“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.
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.”
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.”
Business Standard has always strived hard to provide up-to-date information and commentary on developments that are of interest to you and have wider political and economic implications for the country and the world. Your encouragement and constant feedback on how to improve our offering have only made our resolve and commitment to these ideals stronger. Even during these difficult times arising out of Covid-19, we continue to remain committed to keeping you informed and updated with credible news, authoritative views and incisive commentary on topical issues of relevance.
We, however, have a request.
As we battle the economic impact of the pandemic, we need your support even more, so that we can continue to offer you more quality content. Our subscription model has seen an encouraging response from many of you, who have subscribed to our online content. More subscription to our online content can only help us achieve the goals of offering you even better and more relevant content. We believe in free, fair and credible journalism. Your support through more subscriptions can help us practise the journalism to which we are committed.
Support quality journalism and subscribe to Business Standard.