US Delays Use Of India-Made COVID-19 Vaccine Covaxin. What It Recommended

Covaxin Use in US: Bharat Biotech's India-made COVID-19 vaccine Covaxin has been asked to go the Biologics Licence Application (BLA) route with additional data, nixing hopes of Emergency Use Authorisation.

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, nixing hopes of Emergency Use Authorisation. Ocugen in a statement on Thursday announced that as recommended by the US FDA, it will pursue submission of a biologics licence application (BLA) for Covaxin. Biologics Licence Application or BLA, is a "full approval" mechanism by the FDA for drugs and vaccines. "The company will no longer pursue an Emergency Use Authorisation (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.