Hyderabad-based Bharat Biotech in all likelihood will launch its vaccine, “Covaxin” for Covid-19 in the second quarter next year, the pharma manufacturer said on Sunday.
The company’s vaccine 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.
The firm 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,” said the company in a statement.
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.
“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,” it said.
While the drug major is yet to decide on the price of the shot, it is working out on strategy to supply the vaccine to the government as well as in private markets even as it is in talks with other countries to export the vaccine.
Monday, 02 November 2020 | PNS | New Delhi
