On October 23, Bharat Biotech announced that they were initiating phase three trials of their COVID-19 vaccine candidate Covaxin. In the process, the vaccine developed in collaboration with the Indian Council of Medical Research and National Institute of Virology became the 12th vaccine candidate to commence phase three trials.
With experts claiming that a vaccine might be available by early 2021, many nations have begun drawing out plans to vaccinate their citizens. The World Health Organization's Strategic Advisory Group of Experts (SAGE) has drawn out a vaccination framework for nations to adopt.
The Gavi plan for the vaccine candidate Covax will see nations first immunizing healthcare and social workers followed by those above the age of 65 and high-risk individuals. The third stage will see other priority groups being vaccinated.
However, Biocon Limited Chairperson and Managing Director Kiran Mazumdar-Shaw has a contrarian view. According to Mazumdar-Shaw, after frontline workers teachers and younger people should be vaccinated against COVID-19 before the older population.
Speaking to BOOM, Mazumdar-Shaw said, "The elderly actually get affected because the young are infecting them. They generally stay at home. Most of them stay in joint families at home and just the young are infecting them. So, the young are protected by vaccines, they won't infect the elders.
When you look at the past investments that we've made as India in health and healthcare, particularly public health, how do you think that stacks up in the context of our response so far?
If you look at it, I think we have really focused a lot on rural health care, we focused a lot on immunization. And we've also, as a result of that, understood how to deploy vaccines at a large scale in populations. We have of course, used our ASHA workers and our ANM workers, to basically see how we can utilize them to deliver many of these healthcare needs in terms of public health. The Grand Challenges endeavor was to look at some key aspects of maternal and child health and look at how to make a difference in in public health care as a result of that.
Now, we have come a long way; I think many of these interventions have helped a lot we have seen, you know, some of these indicators improve in many parts of the world. But at the same time, there is much to do, and COVID actually has exposed the weaknesses in our system. And it has also highlighted some of the strengths in our system. So if you think about it, today, we have a daunting challenge of immunizing such a large population in India, with the sort of oncoming COVID vaccines, so to speak.
And the challenge we have is the following. We have had excellent success with the polio vaccine. Remember, the polio vaccine was an orally delivered vaccine, it was also a vaccine delivered to children, and it was done over an extended period of time. Now we have to basically address both speed and scale when it comes to the COVID vaccine. And it is made even more complex, because you'll have not just one vaccine, you'll have multiple vaccines, and they will be staggered. And they have two doses for some vaccines and adjuvant for some vaccine, or single dose for some vaccine. And you need to do all of this at speed, right? And you need to also do this in terms of prioritization because your availability of the vaccine is not going to be at one shot, it's going to come in stages. So how are you going to deal with all this? And for someone like me, I feel that our past learnings are going to be very important. But equally, we need to dovetail it with some smart technology, and also understanding what infrastructure we need to put in place to deal with the cold chain logistics and storage of these vaccines, because you have to do it one month apart and things like that.
I think it's a very complex ask. And also you must remember that giving an injection is very different to giving polio drops. And that requires specialized human resource. Right? You can you must have an army of nurses or doctors, MBBS students to do all of that. So I think it's a big challenge. But it's a very interesting challenge. Because if you can actually deliver on this promise of vaccinating India with the COVID vaccines, I think it will actually create a very strong public health ecosystem, and it will strengthen our whole health care structure.
There's the framing of the solution in the context of a vaccine, why not drugs or treatments, or eventually a cure?
All of these are necessary. I'm not saying one or the other, but because the whole focus is on immunization and vaccination, I think it basically allows you to look at the weaknesses in your system. It allows you to basically look at what is it that we need to do to get people back to work, things like that. Now, as far as treatment is concerned, yes, there are many, many treatments. And I think the fact that you have seen the numbers of fatalities coming down, shows that we are actually treating our patients better. You know, the early days, we didn't even understand what was happening, we now have basically understood what this disease is all about.
It has two phases. The first phase is the viral phase, and 90% of the people just go through dealing with the virus and getting rid of the virus. But there are 10% of people, where the virus actually elicits a hyper immune response. And it is those 10%, who really are the vulnerable ones, who are actually at risk, because it does create a cytokine response. And many of those do then succumb to it. So that's how we've learned to treat the disease, not just with antivirals, but we view we've used steroids, we've used cytokine interrupters, and things like that. So over time, I think we have treated much better.
