Bharat Biotech aims to file for the approval of COVAXIN by June 2021
The Hyderabad-based drugmaker has been planning to start a late-stage or 3rd stage trial of COVAXIN by November 2020 with over 26,000 volunteers.
The Executive Director of Biotech, Sai Prasad has informed that the company expects to file for the regulatory approval of its COVID-19 vaccine candidate COVAXIN by June 2021 only if the results from its late-stage trial are positive.
The Hyderabad-based drugmaker has been planning to start a late-stage or 3rd stage trial of COVAXIN by November 2020 with over 26,000 volunteers, the approval for which came from Indian Drug Controller few days back. The volunteers will be monitored by the firm for drug efficacy.
Reportedly, the vaccine development programme of Bharat Biotech entails an investment of Rs. 400 crores, the bulk of which will go in the trials.
Plans to acquire emergency approval for COVAXIN:
The Executive Director, Sai Prasad while commenting on the approval for COVAXIN stated that the emergency approval is not in the firm’s hands. The drug controllers of India have all the data and at any point the emergency approval can be given by them, if they want. The first set of doses has been expected for the first responders such as nurses, doctors, certain bureaucrats or military.
Mr. Prasad also informed that the government has indicated that certain critical industries can also directly buy the vaccine, if required. Bharat Biotech is yet to discuss emergency-use authorisation of its experimental COVID-19 vaccine with the Indian government.
Large scale trials to speed up the process:
Mr. Sai Prasad while talking about the scale of trials mentioned that the company needs to do large-scale efficacy trials for the country of this size. Just as most international companies have been looking at the large-scale trials, Bharat Biotech also plans to do that.
He further added that if the company waits for Phase 3 trials to be completed, the final license will be able to come sometime in the second quarter of 2021.
Possibility of COVID-19 vaccine in 2020:
As the work on COVID-19 vaccine candidates picks up globally, some of the companies that are involved in research have indicated that they will be able to launch their vaccine for the Coronavirus, if approved, before the end of 2020 in countries such as US. It has raised hope that the pandemic might be controlled soon. However, India still doesn’t has any form of clarity on when the COVID-19 vaccine candidate will be getting an approval.