“If the government intends to do so, it can continue to give us an emergency use authorization, for example by reviewing Phase 2 data. He (the government) can say that we want him now because he is quite vital and we (Bharat Biotech) have a smart animal. Phase 1 and 2 data,” Prasad said, adding that in China and Russia, emergency use authorizations have been carried out through the government.
The company plans to begin enrolling up to 26,000 participants over the age of 18 in its Phase 3 trials starting in mid-next month. The trial will be conducted from 25 to 30 s across the country, and the procedure for obtaining the approval of the individual. The ethics committee is underway, he said.
The main objective of the complex trial, accustomed to the effectiveness of a vaccine, will be to see if the two-dose vaccine can prevent a patient from presenting the symptoms of covid-19.
Phase 3 trials were approved this week by the Committee of Experts on The Subject (SEC) of the Central Organization for Drug Standards Control.
Although knowledge of the Phase 2 trial is not publicly available, the company obtained SEC approval Tuesday on Phase I and II knowledge, as well as knowledge of animal provocation.
Prasad, however, refused to give the main points of the price of the vaccine, saying that discussions were ongoing and depended on factors such as production load, investments and the amount of doses required.
“We don’t have an upper limit yet, but we don’t expect it to surpass the success of our government and what COVAX can buy. But for other corporations such as Serum (Institute of India) and others, they have been given investment through COVAX and the Gates Foundation. We haven’t won that kind of investment,” Prasad said.
Instead, the company is spending around 150 million rupees for the Phase 3 test and 120 to 150 million rupees for a new facility to be operational until December, he said.
Bharat Biotech has started producing threat doses at its Hyderabad plant, its current capacity of around 150 million doses is consistent with the year.
In addition to establishing a new plant, the company is also planning to use a third facility for Covaxin production.
“We are also exploring some other city in India where we have a large-scale facility like the one we have in Hyderabad to manufacture Covaxin and use it (and the new plant), even north of 500 million for a billion doses consistent with the year,” Prasad said.
The Bharat Biotech vaccine is one of 3 applicants being tested lately in humans in India, the other two being the “Covishield” of the Serum Institute of India, which evolved through the University of Oxford and Astrazeneca plc, and ZyCoV-D from ZyCoV-D through Zydus Cadila. While Serum Covishield is in Phase 3 and is considered the leader among vaccines in India, Zydus Cadila, like Bharat Biotech, is in Phase 2 and is expected to move on to complex phase trials soon.
Earlier this month, EU Minister Harsh Vardhan said the government’s estimate of getting and using 400 to 500 million doses as of July 2021 to vaccinate 200 million people.
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