Are you saying that if we get our vaccine infrastructure right and link everything else to it, the public health, the community health infrastructure, then in a way we've evolved or improved our overall public health infrastructure?
So what I'm saying is today, we are going to get a whole bunch of vaccines, which are going to be approved by regulators around the world. And they're only going to give it emergency use authorizations. Now, we really don't have convincing data to show that this vaccine indeed is going to protect you for a long time. We are already seeing in in our populations that the antibody titers that that people who have had COVID generate, start deteriorating after a few months. Why won't it be the same case when it comes to the vaccine, because after all, you're trying to do the same thing. You're mimicking what your body does with a vaccine. So if you're going to start seeing a sort of falling off of antibodies after several months, then it's not the ideal vaccine.
So we've started somewhere, we've got something at least to give to people, but it's not enough. So what we need to really see is how do we create a pandemic preparedness technology platform is what I'm talking about. In that you will have to first have an approach to have surveillance to look for the next epidemic at the early stages to keep tracking viruses. So that's one aspect of the surveillance that you need. The second aspect is that if you do have a outbreak of a viral disease, how quickly can you respond to it with a vaccine? Today, we've actually done it very fast. You know, within nine months, you're almost going to get a vaccine approved. But we don't know whether that's going to be the right vaccine.
So from this particular pandemic, we must look at various platform technologies. And over time, maybe in the next year or two, we will be able to find out which is the most effective vaccine. So is the mRNA vaccine, really the best vaccine, or is the adenovirus vaccine, the best vaccine, or is some other vaccine, the better vaccine, you know, we need to get all that data generated over the next few years, and then create platforms of vaccine development technologies, so that when you have the next outbreak, you can indeed develop a vaccine within four months with confidence that it will work.
You also see this helping overall as a country our response to diseases like tuberculosis and everything that we also suffer from at pretty large scale.
Well, you know, the problem right now is that the focus is so much on COVID that in fact there is a pretty serious concern that a lot of the immunization programmes have not happened because of COVID. And there's actually a drop in the number of people and children immunized for that matter. Secondly, even TB is a disease where we've been very good at making sure with the DOT program that people take the TB medication. But we know that during the law during the COVID times, even this has not been optimally done. And so a lot of people are at risk in terms of TB itself.
So I think we need to understand that at a time of an epidemic, a you need to catch the outbreak and contain it very fast. China seems to have done it quite well, because the way they go about these things, they could actually pounce on the outbreak in Wuhan and restrict it to a small area. We also need to keep looking for outbreaks. And when there is an outbreak, you have to pounce on it and contain it because only then can you prevent it from spreading.
When you look back now and you know, in the beginning, I asked you about the Grand Challenges context. Now when you look back at the scientific investment that's gone into this country or exists in this country, what do we need to do more to build our upstream pipeline, if we can call it that of, you know, of people, skills, infrastructure, in order to better prepare us as a country, and in order to also maybe contribute to the to a more sounder efficient pandemic response platform that you're talking about?
If you think about it, we have all the bits and pieces of capabilities and scientific understanding in our country. So if you look at scientists in our country, they are very good. If you look at vaccine development, we are very good. What we really need to now invest in is through innovation. We need to focus on genomics, CRISPR technologies, this whole area of immunology. We have to do a lot more. And what I would say also is that if you look at the investments that we have made thus far, have actually done us very well, have served us very well, because if you think about it, these scientific investments were the ones who allowed us to quickly develop diagnostic tests. And if you remember, at the start of the pandemic, we were very short of diagnostic tests. Today, we don't have that shortage, we have a large number of diagnostic tests, we're able to do over a million tests a day, it's not enough, but I still think it's a big change from where we started.
