[After India’s regulator on Sunday approved two vaccine candidates – Bharat Biotech’s Covaxin and Serum Institute of India’s Covishield – for ‘restricted’ emergency use, many medical experts have raised questions about the language used by the Drugs Controller General of India (DCGI) in his statement. Questions have been asked about the lack of efficacy and safety data regarding Covaxin.

To discuss these concerns and possible issues regarding the two vaccine candidates, Karan Thapar interviewed professor Gagandeep Kang, one of India’s foremost vaccine experts. The following is a transcript of the video interview published in The Wire.]

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KT: A storm of controversy has broken out over the way the Bharat Biotech vaccine – Covaxin – has been cleared. And now questions are also being asked about the Oxford-AstraZeneca vaccine. Was Bharat Biotech cleared hastily and possibly, improperly? And are there serious questions about Oxford-AstraZeneca that have still to be convincingly answered?

Those are two key issues I shall raise today with India’s most senior, most highly regarded and top vaccine scientist, a professor at the Wellcome Trust Research Laboratory at the Christian Medical College in Vellore, Gagandeep Kang.

Professor Kang, let’s start with the controversy surrounding the Bharat Biotech vaccine, Covaxin. It’s been cleared for “restricted use in emergency situations in clinical trial mode”, although it hasn’t completed its phase three trials and although efficacy data are not available in public. In the present circumstances of a pandemic, is this understandable and acceptable? I believe, the Ebola vaccine was also cleared without phase three trials. Or in this case is it in fact a clearance that’s happened hastily, perhaps even improperly?

GK: If we think about how pandemics or emergencies are responded to when there is a serious or life-threatening situation, and you have a potentially efficacious product – which is the only thing you have available to you, obviously our responsibility as medical scientists is to ensure that the product is used. So, if you know for sure that this is a disease that has a high fatality rate and this vaccine might work… so an equivalent example might be a disease like Nipah – which has a very high case fatality rate – where you would want to vaccinate contacts so that they don’t develop disease. In Ebola, we follow the same principle, which is if you have had contact with an Ebola patient, if you receive the vaccine, the likelihood is that you will be protected.

Ebola and Nipah are very different [viruses] from SARS-CoV-2. In SARS-CoV-2, while it is impossible to predict who might develop a severe disease or not. It would be a hard call to make to consider that it has a case fatality rate that is anything like the Ebola or Nipah viruses. So, in that situation, and also given that we have in the world other licensed products under emergency use authorisation – which have shown proven efficacy – I would ask the question why would you want to give a vaccine that does not have efficacy data and ’emergency use’, ‘restricted use authorisation’?

That said, I think Covaxin’s clinical development plan is a very good plan, very, very well laid out. What they’ve done for their phase one and phase two studies, what they’re doing for their phase three study, is exactly the right thing to be doing.

KT: The important thing is what you said right at the end of that answer – that a), COVID-19 is different to Ebola and Nipah. Secondly, given that we have already got other licensed products, why would we want to give emergency authorisation to a vaccine that does not have efficacy clearance? That’s a very important statement you’ve given, because it clearly suggests this has been done hastily in the case of the Bharat Biotech vaccine, perhaps improperly.

Let me put to you what the chairman of Bharat Biotech, Dr Krishna Ella said yesterday (January 4). He says that the 2019 Clinical Trial Rules explicitly mention that in the case of an emergency and the existence of an untested vaccine, phase two data that establish safety and immune response are acceptable. My question is simple: do the rules which you know of permit this or is Dr Ella mistaken?

GK: Actually, the statements that have been incorporated in the new Clinical Trial Rules allow for an accelerated approval that can bypass all clinical drugs. It does not have to be phase one and phase two. And my understanding is that the intention of those was that currently, when we bring vaccines into the country, we have a requirement for a bridging study. And, at least the way I understood the rules, was that this would allow us to get vaccines in without necessarily needing to do those bridging studies.

I do not recall anywhere seeing that if you do phase one and phase two [trials], you can get licensure without completing the phase three. I would have to review the rules once again to see whether that categorical statement is made. But I don’t think so. Again, Dr Ella and his company have done a really great job so far.

