Covaxin approval in U.S. may take longer

USFDA asks Bharat Biotech partner Ocugen to take BLA route, provide more data, instead of seeking EUA

In a development bound to extend timelines for Covaxin to get approval in the U.S., vaccine maker Bharat Biotech’s partner Ocugen Inc has been advised by US Food and Drug Administration to seek a Biologics License Application (BLA) instead of Emergency Use Authorisation, for the vaccine. “Although we were close to finalising our EUA application for submission, we received a recommendation from the FDA to pursue a BLA path. While this will extend our timelines, we are committed to bringing Covaxin to the U.S.,” said Shankar Musunuri, CEO and co-founder of Ocugen. The US firm, which is co-developing Bharat Biotech’s Covaxin vaccine candidate for COVID-19 in the U.S. and Canadian markets, said it will no longer pursue an EUA for Covaxin.