13,000 volunteers given 2nd Covaxin dose in phase-3 trials: Bharat Biotech

Covaxin has received emergency use approval from India's drug regulator on a 'clinical trial mode'

Bharat Biotech has successfully administered second dose of its COVID-19 vaccine Covaxin to 13,000 volunteers as part of its ongoing phase-3 clinical trials of the jab, Suchitra Ella joint managing director of Bharat Biotech said on Friday.

She said in a tweet, "13,000 volunteers have been successfully administered the 2nd dose in the phase-3 clinical trials of Covaxin. My heartfelt thanks to all of them for their pro-vaccine public health voluntarism.

The city-based vaccine maker has successfully completed enrollment of25,800 volunteers for the Phase-3 trials of Covaxin, Ella had earlier said.

The Central Licensing Authority has granted permission for the sale or distribution of Covaxin for restricted use in emergency situations in public interest as an abundant precaution, in clinical trial mode.

The vaccine-maker in the fact sheet on Covaxin, posted in its website, had said the clinical efficacy of the vaccine is yet to be established and is being studied in Phase 3 clinical trial and hence it is important to appreciate that receiving the vaccine does not mean other precautions related to COVID-19 need not be followed.

Covaxin is India's totally indigenous COVID-19 vaccine developed in collaboration with the Indian Council of Medical Research and National Institute of Virology.

The inactivated vaccine is developed and manufactured in Bharat Biotech's BSL-3 (Bio-Safety Level 3) bio-containment facility, one of its kind in the world.