Why Bharat Biotech’s Covaxin is the object of national pride & scientific scepticism

India, which makes more than 60% of the world’s vaccines, risking transparency with its hasty vaccine approval will directly affect drug pricing and global acceptance.

File photo of Covid vaccine Covaxin under development at Bharat Biotech facility in Hyderabad | ANI Photo

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

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

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

This is unfortunate. With more than 10 million coronavirus infections, India is the world’s second-worst-affected nation after the U.S. 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 valor of our soldiers.”

Our in-house cynics M/s Jairam, Tharoor & Akhilesh are behaving true to form.

They first questioned the valour of our soldiers & are now unhappy that the two vaccines to get DCGI nod are made in India.

Clearly they are on a quest for permanent political marginalization.

— Hardeep Singh Puri (@HardeepSPuri) January 3, 2021

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 three clinical trials. That’s encouraging because another report, published last month, had cited a major New Delhi-based research hospital as saying that 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 three 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 Ltd. The Ahmedabad-based Cadila Healthcare Ltd. is also in the race to develop an indigenous Covid-19 vaccine. Ultimately, it doesn’t matter whether India’s homegrown 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 Aug. 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. – Bloomberg