If approved, Bharat Biotech's Covaxin Covid vaccine to launch by Q2 2021; in Phase-3 now

Bharat Biotech plans to launch its COVID-19 vaccine 'Covaxin' in the second quarter next year if it gets the necessary approvals from the Indian regulatory authorities, the company has said. The Hyderabad-based firm said its immediate focus is to conduct the Phase-3 trials successfully across sites in 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," Bharat Biotech International Executive Director Sai Prasad told PTI.

Covaxin gets DCGI's nod for phase-3 trials

The company has received approval from the Drugs Controller General of India (DCGI) to conduct Phase 3 clinical trial to establish the efficacy of the vaccine candidate, Prasad said while adding that it has begun site preparatory exercises for Phase 3. The recruitment and dosage will begin in November and the interim results of the Phase III trial are likely to be released by April or May next year, he added.

"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.

READ | Bharat Biotech's Covid-19 vaccine 'Covaxin' to begin phase 3 trials in Odisha

Speaking about the investment in the vaccine, Prasad said the investment is about Rs 350-400 crore for the development of the vaccine and the new manufacturing facilities, which include the investments for conducting the Phase 3 clinical trial, in the next six months. When asked about the company's plan to sell the vaccine to the government or to private players, Prasad said that they are looking to supply the vaccine to both government and private markets. Further, the price of the vaccine is yet to be determined, as the company is still looking at the cost of product development, he said.

READ | Covaxin, Bharat Biotech's COVID vaccine, gets DCGI approval for phase 3 of clinical trials

During the phase II trial of Covaxin, the vaccine has been tested in 12 hospitals across the country, and volunteers between the ages of 18 and 55 with no co-morbidity conditions took part in the trial. The vaccine trial took place in Hyderabad, Kancheepuram, Patna, Rohtak, Delhi, Goa, Bhubaneswar and Lucknow among other places. Covaxin vaccine has been developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).

READ | 'Submit Covaxin's Phase II data before proceeding for phase III': CDSCO to Bharat Biotech

READ | COVID-19: Bharat Biotech's Covaxin phase-3 trials to take place in Lucknow and Gorakhpur

(With PTI inputs)