KT: Absolutely. And I’m not casting aspersions on Dr Ella, but I’m simply clarifying a), rules and b), your interpretation of them. And I’m repeating your answer because I think it’s very important. You said the rules do allow bypassing all clinical trials but you believe that was designed to avoid bridging studies, not to avoid phase three which actually establishes efficacy. In this instance – of Bharat Biotech – phase three has been avoided and that, you think, from your interpretation is not what the rules actually were designed to do.

Let me put you another… sorry, you’re about to say something. Go ahead.

GK: Can I just say, phase three has not been avoided. Phase three trials are ongoing. Phase three data will be accumulated and I’m sure, will be submitted to the regulator for a full licensure. For this “restricted use under clinical trial mode”, yes, that data did not need to be available for that approval.

KT: I stand corrected. Phase three has not been avoided. I phrased myself wrongly. The phase three results of efficacy are not available. They have not been made public and clearance has been given without those efficacy results being known.

Let me put you what Dr Balram Bhargava, the head of the ICMR has said. He says the Bharat Biotech vaccine does have efficacy data from animal trials and also from phase one and phase two trials. Now, phase one and phase two trials are actually concerned with safety and immunogenicity, so can we glean sufficient efficacy data from them?

GK: So, actually if you think about animal studies also, the US has a very clearly laid down regulatory pathway for evaluating vaccines and animal models and permitting licensure just based on what is called ‘animal rule’ data. And this has been done in the past, most recently, I think, for the anthrax vaccine. That was after the anthrax scare, post 9/11.

Now, that animal rule requires that the disease is exactly mimicked in animals and that this model is an accepted model of the disease. With all of the vaccines that have been tried in animals – we’ve got hamster studies, we’ve got ferret studies, we’ve got rats, we’ve got mice, we have non-human primates – the results from the Covaxin study do look very good. But right now, we have no evidence to show that those animal models are good mimics of human disease. In fact, there are shortcomings in all of these models.

When it comes to the phase one and phase two studies being used for clinical efficacy, yes, that is feasible; you can continue to follow-up individuals who are recruited into phase 1 and phase 2 studies and wait to see whether they develop disease or not. However, my understanding is that the Covaxin phase one and phase two included only 800 participants and the number of cases that would come from those 800 participants would be so small that we would find it difficult to rely on them for the purposes of a data package for licensure.

KT: Now, both, Dr Balram Bhargava and Dr Vinod Paul, have said that this vaccine has been cleared because they believe it could be better at tackling new strains of the virus and in particular, the British strain. In your eyes, is that just an assumption or do we have good data to believe that would be the case?

GK: I wish we had the data. We don’t, at the moment. At the moment, we have no efficacy data from the vaccine whether that is against the strains circulating in the country or the UK variant. And in fact, in terms of vaccine escape, I’m actually a little bit more worried about the South African variant than I am about the UK variant.

KT: But the important thing is we have no data whatsoever that suggests that the Bharat Biotech vaccine will be better at handling the British variant or any mutations of the original variant. We have no data at all. Therefore, this is an assumption made by doctors Bhargava and Paul.

GK: It is a hypothesis which is based on the fact that you’re using a whole virus instead of a single protein. But so far, all of our understanding about the virus is that the vaccine response is really focused on the spike protein, which is what is included in many of the other vaccine candidates, other than the live attenuated and the inactivated vaccines.

KT: Now, this particular vaccine – the Bharat Biotech vaccine – has been cleared for use “in clinical trial mode”. But the truth is, that this vaccine is already in clinical trials in India. Does this mean that people who hereafter get the vaccine will simply be part of the continuing clinical trials?

GK: This is the part that really confused me about the recommendation that was made public on Saturday and Sunday. What the subject expert committee said and then the release from the DCGI’s office seemed to – at least, for the SEC – seemed to indicate that this would be “in clinical trial mode” and I’m not sure what “in clinical trial mode” really means. It is possible for researchers or companies to do a study that is a single intervention, without a control group, essentially doing everything that a clinical trial does, but looking at results in only people who have received the intervention. Now, while that is feasible, I don’t understand why it was necessary to – if that is what is intended – then what was the need to give this restricted use approval.

