 Hello and welcome to NewsClick. Today we are going to discuss the vaccine trials some of which are now supposed to start in India as well. Of course Serham Institute is one of the big players, generic vaccine players in the market and they have also lined up with Oxford University trials that if it succeeds then they will also produce the vaccines in India. Satyajit, a very peculiar clearance given by ICMR, your friends in Indian Council of Medical Research who seem to have said the vaccine should be ready by 15th of August this year. Now does it seem absurd that the Indian Council of Medical Research should not know there are three places of the trials and they are now asking the vaccine manufacturer who had said that they will run the trials phase 1, phase 2 and phase 3 trials. Over 15 months they should do it in the period of roughly six weeks. The first response that many people had to the letter from the Director General ICMR that you're talking about that emerged as a leak I think they did before yesterday evening was is this some sort of a troll or a scam or a joke because so I have had people asking me do I really think that is his signature and I asked you did they make a mistake about the year in the letter then one person asked that as well so it is it is that extraordinary peculiar a leak but in very brief terms the letter is deeply problematic in two different ways firstly the letter is written to the private sector partner developer biotech industry biotech and to a group of a dozen or so hospitals let me not use the term medical institutions since all of them I suspect cannot be dignified with that term. A dozen or so hospitals who are supposed to be participating in the clinical trial of a SARS-CoV-2 COVID-19 vaccine that ICMR and Bharat Biotech are developing together. Oh ICMR is a partner in this. Oh that is even more strange. I you know the the number of weird things about that letter simply multiply them more carefully you look at the letter so I'm still hoping to wake up and discover that it was some sort of a joke or a mistake and that it wasn't written by the DJ ICMR at all although I suspect that that's not going to turn out to be the case. Can we demand to see his degree is that a legitimate demand the whoever assigned the letter. So but but completely frivolous response is although they are the most appropriate assigned let me point out that there are two ways in which that letter is worrisome two different categories in which that letter is worrisome one category is this is a letter coming from a senior government official. This is not simply the director general of the Indian Council of Medical Research. It is also a full secretary of the government of India in the ministry of health and family welfare and the secretary in charge of the department of health research. So this is then effectively a government letter and basically this is a government letter that is written to a number of parties some in the private sector completely a few in the public sector basically saying to them that they need to fast track and expedite a vaccine clinical trial which is in regulatory terms and extremely carefully hedged about undertaking it is hedged about by legal requirements it is it is encompassed in regulatory stringency all of which is for good reason. I mean normally fast tracking is something others might want but a regulatory body asking the people to fast track development of a vaccine is actually the reverse of what a regulatory body should be doing. So keep in mind that this is not the regulatory body technically speaking because the regulatory body is the CDSCO or the drug control agent in India or people in that component of government if this had been the regulatory body then the conflicts would have been even more problematic. Plus as I said ICMR is a partner developer of the vaccine. Nonetheless to say that is what does the letter say that serious views will be taken of failure to expedite the process to introduce the matter by saying that this matter is being followed at the top most levels of government or words to that effect. All of this is classical bureaucraties to threaten people. So implied in this is a threat that you better do it in six weeks or else. So the inner of the letter is deeply coercive and to have a senior government functionary not just participate in but actually initiate such a coercive letter going out to a number of organizations is really does not bode well for the integrity of our regulatory processes as far as biomedical technology development and drug development and vaccine development are concerned. So that's one whole category and we can talk about all the many facets and dimensions of this difficulty with the tenor of the letter. The other component of that letter which is worrisome is of course what everybody has focused on which is this quite weird deadline in which apparently the director general of the Indian council of medical research thinks that phase one clinical trials can be initiated by about the 7th of July since the letter says you should start recruitment no later than the 7th of July and a phase one phase two phase three clinical trial process including data collection analysis evaluation and regulatory consideration of all the above can be completed in less than six weeks to enable a vaccine to be launched on the hallowed occasion of India's what is it 73rd independence day anniversary this creates worries not simply about coercive government but about the competence of government. I would go a little further Satish and say the sanity of the person signing the letter if he indeed has a degree in sciences and has been reading up the files which I presume he has been in the position he occupies so it's a I'm going to be in the sense you know not as just as restrained as you are okay I know there are