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 second quarter next year if it gets necessary approvals from Indian regulatory authorities,  company has said. Hyderab-based firm said its immediate focus is to conduct Phase-3 trials successfully across sites in  country.

"If we get all approvals after establishing strong experimental evidence and data, and efficacy and safety data in our last st of trials, we aim to launch vaccine in Q2 of 2021," Bharat Biotech International Executive Director Sai Pras told PTI.

Covaxin gets DCGI's d for phase-3 trials

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

" trial to be conducted in 25 to 30 sites across 13-14 states will provide two doses each for vaccine and placebo recipients. About 2,000 subjects could be enrolled per hospital," Pras said.

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

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

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

During phase II trial of Covaxin, vaccine has been tested in 12 hospitals across country, and volunteers between s of 18 and 55 with co-morbidity conditions took part in trial. vaccine trial took place in Hyderab, Kancheepuram, Patna, Rohtak, Delhi, Goa, Bhubaneswar and Luckw among or places. Covaxin vaccine has been developed by Bharat Biotech in collaboration with Indian Council of Medical Research (ICMR).

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

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

(With PTI inputs)