Hyderabad-based firm Bharat Biotech has said that its coronavirus vaccine candidate, Covaxin, is likely to be ready for launch by June, The Indian Express reported on Friday. The firm received go-ahead for phase 3 clinical trials on Thursday.
“If we get all the approvals in place, I think during Q2 of 2021, we should get the efficacy readout from our phase-3 clinical trial – April, May, June, for example,” the company’s Executive Director Sai Prasad told the newspaper. “That is for the full efficacy results.”
Prasad, however, said there may be a change in the plan if the Centre decides to expedite the launch by granting emergency-use authorisation. “We are committed to doing all our phase-1, phase-2 and phase-3 clinical trials in its entirety, but I think the government may also be considering emergency use approval,” he said.
The top executive clarified that his company was not pushing for such approvals. “Our intent is to develop everything to its logical conclusion in terms of empirical evidence and data, and efficacy data and safety data,” he told the newspaper. “But there are discussions, I guess, within the government about that [emergency-use approval],” he said.
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Prasad told the The Indian Express that Bharat Biotech planned to enroll about 26,000 volunteers across the country for the final trial. He added that the plan had been accepted by the Drug Controller General of India and Central Drugs Standard Control Organisation.
He added that the firm was aiming for 25 trial sites. “For the last two months, we have been trying to establish and develop these sites across 12 to 14 states in India as of now,” he said. “It’s well spread between north, south, east and west.”
Prasad did not give details about the vaccine’s price. “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,” he told Mint.
“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.”— Bharat Biotech Executive Director Sai Prasad to Mint
He added that the firm will spend around Rs 150 crore on phase 3 trial and Rs 120 to Rs 150 crore on establishing a new facility by December.
Covaxin, India’s first indigenous vaccine, is an inactivated vaccine created from a strain of the infectious SARS-CoV-2 virus. Inactivated vaccines use the killed version of the germ that causes a disease. It helps the immune system mount an antibody response towards virus. It has been developed in collaboration with the Indian Council of Medical Research.
The Centre had said earlier this week that three crore frontline healthcare workers will be among the first to receive the coronavirus vaccine. Minister of Health and Family Welfare Harsh Vardhan had said last month that India was likely to get the vaccine in the first quarter of 2021.
India’s coronavirus tally rose to 78,14,682 on Saturday after it reported 53,370 new infections in 24 hours. The country’s toll went up by 650 to 1,17,956. There are now 6,80,680 active cases, and 70,16,046 recoveries in the country.