Dr Gagandeep kang, the vice president of the board of Coalition for Outbreak Preparedness Innovations (CEPI), a global association that seeks to proactively develop vaccines for epidemics, and a professor at the Christian Medical College (CMC), Vellore, discusses concerns surrounding the approval process of the two vaccines by DCGI during an interaction with Rema Nagarajan
What do you think of the approval of the two vaccines?
I am completely confused. Yesterday I read the SEC document, 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 in fact cited that language, but its approval for both vaccines is identical.
But for Covaxin, they say it will be administered in clinical trial mode. What does that mean?
I have no idea. I’ve never seen anything like this before.
Isn’t the vaccine already in clinical trial?
Exactly! Either you are conducting a clinical trial or not. I’m confused.
Even for Covishield, shouldn’t the data on which the approval is based should be made public?
What other companies have been doing is going to the regulator. Parallel to the data they send to the regulator, they also send it to the magazines. If we look at Pfizer, Moderna, Gamlaya, Astra Zeneca, all of this has already been published in peer-reviewed journals.
In Covishield’s case, couldn’t ICMR do a preprint in their own journal?
ICMR does not need to do a prepress. You can publish in your own magazine. He has already done that for many articles he has published, such as the one on hydroxychloroquine, the observational study they had and many others.
Wouldn’t publishing it have helped build trust? Would the first people to get the vaccine be the doctors and do they understand the data and the test studies?
So Bharat has released some data and has some data in the works, but as far as I know, there is absolutely no efficacy data that has been presented or published. In fact, it is impossible for them to have it since the vaccine required two doses. The phase III trial started only in November.
And Covishield?
Although it is labeled a phase 2/3 study, it is not a phase 2/3 study in the way recognized in any other part of the world where phase 3 involved clinical efficacy. If you read the CTRI description of what the Serum Institute labels as a phase 2/3 study, you realize that it is actually what would be called a phase 2 study in other parts of the world, that is, for safety and immunogenicity and not efficacy. They rely on the Astra Zeneca data for clinical efficacy, and that was actually in the note that was published in the DCGI statement. And even there what is said, they have said that they are looking for an efficiency of 70%, which is more or less what the UK regulator did, although we know that in the dosing program that is proposed for India and that it has been Tested for India, the actual efficiency is approximately 62%. That’s fine as long as it’s 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 that I know of.
Could we defend this internationally?
How are we different from Russia and China? I really don’t have an answer if someone asks me that question.
Would this add to doubts about the vaccine?
That’s what bothers me because people are already worried, wondering how they developed a vaccine so quickly and how they should have cut corners. Basically, you are giving people who are against vaccines and science a weapon they can use. It is tremendously difficult to think why experts would think this was a good way to go.
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