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The uncertainty over vaccine authorisation

Karan Thapar / Hindustan Times Share:
In India, COVID-19 vaccines sparks a furious scientific debate. Dreamstime

The authorisation of the two vaccines to tackle Covid-19 has been met with as much consternation as celebration. For many, the doubts and questions that have arisen have created fresh concern.

Just when we needed clarity, we have ended up with controversy. When we wanted simple, straightforward answers, we are receiving confused and conflicted responses. Consequently, the authorisation of two vaccines to tackle Covid-19 has been met with as much consternation as celebration. For many, the doubts and questions that have arisen have created fresh concern.

To get a good grasp of the situation, you can’t do better than listen to Prof Gagandeep Kang. She’s considered India’s top vaccine scientist. She’s also a Fellow of the United Kingdom’s prestigious Royal Society, and a recipient of our own acclaimed Infosys Prize. Her views clash with two of the government’s top doctors, Balram Bhargava and Vinod Paul, but her clarity is exemplary. Also, she has no axe to grind. Bhargava is part of the Covaxin project. That’s why it’s worth hearing Kang before you make up your mind.

Kang questions the emergency-use clearance for Covaxin.

She says the precedent set by the Ebola and Nipah vaccines, which were cleared without completing Phase 3 trials and obtaining efficacy data, does not apply to Covid-19. This is both because of differences in their mortality rates as well as the fact we have other licenced products to tackle Covid-19. “I would ask why would you want to give a vaccine without efficacy emergency-use authorisation in these circumstances?” she asks.

The fact the 2019 Clinical Trial Rules permit this has not convinced Kang. Clause 2(A)(d) of the rules refers to an “investigational new drug”. She does not believe that applies to a vaccine. Remember, a drug is a treatment; a vaccine is a preventive. Only the sick are given drugs. Vaccines are given to the healthy.

Kang also questions Bhargava’s and Paul’s defence of Covaxin’s authorisation. Accepting that Covaxin has not completed its Phase 3 trials and, therefore, its efficacy data is not available, Bhargava has said the vaccine’s efficacy can be gleaned from animal trials and Phase 1 and 2 trials. Kang disagrees. She says animal trials may be used in America to clear drugs, but only when you can properly mimic the human disease in animals. So far 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.

Kang also casts doubt on the Bhargava/Paul claim that Covaxin has been cleared because it could be better at tackling new strains of the virus. “I wish we had data to establish this,” she says. “At the moment we don’t.” The Bhargava/Paul claim is simply a “hypothesis”.

Kang says she’s “really confused” Covaxin has been cleared for use “in clinical trial mode”. She’s “not sure what that means”. It suggests people given this vaccine could end up being part of its continuing clinical trials. Of course, that will only happen with their consent but it’s not what they intended. They want a guaranteed vaccine. Not to be part of the process by which that guarantee is established.

Finally, when asked if she would be prepared to take Covaxin, Kang said while she was willing to participate in the clinical trial of any vaccine — as her personal contribution to science — she would not take Covaxin until its Phase 3 trials are complete and the required efficacy data made public.

Now Kang’s views are not shared by the government. Indeed her former tutor, the eminent virologist T Jacob John, has endorsed Covaxin. But many others have spoken in very similar terms. They include the renowned virologist Shahid Jameel, the Dean of KEM Hospital, Hemant Deshmukh, and the All India Drug Action Network.

However, Kang has stolen a march by speaking out comprehensively and forthrightly. Most others have spoken in sound bites. Now that she’s explained her position, we can only benefit from it. Of course, it’s up to us to agree or disagree. Not being experts, we’re unlikely to do so with conviction. But her views can only help. This is why I’ve spelt them out for you.

 

Karan Thapar is author of Devil’s Advocate: The Untold StoryThe views expressed are personal. Hindustan Times

 

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