Bharat Bio to conduct Phase 4 trials of Covaxin

Hyderabad: City-based vaccine manufacturer Bharat Biotech will conduct phase 4 trials of Covaxin to check the real-world effectiveness of the vaccine. The company is currently carrying out its phase 3 trial and it will publish the data in July following which it plans to apply for the full licensure of Covaxin. "Bharat Biotech is also doing phase 4 trials to check on the real-world effectiveness of the vaccines, and to ensure its vaccine met every rigorous scientific standard for safety, effectiveness, and manufacturing quality needed to support emergency use authorization," company sources said.

"It is critical to understand, and further emphasise the Phase-3 data will first be submitted to Central Drugs Standard Control Organisation (CDSCO), followed by peer-reviewed journals, with a timeline of 3 months for publication, and as communicated earlier Covaxin phase 3 results full trial data will be made public during July.

Once data from the final analysis of phase III studies are available, Bharat Biotech will apply for full licensure for Covaxin," the sources said.

On the efficacy of the vaccine, Bharat Biotech said, "Vaccine efficacy refers to the ability of a vaccine to bring about the intended beneficial effects on vaccinated individuals in a defined population under ideal conditions of use. When it comes to efficacy and safety, the efficacy data of Covaxin have been reported at overall efficacy is 78 per cent and efficacy against hospitalizations is 100 per cent."