And we are also developing novel tests based on CRISPR technologies like the Feluda tests, and others, which, of course, other parts of the world have also done but we are right up there. So I think our scientific investments have served us very well, on whether it is our CSIR labs, where the National Institutes of Virology, we have actually done a lot in this very short time. And we've actually unleashed a lot of the potential of these kinds of laboratories, these national laboratories. On the other hand, private sector has also demonstrated its capability. So whether it's the vaccine manufacturers, or whether it is the research in vaccines, all that has happened in a very big way. Startups have also suddenly blossomed because these small startups were always starved for capital, have certainly seen that these are times when they can actually access more capital. So that's been a very big positive from this COVID pandemic. So I for one, just believe that we should keep investing in science and innovation. And we must start encouraging, you know, these startup companies and the more mature companies to get better and better and be a real integral part of the global innovation ecosystem.
If you were to look ahead now, how do you see this coming together? What do we need to do to bring this together in a more cohesive way, or I mean, from right from the startup ecosystem to policy to everything in between?
First and foremost, the way I look at it is we need to have diverse platforms; you cannot just focus on one type of platform. So focusing on diverse vaccine platforms is extremely important. Then as I said, you need to have surveillance and you need to invest a lot in the genomic databases that we're creating. You will need to use AI you will need to use big data analytics etc to keep a vigil on any kind of infectious disease for that matter. And thirdly, we need to invest in some of these new emerging cutting-edge areas, for instance, mRNA technologies for vaccines, we don't have enough capabilities in that. How do we do it? Now mRNA has a big challenge with it. It requires -80 degree transportation, which makes it very difficult in a country like India. Can we work on thermostable vaccines? This is a need for the country.
So when you look at innovation, you need to focus on cutting edge areas, like a CRISPR, you know, some of these antibody technologies, some of the, mRNA technologies and many other DNA based technologies, other viral vector technologies that will actually make you complete in terms of having a diverse platform of vaccine technologies. Then you need to focus on some other key issues. How do you basically bring down the cost of vaccine production? How do you make them thermo stable? How do you measure the efficacy? Can you use technology to predict the efficacy and safety of vaccines? These are very important times. But if we start focusing on that, then I think, you know, we will make a lot of progress.
As you look ahead, one of the challenges is the conundrum that exists between the speed that we want and need, versus the ability of policy and regulation to keep pace. On the other hand, you will have criticism, including yourself, that you're doing it too fast, you're cutting corners, you're not doing the right number of trials, and so on. So how do we manage this going forward?
This particular pandemic has actually opened our eyes to what is possible. For instance, I think we all agree that the rate limiting steps in any kind of drug or vaccine program is the regulatory approval, and the sequential regulatory approvals that we all need. In this case, where they called it operation Warp Speed, where we had emergency use authorizations based on small amounts of data. It showed that it is possible to shrink regulatory processes and timelines. For instance, in the vaccine development itself, they did parallel clinical trials, right, phase one, phase two, phase three in many cases. And that was a actually done in a very, very well thought out way. Now, if that is possible during COVID, why can't it be done beyond COVID is what we are asking. That kind of shaves off almost a year if you want to in the case of vaccines and in drugs for that matter.
Secondly, when you start looking at the emergency authorization of vaccines or drugs, you're basically saying, as long as you have safety data, and you're building the efficacy data, we will give you this emergency use authorization, which is what we even our drug got, we got an emergency use authorization because we were able to demonstrate safety. And we showed some amount of efficacy. And they said, Okay, now keep building your efficacy data and your safety data alongside. I think that's a very good way of making sure that anything promising can reach the patient faster.
Now you think about COVID, you think about cancer, you think about any of these life threatening diseases. If it's going to take five or seven years before that drug can get to patients, you're going to lose so many patients. But if you can actually give an emergency use authorization for many of these life saving medicines, and then ask them to basically collect real world evidence of safety and efficacy and then give your final approval when you get all that data. I think that's a sensible regulatory pathway going forward.
These are all learnings and evolutions, but are there better ways to keep the public at large, including those who are going to buy the drug better informed or aware of how this is happening? Because there is fear and there is anticipation and expectation as on both ends?
I think there is a lot of merit because first and foremost, I think all of us are being asked to conduct phase four studies. And whenever you conduct studies, you have to share it in the public domain. You cannot just keep it to you. So the transparency is there. But I think to keep having real time tracking of every trial becomes difficult. Like, for instance, today you had some report that a Brazilian participant of the AstraZeneca vaccine trial also died. But we don't have enough data on that. Whether that person was on a placebo or the vaccine to begin with. We don't even know that. And what was the death due to? I think, also, in this time and age, I think people want more data and more transparency.
