COVAXIN, India^'s indigenous COVID-19 vaccine by Bharat Biotech is developed in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV). The indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech^'s BSL-3 (Bio-Safety Level 3) high containment facility.

The vaccine received DCGI approval for Phase I & II Human Clinical Trials and the trials commenced across India from July, 2020.

After successful completion of the interim analysis from the Phase 1 & 2 clinical trials of COVAXIN, Bharat Biotech received DCGI approval for Phase 3 clinical trials in 26,000 participants in over 25 centres across India.

Phase-III trials for Bharat Biotech’s COVID-19 vaccine candidate Covaxin are facing a shortage of volunteers with a participant refusal rate of up to 70-80 percent, a senior doctor with the All India Institute of Medical Sciences (AIIMS) in Delhi told ANI on December 16.

Dr Sanjay Rai, Professor of Community Medicine at AIIMS and a principal investigator for the Covaxin trial said has been lost 

as people feel that a vaccine has already been found, the report said. He added that Phase I and II of the trials had zero refusal rate.

Explaining the dwindling interest, Dr Rai said Phase I had 4,500 applicants for 100 volunteer spots, Phase II had 4,000 volunteers for 50 spots, while Phase III which requires 1,500-2,000 participants managed to recruit only 200 participants.

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