Setback to Bharat Biotech: USFDA places clinical hold on Covaxin trials

Malvern: In a major setback to Bharat Biotech its US-based partner Ocugen has announced that the company that the U.S. Food and Drug Administration (FDA) has placed its Phase 2/3 immuno-bridging and broadening study for COVAXIN (BBV152), OCU-002, on clinical hold.

"This is a result of the Company's decision to voluntarily implement a temporary pause in dosing participants of OCU-002 while it evaluates statements made by the World Health Organization following their inspection of Bharat Biotech International Limited's (BBIL) manufacturing facility. We will work with the FDA to address any questions," Ocugen said.

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 is developed using Whole-Virion Inactivated Vero Cell derived platform technology. Inactivated vaccines do not replicate and are therefore unlikely to revert and cause pathological effects. They contain dead virus, incapable of infecting people but still able to instruct the immune system to mount a defensive reaction against an infection.