Daijiworld Media Network - Hyderabad

Hyderabad, Nov 2: Covaxin, the vaccine against coronavirus being developed indigenously by Bharat Biotech, is likely to be launched in the second quarter of 2021, after being subjected to approvals from the Indian regulatory authorities.

The company has maintained that its immediate focus would be conducting the phase 3 trials successfully across the country. Covaxin by Bharat Biotech 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 began site preparatory exercises for Phase 3, whereas the 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.

Talking about the investment aspect, Prasad 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."

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 government and private markets. We are also in preliminary discussions with other countries for probable supply." He also said that the price of the vaccine has not been determined yet as the company is still looking at the cost of product development. "Our immediate focus is to conduct Phase 3 trial successfully across sites," he added.