Controversy swirls around India's home-grown Covid-19 vaccine from Bharat Biotech
NEW DELHI (BLOOMBERG) – A year ago, Krishna Ella was simply known for running a small Indian pharmaceutical company with a reputation for scientific rigour. Then came the pandemic that put the scientist and his family at the centre of one of the world’s loudest furores over a coronavirus vaccine.
In June last year, India’s drug regulator permitted Dr Krishna’s firm – Bharat Biotech International – to develop a home-grown vaccine in record time. Since then the company has been buffeted by controversies ranging from unrealistic government schedules to sporadic reports of adverse reactions. Matters came to a head last month after the government approved its shot before the completion of final human trials.
That fuelled a revolt across the breadth of India with many at the front lines of the pandemic – particularly healthcare workers – refusing the company’s injection. Two weeks in, India’s national vaccine roll-out has fallen flat, with little over half the targeted number of people coming forward for shots – hesitation that’s largely being blamed on the hasty approval of Bharat Biotech’s shot, which is still deep in phase three trials.
From the United States to Norway, vociferous debates over the efficacy and safety of Covid-19 vaccines have beset pharmaceutical giants like Pfizer and AstraZeneca, and governments the world over are battling anti-vaccine sentiment. Yet, experts say India never registered significant resistance to inoculations until now.
The stakes are particularly high because the South Asian country is racing to inoculate 1.3 billion people across villages and crowded slums while grappling with the world’s second-highest number of infections.
“There are many unanswered questions because of the total opaqueness and lack of accountability,” said Mr Dinesh Thakur, a former pharmaceutical executive known for exposing fraud at the Indian drugmaker Ranbaxy Laboratories.
“One thing is abundantly clear: They have successfully now created a significant anti-vaccine movement in India.”
The use of the Bharat Biotech shot – called Covaxin – has drawn particular ire because Prime Minister Narendra Modi’s government has distributed it alongside AstraZeneca’s inoculation, which completed final tests.
Luck of the draw and location determine which shot India’s front-line workers get, leaving many fearful they could end up taking an injection yet to be fully vetted.
“They have compelled them to take Covaxin,” said Dr Dayanand Sagar, the Bengaluru-based president of a resident doctors’ body that represents 5,000 medical workers across the state of Karnataka. “Health workers should be given a choice.”
Both New Delhi and Bharat Biotech have vigorously defended the vaccine’s safety, with health officials taking Covaxin injections on camera. In a December interview, Ms Suchitra Ella, the company’s co-founder and Dr Krishna’s wife, said they have acted “within the law of the land”.
A spokesman for Bharat Biotech and Indian government officials did not respond to requests for comment.
Many believe the speed of its vaccine development has been driven by nationalistic political forces pushing for a “swadeshi” – or locally made – shot, along with the firm’s own ambitions to be a front runner.
“Both things are aligning here, government pressure and the company’s internal competitive drive,” said Mr Prashant Yadav, a healthcare supply-chain expert at the Centre for Global Development in Washington.
In a January press conference, Dr Krishna, the 65-year-old chairman, angrily argued the criticism had become “political”, and used a 41-page slideshow with early- and mid-stage data to prove his vaccine is safe and effective.
His bigger rival, Serum Institute of India, is churning out a billion doses of AstraZeneca’s shot, and he bristled with indignation at the idea that a Britain-sponsored vaccine was not being questioned as deeply.
“Indian companies are targeted by everyone in the world,” said Dr Krishna, who has a PhD in biochemistry from the University of Wisconsin-Madison. “It hurts us as scientists – we don’t deserve that type of bashing.”
Last year, as rich nations showed signs of snapping up scarce supplies of leading vaccine candidates, India sought its own local champion. Besides Serum, only a handful of domestic manufacturers have the capacity to pump out hundreds of millions of doses, making Bharat Biotech an obvious choice as others tied up with foreign developers.
The company has supplied the Indian government and the World Health Organisation with billions of life-saving vaccines for diseases ranging from polio to rotavirus and typhoid – its three main revenue earners. Bharat Biotech threw itself into work on Covaxin, a two-dose shot based on well-trodden technology that uses part of a dead virus.
Dr Krishna’s son Raches – a US-trained scientist – was given responsibility for early trials. During an expert seminar at the end of October Mr Raches said he didn’t condone emergency licences to push out inoculations before final trials were complete.
“I don’t believe in that personally and even Bharat Biotech doesn’t believe in that either.”
So the company raised eyebrows when it filed Covaxin for Indian emergency authorisation in December without completing enrolment for phase three trials, joining the first set of applicants, including AstraZeneca and Pfizer, which both of which already had preliminary final-stage efficacy data.
Minutes from January meetings showed that India’s drug regulatory agency at first insisted on seeing efficacy data for Covaxin, before relenting and approving it for a vaguely defined restricted use in “clinical trial mode”.
While it is unclear who or what caused regulators to relent, the chain of events flummoxed scientists. It also jarred with the account of a company that had always played by the book previously, according to Bloomberg’s interviews with more than a dozen investors, former employees and industry experts.
“In all that they have done so far, they’ve always gone by following protocols, building the right partnerships, having the right kind of science available to them,” said Prof Gagandeep Kang, a professor at Vellore’s Christian Medical College, who worked on clinical trials for Bharat Biotech’s rotavirus vaccine, which was hailed by Mr Modi in 2015 as a prime example of Indian innovation.
“I really don’t understand what the need was to jump the gun for this vaccine.
It was not the first controversy around the shot. India’s medical research body promised Covaxin would be ready by Aug 15 last year: The anniversary of national independence from British colonial rule.
Ms Suchitra told Bloomberg that was a communication “slip”. Then reports emerged of some adverse reactions. Residents in the town of Bhopal – one of the trial sites – said they took the injections in return for 750 rupees (S$14) and that some could not read consent forms because they were illiterate. One participant also died on Dec 21, nine days after a Covaxin shot.
In a statement last month, Bharat Biotech said the death was due to cardiac arrest from suspected poisoning, which is under police investigation. Initial reviews suggest the death wasn’t related to the shot, the company said, adding that the payments were in line with Indian trial reimbursement rules and that nobody was induced.
The vaccine’s advocates have pointed to a peer-reviewed study published in The Lancet medical journal in January that said Covaxin’s first human test covering 375 people showed “tolerable safety outcomes and enhanced immune responses”.
Many remain to be convinced. At Mumbai’s Sir J.J. Hospital, the only facility in the city administering Covaxin, around 35 per cent to 40 per cent of the 100 people called in daily are showing up, according to Dr Lalit Sankhe, the doctor heading up the vaccination efforts there. Most senior doctors there have since taken the shot, he said, adding that he has also been injected and suffered no side effects.
The debate now has the potential to fuel wider vaccine scepticism as the Ellas sign global supply deals. Bharat Biotech has agreed to ship Covaxin to Brazil and work with a company for approval in the US. Whatever Covaxin’s ultimate legacy, it will leave an indelible mark on Dr Krishna’s reputation as a scientist.
“I’m 65,” he said in a December interview with Bloomberg TV. “Before I die I want to make some impact on the public health of the world.”
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