Covid is not something that we can just hope will go away very soon, because there are a lot of unanswered questions, says Kiran Mazumdar Shaw, Chairperson, Biocon.
The biggest question facing all of us is how the battle against Covid is going to pan out? New mutant strains are coming up and new challenges are on the horizon as well. Are we now in a situation where things can improve?
Let me start by saying that depending on which part of the world we are from, we are seeing different levels of comfort or anxiety. For instance, China seems to have brought it well under control. In India also, we should feel very encouraged because our R0 (R naught) number is for the first time below one. We can see declining numbers in terms of daily infections and the mortality rate is very promising and encouraging.
But then you move to the UK which thought it had brought the pandemic under control and they were all very gung-ho about the vaccine being deployed in the UK and now there is not only a surge in cases but they are also seeing new mutant strains which are seemingly more infective. There is a lot of concerns around that mutant strain having escaped to many other parts of Europe and the world. So there are various levels of anxiety and hope. From that point of view, Covid is not something that we can just hope will go away very soon, because there are a lot of unanswered questions.
Even as the vaccines were being approved in the UK and the US and Europe and other parts of the world, we have absolutely no data on how long it is going to protect one and so the concern around durability of response was always there. We only wanted to make sure that we had temporary relief from Covid by vaccinating people with the hope that it would provide long duration protection.
But there has been a very worrying claim from Pfizer saying they can develop a vaccine for any mutant within six weeks and that is not a good thing to say because it means that we will keep needing new vaccines like we have flu vaccines. Covid-19 is not something that you want to keep on developing vaccines for and be vaccinated every year with.
Secondly, we also know that while mRNA vaccines are certainly cutting edge and a very powerful new technology which can keep developing new vaccines as the vaccine mutates, on the other hand, we just do not know what are the long-term side effects of using such a vaccine repeatedly.
Thirdly, we know that adenovirus vaccines cannot be used repeatedly. One can only use it once and hope that it works and it protects you for a long time. So right now, the safest bet is really the whole inactivated virus vaccine which is what Bharat Biotech is developing and which may be what some of the Chinese companies have also developed and are using to vaccinate their population. The jury is out there to see which vaccine is going to work and which vaccine is going to protect you for the longest period of time. It is unpredictably predictable.
What do you make of India’s approach as far as the use of vaccine is concerned? The health minister said we could have the first jabs as early as January but as of now we still do not know who has got the permissions to go ahead!
The Indian regulators are doing a great job, contrary to what the perception of the general public is. The Indian regulator is doing a fine job of reviewing and assessing and taking these decisions to accord emergency use authorisations. So please do not think that we do not have the capabilities or we are not doing a great job.
Secondly, we are having to look at lots of data from various points of view because there has not been a huge amount of data. When you give an emergency use authorisation, it is like a stage gate approach to final approval. This is actually a very good development in the regulatory process because otherwise it would have taken you a few years before you would have approved the vaccine.
Today, because of the emergency, we are giving it a stage gate approach kind of approval process where the first signs of safety and efficacy deserves an emergency use authorisation. As we collect more and more data about durability of response, long term safety, etc, we will go towards the final approval. That is a great development in the regulatory sciences of the world and this is an approach which we should use for not just vaccines but for drugs as well because we have many health emergencies where we cannot simply wait for a drug to take five years to develop and ten years to get into the market.
Let us take cancer for instance. Cancer has a huge number of unmet medical needs and yet each cancer drug takes five to seven years to get into the market in terms of the lab-to-market journey. So, why cannot we use emergency use authorisations for all these very important medicines that can save lives. That is the whole purpose of emergency use authorisations where with limited data you allow an emergency use so that if it can save lives, it will save lives and then you keep on collecting real world evidence on which you can base your final approval. That is a very important step taken by regulatory sciences.
Is it safe though and do you think that an approach like this will give people confidence?Already there are some elements of doubt. It all seems to be a little up in the air from the layman’s perspective.
It is absolutely the right approach. I will ask you one simple question – are you willing to wait for another two years for the vaccine to be approved? I do not think so. The world is going through a pandemic which has never been seen before. They want some level of protection. Now the vaccine is safe. The vaccine is efficacious. We do not know how long it is going to protect you. Is it going to protect you for six months? Is it going to protect you for a year? Is it going to protect you for two years or is it going to be a life-long protection? Those are the questions we do not have answers to right now.
But at least in terms of safety and efficacy, we have pretty good data. We know that it works. We know that it basically evokes immune response which is what you look for in a normal vaccine trial. The only thing we do not know is how long it will protect you for and that is what most vaccine trials do which is wait for the time in which you can get re-infected. Right now, you have only three-month or four-month data to show that you do not get infected within three months or four months. What we want is definitely a vaccine that will work for a much longer time to protect you. But from a safety efficacy point of view, it is fine. I do not think anyone should worry about that.