I’m also not clear about something else to do with this. Does this mean that the government is going to buy the vaccine and then the government will do the clinical trial? Or does it mean that the government wants Bharat Biotech to give the vaccine to a much larger number of people in the form of a single-armed clinical trial? I actually have no clarity on what is planned for this.

KT: But there is a third thing that’s suggested. That the people who get the vaccine, won’t simply be getting the vaccine because it’s believed that the vaccine will prevent infection or disease, they’ll also be getting the vaccine as part of a clinical trial. In other words, the recipients will become part of the trial.

GK: And that’s fine if you were doing a single armed study, or if you were doing a phase four study. These kinds of designs can be set up and done. Phase four usually comes after full licensure of a vaccine, whereas if you wanted to use this vaccine “in clinical trial mode”, I really don’t understand what adaptation of the study design would allow for greater accumulation of data towards full licensure of the vaccine.

KT: Now, as you pointed out, this decision to permit the use of the vaccine “in clinical trial mode” not only confuses the situation, but also raises critical questions about what the role of the recipient will be.

But there’s a further question. Suppose at the end of the clinical trials, it emerges that the vaccine is only found to be 30% effective, will the people given the vaccine thereafter have to be given another vaccine? And secondly, won’t those people feel either let down or misled?

GK: Well, the general principle is that if you are participating in a clinical trial, or any intervention, and that intervention is not found to work and there is an effective intervention that already exists or has been found during the course of the clinical trial, then you should be offered that intervention.

So, in this case, if the vaccine does not work, then the people who participated in this study should definitely be offered a vaccine that is known to work. Now, what people will think about such a happening, I’m assuming is something that would be covered in the informed consent form that I believe people are supposed to sign. At least, that’s what I’ve heard from what people are saying about what a “clinical trial mode” means.

KT: How will the international community view India’s expedited clearance of the Bharat Biotech vaccine? Does it seem now similar to the way the Russians and the Chinese have cleared their vaccines?

GK: I think it’s important to remember that to the international community, the regulator is responsible for protecting the population that he or she serves. And so, what happens within India’s regulatory system for Indians is something that our government, our regulator controls. When we want to take this vaccine outside of India, there will be a reliance on the data that has been submitted to the Indian regulator but that does not mean that anything that was approved by the Indian regulator will be considered sufficient for this vaccine to be used in other places.

So, the data will be necessary but not necessarily sufficient. It’s possible that the WHO will ask for additional information and in fact, this has happened in the past for Bharat Biotech. For example, Biotech developed and licensed in India, a typhoid vaccine and when it came to their WHO pre-qualification, they included with that data on efficacy which had not been generated in India, but was generated in the UK, during the pre-qualification process. The vaccine was pre-qualified and is now in use in many other countries around the world.

KT: In a nutshell, you are aware and I am aware, that a lot of skepticism was voiced internationally about the speed with which Sputnik – the Russian vaccine – and the Chinese vaccines were cleared. Won’t that same level of doubt now apply to the speed with which Bharat Biotech’s Covaxin has been cleared? It might be hurtful to us as Indians, but is it not likely to be the case?

GK: Absolutely. So, if you think about how the world will view this particular approval, there is very little difference from what has been done in China or Russia. Of course, for China, we have very little idea of the kind of data that was submitted to their regulators. For Russia we know that it was very, very limited clinical testing that was included.

Now, again when it comes to the situation for us versus China and Russia, the Chinese and the Russian vaccines are now being used in a limited number of countries around the world – in South America, in Africa and in the Middle East. Is it likely that countries will ask for Indian vaccines, even in this scenario? It’s certainly possible. I think we have to realise that we are in a privileged position because we have so many vaccine companies and will ultimately have a wide array of vaccines to choose from. But if you look at the rest of the world, given that the multinational companies have had the bulk of their doses already booked, there is very little choice, if other countries want to vaccinate large proportions of their population because the COVAX facility is only going to give them enough for 20% of their population.

KT: That’s very well put – very little choice for countries if they want to vaccinate their population. They will have to buy from India, regardless of what concerns they may have about the way Bharat Biotech’s vaccine was cleared. That’s very well put.

