'It's nightmarish': Uphill task as Bharat Biotech gears for vaccine rollout

The lack of phase III trial data didn’t stop Bharat from applying for emergency use authorization this month.
The developer of India’s leading indigenous coronavirus vaccine is already producing millions of doses of its yet-to-be-approved candidate, but the thought of supplying enough shots for half the country’s nearly 1.4 billion people can seem daunting at times.

“It’s nightmarish,” said Suchitra Ella, joint managing director of Bharat Biotech International Ltd. “Sometimes I get goosebumps, sometimes I wake up early in the morning wondering where are we. What are we doing? How do we get there?”

Bharat has already produced about 10 million doses of its Covaxin shot, ahead of an anticipated roll out by the middle of next year. It has a current annual capacity of 300 million shots and expects the first 100 million to be deployed by India, which has partly financed the development.

“We have started producing at risk because we know that it will be an uphill task -- in the Indian context it’s small,” Ella said in an interview from Hyderabad on Monday. “That’s a huge challenge in front of us when we think of the hundreds of millions of doses even if half the country needs to be vaccinated.”

As many as two other countries have also signed preliminary supply agreements with the company, she said, declining to give details.

In its bid to halt the spread of the world’s second-largest coronavirus outbreak, India will likely initially lean on the two-dose vaccines manufactured by Bharat Biotech and the Serum Institute of India Ltd. The latter has partnered with AstraZeneca Plc to make at least one billion doses of their shot, half of which have been earmarked for India.

Emergency Usage

Bharat has spent about $60 million to $70 million so far developing Covid vaccines, and early trial data suggest Covaxin, an inactivated candidate that uses a dead version of the virus, has efficacy rates of at least 60%, which Ella said was a “conservative” projection.

That may improve in the final human study, she said. The trial has recruited half of its 26,000 volunteers, and going into 2021 Ella expects licensing to allow inoculations for public use by May or June.

The lack of phase III trial data didn’t stop Bharat from applying for emergency use authorization this month, though the company and Serum Institute -- which has submitted final phase numbers -- have been asked by Indian regulators to provide additional figures on safety, efficacy, and immunogenicity.

Pfizer Inc. has also applied for urgent approvals of its own vaccine, though its requirements for ultra-cold storage make it an unlikely candidate for widespread use across India, particularly in the impoverished countryside. Both Bharat and Serum’s vaccines can be stored at refrigeration temperature, making them more suited to India’s infrastructure.

The development of Covaxin has also been dogged this year by overambitious pronouncements, including one from the Indian Council of Medical Research that envisaged the vaccine’s distribution on Aug. 15 this year, when the country celebrated its independence from British colonial rule. Ella said there had been a communication “slip,” which was later clarified.

Reports also emerged last month that a volunteer in the first stage of human testing suffered a potentially adverse reaction in August that wasn’t publicly announced at the time. Ella said the illness wasn’t related to the shot, regulators were informed within 24 hours as required under trial guidelines, and that “everything has happened within the law of the land.”

Vaccine Coverage

The shot from Bharat Biotech, which has churned out billions of vaccines for diseases from rabies to typhoid since Ella co-founded the firm in 1996 with her husband Krishna, will be crucial in making up any shortfall given the fierce competition for the limited supply of global front-runners. Although India has secured access to over 2 billion vaccine doses, only 85% of its people can count on those shots. There are 30 other countries in Bloomberg’s Covid Resilience Ranking that have a higher vaccination cover rate for their population.

With India’s total Covid infections crossing the 10-million mark on Saturday, Ella said she hoped that within one to two years the country would be able to vaccinate at least a third of its population.

She voiced confidence in the scale and ability of India’s public immunization system, which inoculates about 27 million babies and 29 million pregnant women every year, to deploy any Covid shot. Ella also pointed to India’s polio program, which uses a vaccine requiring -20 degrees Celsius storage.

“That has been handled very effectively in India,” she said. “It goes to show how strong and robust this mechanism is.”


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