For one reason; this is public money being used to fund a huge public health challenge through vaccine development in a very rapid way. So I think when you're taking all these shortcuts, when you're when you're compressing timelines, I think the public needs to know what's happening, that I agree with. I think the public must be made aware of any adverse event. If there is an adverse event public should know, especially in this vaccine trial. Why do we have to second guess? Why did Johnson and Johnson stop its trial? What was the reason? We don't have any reason. They just said, oh, there is a patient. But what happened to that patient? People need to know. So I don't think that pharma companies have the luxury of selecting what they want to share in the public domain and keeping things to themselves when it suits them. Because this is not their money. This is public money, and they have to share it.
When you say that, I'm assuming you're also saying that you're applying it to yourself, as in tomorrow if someone asked you?
Of course. And that's why we shared a lot of our data. We've been sharing our data a lot.
What is your advice to those who are watching, because people tend to take things lightly and may forget what this can really do? And the second is what are the good parts of the crisis that you yourself are using whether as personally or as Biocon to innovate, normalize and to set up sort of new normal to use a cliche, and of course, your advice to?
So to begin with, in my case, of course, I was one of those fortunate ones who had a moderate case of COVID. So I recovered quite fast. I didn't have to use any of the medication that President Trump used, but I anyway came out of it fine. In a week's time, I was over it. And in two weeks' time, I was rid of the virus because I tested negative in two weeks. And of course, I got back to work thereafter. I feel fine. And I think 90% of the people will have my kind of experience. So I want to give most people that comfort, that there are very few people who actually get into that severe phase. Young people are actually, you know, able to cope with this disease very, very easily.
So for instance, I'll give you an example on our campuses, I think we are one of the safest campuses. In fact, when you ask our employees, they say no, we feel very safe working in this environment. Because fortunately, we have a testing facility and we are testing very rigorously. So every two weeks, an employee gets tested. And we have seen that we have actually reduced the test positivity rates, and they are much below the state average or the national average. So we are half of the state average and the national average. So which is a good thing. And what we are also finding is that we are doing a lot of correlation between CT values and the severity of the disease. And of course, most of these people who are testing positive are asymptomatic when they come to work, obviously, and these people get very mild versions of the disease. So they are actually showing high CT values, which means low viral load, and that's why they're not showing symptoms also, and they all come out of it quite well. Now, the point is that we must make sure that we are also tracking antibody levels.
So what we are also seeing is that these mild cases don't actually develop a lot of antibodies, which means they can be reinfected. So there is a lot of more learnings to do in terms of the disease itself. But now coming to what have we done because of COVID, I think all companies have learned to work remotely. And this remote working is actually very good. Because in many ways, unless you, you know, only the critical jobs, which you can't do remotely have to be done by the people who need to be there. But anything that is a support role, which can be done remotely, is being done remotely. And that actually is helping us to be more efficient. A lot of the women are benefiting from this because you almost naturally give them a work life balance. At the same time, I don't want women to be overworked at home. So that's another negative side of this.
But by and large, I think remote working is very important, because you can actually then think of a four-day work, you know, a four-day working regimen. In terms of another aspect, which I'm really concerned about is how do we prioritize vaccination when it finally arrives? Right now, there's no debate that healthcare workers, the military, the police, and anyone who's in the frontline ought to be given the first round of vaccines. Who is going to be the second and third, I have a slightly contrarian view to most people who say that the elderly and the vulnerable should be given next.
My view is I think teachers should be given the next round of vaccines. I also believe that the young working class should also be given the vaccines so that they can get back to work and get the economy to be resurgent. Because the elderly in our population are a smaller part of our population. In fact, India is fortunate that 90% of our population is below the age of 60. So if you think about it, the elderly actually get affected because the young are infecting them. They generally stay at home, they and we don't have elderly care centers and things where we have a problem. Most of them stay in joint families at home and just the young word infecting them. So the young are protected by vaccines, they won't infect the elders. So my And then secondly, we don't know enough about the vaccines. So why would you want to then vaccinate the elderly and the vulnerable until you know more about the vaccines? So there are lots of discussions to be had in terms of how do we prioritize vaccination?