Bharat Biotech is planning to launch its vaccine for COVID-19 in the second quarter next year if it gets the requisite approvals from the Indian regulatory authorities, a top company official said.
It said its immediate focus is to conduct the Phase 3 trials successfully across sites in the country. Covaxin- has been developed in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV) using inactivated Sars-Cov-2, the virus that causes COVID-19. The virus was isolated in an ICMR lab.
“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.
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.