FDA rejects emergency use authorization for Bharat Biotech’s Covaxin jab
FDA has asked Ocugen, the US partner of Bharat Bio, to launch an additional trial so that it can file for for a full approval
The US Food and Drug Administration (FDA) has rejected Bharat Biotech’s proposal for an emergency use authorization (EUA) of its covid vaccine, delaying the company’s vaccine launch in that country. Ocugen, the US partner of Bharat Biotech, on Thursday said the company will now be seeking a full approval of Covaxin. This is a consequence of the US FDA asking the company to launch an additional trial so that the company can file for a Biologics Licence Application (BLA), which is a full approval.