US FDA Denies Emergency Use Approval to Bharat Biotech's Covaxin

A vaccine that has been administered in India to the tune of 29 million doses has been denied emergency-use approval in the US. Covaxin is the name of a whole-virus inactivated vaccine manufactured by Bharat Biotech, Hyderabad. It received accelerated approval in India on January 3, 2021, after which it became one of the two major vaccines in India’s COVID-19 inoculation drive. However, because India’s drug regulator okayed Covaxin without any data from its phase 3 clinical trial, it was met with considerably vaccine hesitancy that the government itself was forced to acknowledge. Virologist and former INSACOG executive committee chief Shahid Jameel had told The Wire Science in Janaury 3 that Covaxin is in all likelihood safe and meaningfully efficacious, but that the opacity surrounding its approval in India would undermine public confidence. Bharat Biotech had also applied for approvals with the US Food and Drug Administration (FDA) and the WHO.