Indian Coronavirus Vaccine Update: When Will Bharat Biotech’s Covaxin Launch?

Bharat Biotech’s own coronavirus vaccine from India, which was in the second stage of human clinical trials, has finally received the go-ahead for the last phase. The highly anticipated candidate vaccine endorsed by ICMR is expected to launch for the Indian population in June 2021. However, there is a catch. The company has said that the vaccine will arrive in the next eight months if the government does not advance the launch of Covaxin through emergency use authorizations, The Indian Express reported. Citing Sai Prasad, CEO of Bharat Biotech International, the report said that if all approvals are in place, the company will be able to read the full efficacy of the third phase of clinical trials in the second quarter of next year, i.e. , by June 2021.

Bharat Biotech plans to conduct the third phase of trials with more than 20,000 volunteers in 12-14 states in India. It should be noted that the vaccine candidate is ready to go by injecting a “dead version” of the Coronavirus strain that has been wreaking havoc for more than 10 months. Once injected into the body, the vaccine will cause the human body to develop an immune response against the new coronavirus.

The report highlighted that since Bharat Biotech received approval for late stage clinical trials, it has outperformed Oxford’s Covishield which was being tested by the Serum Institute of India. IBS is currently recruiting and vaccinating participants for phase III clinical trials.

According to the report, the company said that Covaxin’s phase 3 trial will be very different from the previous two phases. Prasad said the company intends to have everything so that logical conclusions can be drawn, in terms of empirical evidence and data, along with safety and efficacy data. However, the company is in talks with the government to push for approval of emergency use.

There will be between 25,000 and 26,000 participants from across the country and about 25 clinical sites where the trials will take place. So far, the company has chosen between 12 and 14 states for the Covaxin trial and this includes Haryana, Bihar, Maharashtra, Tamil Nadu and Telangana. Prasad said that at each test site, a multifaceted approach will be introduced.