Bharat Biotech plans Covaxin launch in second quarter of 2021, post requisite approvals

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. 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,” Sai Prasad, Executive Director, Bharat Biotech International 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.

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”.

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.”

Prasad said the price of the vaccine is yet to be determined, as the company is still looking at the cost of product development.