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Bharat Biotech is planning to establish its own vaccine for COVID-19 in the second quarter next year when it will get the requisite approvals in the Indian regulatory authorities, a top company official said.
It stated its immediate focus is to conduct the Phase 3 trials across websites in the nation.
The company’s vaccine candidate -Covaxin- has been created in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV) using inactivated Sars-Cov-2, the virus which causes COVID-19. The virus was isolated in an ICMR laboratory.
“If we get all the approvals after establishing strong experimental evidence and information, and efficacy and safety data in our last stage of trials, we plan to launch the vaccine in Q2 of 2021,” Bharat Biotech International Executive Director Sai Prasad told PTI
Following the company received approval from the Drugs Controller General of India (DCGI) to conduct Phase 3 clinical trial to establish the efficacy of this vaccine candidate, it has started site preparatory exercises for Stage 3, recruitment and dose will begin in November, he added.
“The trial to be conducted in 25 to 30 sites across 13-14 countries will provide two doses each for the vaccine and placebo recipients. About 2,000 subjects could be enrolled each hospital,” Prasad said.
Asked about the investment on the vaccine, he said:”Our investment is about Rs 350-400 crore for the development of vaccine and the new production facilities, which include our investments for conducting the Phase 3 clinical trial, in the next six months”.
On the company”s plan to sell the vaccine to the government or to private players, Prasad said:”We are looking to supply for both private and government markets. We are also in preliminary talks with other countries for likely supply.”
Prasad said the price of the vaccine is yet to be determined, as the company is still looking at the price of product development.
“Our immediate focus is to conduct Phase 3 trial successfully across sites,” he added.
