India ambitious vaccine rollout hits a roadblock

Chris Kay, Tribune News Service

A year ago, Krishna Ella was simply known for running a small Indian pharmaceutical company with a reputation for scientific rigor. Then came the pandemic that put the scientist and his family at the center of one of the world’s loudest furors over a coronavirus vaccine. In June last year, India’s drug regulator permitted Ella’s firm — Bharat Biotech International Ltd. — to develop a homegrown 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 fueled a revolt across the breadth of India with many at the frontlines of the pandemic — particularly health-care workers — refusing the company’s injection. Two weeks in, India’s national vaccine rollout 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 3 trials.

From the US to the Norway, vociferous debates over the efficacy and safety of COVID-19 vaccines have beset pharmaceutical giants like Pfizer Inc. and AstraZeneca Plc 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 Dinesh Thakur, a former pharmaceutical executive known for exposing fraud at the Indian drugmaker Ranbaxy Laboratories Ltd. “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 frontline 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 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, Suchitra Ella, the company’s co-founder and Krishna’s wife, said they have acted “within the law of the land.” A spokesperson for Bharat Biotech and Indian government officials didn’t respond to requests for comment. Many believe the speed of its vaccine 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 frontrunner.

In a January press conference, Krishna Ella, the 65-year-old chairman, angrily argued the criticism had become “political” and used a 41-page slide-show with early and mid-stage data to prove his vaccine is safe and effective.

His bigger rival, Serum Institute of India Ltd., is churning out a billion doses of AstraZeneca’s shot, and Ella bristled with indignation at the idea that a UK-sponsored vaccine wasn’t being questioned as deeply.

“Indian companies are targeted by everyone in the world,” said Ella, who has a Ph.D. 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 Organization 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. The Ella’s son Raches — a US-trained scientist — was given responsibility for early trials. During an expert seminar at the end of October the younger Ella said he didn’t condone emergency licenses 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 authorization in December without completing enrollment for Phase III 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.”

“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 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 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 wasn’t 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. 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 ($10) and that some couldn’t read consent forms because they were illiterate. One participant also died on Dec. 21, nine days after a Covaxin shot.

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% to 40% of the 100 people called in daily are showing up, according to Lalit Sankhe, the doctor heading up the vaccination efforts there. Most senior doctors there have since taken the shot, Sankhe said, adding that he has also been injected and suffered no side effects.

The debate now has the potential to fuel wider vaccine skepticism 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 U.S. Whatever Covaxin’s ultimate legacy, it will leave an indelible mark on Krishna Ella’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.