“It’s a nightmare,” said Suchitra Ella, Deputy Managing Director of Bharat Biotech International Ltd. “Sometimes I get goose bumps, sometimes I wake up early in the morning wondering where we are. What are we doing? How did we get there? there?”
Bharat has already produced around 10 million doses of its Covaxin injection, ahead of an anticipated launch in 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 partially funded the development.
“We have started producing at risk because we know it will be an uphill task – in the Indian context it is small,” Ella said in an interview from Hyderabad on Monday. “That is 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.”
Two other countries have also signed preliminary supply agreements with the company, he said, declining to give details.
In its bid to stem the spread of the world’s second-largest coronavirus outbreak, India will likely initially rely on 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 a billion doses of your injection, half of which have gone to India.
Emergency use
Bharat has spent around $ 60 million to $ 70 million so far developing Covid vaccines, and early trial data suggests that Covaxin, an inactivated candidate using a killed 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, he said. The trial has recruited half of its 26,000 volunteers and, heading into 2021, Ella expects the license to allow the vaccines for public use in May or June.
The lack of phase III test data did not prevent Bharat from applying for emergency use authorization this month, although Indian regulators have asked the company and the Serum Institute, which has submitted the final phase numbers, 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 across India, particularly in the impoverished field. Both Bharat and Serum vaccines can be stored at refrigerated temperature, making them more suitable for the infrastructure of India.
The development of Covaxin has also been affected this year by overly ambitious pronouncements, including one by the Indian Council for Medical Research that envisaged distribution of the vaccine on August 15 this year, when the country celebrated its independence from British colonial rule. She said there had been a communication “slip”, which was later cleared up.
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. She said the disease was not related to the vaccine, regulators were informed within the 24 hours required by the trial guidelines, and that “everything has happened within the law of the land.”
Vaccine coverage
The injection of Bharat Biotech, which has produced billions of vaccines for diseases ranging from rabies to typhoid fever since Ella co-founded the company in 1996 with her husband Krishna, will be crucial to making up for any shortfalls given fierce competition for limited supply. of world leaders. Although India has secured access to more than 2 billion doses of vaccines, only 85% of its population can count on those vaccines. There are 30 other countries in the Bloomberg Covid Resilience Ranking that have a higher vaccination coverage rate for their population.
With total Covid infections in India crossing the 10 million mark on Saturday, Ella said she hoped that within a year or two the country would be able to vaccinate at least a third of its population.
He expressed confidence in the scale and ability of India’s public immunization system, which inoculates some 27 million babies and 29 million pregnant women each year, to deliver any Covid vaccine. She also pointed to India’s polio program, which uses a vaccine that requires storage at -20 degrees Celsius.
“That has been handled very effectively in India,” he said. “This shows how strong and robust this mechanism is.”
This story has been published from a news agency feed with no changes to the text. Only the title has been changed.
.