Let me put this to you, professor Kang. If the authorities are really worried about the spread of the British variants – the British mutation – rather than clear Bharat Biotech, should they not have opted for what I call, the ‘British solution’, which is permitting the second dose of the Oxford AstraZeneca to be given after 12 weeks, rather than just three weeks or 28 days? That would have a), ensured that more people get the first dose and if, as the MHRA [Medicines and Healthcare products Regulatory Agency] in Britain believes, is the case – that the first dose confers up to 70-80% protection, then the level of protection provided to that increased number would also have been very acceptable. Would that not have been a better alternative to Bharat Biotech as a measure of tackling the spread of the British variant of the virus?

GK: Well, I think in terms of covering populations, being able to delay the second dose is certainly an opportunity that we should explore. My understanding is that this is based on data that was modelled by the MHRA and the JCVI [Joint Committee on Vaccination and Immunisation]. So, if we look at the numbers that will be covered in India, it may be worthwhile for us to do a modelling exercise and see what the benefits might be for us to go with a single-dose approach – provided that we know when the second dose is coming.

Now, in terms of both Bharat as well as with Serum Institute [of India], the number of doses that we have at the moment are limited but are ramping up. So, if it is a question of using the Bharat vaccine, I think that is a decision that will be taken by the vaccine task force with appropriate inputs from experts.

KT: Just to sum up your position on the Bharat Biotech vaccine called Covaxin, you’ve given at several stages in this interview, the impression that it’s been rather hastily cleared. You’ve given at several stages, the impression that some of the arguments and defences put up, either by Dr Balram Bhargava or by Dr Vinod Paul, do not necessarily hold. I, therefore, come back to that initial question: on reflection – and I know this is a sensitive issue – on reflection, has this vaccine been improperly or hastily cleared? Give me a short sharp answer for the audience.

GK: The vaccine has been given limited approval without efficacy data. I find this extremely confusing. If it was a question of saying that this vaccine is you know, is there a negative about the vaccine, as far as I’m aware, the vaccine’s safe. Is it likely to be efficacious? Yes, it is. But do we know that at this time? We do not.

KT: So, should it have been cleared the way it has? That’s the question.

GK: I’m confused. I’m not the expert on the SEC. So, if it was up to me, I would say, without efficacy data we should not be clearing any vaccines – Covaxin or anything else. Clinical trials are there for a purpose.

KT: That’s very, very clear. Without efficacy data, don’t clear a vaccine – that is very clear. Which means the basis on which this vaccine has been cleared, in your opinion, is not justified. That’s very, very clear.

Let me at this point, Dr Kang, put to you a defence of the Biotech vaccine made by the eminent virologist T. Jacob John in an interview to the Business Standard today [January 5]. First of all, he says a team of experts have recommended that the vaccine be cleared, not a single individual. And he says, the people sitting on this committee are not ignorant.

Secondly, he says, at least 11,500 people have got at least one dose of this vaccine and none of them has got COVID. And on this basis, he concludes that, he, T. Jacob John would go for the Bharat Biotech’s Covaxin and not Covishield. Now, I know that Mr Jacob John, in fact, taught you. How do you respond to what he said?

GK: Dr John is my teacher. I have tremendous respect for him, but I also think this is not about the product, right. I think Covaxin, in all likelihood, will be an amazing product, will be used very widely. I’d be really happy to volunteer for a clinical trial of Covaxin. Unfortunately, it’s not being done. But when it comes to approving a vaccine without having sufficient data, I don’t agree with Dr John at all.

KT: That’s very clear. Now, out of fairness I also want to take the opportunity of this interview to put to you some of the critical questions that are now being asked about the Oxford AstraZeneca vaccine, which is the second vaccine that has been cleared for usage in India.

First of all, what do you make of the fact that an accident happened during the Oxford vaccine’s trials which led to two results: 60% efficacy from two full doses but 90% efficacy from a half-dose followed by a full dose. Now, I know that this is a serendipitous outcome but is it scientifically well-established?