Going into 2021, would it not be a big concern that there are already many kinds of mutations?
First and foremost, we do not know how far this new strain has spread. If certain parts of the world are living with the old strain, the present vaccines will work very well. We do not know the level of mutations and the extent to which you need a new vaccine and those are unanswered questions. We also have a number of vaccines on different platforms and that is also a good sign. We have heterogeneous vaccines. If it was all a homogeneous vaccine portfolio, it would have been a problem. But today, we have multiple kinds of technology platforms for vaccines which includes the mRNA vaccines, the subunit vaccines, the inactivated whole viral vaccines and of course, the adenoviral vaccines.
Most of them are using the spike protein as the antigen but in certain cases there are other subunits and in many cases the whole viral antigens are being used. We need to see which one of these will be the most effective. I am very hopeful that some of these will be more enduring than others. So let us not give up hope in terms of whether vaccines will be effective or not because we really need to find out whether these mutations are going to start making the present vaccines ineffective or if they will give you some protection. We need to see for how long because if these new mutants are now raising the bar for the vaccines, then we will have to keep developing new vaccines and it is not a good idea to keep on having to chase a mutating virus. It would be good if we have a vaccine that can work for any kind of mutations.
The other big question in the Indian context is how wide would the need for the vaccine be? Where do you fit India’s progress on Covid by all the measures taken so far?
I just feel that in terms of addressing this pandemic, we need data driven and science driven approaches. Right now, there are too many assumptions, hypothesis and conjunctures. Now if we are saying that we have got a high level of zero positive people in this country, where is the data? We do dipstick analysis and we say there is a high, zero prevalence in this population or that population! There is a possibility of that happening but we need to validate it. Today we have enough antibody tests and we can at least start testing people on antibody levels.
For instance, if you find people with Covid-19 antibodies, then those people can be shifted to a less priority vaccination programme. Why should you vaccinate people who have already got antibodies in their system first? So doing antibody surveillance and antibody assessment before vaccinating populations is important. But we do not do all of that and now we are making these hypothetical conjunctures that we have got herd immunity! But is that the reason why the numbers are coming down? Is that the reason why India is in a better shape? Let us validate it. And I think it can easily be done.
We just need to go about this in a more scientific way and we need to test more. We all get very complacent when we start seeing numbers coming down and then suddenly we see a surging of numbers because we have let our guard down. If we can do a real surveillance in some of these areas where the numbers have truly come down like Mumbai and Delhi, why cannot we do a zero prevalence exhaustive study to make sure that indeed these numbers have come down because people have actually got infected but have recovered? If that is the case, then we are in very good shape.
How do you see things panning out from two aspects – one is mediclaim. What will happen with Covid-19 and the other from a business perspective as businesses have pretty much managed to survive? What does the picture look like to you as of now?
I would expect that by the start of FY22, that is from April onwards, we should be in a much better state to understand how we are dealing with the pandemic. I am very hopeful that the vaccines will start building some immunity in various parts of the world and I for one believe that we need to start vaccinating people to bring back the confidence and the comfort to open up economies quite well. I for one believe that we are going to see a rebounding of the economy. I think we will see a resilient economy in FY22 and I for one believe that with the lot of measures, we will have to keep masking, you will have to keep doing some of the social distancing and hand sanitisation protocols through FY22. I do not think we are out of the woods as yet because it will be a staggered vaccination programme around the world.
I think we will have to indulge in many of these protocols and protection measures but as the vaccines get deployed, we will be in a safer place and the economy will open up and of course it is not going to be business as usual because businesses have learnt to reshape and restructure in terms of hybrid models of work from home and onsite working or remote onsite working models. I also believe that the digital world has taken over and we are going to see a lot of new businesses and new ways of conducting business.
I think you will see less business travel I feel because I think the kind of crazy travel we used to do in the past just to attend meetings in person will give way to virtual meetings because they are as effective, if not more effective. You are likely to see very focussed business travel and businesses will become more efficient because you are going to use a lot of digitalisation and digital technologies.
Overall, I see Covid COVID has brought a very positive impact on the business segments. We are going to see people focusing on using different forms of digital technologies to reinvent themselves, to drive efficiency and take strategic decisions. I remain very optimistic and positive in terms of business revival and business growth. We still have to contend with the fact that we do not know how long the vaccines will protect us. Once we know a lot more about the vaccines, we will be far more confident in terms of how we completely open up the economy. But I still feel that with the combination of testing, vaccination and surveillance, one can operate at near normalcy.
