FDA rejects emergency use authorisation for Covaxin in a setback for India-made jab

FDA suggests Biologics Licence Application - a "full approval" mechanism by the FDA for drugs and vaccines - route for approval in the United States

Hyderabad: In a setback to Bharat Biotech's COVID-19 vaccine Covaxin, the US Food and Drug Administration has "recommended" Ocugen Inc, the US partner of the Indian vaccine maker, to go for Biologics Licence Application (BLA) route with additional data, nixinghopes of Emergency Use Authorisation. Ocugen in a statement on Thursday announced that as recommended by the FDA, it will pursue submission of a biologics licence application (BLA) for Covaxin. BLA, is a "full approval" mechanism by the FDA for drugs and vaccines. "The company will no longer pursue an Emergency Use Authorization (EUA) for Covaxin. The FDA provided feedback to Ocugen regarding the Master File. The company had previously submitted and recommended that Ocugen pursue a BLA submission instead of an EUA application for its vaccine candidate and requested additional information and data," Ocugen said.