InvestorQ : How is Bharat Biotech planning to test COVAXINE and launch it by August 15?
Juvina Maggie made post

How is Bharat Biotech planning to test COVAXINE and launch it by August 15?

Answer
user profile image
Anamika Sodhani answered.
3 months ago


Bharat Biotech, floated by Krishna Ella, will start testing COVAXINE on over 1100 humans in two phases. Bharat Biotech secured regulatory approval to start human clinical trials for its vaccine after the regulator was satisfied with the data supplied for its animal trials. The Phase 1 trials will start next week. ICMR has asked Bharat Biotech to expedite the trials.

ICMR has selected 12 institutes including AIIMS in Delhi and Patna to conduct these trials. The first batch will be of 375 persons and depending on the results of the first trial, Bharat Biotech will enrol another 750 people for the second phase of the trial. Whether the vaccine eventually gets approved will depend on the outcomes of those trials.

COVAXINE has demonstrated safety and immune response in pre-clinical studies, although the real human impact will only be known after the human trials. ICMR is pushing for a August 15 deadline, although most scientists and experts are against expediting the process. At the same time, Zydus will also conduct COVID-19 vaccine trial on 1000 volunteers.