GK: It’s really messy. So, when you have data that is messy from a clinical trial, then it leads to a situation where you don’t know what to look at. And if it was me – and as Dr John pointed out – you know, experts on a subject expert committee or other experts will review the data and come to a decision. But if I was given data from two separate dosing schedules that had different outcomes, then what I would do is go by what had been the originally planned clinical trial.

So, if it was intended to be “standard dose, standard dose” in the AstraZeneca trial – and that resulted in a 62% efficacy, that’s the data that I would take to the regulator. Anything that was not per protocol or “per protocol as originally designed” is an interesting, serendipitous finding that requires follow-up. But in, at least in my view, should not have gone to a regulator.

Now, I’m also told that the MHRA asked for the data and that’s fine, for the MHRA. But the fact remains that the trial was designed to be done one way. So, you should take the data that followed what you had planned.

KT: Absolutely. And so, if you had been the regulator, you would not have considered, you would have set aside the data from what I call the ‘accident’: the half-dose followed by a full-dose which leads to 90% efficacy. You would have gone with the standard procedure that they had planned to adopt, which only gives you 60% efficacy.

Now, there’s a second concern about the Oxford-AstraZeneca vaccine, raised this time by Dr Krishna Ella. And I should point out, he now sees himself as a sort of rival. He has said in a press conference yesterday [January 4], that Oxford AstraZeneca was giving paracetamol to suppress side effects or possible adverse reactions. If that turns out to be true, how serious would it be?

GK: We have to recognise the difference between “common adverse events” and “rare adverse events” that follow immunisation. So, anybody who has children and gets them vaccinated knows that in baby clinics or in private practice, you’re usually given a baby aspirin to give to the child because fever is a common side effect of vaccination.

So, when you record safety events after vaccination, you record all the common ones and you look especially for the uncommon serious effects. And you also look for what are called “adverse events of special interest”. The WHO has actually come out with very good guidance on what needs to be looked for. When you think about fever and common side effects, those are anticipated with any parental vaccine and usually if it’s not a high-grade fever or it is not something that results in seizures, that’s not something that could be considered particularly unusual following a vaccine.

So, what it will mean in the case of Covishield and Covaxin is that you will not be comparing like with like. You will have one set of people that are likely to have fewer common side effects – fever, pain in the arm – versus people who did not receive the paracetamol and therefore might have a somewhat higher incidence of fever. But in this case, we are not looking at that kind of comparison. The interest in serious side effects is one that is much more important and that will come only when vaccines are used in very large numbers of people.

KT: So, in other words, the fact that paracetamol was given to preclude or take care of minor side effects is not a major problem. However,…

GK: It is not a deal breaker for licensure.

KT: It’s not a deal breaker. T. Jacob John, however, raises what could possibly be a major problem. He raises the fact that there have been one or two instances of neurological problems after the Oxford-AstraZeneca vaccine was given. And then he asks – and I’m quoting him – “can you confidently exclude the link between the vaccine and the neurological symptoms?”. What’s your answer to his question?

GK: I don’t think that any vaccine is 100% safe. But I also don’t think that if you have two cases or three cases of neurological side effects in several thousand people, you can confidently say that these are associated with vaccine. So, it’s very difficult to rule out the association and that’s the reason why we have multiple layers of safety assessment. The investigator, the institutional ethics committee, the data safety monitoring board, the regulator: all of them are expected to investigate every adverse event of special interest and look for causality. It’s quite possible…

KT: In other words

GK: Sorry, go ahead.

KT: I’m just interpreting what you said. Two or three cases of neurological side effects in a situation where a thousand or more have been given the vaccine is not particularly worrying. You cannot really say this is because of the vaccine, even if you can’t rule out the causality either.

GK: So, when you do causality assessment you need to have an understanding of what the background rate of that particular illness is. So, if I was to follow 20,000 people for two months, how many of them are likely to manifest a neurological symptom? Once I know that, I can then look at vaccinated individuals and say that this rate is the same as background rate or above background rate. My understanding is that this has been looked at by AstraZeneca and they have felt that these are not causally related. If we follow 100,000 people and we start to see the signal being maintained, we’ll need to keep reassessing.

KT: But at the moment, to use the language you used earlier, this is not a deal-breaker for licensure.

