Bharat Biotech’s COVID-19 vaccine Covaxin is likely to be released in the second quarter of 2021 if the required approvals are in place, a top company official has told PTI.
According to the official, the current priority of the company is to successfully conduct the Phase 3 trials of the vaccine across the country.
“If we get all the approvals after establishing strong experimental evidence and data, and efficacy and safety data in our last stage of trials, we aim to launch the vaccine in Q2 of 2021,” Sai Prasad, the executive director of Bharat Biotech International told PTI.
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The Hyderabad-based firm is developing the COVID-19 vaccine candidate in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV) using inactivated Sars-Cov-2, the virus responsible for COVID-19.
The firm has already received the nod of the drug regulator to conduct the Phase 3 clinical trials of the vaccine across the country.
“The trial to be conducted in 25 to 30 sites across 13-14 states will provide two doses each for the vaccine and placebo recipients. About 2,000 subjects could be enrolled per hospital,” Prasad said.
The recruitment of volunteers for the trials and dosage will begin in November while site preparation has already started. The interim results are expected to be out by April or May next year.
The vaccine during the Phase 2 trials, has been tested in 12 hospitals across the country. Healthy volunteers in the ages between 18 and 55 have participated in the trials which took place in Hyderabad, Rohtak, Patna, Kancheepuram, Delhi, Goa, Bhubaneshwar and Lucknow among other places.
“The benchmark for the efficacy of our anti-COVID-19 vaccine is 60 per cent. We will be conducting the largest Phase 3 trial for Covaxin, and the efficacy results should be available by early April-May, 2021,” Sai Prasad said.
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Sai Prasad said the company has invested between ₹350-₹400 crore for the development of the vaccine and the new manufacturing facilities.
He said the firm plans to sell the vaccine both to the government and private markets. “We are also in preliminary discussions with other countries for probable supply,” he added.
He, however, said the company is yet to decide on the price of the vaccine, as it is still looking at the cost of product development.