It’s possible that 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. (Amal KS/HT PHOTO)
It’s possible that 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. (Amal KS/HT PHOTO)

Address questions on Covid-19 vaccine policy

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
UPDATED ON JUN 08, 2021 07:34 AM IST

A useful trick for handling questions you can’t or don’t want to answer is to pretend you have been asked something else and respond to that. It will take a while before the anchor realises you have deflected the discussion, and if you are 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 finance minister 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, head of the Indian Council of Medical Research, claimed efficacy could be gleaned from animal trials and phase 1 and phase 2 trials. 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 that 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 laypeople, 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 that I regularly speak to have mentioned them. I can’t name the people but I can repeat what they have 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 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 National Technical Advisory Group on Immunisation (NTAGI) chairperson, NK Arora, is we only started collecting details on April 8, 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 later, 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-January and, nearly 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 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, the finance minister too!

Karan Thapar is the author of Devil’s Advocate: The Untold Story

The views expressed are personal

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