GK: Well, I actually used the ‘deal-breaker’ for minor side effects. Serious side effects might be a deal-breaker. It depends on their frequency. For example, we know that with rotavirus vaccines intussusception happens in one in somewhere between 16,000 and 100,000 vaccinated children, and yet we are using these vaccines.

KT: That’s a very clear answer. In other words, we know with several other vaccines that in one or 10,000 or one in 16,000, there can be serious problems but nonetheless, we accept that and use the vaccines. That could also be the case with Oxford-AstraZeneca. That said and done, I want to quote you one more time what T. Jacob John said in that interview to the Business Standard this morning. He says the expert group looked at the Oxford vaccines data from the UK and India and – I’m now quoting him – “has decided that they will bend over backwards and accept their data”. T. Jacob John is clearly suggesting that Oxford has been given special favours. Do you agree with that view?

GK: So, if we read the guidance that was put out by the DGCI’s office in September of 2020, they had said what data they wanted to look at from vaccines that were developed outside of the country. And this guidance was very similar to what had been developed by the FDA [US Food and Drug Administration]. It required that a vaccine underwent an efficacy trial, showed at least 50% efficacy, and had at least two months of safety data for the median population that was recruited for that study.

So, in terms of that, AstraZeneca data has been provided to the SEC. If we look at the data that has been generated in India, and my understanding is that Serum’s trial isn’t complete as yet, even though they have finished recruitment of the 1,600 participants that they were asked to recruit and they’ve submitted, I believe, immunogenicity data for a subset of the 400 that they were supposed to recruit for the immunogenicity studies.

So, if we go back and look at how other vaccines have been licensed in the country, when a vaccine is made elsewhere, the bridging study that is required to be done in India is a relatively small number of participants. From my own field, I remember that when the Merck vaccine RotaTeq was to be licensed in India – and for rotavirus vaccines immunogenicity can vary a lot across populations, unlike injectable vaccines – the total number of people in the study was 89.

So, in terms of saying that people bent over backwards, I think given the guide rails that were laid down by the DCGI, given that the phase 2-3 study for Serum was one that had been approved by the same subject expert committee, I’m assuming that they did exactly what they were told to do – except that they’ve gone back in to ask for an emergency use authorisation, instead of waiting until they completed the entire study and asking for a full licensure.

KT: So, you don’t believe the subject expert committee has bent over backwards to clear Oxford-AstraZeneca? That is the end result of your answer? You don’t believe special favours have been granted?

GK: As far as I’m aware, they’ve done what they were told to do. Serum has done what they were told to do and while they haven’t completed their trial, and their trial is a lot smaller than the Bharat Biotech trial – is going to generate a lot less data – it’s still incomplete. But at least on paper, they have all the pieces that they needed to have.

KT: Now, let me then ask you this, professor Kang – and I don’t mean it as a trick question, even if it sounds like one – if you had a choice of the two vaccines: the Oxford-AstraZeneca and the Bharat Biotech, which would you be happier to have?

GK: I’ll take that in two parts. Would I participate in a trial and which vaccine would I choose to take? I think participating in a trial I would wherever a study is being done, if I’m eligible, I’d be happy to participate because I see that as my contribution to the research enterprise. Currently, there are no ongoing trials of either vaccine where I am. So, I have been thinking about whether I should go somewhere else to participate. But if it is a question of which vaccine would I take, I would take any vaccine that has efficacy data and has been approved by the regulator.

KT: Hang on a second, that clearly means you wouldn’t take Bharat Biotech. Bharat Biotech may have been approved for restricted use, but as you’ve repeatedly said, it doesn’t have efficacy data. So, that would rule out Bharat Biotech.

GK: Well, you’re not offering me the vaccine this minute.

KT: But nonetheless, if you’re consistent with what you said earlier in this interview, Bharat Biotech doesn’t have efficacy data, so you would not take it.

GK: At this time, Bharat Biotech does not have efficacy data. I would take Bharat Biotech’s vaccine in a clinical trial. I would not take it outside of a clinical trial, until it had efficacy data.

KT: That’s very clear. We’re coming to the end of this interview. I just want to ask you a couple of questions about the way vaccines are being cleared in India. Will the controversy surrounding Bharat Biotech increase vaccine hesitancy in India? Could it put more people off taking vaccines?

