FDA recommended that Ocugen “pursue a Biologics Licence Application (BLA) submission instead of an EUA application” and “requested additional information and data”. Ocugen anticipates that data from additional clinical trials will be needed to support the submission. “We were close to finalising our EUA application when we received (FDA’s) recommendation to pursue a BLA path. While this will extend our timelines, we are committed to bringing Covaxin to the US,” said Ocugen’s Shankar Musunuri. agencies
New Delhi: The US Food and Drug administration has denied approval for emergency use of Bharat Biotech’s Covaxin, and has asked for additional data, biopharmaceutical Ocugen, the US partner of the Indian vaccine maker has said.