Like many things in India nowadays, the science of vaccine approval has also run into the politics of chest-thumping nationalism.

Alongside authorising Covishield, the Covid-19 protection developed by Oxford University and AstraZeneca and manufactured by the Serum Institute of India, the country’s drugs regulator on Sunday gave a go-ahead to an indigenous vaccine for which critical phase 3 trial data isn’t yet available.

The hasty nod for Bharat Biotech International’s Covaxin, developed in collaboration with the Indian Council of Medical Research and National Institute of Virology, has raised eyebrows in the scientific and health-care communities about a “public rollout of an untested product”, according to a national network of non-governmental organisations.

This is unfortunate. With more than 10-million coronavirus infections, India is the world’s second-worst affected nation after the US. New Delhi’s strategy for vaccinating 1.3-billion people will matter greatly for bringing the global pandemic to a decisive end. The country’s virus-battered economy and its overstretched health systems are also yearning for a reprieve. It will be dangerous to allow political calculations to enter the equation and shake people’s confidence in what’s being offered to them — and on what basis.

That’s just what seems to be happening with the unusual approval for Covaxin, which comes with the odd caveat that its use will be restricted to “public interest as an abundant precaution, in clinical trial mode, especially in the context of mutant strains”. Nobody seems to know what this will mean on the ground. Who’ll get Covishield, and who’ll be given Covaxin? More importantly, who’ll decide? In a country beset by massive inequalities in income, wealth and social status, these aren’t trivial questions. 

When opposition leaders raised doubts about the vaccine selection process, a minister in Prime Minister Narendra Modi’s cabinet likened their objections to questioning “the valour of our soldiers”.

To be sure, India is not even in the front row of vaccine nationalism. China and Russia are more desperate to beat the West in saving the world. But as my colleague Clara Ferreira Marques has noted, both countries’ vaccine candidates face a transparency deficit, which could limit their global acceptance. 

That’s a risk that India, which manufactures more than 60% of the world’s vaccines, should avoid at all cost. According to media reports, Hyderabad, India-based Bharat Biotech has enlisted 23,000 volunteers for phase 3 clinical trials. That’s encouraging because another report, published in December, had cited a major New Delhi-based research hospital as saying it couldn’t find enough subjects for the study. If the drug proves to be effective, introducing it even at a later date should pose no problems. Naming Covaxin as an alternative even in the absence of phase 3 data could be a commercial tactic to squeeze “better discounts” on bulky Covishield purchase contracts, brokerage Jefferies says. Still, cutting corners with science isn’t exactly the best strategy to negotiate drug prices. 

The Kremlin-backed Sputnik V is also undergoing trials in India, in partnership with local manufacturer Dr Reddy’s Laboratories. The Ahmadabad-based Cadila Healthcare is also in the race to develop an indigenous Covid-19 vaccine. Ultimately, it doesn’t matter whether India’s home-grown shots make the final cut. Serum Institute, the world’s largest producer, has already stockpiled 70-million doses of Covishield. Big parts of the developing world will rely on Indian manufacturers to supply easy-to-administer, affordably priced vaccines in large quantities.

Nationalism can only muddy the waters with vacuous slogans and irrational goals. The Indian Council of Medical Research was pushing Bharat Biotech to launch Covaxin by August 15, India’s independence day. Thankfully, that deadline came and went. But the impatience we saw back then is once again rearing its head when the message for India should be the exact opposite. Properly designed and implemented studies, honestly reported side effects, and transparently shared efficacy data will boost the world’s confidence in Made in India jabs. Cutting corners will damage trust. It’ll be helpful to leave soldiers alone, and stick to science — and established scientific protocols.  


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