circuit in which you must intersect with ICMR so after which this discussion that might not take place in the future but in this is and I we haven't had a response from ICMR after all this has come out well I have seen somewhere in media a response by ascribed to an ICMR official named Dr Sharma I think who appears to have said something to the effect that this is simply encouraging all parties to work as hard and as quickly as possible and that the date is simply an aspirational date and I can imagine that containment of the adverse fallout to this letter can best be done by that kind of rubber-walling. Yeah but you know even if it's an aspiration it has to be an aspiration which is achievable just like I said if it was something which the ministry of health and IS officer had written I would have said okay it's aspiration but this is the Indian council of medical research so they should know at least better than lay persons what this phase one phase two is not simply that if you actually look at the trial date information that is in the public domain this is the trial about which that letter is has been written the trial itself says that it will last for about a year and I think two months or three months 15 months is I think the trial period roughly so the trial is perfectly reasonably initiated the trial does not also say that it's a combined weird phase one phase two phase three trial the trial says it's a phase one phase two trial so there is nothing in the background of this letter to support the extraordinary claims of this letter nothing in the background from the council from Bharat biotech from any of the participating institutions to suggest that the weird claim of 15th of august 2020 is on any of their horizons so okay I think we've spent a lot on what could be called hot air of the bureaucratic handling of ICMR of a very serious medical technical research issue how should safety trials be conducted for an accident and what should the duration both of which are really important issues and troubling a lot of the people worldwide because of course if you could produce a vaccine very quickly that would be of great help but the same time you don't want to produce something which actually backfires because the wrong vaccine or the bad vaccine would have very adverse repercussions on the total scheme of vaccines itself it will create doubts and as you know there are anti-vaxxers all over the world saying vaccines are bad so you are also fighting that in fact one of the one of the statements I think by Fauci is that 50% of the US people may not vaccinate themselves because they don't believe in vaccines so the anti-vaxxer problem is quite acute so in this climate if you produce a bad vaccine it's really going to rebound on us in more ways than one throwing doubts on the Indian capability of producing vaccines manufacturing selling vaccines and of course of the vaccine process itself absolutely as a matter of fact I would worry quite a bit about this particular vaccine candidate as you know I tend to worry pedantically about terms we use and so long as a vaccine is actually not licensed I would much rather that we refer to it carefully as vaccine candidates rather than vaccines and this vaccine candidate is essentially simply the virus which is where ICMR's participation comes in because ICMR this is an isolate of the virus a strain of virus that ICMR has grown in Pune at the National Institute of Virology from infected Indian patients that it has isolated it from so and the vaccine is formulated as grow the virus kill the virus and inject the killed virus and this is an old in fact it's the oldest of the many vaccine technology categories that we've discussed in the recent past and it's not technically perhaps the most demanding vaccine formulation to make in some ways but in other ways and it has its own potential caveats and limitations so for example the vaccine candidates for the older SARS the 20-year-old SARS-CoV-1 disease for which people were making vaccines or the MERS disease virus MERS-CoV-1 for which people were making vaccines in both of those this kind of killed virus vaccine led to some difficulties in animal studies while they provided protection against the virus challenge they did lead to some more inflammation in lung tissues than would be desirable in the in the vaccinated animals now this is not at all to say that the present killed virus vaccine will be similar and in fact again if you remember the first vaccine that we discussed in these ongoing COVID-19 discussions from Sinovac the Chinese company which put out oh two months ago now data on Rhesus monkey experiments showing that there was some measure of protection those data looked at monkey lungs and did not find inflammation so it's not at all my suggestion that that's what's going to happen here I'm simply bringing it up as the as an example of the kind of worries that you point to about vaccines and their safety and efficacy related issues that we have all have to be careful any vaccine needs safety and that's why you have phase three trials that's essentially the part of the phase three trials absolutely large numbers there is already adverse reaction in certain sections and and and as we have discussed here is the paradox in the speed of SARS-CoV-2 COVID-19 vaccine development which is that the better we control the rate of spread of the pandemic the slower vaccine development is going to be fortunately the US Brazil and India is providing now a sufficient speed of the disease I would not have used the term fortunately but yes I was being sarcastic I have to agree with with that and as a matter of fact you will note that that's precisely why all the phase three clinical trials that I'm aware of that are that have been initiated have been in Brazil yes that's right if the Chinese one is in Brazil