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  • Address questions on Covid-19 vaccine policy

    Posted On June 6, 2021

    By Karan Thapar

    A useful trick handling questions you can’t or don’t want to answer is to pretend you’ve been asked something else and respond to that. It’ll take a while before the anchor realizes you’ve deflected the discussion and if you’re lucky you might get away with it. Although many of our politicians seem unaware of this ploy some ministers are using it to tackle concerns raised earlier about the vaccines used in India.

     

    The intention is to suggest critics of the vaccine are contradicting themselves. So Nirmala Sitharaman questions their right to criticise the Modi government for failing to ensure a sufficient quantity of vaccines because, earlier, they had raised questions about safety. I’m sorry she’s wrong but I give her credit for trying.

     

    What was questioned was the efficacy of Covaxin. No one said anything about its safety. And no one had doubts about Covishield. But the reservations about Covaxin’s efficacy were well founded.

     

    Briefly, let me explain. Covaxin was given emergency-use clearance without awaiting its full trial 3 results. This means its efficacy had not been established. In fact, those trial 3 results are still not available. All we’ve been given is two sets of interim results. No doubt they’re promising but what about the full results?

     

    Now, Balram Bhargava, the Head of ICMR, claimed efficacy could be gleaned from animal trials and phase 1 and phase 2 trials. Prof. Gagandeep Kang, our foremost vaccine scientist and a member of Britain’s prestigious Royal Society, disagreed. Animal trials, she said, may be used in America to clear drugs but only when you can properly mimic the human disease in animals. That hasn’t happened for Covid-19. As regards Covaxin’s phase 1 and 2 trials, they only involved 800 participants which is far too small for reliable efficacy data.

     

    It’s possible Nirmala Sitharaman is unaware of this but by converting concerns about efficacy into questions of safety she’s not only distorted what critics said but tried to make them appear contradictory. This might work with lay people, who no longer remember the original concerns and after 29 million Covaxin jabs have accepted its efficacy. But by raising an issue that was best left forgotten she’s aroused fresh concerns that cannot do the government’s cause any good. Several top scientists and doctors I regularly speak to have mentioned them. I can’t name the people but I can repeat what they’ve said. (Incidentally, Prof. Kang is not one).

     

    First, what’s happened to Covaxin’s full trial 3 results? The vaccine was initially permitted for use in clinical trial mode but after the first interim efficacy results that condition was dropped. But where are its full trial 3 results? And what about Covishield’s bridging trials? Like Covaxin, it was permitted for emergency-use whilst awaiting the results. Five months have passed and but neither has been published in peer reviewed journals.

     

    Second, why haven’t we been given information about breakthrough infections connected with both vaccines? One explanation, revealed by NTAGI Chairperson, N. K. Arora, is we only started collecting details on April 8th, almost three months after the first jab. That was a terrible error but I doubt we’ll ever be given an explanation, leave aside an apology. That apart, even two months after April 8th, why are we still in the dark?

     

    Third, are we doing phase 4 trials to check on the real world effectiveness of the vaccines we’re using? This is particularly necessary because the vaccines are only cleared for emergency-use and Covaxin, initially, only in clinical trial mode. Given jabs began in mid-Janaury and, at least, 25 million have been given we must have credible and sizeable data. So why hasn’t it been made public?

     

    Not that she intended it but I want to thank Nirmala Sitharaman for provoking our experts to privately share these questions. Sadly, they can’t publicly voice them for fear of reprisal. But that’s also why they’ve given me a useful tip. So, today, I’d like to thank them – and, of course, Mrs. Sitharaman too!


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