“It’s a nightmare,” said Suchitra Ella, Deputy Managing Director of Bharat Biotech International Ltd. “Sometimes I get goosebumps, sometimes I wake up early in the morning wondering where we are. What do we do? How can we do it? ”
Bharat has already produced around 10 million doses of its Covaxin injection, ahead of a planned deployment 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 funded the development.
“We started producing at risk because we know it will be a tough task – in the Indian context, it’s small,” Ella said in an interview in Hyderabad on Monday. “It’s a huge challenge that awaits us when we think of the hundreds of millions of doses even though half the country needs to be vaccinated.”
No less than two other countries have also signed preliminary supply agreements with the company, she said, declining to give details.
In its attempt to stop the spread of the world’s second largest coronavirus outbreak, India will likely initially rely on the two-dose vaccines manufactured by Bharat Biotech and the Serum Institute of India Ltd. The latter has partnered with AstraZeneca Plc to manufacture at least one billion doses of their injection, half of which is destined for India.
Bharat has spent around $ 60-70 million so far to develop Covid vaccines, and early trial data suggests that Covaxin, an inactivated candidate that uses a dead version of the virus, has efficacy rates of at least minus 60%, which Ella said was a “conservative”. ” projection.
That could improve in the final human study, she said. The trial has recruited half of its 26,000 volunteers, and by 2021 Ella expects the license to allow inoculations for public use by May or June.
The lack of Phase III trial data did not prevent Bharat from applying for an emergency use authorization this month, although the company and the Serum Institute – which submitted the final phase figures – were asked by Indian regulators to provide additional figures on safety, efficacy and immunogenicity.
Pfizer Inc. has also requested urgent approvals for its own vaccine, although its ultra-cold storage requirements make it an unlikely candidate for widespread use in India, especially in poor countryside. Bharat and Serum vaccines can be stored at refrigeration temperature, making them more suitable for Indian infrastructure.
The development of Covaxin has also been hampered this year by over-ambitious statements, including one from the Indian Council for Medical Research that envisaged the vaccine to be distributed on August 15 this year, when the country celebrated its independence from British colonial rule. . Ella said there was a communication “slip”, which was then clarified.
Reports also emerged last month that a volunteer in the first stage of human testing suffered a potentially adverse reaction in August that was not publicly announced at the time. Ella said the illness was unrelated to the shooting, regulators were notified within 24 hours, as required by trial guidelines, and that “it all happened within the law of the country.
The shot from Bharat Biotech, which has produced billions of vaccines against diseases from rabies to typhoid since Ella co-founded the business in 1996 with her husband Krishna, will be crucial in closing any shortfall given the fierce competition. for the limited supply of world leaders. Although India has gained access to more than 2 billion doses of vaccine, only 85% of its population can rely on these vaccines. There are 30 other countries in Bloomberg’s Covid Resilience Rankings that have higher vaccine coverage rates for their populations.
With total Covid infections in India surpassing the 10 million mark on Saturday, Ella said she hoped that within one to two years the country would be able to immunize at least a third of its population.
She expressed confidence in the scale and ability of India’s public immunization system, which inoculates around 27 million babies and 29 million pregnant women each year, to deploy any Covid vaccine. Ella also pointed to India’s polio program, which uses a vaccine that requires storage at -20 degrees Celsius.
“It has been managed very effectively in India,” she said. “It shows how strong and robust this mechanism is.”
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