Chinese don't have patients clearly and so the Oxford trial is in Brazil Oxford trial is also in Brazil oh yes yes okay why aren't any of them happening in India except the this Bharat biotech one the proposed Bharat biotech one any idea oh I think that well honestly I don't know why none of them is happening in India I think that one possible explanation is that the growth of the epidemic the spread of the epidemic in India is very heterogeneous okay and because of that there's always going to be difficulty about setting up the trial where the two groups vaccinated and unvaccinated are going to be exposed to over succeeding time to an equivalent risk of virus exposure so that extent Brazil provides quote unquote a better place to trial to hold trials that appears I'm guessing that may be one possibility another possibility may be that the Brazilian regulatory establishment and landscape is somewhat more rapid in its responses to requests the other other point and this is really the last point that before in today's discussion because you know we would tap you again and again on the other discussions as well but the last discussion coming out of the vaccine trials that we are talking about the hospitals it's also interesting that because of the NHS hospitals in in England in the United Kingdom they have been able to conduct much larger drug trials and what other places have been able to and that's primarily because the public health system is still there in England that the you have the NHS in England and you don't have similar things for instance in India a large number of hospitals working under the same agency or in the United States which are the two other places where you could have you could have seen a large number of patients but the hospitals are completely fragmented unlike the unlike the case of UK that's absolutely true in in in terms of sheer magnitude yes you're absolutely correct even though I can imagine a very large number of as they're called insurance system hospital chains in the US being being quite able to undertake drug trials of this kind the fact remains that the NHS in the United Kingdom is as you say an absolutely stellar example of how a true public sector public health system can even in the midst of great existential difficulties let's make no bones about that still work together and effectively to conduct not simply patient care duties but also these kinds of pressing research undertakings such as drug and other therapeutic trials and it's also interesting that the results from this have been more conclusive because of the sheer numbers as you talked about recovery trials have actually done certain things identifying dexamethasone talking about hydrochloroquine and it's not being effective and also in this aware all of these seem to show that they have an ability which others do not seem to show and even WHO which has been talking about its solidarity trials and yet to get off the ground or you know at least this numbers are relatively much smaller even the scale of the solidarity effort is is somewhat different and therefore I can imagine that the difficulties are larger but but but let me bring this point that you raise back at the end to the Bharat biotech ICMR vaccine that we began conversation with because in this context too it's interesting that the dozen or so hospitals that the director general ICMR has apparently written to who are the participants in the clinical trial range over an extraordinary variety of medical centers there are apparently apparently there are private hospitals there are apparently there there are quasi complementary medicine Ayurvedic centers there's there's a whole diversity across the country of centers which have been pulled together to undertake such a vaccine trial and one wonders on what basis were these selected who selected them how well are they going to be able to work together are all of them on the same page in terms of experience as well as in terms of institutional mechanisms and structures to do clinical trials of vaccines of this kind all of these become issues and this in a country where we have one of the world's largest ostensible public health system that's quite true that this this should have seen public health systems more closely involved because hopefully there would have been a standardization and a minimum level of competence and we do not know some of this Ayurvedic centers you've talked about but they were involved with the coronal trials of Ramdev Patanjali so we don't know of course we hope not but that's a question that still can perhaps be explored but you're right that after all Ayurveda does not accept double blind trials randomized trials anyway well the ability to conduct I don't even want to get at this point into the issue of evidence-based medicine and what it encompasses and what it does not all I'm trying to say at this point is in a country of 125 crore people with the world's so-called largest public health network we cannot find a dozen reputable public sector institutions of high credibility to carry out clinical trials for a pressing need vaccine that's a big that says something deeply distressing about the state of our both public health system and about our biomedical research systems well on the rather somber note and from my side a question mark on the sanity of the person who signed the letter or drafted the letter we will conclude our today's discussion I hope that ICMR at least will do some clinical trials about the sanity of his officials before it proceeds further on doing clinical trials about the vaccine thank you very much Satith for being with us and with my rather inclementary remarks on your fellow professionals in medical research thank you this is all the time we have a news click today do keep watching this click and follow our other interviews as well