GK: I don’t think it’s just Bharat Biotech. I think with the information on AstraZeneca and Covishield, the way adverse events have been handled, I think we’ve got a real communication problem here. There is a lot that we need to do to convince people that we’ve done the right thing in developing vaccines as quickly as possible and that these vaccines are safe and efficacious.

We need to back up any such communications that we have with the best available information. I know the pandemic creates a sense of urgency. But this is a virus that is really going to be with us for a very, very long time and if we are to use vaccines for a long time, we need to start building the trust from the beginning.

My worry, really, is now about the mutant strains and what this will mean. These are early days at this time but we have evidence that some of the mutants that we are seeing might be able to escape vaccines. Does that mean that we are going to need to continue to revise our vaccines? It’s possible. There’s a lot of data that is just emerging and just speaks to the need, if we need vaccines to be used, we have to have people trust them.

KT: And that element of trust, which is critical, could have been impaired or damaged by not just the speed with which Bharat Biotech has been cleared, but the controversy is the questions that now surround it. Now, the DCGI

GK: Not just Bharat Biotech, Serum as well.

KT: Serum as well, absolutely, because we raised many of the questions about the Serum-Oxford-AstraZeneca vaccine. This whole process of clearing vaccines for COVID would have damaged trust and increased questions. The DCGI, when he cleared the vaccine – both the Serum vaccine and the Bharat Biotech vaccine – refused to take any questions. In contrast, both the MHRA in the UK and the FDA in the US spent a lot of time answering questions. Should our DCGI have behaved similarly? Should he have been more open to questions and gone out of his way to answer them with full detail?

GK: Well, I think all of our governmental authorities should be more available to answer questions, because the concerns that people have are really important. And, I’ve said this before, the more open and transparent we are with why we make decisions the way we make them – if we seek to address questions, even if they sound obvious or silly, that makes all the difference in having people trust the interventions that we are offering. That applies, you know, I think, to masks as much as it does to vaccines. So, the more openness, the more transparency, the more answering of questions, the better.

KT: In that context – the more open, the more transparent, the better – I put my last question to you: We don’t, today, know the names of the members of the subject expert committee or even the names of the members of the National Expert Group on COVID. Should these names not be public?

GK: I think, if we look at committees that are in other parts of the world, usually, the names are available. The only reason, well – I can’t think of a reason why you would not want them – except that you know there’d be a lot of pressure on individuals if they were identified as being part of important decision-making bodies. So, perhaps that’s the reason that the government wants to protect them.

KT: Surely that’s the wrong reason. These people are experts, they should have the capacity to defend their expertise and the decisions they take. After all, it’s being taken on behalf of and will affect the lives of hundreds of millions of people. Therefore, if defending their decision puts pressure on them, that’s acceptable pressure, they shouldn’t be protected from it. And let me just add, when the MHRA went public, Dr June Raine, who’s head of it, was present with Sir Munir Pirmohamed and a fellow scientist who, I believe is Vietnamese. And they were there, answering all the questions themselves and they continue to do so.

GK: I think we’ve had voices from the government. Dr Paul speaks to the decisions and the recommendations that are being made by his committee. There are other governmental representatives that speak on this subject as well. So, I guess, there is information that is emerging or perhaps there will be a time to come when questions will be welcome as well.

KT: In that hope, we all live. Perhaps, a time will come when questions will be welcome as well. That’s a very sad situation for a democracy to find itself in. That at the moment, a time has not come when questions are acceptable and welcome. I think that speaks volumes. Dr Kang, thank you very much for this interview. Thank you for taking the time to clarify all the issues and concerns, both about the Bharat Biotech vaccine, as well as the Oxford-AstraZeneca one. And thank you also for making clear that whilst you’re happy to participate in clinical trials, you would not be willing to take the Bharat Biotech vaccine until the full efficacy details are known and made public. I’m grateful for that. Thank you very much. Take care, stay safe.

GK: Thank you.

(Karan Thapar is a well known journalist, television commentator and interviewer. Article courtesy: The Wire.)