InvestorQ : Where is Indian company, Bharat Biotech in the Vaccine Race currently?
Mitali Bhutta made post

Where is Indian company, Bharat Biotech in the Vaccine Race currently?

2 years ago

The good news is that Bharat Biotech International has already started phase 3 of clinical trials of its COVID-19 vaccine Covaxin. As of now the company plans to enrol 26,000 participants for the first phase 3 efficacy study. Other global players like Pfizer and Moderna have reported 94% efficacy rates on their Phase 3 samples.

Under the broad plan of Bharat Biotech, the trial volunteers will receive two intramuscular injections about 28 days apart and it will be restricted to adults only. The samples will be randomly assigned to either receive two 6-mg injection of Covaxin or two shots of a placebo. Neither investigators nor participants will be aware of grouping.

Covaxin was evaluated based on 1,000 participants in Phase 1 and 2 clinical trials, with results reportedly showed promising safety and immunogenicity. The primary trigger point of the late-stage trial, to determine efficacy, will be to examine if the two-dose shot can prevent a patient from developing symptoms of COVID-19. That is followed by effectiveness study.

Bharat Biotech plans to launch Covaxin by June 2021, unless the government decides to give the vaccine an emergency use authorization before that. The company is investing around Rs.300 crore jointly on the phase 3 trials and in setting up a new operating facility.