INDIA’S COVAXIN – SHOT IN THE DARK?

about 9 months ago
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Nothing would be better than taking a vaccine for the dreaded Covid by a product manufactured in India. But at this juncture, even if the product was available, most of us would be wary and if given an option, if there is ample supply available, Pfizer would be the most preferred vaccine.

Its not because we love foreign pharma companies; its simply because we do not trust the data or rather no credible data coming from India on its approved ‘Made in India’ vaccine.

On Sunday, the Drugs Controller General of India (DGCI), based on the recommendations submitted by a Covid-19 subject expert committee of the Central Drugs Standard Control Organisation (CDSCO), gave its approval to use of two vaccines – one is AstraZeneca-Oxford University’s ‘Covishield’, made by Serum Institute and the second is Bharat Biotech’s Covaxin.

Both were given the approval, like rest of the world, for restricted use in emergency situation.

DGCI stated that it found Covishield to be 70.42% efficient and in case of Covaxin, the report was very grey – there was no statistical data in terms of efficiency like that given for Covishield. The DGCI instead waxed eloquent, saying that it found the vaccine to be safe and provides a robust immune response while saying that the “clinical trial ongoing within the country by the firm will continue.”

Covishield, because it comes from a MNC and enough data has already been published globally, we have no worry. Yet, on account of its efficiency being lower, we automatically will veer towards Pfizer.

But the approval for Covaxin could not have been more opaque. How does one trust this vaccine, barring a sense of patriotism, when there is no data to support the “safe and robust response?” No credible country in the world has given this kind of statement with no data from the clinical trials. Transparency and accountability were never the virtues of DGCI but at this juncture, to give this kind of shoddy data is shameful. We are now in the same ranks as Russia and China – their vaccines are also approved, but no one is really queuing up to take the shots as there is no data published anywhere which builds a sense of trust on these vaccines.

As against this, the US FDA live streamed the entire regulatory review process of its vaccine approval and then issued a very detailed memo giving all inputs necessary to make a decision. So, we should strive to be like the FDA or follow the footsteps of China and Russia?

Yes, we all need a vaccine as quickly as possible but nothing could be more dangerous than pushing through something which is unsafe or less effective – this is worse than having no vaccine.

At this juncture, for all the tall talks of the Govt, when we are striving to become a global country, we need to follow the good business practices. We need to be transparent at every stage and just mere laudatory words will not work.

For India to have credibility on the world arena, to make our vaccine acceptable, data on its safety and efficacy needs to be shared. Unless we open up, this vaccine will be a shot in the dark, something which unfortunately will be pushed into rural India and gullible urban population.

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