US FDA to consider India’s Covaxin as vaccine candidate in America; Lifts clinical hold on Bharat Biotech’s vaccine application

Bharat Biotech’s COVAXIN will be evaluated as a COVID-19 vaccine candidate in the United States. Company said, US Food and Drug Administration (FDA) has lifted its clinical hold on COVAXIN. Ocugen is co-developing COVAXIN for COVID-19 in the US and Canada.

Covaxin is India’s indigenous COVID-19 vaccine by Bharat Biotech and has been developed in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV). It has been developed using Whole-Virion Inactivated Vero Cell-derived platform technology.

As inactivated vaccines do not replicate they are unlikely to revert and cause pathological effects. According to Bharat Biotech, they contain dead virus, incapable of infecting people but still able to instruct the immune system to mount a defensive reaction against an infection.