Bharat Biotech is planning to launch its COVID-19 vaccine in the second quarter next year if it gets the requisite approvals from the Indian regulatory authorities, a top company official said.
The company which developed indigenous vaccine–Covaxin in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV) 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 was quoted as saying by PTI.
After the company received approval from the Drugs Controller General of India (DCGI) to conduct Phase 3 clinical trial to establish the efficacy of the vaccine candidate, it has begun site preparatory exercises for Phase 3, recruitment and dosage will begin in November, 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.
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 manufacturing facilities, which include our investments for conducting the Phase 3 clinical trial, in the next six months”.