2 min read.Updated: 23 Oct 2020, 05:52 PM ISTLeroy Leo
The vaccine maker to enrol 26,000 subjects for phase 3 trial starting mid-November. The trial will be conducted across 25-30 sites in the country and the process of getting ethics committee approvals of individual sites is on
NEW DELHI: Bharat Biotech International Ltd plans to launch its covid-19 vaccine--Covaxin--by June next year, unless the government decides to give the vaccine an emergency use authorisation before that, based on data from earlier phases of clinical trials, executive director Sai Prasad told Mint.
"If the government intends, they could proceed by giving us emergency use authorization, say, by reviewing the phase 2 data. They (the government) may say we need it now because it is quite important and we (Bharat Biotech) have good animal testing and phase 1 and 2 data," Prasad said, adding that in China and Russia, emergency use authorisations have been led by the government.
The company plans to start enrolling up to 26,000 participants of age 18 years and above in its phase 3 trials from the middle of next month. The trial will be conducted across 25-30 sites in the country, and the process of getting ethics committee approvals of individual sites is on, he said.
The primary end-point of the late-stage trial, used to determine the efficacy of a vaccine, will be to see if the two-dose shot can prevent a patient from developing symptoms of covid-19.
The subject expert committee (SEC) of the Central Drugs Standards Control Organisation earlier this week gave approval for the phase 3 trials.
While the phase 2 data of the trials are not publicly available, the company received an approval from the SEC on Tuesday based on data from Phase I and II along with animal challenge data.
Prasad, however, declined to give pricing details for the vaccine, saying that discussions are underway and depend on a variety of factors, like the cost of production, investments, and also the quantity of doses required.
"We don't have an upper limit yet but, we don't expect it to be out of reach of our government and what COVAX can buy. But for other companies like Serum (Institute of India) and some others, they were given funding by COVAX and the Gates Foundation. We have not received that kind of funding," Prasad said.
Instead, the company is spending around ₹150 crore on phase 3 trial and another ₹120-150 crore in setting up a new facility that will be operational by December, he said.
Bharat Biotech has started manufacturing some doses at-risk at its Hyderabad plant, using its current capacity of around 150 million doses per annum.
Apart from setting up a new plant, the company is also exploring using a third facility for production of Covaxin.
"We're also exploring in another city in India where we have access to a large scale facility like the one that we have in Hyderabad for manufacturing Covaxin and using that (and the new plant), scale it up even north of 500 million to 1 billion doses per annum," Prasad said.
Bharat Biotech’s vaccine is one of three candidates that are currently in human trials in India, with the other two being Serum Institute of India’s ‘Covishield’--which was developed by the University of Oxford and Astrazeneca plc—and Zydus Cadila’s ZyCoV-D. While Serum’s Covishield is in phase 3 and is considered the frontrunner among the vaccines in India, Zydus Cadila, like Bharat Biotech, is in phase 2 and is expected to soon move into late-stage trials.
Earlier this month, Union Minister Harsh Vardhan said the government’s rough estimate is to receive and utilise 400 to 500 million doses by July 2021 to immunise 200-250 million people.
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