 Hello and welcome to NewsClick. When the approvals were given to co-vaccine, it was sent in basically what's called clinical trial mode. If we look at what's happening today, it's clear that these are full-fledged vaccinations right the government is doing. AstraZeneca has about two-thirds, one-third of it right now is co-vaccine and this is not being done in so called clinical trial mode. This is really the vaccination right. At the same time we're also told that the volunteers are being asked to sign a form giving informed consent for clinical trials. Now clinical trials generally are double-blind etc etc so none of that is happening. So how do you see this amalgam of vaccination come clinical trials come informed consent that is currently taking place? So there are two cardinal issues involved in this that should be of concern to all of us. The first is the absolute lack of transparency and information availability on the part of the regulatory authorities meaning on the part of the government. The regulatory authorities have not clarified what they've been by approval in clinical trial. How they want the clinical trial mode to be operated, what sort of data, what sort of consent process, what sort of analytical approaches, nothing has been clarified. In fact, Bharat Biotech pointed out that they didn't quite understand it either and we have heard nothing subsequently about whether they have now understood it or not. First, second the vaccine is being purchased by the government and implemented it which means that the government is responsible for its administration yet consent forms are being required from the individuals being given this vaccine and the consent forms identify Bharat Biotech as the agency involved and responsible particularly for treatment of adverse effects and so on and so forth. So the entire landscape of co-vaccine administration is a regulatory mess. Added to this is the problem of at least implicit coercion because this is keep in mind a vaccination campaign that's currently focused on healthcare workers primarily in the public or semi-public sectors. What they are being offered is a vaccine and if they are that small minority at the moment, since vaccine supplies are very small for co-vaccine, if they are being offered co-vaccine they don't have the option to say I don't want this, I want that. As far as we the rest of us can tell they seem to be given the option you either take the vaccine that's being given to you or you don't get a vaccine and that because co-vaccine is in clinical trial mode it appears to be a violation of freedom of choice and keep in mind that the signals coming about co-vaccine have been so complicated and so undirectional as to create almost legitimate vaccine anxieties and I'm saying this despite my concern that we may be feeding vaccine anxieties. The government on the one hand puts out through its spokespeople statements that the vaccine is efficacious yet there is no evidence even today even of the preliminary kind about its efficacy the people who are receiving it are being told that they are being given it for protection yet they are being told that they are being given it in clinical trial mode where protective efficacy is being tested for or this is a regulatory and public relations mess of governance. Frankly clinical trials in India our friends in public health activism will tell us has seen many such examples of drug trials and related issues in India our soft implementation to be euphemistic about it of regulatory regimes makes all sorts of violations possible. The sad part is that in a high-profile public sector pandemic response situation we seem to be behaving in exactly the same poor fashion. So there are some of the new issues that have cropped up and hence this conversation or hence these comments two main areas one is that from CSIR a preprint has been published where CSIR employees have been evaluated for the SARS-CoV-2 responses and along with the epidemiological data that they have collected. So that is an interesting bit because it's a study which is not perfectly planned in the sense it's not a epidemiologically sound sampling method but they are trying to claim that there might be association with smoking association with non-vegetarian food both the non smokers are more prone to infection non-vegetarian food eaters are more prone to infections and these are based on some of the serological data that they have collected somehow the associations are particularly weak and the claims that they have made based on antibody positivity and neutralizing antibody positivity are sounding very weird. So that is something that needs to be taken with a pinch of salt and a major limitation in my opinion is that they have included people who are relatively more affluent and who are the regular staff members and the others who are contract members so they are putatively from lower socioeconomic status. So comparing both these categories in one go is compromising the soundness of the data in my opinion because we know that crowded localities poor hygiene all of these contribute to higher frequency and despite all of this their seropositivity is about 11 percent which takes me to the second point which is the need for the vaccine since yesterday that is 16 17th of January the vaccination campaign has started in India and what has been done is healthcare workers and frontline workers have been identified and about three crore individuals are supposed to get vaccinated in this first round initial round of vaccination and for this two different vaccines have been quote unquote approved the first vaccine is a Covishield vaccine produced by serum institute of India for which there are sound reasonably sound data of protection and admittedly short term protection but the protection has been proven based on global studies and hence Indian authorities CDSCO have given it approval for emergency use which seems reasonably fair this is what has been done for other vaccines globally as well but the second case is of a peculiar nature the trade name is so-called Covaxin it is an inactivated viral vaccine which was which is claimed to be completely indigenous and that claim of being indigenous vaccine seems to provide it with some undue advantages beyond the science of it phase one and phase two trials for Covaxin have been completed there are no data available which to show protective efficacy from the phase three trials because phase three trials haven't progressed for a sufficient duration to arrive at such a conclusion without such hardcore data somehow the expert committee seems to have decided about giving even emergency approval to the Covaxin use and then within 24 hours this is based on what was available as media information within 24 hours they provided approval in so-called clinical trial phase this seems to be a novel nomenclature and what