drug Controller of India giving you a license to produce.

So I think nothing should be rushed, and that was not the intention of either ICMR or Bharat Biotech. They were just hopeful to just get everything fast and get it done quickly. It wasn't that they said it has to be launched on the 15th of August, which was physically impossible because you're not even finished phase one trials. And so, every company in India is following all the rules, including Bharat Biotech, Serum Institute, Biological E, Mynvax Biotech, Zydus Cadila. So there are a lot of companies in India making vaccines, very good companies. And we just have to wait and be patient for all the phase one, two, and three studies to get completed. We have to follow the rules of the CDSCO and the Drug Controller of India. And we have tightened and fast-tracked a lot of regulatory procedures which would have taken a year or two, but that has been shrunk into a much shorter time frame because of all the focus that has been put and the powers given in an emergency situation to fast-track, not the science, but the regulatory time that it takes to respond and conduct trials and do all of that. So let me again make it very clear: nobody is going to be flouting any rules or circumventing any rules. We're only shortening the regulatory time frame and period taken. And I just hope that all new vaccines will also enjoy this new fast-tracking procedure, which will be a great boost to India because, as you know, India makes more vaccines than any country on the planet right now. And we're a leader in this. To fortify our position further and become leaders globally for all the new vaccines and development, all the companies in India making vaccines hope that the regulatory procedures continue like this at this fast pace, which was always an issue before the COVID crisis.

I think these are all very unsubstantiated statements. Nobody knows how effective which vaccine will be, whether it's zero, whether it's 100%, whether it's anything. Before we see data in human beings, for anyone to conclude any vaccine is working or not is just a hypothesis. He's probably making a prediction, but it's not a recommendation and certainty. That will only come after the phase three trials of any vaccine are concluded properly with a regulator of the country in which they're being conducted. That's when we can conclude which vaccine will work how much. Before that, making anything is just a prediction. It's like predicting where the economy will be in a year or two years or any of that sort of thing. So these are only hypotheses. And people, let's hope that we have some good news on that front and access to the vaccine as soon as possible. Thank you very much, Mr. Poonawalla, for joining us.