Home-grown biotechnology company Bharat Biotech will conduct the phase-4 trial of Covaxin to check the effectiveness of the indigenously developed vaccine.
The company will also apply for a full license for Covaxin after getting the final analysis data of phase-3 trials.
According to the company, besides checking the real-world effectiveness of the vaccines, the phase-4 trials will also ensure that “Its vaccine met every rigorous scientific standard for safety, effectiveness, and manufacturing quality needed to support emergency use authorization (EUA).”
“It is important to note, the inoculation which began in mid-January and with several million doses administered, will have credible and sizable data soon,” the company said.
“Once data from afinal analysis of phases-3 studies are available, Bharat Biotech will apply for full licensure for Covaxin,” the company said, adding that “Covaxin has undergone and will continue to undergo the most intensive safety and efficacy monitoring in Indian vaccine history.”