is the problem with Covaxin is now it is being introduced in this national vaccination program without having proper data which is worrying because the same government which is making rules is also breaking rules and is this primarily because this Covaxin is considered an indigenous vaccine that's the question that needs to be kept in mind and transparency in data sharing assurance to the users that the vaccine is really useful are some of the considerations that we need to take into account none of that has happened for Covaxin and some of the health workers are also questioning whether they can take the vaccine it's also seems as if there is some coercion which is getting reported that if you do not say yes to the Covaxin you will not get vaccine is what is getting reported that is highly worrisome and we need to think about ethical ways of providing vaccination to the health care workers so I think we should actually just start with Covaxin today go on for a few few weeks because we are not going to cover too many people in a I mean all three crore people and after Covaxin results are proper results of efficacy are available even that vaccine can be implemented in the vaccine trial all day people science network had issued a statement on the vaccine all out a few days back the one of the main points and that was that we urged that the state governments take a hard decision on about deploying Covaxin widely and that they preferably keep the stocks keep the vaccines which have come out in stock and not administer them till greater clarity is given by the government or till CDACO ACC approval conditions are met as was promised by Bharat by attack initially Bharat by attack had initially fired for clinical trials saying that they will do phase three trials and subsequently they made an amendment on 7 January after the approval was given where they have removed the phase three trials and just put in as approved and given the details of one in phase two so it's important that the efficacy be clearly established before proceeding to a larger population as also the safety on a larger for a larger population so typically phase three trial part from addressing efficacy also addresses the question of safety in a larger cohort the example in Norway when not being alarmist is really in question because as you would know in Norway the Pfizer vaccine 23 people had casualties I mean there were casualties of 23 people especially the terminally ill and old people so now they have said maybe it should not be administered to terminally ill ill and old people so there can be modifications that come when you have this is for Pfizer which phase three trials have been done and people have actually gone through them rigorously so it's essential that we take all precaution and just because the vaccine has been made by Bharat Bhaitek and I think it does not give it some special aura which allows it to go beyond the scientific rigor so and there's no necessary urgency that it should be released now as has been said earlier also one can work with Kovishil right now and by February end or March by which time if the efficacy data is available from Bharat Bhaitek Kovishil can go ahead with this the other problem is that in the APS statement we also said that there should be proper consent obtained and ethical standards should be followed it appears that there is a consent form that is where people are getting those who take co-action have to sign but if one looks at the consent form the first page of the consent form talks about co-action and how it's only phase one phase two are done and how when there is any adverse effects compensation will be paid by Bharat Bhaitek and in the second page is all details about the individual and the third page where the actual vaccine is mentioned it you know there that it doesn't say anything about co-action in terms of the details it just says that I I agree to be vaccinated and there is one tab where it says the co-action want dosage and the person who's given the this thing so the third page which is actually the one which is being signed and probably that is the only one which will be shown to people because most often as happens in our place the people just show up place and ask you to sign that last page so the first page is actually should be the one where people should be signing because that is where all the details are given and it's sort of a dummy consent because if you don't agree to the consent then you lose the chance to get vaccinated so it is a asset that those who only choice they have is either not to get vaccinated or to get vaccinated by co-action which is whose efficacy has not been proven no so if if this is the case why don't just like Putin administered his vaccine to his daughter no all the the entire cabinet could get administered the vaccine co-action and you know then we wait for 48 days and after the trials are done it could be done so this whole thing is a meaningless thing because you can't go by such ways no you can't say that these people have been administered and therefore it's safe that's what people are trying to true that and doctors who are in the business of this have expressed their own reservations so I think it's important that rather than going for some chest beating and just because it has to be announced on January 26 instead of that a more scientific after all if you say that India has to be a scientific leader then it has to show that it follows scientific principles and therefore it's necessary that Kovishield be used now but co-action be kept aside and used only after efficacy data is made available publicly I think this is the only stand that can be scientifically valid and without bringing in any ultra nationalism and such stupid issues I think it's necessary we for the safety of the people for the safe you know make sure people who get the vaccine get some benefit from it otherwise what will happen is you give a vaccine the there's a very low efficacy and then the person again will that person be getting another vaccine administered later if the efficacy is proven to be low only adverse side effects are going to be compensated with barithymetic what what happens if the efficacy is not enough then who will compensate for that person so these are issues which are not there at all in any normal textbook reading a vaccine rollout and it's important therefore we follow established protocols and use only Kovishield now and keep aside co-vaccine and that is what the AAPS statement also said and I think at this time it we must go by that rather than give the choice which is not really a choice to the people at large especially the frontline workers who are the ones who will be most exposed to the covid or any second or third waves that come this is all the time we have a news click today do keep watching news click and do look at our website as well