Bharat Biotech To Launch Covaxin Soon
A top Bharat Biotech company official said that if the company obtains the required approvals for its COVID-19 vaccine from the Indian regulatory authorities, the firm plans to launch its Covaxin vaccine in the second quarter next year. The successful completion of Phase 3 trials across sites in the country is the company’s immediate focus.
Utilizing the inactivated COVID-19 causing virus, Sars-CoV-2 virus, isolated in an Indian Council of Medical Research (ICMR) lab, Bharat Biotech has been developed the Covaxin vaccine in collaboration with the National Institute of Virology (NIV) – ICMR.
The Executive Director of Bharat Biotech, Sai Prasad said, “We intend to launch the vaccine in Q2 of 2021 once we receive all the approvals after providing solid experimental data and proof, and safety and efficacy in the final stage of the vaccine trials.”
He added that the company has started site preparatory operations for Phase 3 after it got the approval to start Phase 3 clinical trial to confirm the vaccine candidate’s efficacy, from the Drugs Controller General of India (DCGI) and that in November, the company will start the recruitment and dosage process.
Prasad said, “In the trial, there will
be around 2000 subjects enrolled per hospital and will be provided two doses each for the vaccine and placebo recipients, with the trial being conducted across 13-14 states in 25-30 sites.”Prasad spoke regarding the investment in the vaccine saying, “For the new production facilities, development of the vaccine, and our expenses for handling the Phase 3 clinical trial in the following 6 months, our investment is around 350-400 crore.”
Prasad spoke about the firm’s plan for selling the vaccine to private companies or the government, he said that they are in plans of supplying for both government and private markets, and are also in preliminary discussions with other countries for probable supply.”
He said that the company is in the process of looking at the cost of product development and so the cost of the vaccine is yet to be decided.
