[<<*But for Covaxin, they say it will be given in clinical trial mode. What does that mean?* I have no clue. I have never seen anything like this before.>>
Neither of the two vaccines, as yet "approved" in India, has completed "clinical trials" in India. While one - Covishield, has claimed just about 70% efficacy (after two doses), based on global data, there's, apparently, no public disclosure as regards the second. (Ref.: < https://www.ndtv.com/india-news/oxford-covid-19-vaccine-bharat-biotechs-covaxin-get-final-approval-by-drug-regulator-will-be-indias-first-vaccines-2347053 ?>.) In case of the second - Covaxin, as it appears, the third stage clinical trial would be conducted/completed via mass vaccination! *That's nothing short of astounding!* The "approval" itself, reportedly, reads that, apart from being on the basis of "emergency" - to be periodically reviewed for renewal, it's on "clinical trial basis". (Ref.: < https://www.thequint.com/news/india/dcgi-approves-oxford-covid-19-vaccine-covishield-bharat-biotech-covaxin-for-emergency-use#read-more >.) The Bharat Biotech, only on this January 2nd, announced that it was yet to complete the process of recruitment of the targeted number of volunteers for the "third stage trial". (Ref.: < https://m.hindustantimes.com/india-news/bharat-biotech-recruits-23-000-volunteers-for-phase-3-clinical-trial-of-covaxin/story-cCJRx3VK0BuD0AAsQQgmsK_amp.html ?>.) The "approval" would follow the next day. Thus, those, who would be administered, would, in effect, be "trial volunteers", for the requisite "third stage clinical trial" - sans the mandatory "informed consent". It's hugely criminal; yet another stupendous scam. The media is keeping its trap tightly shut, though. Both the efficacy and safety can be ascertained, with reasonable level of surity, only after completion of the trials, at the very least. All assurances, prior to that, are mere window dressing. Please look also up: < https://www.businessinsider.in/india/news/aidan-asks-dcgi-to-withdraw-approval-for-bharat-biotechs-covaxin/articleshow/80078041.cms >.] https://m.timesofindia.com/india/i-have-no-clue-i-have-never-seen-anything-like-it/amp_articleshow/80087336.cms ? 'I have no clue. I have never seen anything like it' Rema Nagarajan | TNN | Updated: Jan 4, 2021, 15:11 IST TNN Dr Gagandeep Kang, the vice-chair of the board of Coalition for Epidemic Preparedness Innovations (CEPI), a global partnership seeking to proactively develop vaccines for epidemics, and professor at the Christian Medical College (CMC), Vellore, talks about concerns around the approval process of the two vaccines by DCGI during an interaction with Rema Nagarajan *What do you make of the approval of the two vaccines?* I am completely confused. I read the SEC document yesterday, the approval, the SEC recommendations. I can understand what they are saying about the Covishield vaccine and then they have this very complicated language for the Covaxin vaccine. The DCGI has actually quoted that language, but its approval for both of the vaccines is identical. But for Covaxin, they say it will be given in clinical trial mode. What does that mean? I have no clue. I have never seen anything like this before. *Isn't the vaccine already on clinical trial?* Exactly! Either you are doing a clinical trial or you are not. I am confused. *Even for Covishield, shouldn't the data on which the approval is based be made public?* What other companies have been doing is going to the regulator. In parallel to the data they are submitting to the regulator, they are also submitting to journals. If we look at Pfizer, Moderna, Gamlaya, Astra Zeneca, all of this has already been published in peer reviewed journals. *In case of Covishield, couldn't ICMR do a pre-print in its own journal?* ICMR does not need to do a pre-print. It can publish in its own journal. It has already done that for many papers that it has published, like the hydroxychloroquine one, the observational study they had and many others. *Wouldn't publishing it have helped build trust? The first people to get the vaccine would be doctors and they do understand data and trial studies?* So Bharat has put some data out there and has some data in preparation, but as far as I am aware there is absolutely no efficacy data that has been presented or published. In fact, it is impossible for them to have it given that the vaccine required two doses. The phase-III trial started only in November. *And what about Covishield?* Even though it is labelled a phase2/3 study, it is not a phase2/3 in the form recognised in any other part of the world where phase-3 implied clinical efficacy. If you read the CTRI description of what is labelled a phase 2/3 study by Serum Institute, you realise that it actually is what would be called a phase-2 study in other parts of the world, i.e. for safety and immunogenicity and not for efficacy. They are relying on, and that in fact was in the note that was put out in the DCGI statement, they are relying on the Astra Zeneca data for clinical efficacy. And even there what is stated, they have said that they are looking at 70% efficacy which is pretty much what the UK regulator did even though we know that in the dosing schedule that is proposed for India and that has been tried for India, the actual efficacy is about 62%. That's fine as long as it is over 50%. So definitely for Covishield, there is data that an equivalent vaccine tested elsewhere is over 50%. But for Covaxin there is no such data available anywhere to my knowledge. *Doesn’t this dent the reputation of the indigenous vaccine, Covaxin?* How is this an indigenous vaccine if the adjuvant that is in the vaccine is one that came from the US? Yes, the strain is an Indian strain but a key component of the vaccine is the adjuvant and that’s not Indian. So you could argue that Covishield is Indian because they just imported the viral vector and after that they have done everything in the development themselves here. We should take pride in our vaccine industry for how much service they have done but this kind of thing is not going to be good for our reputation. Would we be able to defend this internationally? *How are we different from Russia and China? I really don't have an answer if anyone asks me that question.* The list of experts in the subject expert committee (SEC) is also not in the public domain. *Does that add another layer of distrust?* Earlier membership of SECs used to be in the public domain. And I guess they have now decided this wasn’t a good idea. I have nothing to say except that I am confused. I don’t understand the language, I don’t understand what this means for the way forward for us. I guess the government will give us clarity in the days ahead about how this is actually going to be used. I see a difficult time ahead in trying to explain to people why we are going to work like this. *Would this add to the vaccine hesitancy?* That's what bothers me because people are already worried, wondering about how they developed a vaccine so fast and how they must have cut corners. Essentially you are handing people who are anti-vaccine, anti-science a weapon that they can use. It is horrendously hard to think of why experts would think that this was a good way to go. -- Peace Is Doable -- You received this message because you are subscribed to the Google Groups "Green Youth Movement" group. To unsubscribe from this group and stop receiving emails from it, send an email to [email protected]. To view this discussion on the web, visit https://groups.google.com/d/msgid/greenyouth/CACEsOZjmcXOLKOJ16mv%3D8msnomgTC1U-UKq5OgORx0uyL1HmPw%40mail.gmail.com.
