 "Bharat Biotech, Covaxin")
After its US partner Ocugen said that it would follow the biologics license application (BLA) route to seek full licensure of Covaxin, Bharat Biotech said on Friday that they would conduct additional clinical trials. This, however, would delay the timelines.
"Our US partner, Ocugen has received a recommendation from the FDA to pursue Biologics License Applications (BLA) path for Covaxin, which is full approval. All applications have to follow the BLA process, which is the standard process for vaccines. Therefore, for BLA, data from an additional clinical trial will be required to support the marketing application submission for Covaxin. This
